Interventions for adults with a history of complex traumatic events: the INCiTE mixed-methods systematic review

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Chapter 1 Background

Chapter 2 Methods of the effectiveness review and meta-analysis

Parts of this chapter are based on Coventry et al. 33 © 2020 Coventry et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Chapter 3 Methods of the qualitative acceptability review

Chapter 4 Results of the effectiveness review

Flow of the studies included

The searches identified 16,552 records, which were downloaded, imported into EndNote bibliographic software and de-duplicated to leave 10,212 unique records. In addition, 42 records were identified from International Pharmaceutical Abstracts. A total of 10,254 titles and/or abstracts were screened.

Approximately 10% of the titles and abstracts were pilot screened to achieve consistency and agreement between researchers. Full-text records were double screened at the following stage, and 328 were excluded for the reasons summarised in Figure 1.

FIGURE 1.

The PRISMA flow diagram indicating the flow of studies through the review process.

Quality of the studies included

Randomised controlled trials

The quality of the RCTs included was assessed using the Cochrane Collaboration’s risk-of-bias tool, as described in Chapter 2, Randomised controlled studies of clinical effectiveness. The grading of each study across six domains can be found in Appendix 8.

Overall, reporting was quite variable, with a large proportion of responses being graded as ‘unclear’. Five of the six domains were largely assessed as being at an unclear or high risk of bias. This indicated that studies reported insufficient detail to make a clear decision about the risk of bias across these domains or, in most cases, that the study designs did not appropriately account for sources of bias. The exception to this was the domain of ‘other bias’, which was graded as a low risk of bias for over 80% of studies.

A small proportion of trials were rated as being at a high risk of selection bias. The majority of studies were unclear in reporting on selection bias (Figure 2). However, less than 20% were considered as at a low risk of bias based on allocation concealment and less than 50% were at a low risk based on random sequence generation.

FIGURE 2.

Proportional distribution of the risk-of-bias grades across the RCTs included per domain of bias.

Over half of the trials were rated as being at high risk of performance bias because the blinding of participants and personnel was inadequate or infeasible. The latter was especially true in the case of most psychological interventions, in which the nature of the allocated intervention could not easily be disguised.

Detection bias was generally considered as low risk or unclear for the majority of trials, with a slightly larger proportion being rated as unclear than low risk. This was indicative of the outcome assessment being blinded effectively or reported unclearly. Approximately 10% of studies were considered as being at high risk of detection bias.

In terms of attrition bias, gradings of low risk, high risk or unclear bias were almost equally prevalent across studies. This suggested that the majority of studies experienced high dropout and did not handle it appropriately or did not report sufficiently on the number of participants and withdrawals.

Selective reporting was assessed via the reporting bias domain, for which a large majority of studies were graded as being unclear, typically owing to a lack of preregistration (see Figure 2). Close to 10% were considered as low risk in this domain of bias, and nearly 20% were considered as high risk.

Finally, there was generally a low risk of bias from other sources across the large majority of studies. The remainder of studies were graded as having an unclear risk of bias from sources not covered within the other domains. Just one study was graded as high risk from other sources of bias. 100

Non-randomised controlled trials

The quality of the nine non-randomised trials included was assessed using the NICE (2012)42 tool as described in Chapter 2, Methods, Non-randomised controlled intervention studies; the grading is presented in Table 1. Overall, methods were reported adequately to make summary judgements on studies. Notable exceptions were the availability of information to grade contamination (domain 2.6; present in only three studies148,152,156) and information regarding the similarity of other interventions across study arms (domain 2.7; clearly reported in four studies148,149,151,156).

TABLE 1 - Risk-of-bias gradings for the non-randomised controlled studies included

Authors (year)	Population bias			Allocation							Outcomes		Analyses			Summary
	1.1: Is the source population or source area well described?	1.2: Is the eligible population or area representative of the source population or area?	1.3: Do the selected participants or areas represent the eligible population or area?	2.1: Allocation to intervention (or comparison). How was selection bias minimised?	2.2: Were interventions (and comparisons) well described and appropriate?	2.4: Were participants or investigators blind to exposure and comparison?	2.6: Was contamination acceptably low?	2.7: Were other interventions similar in both groups?	2.8: Were all participants accounted for at study conclusion?	2.10: Did the intervention or control comparison reflect usual UK practice?	3.1: Were outcome measures reliable?	3.3: Were all important outcomes assessed?	4.1: Were exposure and comparison groups similar at baseline? If not, were these adjusted?	4.2: Was intention-to-treat analysis conducted?	4.4: Were the estimates of effect size given or calculable?	5.1: Are the study results internally valid (i.e. unbiased)?	5.2: Are the findings generalisable to the source population (i.e. externally valid)?
King et al. (2013)148	++	++	+	+	++	–	++	++	++	NA	+	+	++	+	++	+	+
Levi et al. (2016)150	++	++	+	–	++	–	NR	NR	+	NA	+	+	++	+	++	–	+
Morgan and Cummings (1999)152	+	+	+	+		–	++	NR	++	NA	+	–	+	+	+	+	+
Saxe and Johnson (1999)156	+	+	++	+	+	–	++	–	+	NA	+	–	++	–	++	–	+
Pivac et al. (2004)154	+	+	NR	NR	+	–	NR	NR	NR	NA	+	+	+	NR	–	NR	+
Lundqvist et al. (2006)151	+	+	+	–	–	–	NR	–	+	NA	+	–	+	–	+	–	+
Salo et al. (2008)155	++	+	++	–	+	NR	NR	NR	–	++	++	++	–	–	++	+	++
Narimani et al. (2008)153	–	+	++	+	++	NR	NR	NR	–	++	+	+	NR	NR	–	+	–
Kruse et al. (2009)149	++	+	++	+	++	NR	NR	+	–	++	++	+	++	–	++	+	++

Generally, population bias domains were well reported, with minimal or some potential sources of bias.

Allocation bias domains presented the largest subset of quality assessment and were also the most poorly reported. Investigator blinding (domain 2.4) was the highest risk domain, with a high risk of bias across all studies that reported sufficient detail to make a judgement. 148,150–152,154,156

Outcome domains were also well reported, with most studies attaining a ‘+’ grading indicating some potential sources of bias, but not high risk.

Domains regarding analyses were mostly well reported, with baseline similarities between study arms (domain 4.1) and estimates of effect being given or calculable (domain 4.4), mostly showing low or some sources of bias.

Finally, summary grades of the overall risk of bias were mostly indicative of designs attempting to address sources of bias, with some potential risks. External validity showed minimal risk of bias; just one study was graded as high risk. 153 By contrast, internal validity was not considered low risk in any study; three trials were judged to be high risk150,151,156 and one did not report sufficient detail. 154

Meta-analyses of clinical effectiveness

Of the 104 RCTs and non-RCTs included in the systematic review, 79 included effectiveness data that could be meta-analysed. 53–56,58,59,62,64–67,69,71–74,76,78,79,81,82,84–92,94–96,98–101,104–113,115,118,121–123,125–127,131,132,135,137–140,142–147 All of these studies were RCTs. We conducted a series of meta-analyses to investigate the effectiveness of psychological and pharmacological interventions on the primary outcome and, when the data permitted, a number of secondary outcomes. In summary, the comparisons that were meta-analysed were:

• psychological interventions versus control for all populations combined

• psychological interventions versus control in veteran populations

• psychological interventions versus control in war-affected populations

• psychological interventions versus control in childhood sexual abuse populations

• psychological interventions versus control in refugee populations

• psychological interventions versus control in domestic violence populations

• pharmacological interventions versus placebo in veteran and childhood sexual abuse populations.

When the data permitted, the following outcomes were meta-analysed:

• PTSD symptoms

• CPTSD symptoms

  • emotional dysregulation

  • interpersonal problems

  • negative self-concept

• depression symptoms

• anxiety symptoms

• quality of life

• sleep quality.

All populations and trauma exposure combined

Post-traumatic stress disorder total symptoms

A summary of meta-analyses of the effectiveness of psychological interventions across all populations for PTSD symptoms is shown in Appendix 9, Table 34. Overall, when all eligible trials were combined (39 trials, n = 2506)53–55,62,66,69,74,76,78,81,86,88,89,91,92,94–96,98,100,101,106–109,121,126,131,132,140,142–146,157–159 across all populations, psychological interventions were associated with a large and significant post-treatment effect in favour of a reduction in PTSD total symptoms (Figure 3).

FIGURE 3.

Meta-analysis of post-treatment effect size (ES) for PTSD total symptoms, comparing all psychological interventions with control. CETA, common elements treatment approach; CPT, cognitive processing therapy.

Of the six trials (n = 259)71,84,87,113,137–139,160 that compared psychological interventions with an active control, the post-treatment effect size was smaller and in favour of a reduction in total PTSD symptoms, but not significantly (SMD –0.35, 95% CI –0.72 to 0.03; I² = 47.0%). Ten trials (n = 738)78,81,92,95,98,121,132 measured outcomes after < 6 months and showed that psychological interventions were associated with a medium and significant effect in favour of a reduction in PTSD total symptoms (SMD –0.38, 95% CI –0.68 to –0.08; I² = 79.4%).

When treatment effects were meta-analysed by intervention type, we showed that IPT was associated with the largest post-treatment effect on total PTSD symptoms (SMD –1.41, 95% CI –1.97 to –0.85; I² = 0%). This result is based on two small studies (n = 66)98,108 and associated with a high degree of uncertainty, as indicated by the wide CIs for the individual and combined point estimates (see Appendix 10, Figure 27).

There was strong evidence from 21 trials (n = 1283)55,62,66,81,86,92,94–96,100,101,106,107,109,126,140,143,144,158,159 that trauma-focused CBT is effective for reducing PTSD total symptoms (see Appendix 10, Figure 28). Four trials (n = 206)81,87,92,113 that tested trauma-focused CBT measured outcomes at follow-up after < 6 months and were associated with a large and significant treatment effect (SMD –0.64, 95% CI –1.10 to –0.18; I² = 44.9%). However, we did not find evidence of the effectiveness of trauma-focused CBT versus active controls.

Evidence from seven trials (n = 244)53,54,74,76,88,91,157 showed that EMDR was similarly effective at reducing PTSD symptoms post treatment (see Appendix 10, Figure 29). Two trials (n = 71)138,139 compared EMDR with an active control. Post-treatment effects were in favour of a small reduction in PTSD total symptoms, but this result was non-significant (SMD –0.15, 95% CI –0.62 to 0.32; I² = 0%).

Mindfulness (three trials, n = 183)95,121,142 was associated with a small non-significant effect in favour of symptom reduction when compared with control post treatment (see Appendix 10, Figure 30). In two trials95,121 that measured outcomes at follow-up after < 6 months, mindfulness was not effective for PTSD symptoms (SMD –0.08, 95% CI –1.56 to –0.32; I² = 59%).

Non-trauma-focused CBT (three trials, n = 548)62,78,131,132 was associated with small non-significant effects in favour of symptom reduction when compared with control post treatment (see Appendix 10, Figure 31). Treatment effects were also non-significant for non-trauma-focused CBT for PTSD outcomes in two trials78,132 that measured outcomes after < 6 months (SMD –0.02, 95% CI –0.25 to 0.20; I² = 0%).

When interventions from 22 trials (n = 1191)53–55,62,66,74,76,81,86,89,91,92,94,96,100,101,106,107,109,126,144,157,158 were grouped using composite intervention categories, we showed that single-component and trauma-focused interventions based on a single theoretical approach were associated with a large and significant treatment effect in favour of a reduction in PTSD symptoms (see Appendix 10, Figure 32). A large effect was also observed in a meta-analysis of five trials (n = 276)54,78,81,95,98,132 that measured outcomes at follow-up after < 6 months (SMD –0.94, 95% CI –1.56 to –0.32; I² = 77.6%).

Seven trials (n = 440)69,88,140,143–145,159 delivered multicomponent and trauma-focused interventions (DBT, EMDR, trauma-focused CBT and other psychotherapeutic approaches) and were associated with a large and significant effect in favour of a reduction in PTSD symptoms (see Appendix 10, Figure 32).

There was evidence (11 trials, n = 936)62,78,95,98,106,108,121,131,132,142,146 that single-component non-trauma-focused interventions (CBT, mindfulness, counselling, IPT and other psychotherapeutic approaches) were associated with a significant and moderate treatment effect in favour of a reduction in PTSD symptoms post treatment (see Appendix 10, Figure 34). In five trials (n = 462)78,95,98,121,132 that measured outcomes after < 6 months, the treatment effect for single-component non-trauma-focused interventions was small and non-significant (SMD –0.05, 95% CI –0.23 to 0.14; I² = 0%). When compared with an active control (two trials, n = 62),137,160 single-component non-trauma-focused interventions were associated with a non-significant large treatment effect in favour of a reduction in PTSD symptoms (SMD –0.64, 95% CI –1.82 to 0.53; I² = 76.9%).

Figure 4 shows the results of a meta-analysis that compared phase-based psychological interventions with control. Only six studies (n = 190)69,88,98,107,108,140 were coded as phased based for PTSD outcomes. The results show that a variety of trauma- and non-trauma-focused interventions (DBT, EMDR, IPT and trauma-focused CBT) are associated with a large and significant improvement in PTSD symptoms when delivered as part of a phase-based approach with a stabilisation component.

FIGURE 4.

Meta-analysis of post-treatment effect size (ES) for PTSD total symptoms, comparing phase-based psychological interventions with control.

Complex post-traumatic stress disorder symptoms

A summary of meta-analyses of the clinical effectiveness of psychological interventions across all populations for CPTSD symptoms is shown in Appendix 9, Table 35.

Emotional dysregulation

Seven studies (n = 289)69,79,86,98,106,108,142 included data about symptoms of emotional dysregulation that could be meta-analysed across populations and trauma exposure. Figure 5 shows the results of a meta-analysis that compared all psychological interventions with control as regards a reduction in symptoms of emotional dysregulation at the end of treatment. The results favoured the interventions but did not reach statistical significance.

FIGURE 5.

Meta-analysis of post-treatment SMD for emotional dysregulation, comparing all psychological interventions with control.

Of these seven trials, three compared trauma-focused CBT with control. 79,86,106 At the end of treatment, trauma-focused CBT was associated with a small effect in favour of a reduction in symptoms of emotional dysregulation, but this result did not reach statistical significance (see Appendix 10, Figure 35). Two small studies (n = 51)79 that compared trauma-focused CBT with control measured outcomes after < 6 months and were associated with a medium but non-significant treatment effect (SMD –0.42, 95% CI –1.53 to 0.69; I² = 72.3%).

Four studies (n = 163)98,106,108,142 compared single-component and non-trauma-focused interventions with control. At the end of treatment, the meta-analysis showed that single-component and non-trauma interventions were not significantly associated with a reduction in symptoms of emotional dysregulation (see Appendix 10, Figure 36).

The largest treatment effect for emotional dysregulation was associated with three studies (n = 112)69,98,108 that tested interventions that can be characterised as phased based. However, while the large treatment effect favoured a reduction in symptoms of emotional dysregulation, it was statistically non-significant (Figure 6).

FIGURE 6.

Meta-analysis of post-treatment SMD for emotional dysregulation, comparing phase-based psychological interventions with control.

Negative self-concept

Five studies (n = 215)92,100,101,125,142 included data about symptoms of negative self-concept that could be meta-analysed. Figure 7 shows the results of a meta-analysis that compared all psychological interventions with control as regards a reduction in symptoms of negative self-concept at the end of treatment. When combined, psychological interventions were associated with a large treatment effect in favour of a reduction in symptoms of negative self-concept, albeit with a high degree of uncertainty and heterogeneity.

FIGURE 7.

Meta-analysis of post-treatment SMD for negative self-concept, comparing all psychological interventions with control (positive SMD equals improvement in symptoms).

Figure 37 (see Appendix 10) shows that, when only the trauma-focused CBT studies were meta-analysed (three trials, n = 145),92,100,101 the effect size was very large and significant but with high degree of uncertainty about the combined point estimate and high levels of heterogeneity (SMD 2.22, 95% CI 0.75 to 3.70; I² = 90.4%).

A more homogeneous and significantly large treatment effect was associated with the two studies (n = 117)100,101 that were characterised as comparing multicomponent and trauma-focused interventions with control (SMD 2.93, 95% 2.40 to 3.45; I² = 0%; see Appendix 10, Figure 38).

Single-component non-trauma-focused interventions (two studies; n = 70)125,142 were also associated with large and significant effects in favour of improvement in negative self-concept, but the overall point estimate had a high degree of uncertainty (SMD 1.14, 95% CI 0.01 to 2.27; I² = 72.6%; see Appendix 10, Figure 39).

Interpersonal problems

Only two studies (n = 94),69,98 both testing phase-based interventions, were identified that included outcome data for interpersonal problems that could be meta-analysed. The overall treatment effect was large and in favour of a reduction in symptoms associated with interpersonal problems, but did not reach significance (SMD –0.59, 95% CI –1.28 to 0.11; I² = 61.9%; see Appendix 10, Figure 40).

Depression symptoms

A summary of meta-analyses of the clinical effectiveness of psychological interventions across all populations for depression symptoms is shown in Appendix 9, Table 36. Figure 8 shows the results of the meta-analysis of the 31 studies (n = 1866)53–55,62,69,74,76,81,92,95,96,98,100,101,106,108,109,111,121,125,137,140,142,144,157–159 that compared all psychological interventions with control post treatment for depression symptoms. The results show that interventions were associated with a large effect in favour of a reduction in depression symptoms. When all psychological interventions were compared with control at follow-up after < 6 months, there was a medium and still significant effect in favour of a reduction in depression symptoms (SMD –0.51, 95% CI –0.80 to –0.22; I² = 48%; nine trials, n = 410). 54,78,81,87,92,95,98,111,121

FIGURE 8.

Meta-analysis of post-treatment effect size (ES) for depression symptoms, comparing all psychological interventions with control. CETA, common elements treatment approach; CPT, cognitive treatment therapy.

When interventions were meta-analysed by type, studies that tested trauma-focused CBT were the most numerous. Fifteen studies (n = 1115)62,81,92,96,100,101,106,109,126,140,143,144,159 compared trauma-focused CBT with control post treatment. Figure 41 (see Appendix 10) shows that trauma-focused CBT was associated with a large and significant effect in favour of a reduction in depression symptoms. There was also a positive effect in the three studies (n = 104)81,87,92 that compared post-treatment outcomes at follow-up after < 6 months, although the point estimate was associated with considerable uncertainty (SMD –0.72, 95% CI –1.43 to –0.01; I² = 56.6%).

Large and significant treatment effects in favour of a reduction of depression symptoms were also similarly observed in a meta-analysis (five trials, n = 182)53,54,74,76,157 that compared EMDR with control post treatment (see Appendix 10, Figure 42). In the two studies (n = 72)138,139 that compared EMDR with an active control, at the end of treatment the effect on depression symptoms favoured the intervention, but did not reach significance (SMD –0.32, 95% CI –1.23 to 0.59; I² = 47.8%).

There was also some evidence from two small studies (n = 66)98,108 that IPT compared with control was effective at reducing symptoms of depression (see Appendix 10, Figure 43).

Three studies (n = 186),95,121,142 all of which included veteran populations, compared mindfulness with control post treatment. Mindfulness interventions were associated with a medium effect size in favour of a reduction in depression symptoms (see Appendix 10, Figure 44). In the two studies95,121 that measured outcomes at follow-up after < 6 months, mindfulness was also associated with a medium and significant treatment effect (SMD –0.41, 95% CI –0.79 to –0.02; I² = 0%).

Non-trauma-focused interventions78,137 were not effective in reducing depression symptoms (see Appendix 10, Figure 45).

Using composite intervention categories, we showed that single-component and trauma-focused interventions (17 studies; n = 1034)53–55,62,74,76,81,92,96,100,101,106,109,126,144,157,158 based on a single theoretical approach were associated with a large and significant treatment effect in favour of a reduction in depression symptoms (see Appendix 10, Figure 46). A large and significant effect was also observed in the four studies (n = 174)53,81,87,92 that compared outcomes at follow-up after < 6 months (SMD –0.85, 95% –1.42 to –0.29; I² = 62.5%).

Six studies (n = 340)69,140,143,144,159 compared multicomponent and trauma-focused interventions with control and were associated with a similarly large and significant effect in favour of a reduction in depression symptoms (see Appendix 10, Figure 47).

A smaller but still significant and favourable treatment effect was observed in the 10 studies (n = 594)62,78,95,98,106,108,111,121,137,142 that compared single-component and non-trauma-focused interventions with control post treatment (see Appendix 10, Figure 48). There was a small and non-significant effect in the five studies (n = 236)78,95,98,111,121 that measured outcomes at follow-up after < 6 months (SMD –0.30, 95% –0.56 to 0.04; I² = 0%).

Figure 9 shows that, post treatment, compared with control, phase-based interventions were associated with a large and significant treatment effect in favour of a reduction in depression symptoms, although this result is based on just four small studies. 69,98,108,140

FIGURE 9.

Meta-analysis of post-treatment effect size (ES) for depression symptoms, comparing phase-based interventions with control.

Anxiety symptoms

A summary of meta-analyses of the clinical effectiveness of psychological interventions across all populations for anxiety symptoms is shown in Appendix 9, Table 37. Figure 10 shows the result of a meta-analysis of 13 studies (n = 1136)62,69,74,76,81,91,96,126,143,144,157 that compared all psychological interventions with control post treatment. Interventions were associated with a large and significant treatment effect in favour of a reduction in anxiety symptoms.

FIGURE 10.

Meta-analysis of post-treatment effect size (ES) for anxiety symptoms, comparing all psychological interventions with control. CETA, common elements treatment approach; CPT, cognitive treatment therapy.

The majority of the studies (eight studies; n = 7)62,81,96,106,126,143,144 that included data about anxiety symptoms tested trauma-focused CBT. When compared with control post treatment, meta-analysis showed that trauma-focused CBT was associated with a large and significant effect in favour of a reduction in anxiety symptoms (Figure 11).

FIGURE 11.

Meta-analysis of post-treatment effect size (ES) for anxiety symptoms, comparing trauma-focused CBT with control. CETA, common elements treatment approach; CPT, cognitive treatment therapy.

The largest effects in favour of a reduction in anxiety symptoms were observed in a meta-analysis of four studies (n = 102)74,76,91,157 that compared EMDR with control post treatment (see Appendix 10, Figure 49).

There were no data that could be meta-analysed that compared mindfulness or non-trauma-focused CBT with either control or an active control.

Using composite intervention categories, we showed in a meta-analysis that single-component and trauma-focused interventions (10 studies; n = 757)62,74,76,81,91,96,106,126,144,157 were associated with a large and significant treatment effect in favour of a reduction in anxiety symptoms (see Appendix 10, Figure 50).

Compared with control, multicomponent and trauma-focused interventions were associated with the largest treatment effect in favour of a reduction of anxiety symptoms (SMD –0.85, 95% CI –1.60 to –0.10; I² = 80.4%). 69,143,144 This meta-analysis included studies that tested a phase-based intervention and trauma-focused CBT (see Appendix 10, Figure 51).

Only two studies (n = 225)62,106 compared single-component and non-trauma-focused interventions with control post treatment: one tested a counselling intervention and one tested non-trauma-focused CBT. Although the treatment effect favoured a reduction in anxiety symptoms, the effect was small and did not reach significance (see Appendix 10, Figure 52).

Quality of life

A summary of meta-analyses of the clinical effectiveness of psychological interventions across all populations for quality of life is shown in Appendix 9, Table 38. We identified five trials (n = 307)95,96,106,109,143 that included quality-of-life data that could be meta-analysed. Figure 12 shows the result of a meta-analysis that compared all psychological interventions with control post treatment.

FIGURE 12.

Meta-analysis of post-treatment effect size (ES) for quality of life, comparing all psychological interventions with control (positive ES favours intervention).

Four of these five studies (n = 260)96,106,109,143 compared trauma-focused CBT with control post treatment. Although interventions favoured a small improvement in quality of life, the effect size did not reach significance (SMD 0.23, 95% CI –0.33 to 0.79; I² = 73.9%; see Appendix 10, Figure 53).

Sleep quality

A summary of meta-analyses of the clinical effectiveness of psychological interventions across all populations for sleep quality is shown in Appendix 9, Table 39. Only three studies (n = 111)140,142,159 included data about sleep quality that could be meta-analysed. When compared with control post treatment, all psychological interventions were associated with a large and significant effect on sleep quality (SMD –1.00, 95% CI –1.49 to –0.51; I² = 28.8%; see Appendix 10, Figure 54). A larger and significant treatment effect in favour of improved sleep quality was observed in a meta-analysis of just two small studies140,159 that compared trauma-focused CBT with control post treatment (SMD –1.30, 95% CI –1.87 to –0.73; I² = 0%; see Appendix 10, Figure 55).

Psychological interventions versus control

A summary of all of the clinical effectiveness meta-analyses undertaken within each trauma exposure can be found in Appendix 9.

Veterans

A summary of meta-analyses of the clinical effectiveness of psychological interventions in veterans for PTSD, depression and anxiety symptoms is shown in Appendix 9, Table 40. Twenty-three trials were identified that included data about veteran populations. Five trials were not included in the meta-analysis: three compared head-to-head interventions,120,124,128 one compared trauma-focused CBT with exposure alone60 and one did not include extractable data. 83

Post-traumatic stress disorder symptoms

Figure 13 shows the result of a meta-analysis (14 trials, n = 502)74,78,81,88,91,94,95,107,121,126,140,142,157,159 that compared all psychological interventions with control post treatment. The medium treatment effect favours a significant reduction in PTSD symptoms.

FIGURE 13.

Meta-analysis of post-treatment SMD for total PTSD symptoms, comparing all psychological interventions with control in veteran populations.

Four trials (n = 180)78,95,121 measured PTSD outcomes at follow-up after < 6 months and, while psychological interventions were associated with a small treatment effect in favour of interventions, this did not reach significance (SMD –0.20, 95% –0.72 to 0.33; I² = 63.1%).

Six trials (n = 106)81,94,100,107,126,159 compared trauma-focused CBT with control post treatment. Trauma-focused CBT was associated with a large and significant treatment effect in favour of a reduction in PTSD total symptoms (SMD –0.77, 95% CI –1.20 to –0.33; I² = 44.6%; see Appendix 10, Figure 56).

A meta-analysis of four trials (n = 106)74,88,91,157 showed that EMDR was associated with a smaller but still significant treatment effect when compared with control post treatment (see Appendix 10, Figure 57).

Studies that included veterans95,121,142 provided all of the data in the previous meta-analysis that compared mindfulness with control post treatment and at follow-up after < 6 months (see Appendix 10, Figure 58).

No studies that included veterans compared non-trauma-focused CBT with either a control or an active control group.

Figure 59 (see Appendix 10) shows the results of a meta-analysis (seven trials, n = 219)74,81,91,94,107,157 that compared single-component and trauma-focused interventions with control post treatment. This shows that single-component and trauma-focused interventions were associated with a medium and significant effect in favour of a reduction in PTSD symptoms. The size of the effect was about half that observed in the equivalent analysis for all populations and trauma exposures pooled.

The largest effect was observed in a meta-analysis of three small studies (n = 86)88,140,159 that compared multicomponent and trauma-focused interventions with control post treatment (see Appendix 10, Figure 60).

Single-component and non-trauma-focused interventions were not associated with a significant treatment effect in favour of a reduction in PTSD symptoms post treatment in veterans (see Appendix 10, Figure 61). 78,95,121,142

Four trials compared psychological interventions with active control (sleep and nightmare management, placebo and psychoeducation). 71,84,137,160 It was unclear if psychological interventions as a whole (SMD –0.44, 95% CI –0.98 to 0.10; I² = 64%; four trials, n = 188) or trauma-focused CBT (SMD –0.26, 95% CI –0.88 to 0.35; I² = 51.1%; two trials, n = 126) were effective for PTSD symptoms.

Depression

Figure 14 shows the results of a meta-analysis (11 trials; 445)74,78,81,95,111,121,126,137,140,142,157,159 that compared all psychological interventions with control post treatment. The size of the treatment effect is smaller than the effect observed in the equivalent analysis that pooled PTSD outcomes across all populations and trauma exposures. In five studies (n = 201)78,81,95,111,121 that measured outcomes at follow-up after < 6 months, all psychological interventions were associated with a medium effect in favour of a reduction in depression symptoms, but this effect was not significant (SMD –0.38, 95% CI –0.78 to 0.01; I² = 42.3%).

FIGURE 14.

Meta-analysis of post-treatment SMD for total depression symptoms, comparing all psychological interventions with control in veteran populations.

When only those studies that compared trauma-focused CBT with control post treatment were considered, the meta-analysis (three trials, n = 112)81,126,159 showed that interventions were associated with a large and significant treatment effect in favour of a reduction of depression symptoms (see Appendix 10, Figure 62). There was, however, no evidence of a significant difference between trauma-focused CBT and active control (SMD –0.04, 95% CI –0.55 to 0.48; I² = 38.7%; two trials, n = 128). 71,84

Compared with control post treatment, EMDR was similarly associated with large effects in favour of a reduction in depression symptoms, but the overall point estimate was non-significant and associated with considerable uncertainty (see Appendix 10, Figure 63). 74,157

The pooled population meta-analysis that compared mindfulness with control post treatment and after < 6 months included only studies with veterans and is shown in Appendix 10, Figure 64. 95,121,142

No studies that included veteran populations compared non-trauma-focused CBT with control for depression symptoms.

Single-component and trauma-focused interventions were associated with large and significant effects in favour of a reduction in depression symptoms (see Appendix 10, Figure 65). 74,81,126,157

There was less evidence in favour of multicomponent and trauma-focused interventions, which were not significantly associated with a reduction in depression symptoms in a meta-analysis that included only two small trials (see Appendix 10, Figure 66). 140,159

By contrast, a meta-analysis that included five studies (n = 268)78,95,111,121,142 that compared single-component and non-trauma-focused interventions showed that interventions were associated with a medium but significant effect in favour of a reduction in depression symptoms (see Appendix 10, Figure 67). Four of these studies (n = 188)78,95,111,121 measured outcomes after < 6 months, but the effect was not significant (SMD –0.27, 95% CI –0.56 to 0.02; I² = 0%).

Anxiety

There was less evidence for using psychological interventions for managing anxiety symptoms than other symptoms in veteran populations. We identified five studies (n = 153)74,81,91,126,157 that showed, in a meta-analysis, that overall, when pooled together, psychological interventions compared with control were associated with a large and significant effect in favour of a reduction in anxiety symptoms (Figure 15).

FIGURE 15.

Meta-analysis of post-treatment SMD for total anxiety symptoms, comparing all psychological interventions with control in veteran populations.

Only two studies (n = 90)81,126 compared trauma-focused CBT with control post treatment in veterans. Meta-analysis showed that interventions favoured a reduction in anxiety symptoms, but this effect was not significant and was associated with a high degree of uncertainty (see Appendix 10, Figure 68).

By contrast, EMDR compared with control was associated in a meta-analysis (three trials, n = 63)74,91,157 with a large treatment effect in favour of a reduction in anxiety symptoms post treatment (see Appendix 10, Figure 69). The size of this effect was marginally smaller than that observed in the meta-analysis that pooled all populations and that included more studies.

War-affected populations

A summary of meta-analyses of the clinical effectiveness of psychological interventions across war-affected populations for PTSD, depression and anxiety symptoms is shown in Appendix 9, Table 41. Ten studies that included war-affected populations were identified; eight were included in the meta-analyses. Azad Marzabadi and Hashemi Zadeh57 did not report outcomes that were sufficiently similar to other studies (i.e. they only reported on the WHO Quality of Life questionnaire) and Bichescu et al. 61 compared head-to-head interventions; therefore, these were not meta-analysed.

Post-traumatic stress disorder total symptoms

Figure 16 shows the results of a meta-analysis that compared all psychological interventions (eight trials, n = 933)62,86,96,109,143–145 with control post treatment. The results show that psychological interventions were associated with a medium effect size in favour of a reduction in total PTSD symptoms. The size of this effect was comparable to that observed for veteran populations.

FIGURE 16.

Meta-analysis of post-treatment effect size (ES) for total PTSD symptoms, comparing all psychological interventions with control in war-affected populations. CETA, common elements treatment approach; CPT, cognitive treatment therapy.

The majority of the studies (seven trials, n = 743)62,86,96,109,143,144 in war-affected populations compared trauma-focused CBT with control post treatment. Figure 70 (see Appendix 10) shows that trauma-focused interventions were associated with a medium and significant effect in favour of reducing PTSD symptoms in war-affected populations.

A very similar result was found when single-component and trauma-focused interventions were compared in a meta-analysis (five trials, n = 566)62,86,96,109,144 with control post treatment (SMD –0.51, 95% CI –0.80 to –0.23; I² = 55.9%).

Three studies delivered therapies as part of a multicomponent and trauma-focused intervention. 143–145 When meta-analysed, these three studies (n = 253) showed that multicomponent and trauma-focused interventions were associated with a medium effect size in favour of a reduction in PTSD symptoms post treatment, but the overall point estimate was more uncertain than in the other meta-analyses in this population subgroup (see Appendix 10, Figure 71).

Depression symptoms

Six trials (n = 827)62,96,109,143,144 were identified that included data that could be meta-analysed for depression symptoms in the war-affected subgroup. All of these studies compared trauma-focused CBT with control post treatment. When meta-analysed together, Figure 17 shows that trauma-focused CBT is associated with a medium and significant effect size in favour of a reduction in depression symptoms.

FIGURE 17.

Meta-analysis of post-treatment effect size (ES) for total depression symptoms, comparing all trauma-focused CBT interventions with control in war-affected populations. CETA, common elements treatment approach; CPT, cognitive treatment therapy.

When trauma-focused CBT was delivered as part of a single-component intervention and compared with control, the meta-analysis (four trials, n = 536)62,96,109,144 shows that the intervention was associated with a similarly medium and significant effect size in favour of a reduction in depression symptoms (see Appendix 10, Figure 72). However, in the two studies that tested trauma-focused CBT as part of a multicomponent intervention, the meta-analysis (n = 177)143,144 shows that the treatment effect favoured a reduction in depression symptoms but did not reach significance (see Appendix 10, Figure 73).

Anxiety symptoms

Five trials (n = 691)62,96,143,144 were identified that included data that could be meta-analysed for depression symptoms in the war-affected subgroup. All of these studies compared trauma-focused CBT with control post treatment. When meta-analysed together, Figure 18 shows that trauma-focused CBT is associated with a large and significant effect size in favour of a reduction in anxiety symptoms.

FIGURE 18.

Meta-analysis of post-treatment effect size (ES) for total anxiety symptoms, comparing trauma-focused CBT with control in war-affected populations. CETA, common elements treatment approach; CPT, cognitive treatment therapy.

When trauma-focused CBT was delivered as part of a single-component intervention and compared with control, the meta-analysis (three trials, n = 514)62,96,144 shows that the intervention was associated with a large effect size in favour of a reduction in anxiety symptoms, but this effect did not reach significance (see Appendix 10, Figure 74). Similarly, in the two studies143,144 that tested trauma-focused CBT as part of a multicomponent intervention, the meta-analysis (n = 177) shows that the treatment effect favoured a reduction in depression symptoms but did not reach significance and was associated with considerable uncertainty (see Appendix 10, Figure 75).

Childhood sexual abuse

A summary of meta-analyses of the clinical effectiveness of psychological interventions across populations exposed to childhood sexual abuse for PTSD, depression and anxiety symptoms is shown in Appendix 9, Table 42. Thirteen of these studies included data that could be meta-analysed in the childhood sexual abuse subgroup; nine studies (n = 687)66,69,76,92,98,106,131,132,146 were included in the meta-analyses. Those excluded from the meta-analyses were Cloitre et al. ,69 which was a deconstruction trial; Lau and Kristensen,103 which compared analytic with systemic group therapy; Classen et al. ,68 which combined data from trauma-focused CBT and present-centred therapy groups, making it difficult to separate out and interpret the intervention effects; and Owens et al. ,117 which only reported loss of PTSD diagnosis (an outcome not reported in any other study in this population).

Post-traumatic stress disorder total symptoms

Figure 19 shows the results of a meta-analysis (nine trials, n = 687)66,69,76,92,98,106,131,132,146 that compared all psychological interventions with control post treatment. The treatment effect was large and significant and about twice the size of the comparable result in the meta-analysis that assessed the effectiveness of all psychological interventions across all populations. Three studies (n = 323)92,98,132 measured outcomes at follow-up after < 6 months. The meta-analysis of these three studies showed that the treatment effect still favoured a reduction in PTSD symptoms, but it did not reach significance (SMD –0.27, 95% CI –0.71 to 0.17; I² = 53.6%).

FIGURE 19.

Meta-analysis of post-treatment SMD for total PTSD symptoms, comparing all psychological interventions with control in childhood sexual abuse populations.

Three studies (n = 153)66,92,106 compared trauma-focused CBT with control post treatment. The meta-analysis shows that trauma-focused CBT was the most effective intervention in this subgroup. Figure 76 (see Appendix 10) shows that this intervention was associated with a large effect in favour of a reduction in PTSD symptoms, but the wide CIs suggest that this result is particularly uncertain.

By contrast, non-trauma-focused CBT, meta-analysed in two studies (n = 368),131,132 did not favour the intervention when compared with control post treatment (see Appendix 10, Figure 77).

When studies (three trials, n = 119)66,76,92,106 were grouped using the composite categories, we showed that single-component and trauma-focused interventions were associated with a large and significant effect in favour of a reduction in PTSD symptoms (see Appendix 10, Figure 78).

Larger and significant effects in favour of a reduction in PTSD symptoms were observed in the meta-analysis that compared multicomponent and trauma-focused interventions with control post treatment, but the treatment estimate was associated with considerable uncertainty (SMD –1.82, 95% CI –2.83 to –0.81; I² = 81.3%; two trials, n = 122). Single-component and non-trauma-focused interventions (five trials, n = 494)98,106,131,132,146 were shown, in a meta-analysis, to be associated with a medium and significant effect that favoured a reduction in PTSD symptoms (see Appendix 10, Figure 79). This analysis included a phase-based study of IPT that was associated with a large and significant effect. 98 Two of these trials measured outcomes at follow-up after < 6 months and a meta-analysis shows that there was no significant difference between interventions and control (SMD –0.08, 95% CI –0.31 to 0.15; I² = 0%). 98,132

Depression

Figure 20 shows the result of a meta-analysis (six trials, n = 307)69,76,92,98,106 that compared all psychological interventions with control post treatment. Psychological interventions were associated with a large and significant effect in favour of a reduction in depression symptoms.

FIGURE 20.

Meta-analysis of post-treatment SMD for depression symptoms, comparing all psychological interventions with control in childhood sexual abuse populations.

Two of these six trials measured outcomes at follow-up after < 6 months; the treatment effect still favoured interventions and was significant (SMD –0.52, 95% CI –0.99 to –0.04; I² = 0%). 92,98

Figure 80 (see Appendix 10) shows that trauma-focused CBT, when compared with control post treatment, is associated with a large but non-significant effect size in favour of a reduction in depression symptoms. This analysis was based on three small studies (n = 152) and there is considerable uncertainty regarding the overall point estimate.

There was some tentative evidence from a meta-analysis of three studies (n = 118)76,92,106 that single-component and trauma-focused interventions were similarly associated with a large and significant effect size (see Appendix 10, Figure 81).

Single-component and non-trauma-focused interventions were associated with a medium and significant effect in favour of a reduction in depression symptoms in this subgroup (see Appendix 10, Figure 82). This analysis was based on three small studies (n = 118). 76,92,106

Larger and significant effects in favour of a reduction in depression symptoms were observed in the meta-analysis that compared multicomponent and trauma-focused interventions with control post treatment, but the treatment estimate was associated with considerable uncertainty (SMD –1.63, 95% CI –2.40 to –0.85; I² = 69.7%; two trials, n = 122).

Anxiety symptoms

Only two studies (n = 90)76,106 included anxiety outcome data that could be meta-analysed. Figure 83 (see Appendix 10) shows that single-component and trauma-focused interventions (one testing EMDR, one testing trauma-focused CBT) are associated with a large effect in favour of a reduction in anxiety symptoms, but the effect did not reach significance.

Refugee populations

A summary of meta-analyses of the clinical effectiveness of psychological interventions across refugee populations for PTSD, depression and anxiety symptoms is shown in Appendix 9, Table 43. Twelve studies that included refugee populations were identified; however, few meta-analyses were possible. The following trials did not appear in any meta-analyses:

• Neuner et al. 114 compared trauma-focused CBT, supportive counselling and psychoeducation and there was no comparison with a control group.

• Paunovic and Ost119 compared trauma-focused CBT with an exposure-only intervention.

• In Stenmark et al. ,136 trauma-focused CBT data were not extractable.

Post-traumatic stress disorder symptoms

Figure 21 shows the results of a meta-analysis (six trials, n = 188)53–55,89,108,136,158 that compared all psychological interventions with control post treatment. Interventions were associated with a very large and significant effect size in favour of a reduction in PTSD symptoms. Three studies (n = 235)54,87,113 measured outcomes at follow-up after < 6 months and, in the meta-analysis, the treatment effect was large and significant at follow-up (SMD –0.66, 95% CI –1.22 to –0.09; I² = 72.7%).

FIGURE 21.

Meta-analysis of post-treatment SMD for total PTSD symptoms, comparing all psychological interventions with control in refugee populations.

Three small studies (n = 71)55,89,158 compared trauma-focused CBT with control post treatment and were associated in a meta-analysis with a very large and significant treatment effect in favour of a reduction in PTSD symptoms (see Appendix 10, Figure 83). Two larger studies (n = 165)87,113 that compared trauma-focused CBT with control measured outcomes at follow-up after < 6 months. The meta-analysis of these two studies showed that the treatment effect favoured interventions but did not reach significance (SMD –0.40, 95% CI –0.87 to 0.06; I² = 86.3%).

There was some evidence, based on two small trials (n = 99),53,54 that EMDR, when compared with control post treatment, was effective at reducing total PTSD symptoms (see Appendix 10, Figure 85).

A large and significant effect in favour of a reduction in total PTSD symptoms was observed in a meta-analysis (five trials, n = 170)53–55,89,158 that compared single-component and trauma-focused interventions with control post treatment (see Appendix 10, Figure 86). Two studies (n = 133)54,87 measured outcomes at follow-up after < 6 months and, in a meta-analysis, the treatment effect favoured the interventions but did not reach significance (SMD –0.67, 95CI% –1.65 to 0.32; I² = 86.3%).

In addition to the comparisons with control, two studies (n = 71)138,139 compared EMDR with stabilisation only. There was insufficient evidence to conclude that EMDR was more effective post treatment (SMD –0.15, 95% CI –0.62 to 0.32; I² = 0%) and at follow-up after < 6 months (SMD –0.15, 95% CI –0.80 to 0.49; I² = 22.4%).

Depression symptoms

Figure 22 shows the results of a meta-analysis (five trials, n = 148)53–55,108,158 that compared all psychological interventions with control post treatment. There is evidence that psychological interventions are effective in reducing symptoms of depression in refugee populations.

FIGURE 22.

Meta-analysis of post-treatment SMD for depression symptoms, comparing all psychological interventions with control in refugee populations.

There was only modest evidence from a meta-analysis of two small trials (n = 31)55,158 that trauma-focused CBT when compared with control is associated with large and significant treatment effects in favour of a reduction in depression symptoms; the wide CIs suggest this result is uncertain (see Appendix 10, Figure 87). Two other trials (n = 133)54,87 measured outcomes at follow-up after < 6 months and a meta-analysis shows that the treatment effect favoured interventions but did not reach significance (SMD –0.73, 95% CI –1.57 to 0.10; I² = 81.3%).

Evidence to support the use of EMDR for managing depression in this population was also based only on data from two small trials (n = 99). 53,54 When compared with control post treatment, EMDR was associated with a large and significant treatment effect in favour of a reduction in depression symptoms (see Appendix 10, Figure 88).

Taken together, single-component and trauma-focused interventions that included trauma-focused CBT and EMDR were effective at reducing depression in refugee populations. A meta-analysis (four trials, n = 130)53–55,158 showed that, overall, these interventions are associated with a large and significant treatment effect (see Appendix 10, Figure 89).

Two studies also compared EMDR with stabilisation only. 138,139 There was insufficient evidence to conclude that EMDR was more effective post treatment (SMD –0.32, 95% CI –1.23 to 0.59; I² = 47.8%; two trials, n = 72) or at follow-up after < 6 months (SMD –0.01, 95% CI –0.47 to 0.45; I² = 0%; two trials, n = 73).

Anxiety symptoms

Only data from two studies that compared EMDR with stabilisation included data on anxiety symptoms that could be extracted. 138,139 There was no evidence that EMDR was effective in reducing anxiety symptoms in refugee populations post treatment (SMD –0.36, 95% CI –0.82 to 0.11; I² = 0%; two trials, n = 73) or at follow-up after < 6 months (SMD –0.43, 95% CI –1.21 to 0.35; I² = 35.1%; two trials, n = 73).

Domestic violence

A summary of meta-analyses of the clinical effectiveness of psychological interventions across populations exposed to domestic violence for PTSD, depression and anxiety symptoms is shown in Appendix 9, Table 44.

Post-traumatic stress disorder symptoms

Three trials were identified that measured PTSD symptoms in populations affected by domestic violence. Two of the three trials were included in the meta-analyses that compared trauma-focused CBT with control post treatment and interventions were associated with a large and significant treatment effect (SMD –2.92, 95% CI –3.45 to –2.39; I² = 0%; two trials, n = 117). 100,101

The other trial in this subgroup compared forgiveness therapy with an alternative treatment including anger validation, assertiveness and interpersonal skills training and could not be meta-analysed. 125

Depression symptoms

The same two trials that compared trauma-focused CBT with control also reported post-treatment outcomes for depression. A meta-analysis showed that interventions were associated with a large and significant treatment effect, but there is a high degree of uncertainty about the overall point estimate (SMD –3.24, 95% CI –4.40 to –2.09; I² = 66.6%; two trials, n = 117). 125

Pharmacological interventions versus placebo

Nineteen trials were identified that compared pharmacological interventions with placebo. Rezaei Ardani et al. 56 tested rivastigmine augmentation and this study was not included in the meta-analyses because there were no other comparable interventions to combine it with. Two other studies were excluded from the meta-analyses because they compared head-to-head interventions, with no placebo group. 65,67 All the trials (n = 16)58,59,72,73,82,84,85,99,104,110,112,118,122,123,135,147 included in the meta-analyses, except one trial in childhood sexual abuse, were in veteran populations.

Total post-traumatic stress disorder symptoms

A summary of meta-analyses of the clinical effectiveness of pharmacological interventions for PTSD symptoms is shown in Appendix 9, Table 45. A meta-analysis of six trials (n = 338)59,73,82,112,118,147 compared antidepressants with placebo post treatment. The results show that there was a medium treatment effect in favour of antidepressants, but this did not reach significance (see Appendix 10, Figure 90).

Four trials (n = 293)82,112,118,147 were included in a meta-analysis that compared SSRIs with placebo. Figure 91 (see Appendix 10) shows that SSRIs were associated with a large effect in favour of a reduction in total PTSD symptoms, but this did not reach significance.

Data about the effectiveness of antipsychotics were meta-analysed in five trials (n = 365). 58,85,99,110,135 Antipsychotics were associated with a medium and significant treatment effect in favour of a reduction in total PTSD symptoms post treatment (see Appendix 10, Figure 92).

Only two trials that compared anticonvulsants with placebo were meta-analysed and there was little evidence that these classes of drugs were effective at reducing total PTSD symptoms (see Appendix 10, Figure 93). 72,104

Three trials (n = 110) compared prazosin with placebo and a meta-analysis showed that this sympatholytic medication is associated with a medium treatment effect post treatment in favour of reducing total PTSD symptoms (see Appendix 10, Figure 94). 84,122,123

Depression symptoms

A summary of meta-analyses of the clinical effectiveness of pharmacological interventions for depression symptoms is shown in Appendix 9, Table 46. Antidepressant medication was compared with placebo post treatment in a meta-analysis that included three trials (n = 220). 59,73,82 The results were inconclusive, with no evidence that these classes of drugs were effective in reducing depression symptoms in veteran populations (see Appendix 10, Figure 95).

There was some evidence drawn from two trials (n = 266)99,135 that antipsychotic medication compared with placebo post treatment favoured the intervention, but the treatment effect did not reach significance (see Appendix 10, Figure 96).

There was very little evidence that anticonvulsants compared with placebo post treatment were effective in reducing depression symptoms. A meta-analysis of two trials (n = 106)72,104 showed that the treatment effect marginally favoured the placebo group (see Appendix 10, Figure 97).

In a meta-analysis of two trials (n = 76)84,123 that compared prazosin with placebo post treatment, the treatment effect favoured prazosin but did not reach significance.

There were insufficient data to assess the effectiveness of SSRIs. Only one study that compared SSRIs with placebo reported a depression outcome. 82 Among the other studies that tested SSRIs, one study did not report depression outcomes separately and instead presented combined depression and anxiety data using the Hospital Anxiety and Depression Scale total,112 and two other trials did not report any depression outcome data. 118,147

Anxiety symptoms

No meta-analyses were possible for anxiety outcomes.

Psychosis symptoms

A summary of meta-analyses of the clinical effectiveness of pharmacological interventions for psychosis symptoms is shown in Appendix 9, Table 47. All of the trials included in the meta-analyses that compared antipsychotic medication with placebo tested risperidone. Three trials were identified that included post-treatment outcome data related to symptoms of psychosis; all used the Positive and Negative Syndrome Scale (PANSS). 58,85,99

There was no good evidence that antipsychotic medication reduces symptoms of psychosis in veteran and childhood sexual abuse populations.

In a meta-analysis of three trials (n = 329),58,85,99 risperidone was associated with a reduction in positive psychotic symptoms on the PANSS, but the treatment effect did not reach significance and the overall point estimate was very uncertain (see Appendix 10, Figure 98).

In a meta-analysis of one small and one medium-sized trial, the treatment effect did not favour risperidone for either negative or total scores on the PANSS, although the effects were not significant (see Appendix 10, Figures 99 and 100). 85,99 In the same meta-analysis, there was some evidence that risperidone favoured an improvement on the general psychopathology scale of the PANSS, but the effect did not reach significance (see Appendix 10, Figure 101).

Sleep quality

A summary of meta-analyses of the clinical effectiveness of pharmacological interventions for sleep quality is shown in Appendix 8, Figure 26. Prazosin was the only pharmacological intervention with sufficient data to conduct meta-analyses; it was more effective than placebo (mean difference –2.53, 95% CI –3.82 to 1.23; I² = 0%; three trials, n = 109). 84,122,123

Meta-analysis of attrition

Of the RCTs included, 46 studies representing 47 trials in psychological interventions reported attrition data. 53,55,62,64,66,69,71,76,78,79,81,83,84,86–92,94–96,98,100,105–109,111,115,121,125,126,128,131,132,135–140,144,145 Thirteen RCTs reported attrition data for pharmacological interventions. 56,58,72,73,82,84,85,99,104,110,118,127,141 We conducted meta-analyses to investigate the odds of attrition from psychological and pharmacological interventions. Owing to a subset of trials reporting zero attrition, ORs were not calculable for eight trials;88–91,94,111,125,138 therefore, these were excluded from the analyses presented. The comparisons meta-analysed for odds of attrition from psychological interventions were considered two ways:

1. psychological interventions versus control for all populations combined, reported by intervention category

2. all psychological interventions versus control, reported by trauma experience.

All pharmacological interventions included in this analysis were in veteran populations, with the exception of one study in individuals with a history of childhood sexual abuse;127 therefore, veterans-only pharmacological intervention attrition meta-analyses were undertaken (see Veterans).

Intervention categories

Trauma-focused cognitive–behavioural therapy

Twenty-one studies (n = 1557)55,62,66,79,81,83,86,87,92,96,100,105–107,109,126,128,136,140,144 reported attrition figures in trauma-focused CBT across all populations, and indicated participation in a trauma-focused CBT intervention was significantly associated with a reduction in the odds of dropout compared with controls (Figure 23).

FIGURE 23.

Meta-analysis of ORs of attrition for trauma-focused CBT interventions compared with control. CETA, common elements treatment approach; CPT, cognitive treatment therapy.

Four trials stood out owing to ORs that favoured increased attrition from the intervention; these had smaller sample sizes (< 20 participants per arm) and did not have a common trauma population (including veterans,105,107 domestic violence populations100 and refugees55).

Eye movement desensitisation and reprocessing

Few controlled EMDR trials reported attrition data (three trials, n = 179). 53,64,76 All favoured increased odds of attrition in the intervention group, with a non-significant pooled estimate suggesting uncertainty (OR 1.79, 95% CI 0.79 to 4.07; I² = 0.0%). Trials included within this analysis were each from different populations (refugees,53 veterans64 and those with a history of childhood sexual abuse76).

Mindfulness

There were also few mindfulness trials reporting attrition (three trials, n = 141). 57,95,121 The pooled estimate suggested that the odds of attrition of individuals in mindfulness interventions were one-third those of individuals on a waitlist, but this finding did not reach significance (OR 0.29, 95% CI 0.05 to 1.74; n = 141). There was also moderate heterogeneity in the sample with the CI including 1, suggesting mindfulness interventions could also have greater odds of attrition than waitlists.

Non-trauma-focused cognitive–behavioural therapy

There were insufficient data comparing non-trauma-focused CBT with an inactive control to perform analyses.

Trauma populations

Meta-analyses were carried out according to each intervention category within populations in which there were multiple studies present. The results for each of these can be found in Appendix 10. The following sections give the results of attrition from any psychological intervention within each population and highlight notable contrasts due to the sparsity of data in grouped meta-analyses.

Veterans

Twelve trials (n = 616)66,78,81,83,95,105–107,109,121,128,157 were included in this meta-analysis, which compared psychological intervention with a control (see Appendix 10, Figure 102). Veterans receiving any psychological intervention had less than half the odds of attrition as those on a waitlist (OR 0.49, 95% CI 0.26 to 0.92; I² = 41.8%), a statistically significant result. This suggests that it is likely that psychological therapies experience favourable dropout in comparison with waitlists or non-interventions in veteran populations.

Four trials (n = 225) compared psychological interventions with an active control71,84,115,137 and also showed reduced attrition among veterans receiving psychological intervention (OR 0.34, 95% CI 0.17 to 0.68; I² = 0.0%; see Appendix 10, Figure 103).

Pharmacological interventions

A sufficient number of pharmacological trials in veterans reported attrition to analyse the odds of dropout in antidepressant intervention, including three studies of SSRIs82,118,141 (OR 0.56, 95% CI 0.29 to 1.07; I² = 24.9%; four studies, n = 345; see Appendix 10, Figure 104)73,82,118,141 and antipsychotics (OR 0.46, 95% CI 0.14 to 1.56; I² = 56.5%; four studies, n = 414; see Appendix 10, Figure 105). 58,85,99,110 Two studies reported attrition for the use of anticonvulsants72,104 (see Appendix 10, Figure 106).

Although all had an OR that favoured reduced attrition in the intervention group, none was significant.

Childhood sexual abuse

Based on five trials (n = 414),69,92,98,131,140 individuals with experience of childhood sexual abuse and receiving psychological therapy had almost one-quarter the odds of dropout as inactive controls (OR 0.24, 95% CI 0.08 to 0.75; I² = 26.5%; see Appendix 10, Figure 107). Three of the five studies in the analysis were also phased based. 69,98,140

One trial reported attrition data for a pharmacological intervention, comparing antipsychotics with placebo; therefore, an OR was not calculated for these data. 127

Refugee populations

Evidence for attrition in refugee populations was mixed. Five studies (n = 298)53,55,87,108,136 were associated with psychological intervention having greater odds of attrition than controls, a finding that was not significant (OR 1.21, 95% CI 0.69 to 2.12; I² = 0.0%; see Appendix 10, Figure 108). Across trials, odds were not consistent in favouring increased or decreased odds of attrition, resulting in a wide CI for the pooled estimate.

Domestic violence

There were only two studies on psychological interventions for individuals exposed to domestic violence. 62,100 Both investigated individual therapies and they had opposing directions of effect for attrition (see Appendix 10, Figure 109).

War-affected populations

Six trials of psychological interventions gave a pooled OR that suggested reduced attrition for psychological intervention (when compared with inactive controls) in war-related trauma populations (OR 0.66, 95% CI 0.27 to 1.60; I² = 36.7%; n = 695). 57,86,96,144,145 However, the CI includes 1, while an equivalent number of trials favour both reduced and increased odds of attrition. There is large uncertainty as regards the direction of effect, despite low to moderate heterogeneity (see Appendix 10, Figure 110).

Components network meta-analyses

We fitted four models to assess the impact of different combinations of interventions on reducing trauma. Owing to the instability of models when assessing different trauma scales combined, we conducted all analyses on the CAPS (the most frequently reported trauma scale). Figure 24 shows all of the combinations of intervention components extracted from the studies included. The thickness of the lines for each node are weighted by the number of studies (i.e. the thicker the line, the more studies comparing a particular combination of components with an active control or a waitlist).

FIGURE 24.

Network plot for all combinations of components extracted from the studies included.

Model selection

Models 1, 2 and 4 did not fit the data well, reflected by the very high total residual deviance found for each of these models. Model 3 had an acceptable goodness of fit (total residual deviance = 36.33) and the DIC was substantially lower than in other models. Therefore, further analyses were conducted using model 3 (Table 5).

TABLE 5 - Comparing the goodness of fit for different component network meta-analysis models

Model	Posterior mean deviance	DIC	Total residual deviance	τ
Model 1: waitlist, active control, trauma-focused CBT, EMDR, mindfulness, DBT, IPT	25.72	252.99	70.03	0.043
Model 2: waitlist, placebo, support, psychoeducation, relaxation, cognitive restructuring, in vivo exposure, imaginal exposure, virtual reality exposure, mindfulness, phased based	28.60	267.93	70.57	0.042
Model 3: waitlist, placebo, support, psychoeducation, relaxation, cognitive restructuring, in vivo exposure, imaginal exposure, virtual reality exposure, phased based, support + psychoeducation, psychoeducation + relaxation, psychoeducation + cognitive restructuring, psychoeducation + imaginal exposure, relaxation + mindfulness, relaxation + cognitive restructuring, relaxation + imaginal exposure	30.94	235.45	36.33	0.13
Model 4: full interaction model	30.56	264.89	66.09	0.04

Findings from the intervention component network meta-analysis (model 3)

The intervention components with evidence of effectiveness and sufficiently precise credible intervals were mindfulness, cognitive restructuring, phase-based approaches, relaxation + imaginal exposure and relaxation + cognitive restructuring (Table 6).

TABLE 6 - Mean difference for outcomes by intervention component

Intervention component	Mean difference vs. waitlist (95% CI)
Active control	–0.07 (–61.71 to 62.21)
Placebo	–27.6 (–57.76 to 2.60)
Support	16.78 (–13.07 to 47.08)
Psychoeducation	–0.24 (–30.23 to 29.76)
Relaxation	24.32 (–12.12 to 60.56)
Mindfulness	–32.22 (–53.18 to –10.52)
Cognitive restructuring	–39.24 (–54.05 to –23.88)
Virtual reality exposure	–8.6 (–42.08 to 25.84)
Imaginal exposure	–1.18 (–32.16 to 29.76)
Phased based	–26.95 (–41.59 to –11.96)
In vivo exposure	14.45 (–32.74 to 61.39)
Support + psychoeducation	21.3 (–10.29 to 52.64)
Psychoeducation + relaxation	32.09 (–6.64 to 70.77)
Psychoeducation + cognitive restructuring	10.56 (–8.07 to 29.29)
Psychoeducation + imaginal exposure	18.28 (–13.0 to 49.48)
Relaxation + mindfulness	28.03 (–17.44 to 73.86)
Relaxation + cognitive restructuring	–28.29 (–47.56 to –8.79)
Relaxation + imaginal exposure	–45.34 (–70.86 to –19.52)
Mindfulness + cognitive restructuring	28.41 (–16.96 to 74.14)
Cognitive restructuring + in vivo exposure	14.31 (–32.8 to 61.41)
In vivo exposure + imaginal exposure	15.42 (–18.72 to 49.73)

Chapter 5 Results of the qualitative acceptability review

Studies included

In total, 1609 titles and abstracts were screened and 1560 were excluded. In addition, 49 full-text papers were screened and 41 were excluded, with the reasons summarised in Figure 25. We included nine papers, constituting eight unique studies, that were found to use qualitative methods or a mixed-methods approach with a strong qualitative component. Qualitative components included data collection using interviews (unstructured or semistructured) and focus groups, and the data were analysed following a qualitative methodology, with methods such as thematic analysis, ethnography or a phenomenological approach.

FIGURE 25.

The PRISMA diagram of the flow of records through the review process.

Of the studies selected for inclusion in the qualitative review, the majority were from North America (n = 7); two studies were performed in Canada but most of the research was performed in the USA (n = 5). The other studies were performed in Bangladesh (n = 1) and the UK (n = 1).

In terms of the types of trauma that participants were exposed to, four studies involved participants exposed to intimate partner violence,161–164 of which two are linked. 163,164 Two studies involved veterans,165,166 two studies involves participants exposed to childhood sexual abuse167,168 and one study involved asylum seekers. 169

The intervention classifications include group mindfulness-based stress reduction (MBSR; n = 3163–165), motivational interviewing (n = 1162), prolonged exposure (n = 1166), mental health counselling (n = 1161), group healing or group treatments (n = 2167,168) and trauma-focused CBT (n = 2166,169), which, in one case, was a combined treatment with prolonged exposure (n = 1166). Table 13 provides details of all of the studies included.

TABLE 13 - Risk-of-bias assessment of the qualitative studies included using the CASP tool

C, cannot say; N, no; Y, yes.

Linked studies.

Research question	Authors (year)
	Hundt et al. (2017)166	Martinez et al. (2015)165	aBermudez et al. (2013)163	aDutton et al. (2013)164	Hughes and Rasmussen (2010)162	Naved et al. (2009)161	Palmer et al. (2007)167	Parker et al. (2007)168	Vincent et al. (2013)169
1. Was there a clear statement of the aims of the research?	Y	Y	Y	Y	Y	Y	Y	Y	Y
2. Was a qualitative methodology appropriate?	Y	Y	Y	Y	Y	Y	Y	Y	Y
3. Was the research design appropriate to address the aims of the research?	Y	Y	Y	Y	Y	C	Y	Y	Y
4. Was the recruitment strategy appropriate to the aims of the research?	Y	Y	Y	Y	N	N	C	Y	Y
5. Were the data collected in a way that addressed the research issue?	Y	Y	Y	Y	Y	Y	Y	Y	Y
6. Has the relationship between researcher and participants been adequately considered?	C	C	C	Y	Y	Y	Y	Y	C
7. Have ethical issues been taken into consideration?	Y	Y	Y	C	Y	Y	C	Y	Y
8. Was the data analysis sufficiently rigorous?	Y	Y	Y	Y	C	C	Y	Y	C
9. Is there a clear statement of findings?	Y	Y	Y	Y	Y	Y	Y	Y	Y
10. How valuable is the research?	Score 8.5	Score 8.5	Score 8.5	Score 8.5	Score 7.5	Score 7.5	Score 8.0	Score 9.0	Score 8.0

Chapter 6 Patient and public involvement and the research prioritisation exercise

Although the overarching focus and framework of the current review was prespecified by the commissioned brief, we recognise that patient and public involvement (PPI) in systematic reviews is a critical means to ensure that the research process and products are more accessible, relevant and meaningfully used through active involvement of service users (known as ‘experts by experience’) and key stakeholders. 170 However, there is a broad range of conceptual models of service user involvement in systematic reviews, from one-off consultation to ongoing collaboration, and early engagement with potential contributors at a conceptual level is likely to shape the content and style of user involvement. 171

Our strategy was informed by an understanding that knowledge mobilisation is a dynamic and interactive process that is reliant on forming equitable transactional relationships with patients, the public and stakeholders. 172 Our user engagement strategy was informed by an understanding that experts by experience can bring critical insights and perspectives that can add value to contextualising the findings of our review and contribute to enhancing the reach of dissemination activities, especially in relation to setting future research priorities.

Chapter 7 Discussion

Acknowledgements

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Appendix 1 Literature search strategies for the effectiveness review

Literature searches of the following databases were conducted: CINAHL, CENTRAL, EMBASE, International Pharmaceutical Abstracts, MEDLINE, PILOTS, PsycINFO and Science Citation Index.

The original searches carried out in April and May 2017 identified 17,177 records, which were downloaded, imported into EndNote bibliographic software and de-duplicated to leave 10,212 unique records.