Development and evaluation of a collaborative care intervention for male prison leavers with mental health problems: the Engager research programme

Article history

The research reported in this issue of the journal was funded by PGfAR as project number RP-PG-1210-12011. The contractual start date was in August 2013. The final report began editorial review in October 2020 and was accepted for publication in March 2022. As the funder, the PGfAR programme agreed the research questions and study designs in advance with the investigators. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PGfAR editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.

Disclaimer

This report contains transcripts of interviews conducted in the course of the research, or similar, and contains language that may offend some readers.

Copyright statement

Copyright © 2022 Byng et al. This work was produced by Byng et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.

2022 Byng et al.

How to navigate the Engager research programme and report

The National Institute for Health and Care Research-funded Engager research programme ran between 2013 and 2020, across two phases. Figure 1 depicts the whole Engager research programme. The Engager research programme was designed to work iteratively between questions relating to intervention development and questions relating to trial science. The Engager research programme included four interlinked workstreams delivered across two phases. Workstream 4, addressing health economics, continued across both phases.

FIGURE 1.

The Engager research programme.

Alterations to the programme

The initial contract was to develop the intervention and to carry out an exploratory trial. A proposal to switch to a definitive trial was agreed at the mid-programme checkpoint report. An extension to collect data at 12 months was agreed once recruitment viability had been established in the main trial. Owing to the decision to have a definitive trial, along with issues of data availability, it was agreed that the initial plan for decision modelling of economic benefits of a full trial would be replaced by carrying out a trial-based cost–consequence analysis.

Realist review

The realist review has been published36 and, in accordance with RAMESES II (Realist And Meta-narrative Evidence Syntheses: Evolving Standards II) reporting standards,31 the realist review aimed to specify how an integrated person-centred system to improve the mental health of offenders with common mental health problems might work. Therefore, the focus was on in-depth theory-building as a key contribution to the development of the intervention. The review is methodologically novel in the way that it operationalises a realist approach [e.g. use of ‘if–then’ statements, structured questions for synthesis of context–mechanism–outcome (CMO) configurations] in parallel with the timelines and methods of a large research project. The following three-stage process was used:

1. We identified sources providing rich descriptions of interventions (and/or their delivery) providing care for offenders with common mental health problems through hand-searching a core set of 16 journals, citation-chasing, elicitation from experts (including men with lived experience of prison and release) and database searches. Searches were extended beyond offender health where insufficient sources were located. Screening of sources, therefore, included those relating to mental health care, and health and social inclusion service delivery in vulnerable groups.

2. We identified explanatory accounts (i.e. ideas about how a problem can best be addressed) (n = 347). ‘Working backwards’ from outcomes (including those from meetings with the Peer Researcher Group of men with lived experience), explanatory accounts were extracted and tabulated, and then expressed as ‘if–then’ statements, specifying (as far as the source allowed) CMO configurations.

3. We consolidated explanatory accounts (n = 75) and produced a conceptual platform (i.e. a core set of processes about how intended effects could be achieved). To enable feedback about expression and scope, consolidated explanatory accounts were shared throughout the process with our expert group of practitioners and academics.

An overview of the conceptual platform developed for the Engager intervention depicts the key agents and their relationships (Figure 2). The three columns in Figure 2 describe different key interactions relating to participating in a mental health improvement intervention both before and after release from prison. The contextualised interactions can be between practitioners and offenders, between the practitioner/offender and other practitioners, or between the offender and family members, peers or mentors. At the centre of the intervention are the core interactions between practitioners and offenders. It is within these interactions that the intervention had the potential to activate mechanisms that affect offenders’ thinking, emotions and behaviours. In between these core interactions, the interactions of both the practitioner and offender with other people (i.e. the central three circles in Figure 2) can further affect changes in thinking, emotions and behaviours, and how these interact with their contexts. These changes influence the subsequent interaction between the practitioner and offender and generate other potentially beneficial effects.

FIGURE 2.

Conceptual platform developed for Engager. Reproduced with permission from Pearson et al. 36 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the figure.

Reproduced with permission from Pearson et al. 36 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the figure.

This realist review contributed substantively to our understanding of how an integrated person-centred system might work. Findings suggested that supporting positive mechanisms for change involved optimising the local support available and minimising the potential for complex relationships with services to destabilise an individual. Box 1 outlines the core set of processes proposed in the conceptual platform.

For pragmatic resource reasons, we did not take on the task of reviewing psychological therapies, having made an early decision to use mentalisation-based approaches (MBAs)37 to support existing competencies because of high co-occurrence of traits, such as emotional reactivity linked to the diagnosis of a personality disorder. The realist review also provided a detailed methodological example of theory-driven intervention development. In particular, the conceptual platform was used to help us understand where we had gaps in our understanding and how the organisational case studies, focus groups and peer researchers could help fill these gaps. For example, the conceptual platform highlighted a gap in our understanding of how families and peer mentors may inform the intervention and, therefore, one of the focus groups was developed to look at the role of families and another organisational case study site involved analysis of the use of peer mentors.

Organisational case studies

The organisational case studies article is published. 38

The organisational case studies aimed to augment our emerging core intervention theory by gaining learning from a range of promising services that provided support and/or treatment for people experiencing common mental health problems within the CJS. The organisational case studies also aimed to identify key elements of practice, for example what was and was not effective in engaging people and maintaining contact with the service. Organisational case studies were particularly useful in eliciting grounded knowledge that was unpublished and, therefore, unavailable for the realist review.

Four cases were selected. Organisational case studies 1 and 2 were undertaken prior to the formative evaluation and organisational case studies 3 and 4 were undertaken after the formative evaluation. Data included documents (e.g. service standard operating procedures), field notes and semistructured interviews. Realist-informed interview schedules (see Report Supplementary Material 1) were constructed using the CMO configurations in our developing theory. All documents were analysed using deductive content analysis. Interview data were interrogated through a qualitative framework approach. 39

Seven main themes were identified: (1) collaboration, (2) client engagement, (3) client motivation, (4) supervision, (5) therapeutic approach, (6) peers and (7) preparations for ending. The case studies highlighted that engaging and motivating clients was dependent on the relationship built with the professional. Consistent, respectful, open and honest communication over time was needed to activate mechanisms that produced a sense of trust and rapport. Professionals were often unable to provide this level of support if they did not work in multiagency collaborations, supported by supervision.

Engager organisational case studies highlighted the clear need for an intervention to have in its toolbox a range of psychological therapies. In addition, the case studies suggested that the addition of a MBA would be beneficial to support the relationship between the practitioner and client, as well as to help deal with mood lability. Supporting individual offenders to mentalise effectively about their situations also aligned with the realist notion of activating generative reasoning mechanisms that enable change in thinking, emotions and behaviours.

The organisational case studies were also critical to our understanding of the importance of a ‘strong’ IDP (i.e. manual, training and supervision) that would support the practitioners in operationalising the Engager theory. The findings focused specifically on the role of supervision in ensuring ongoing support for practitioners as part of a team and on the additional need for external supervisors.

Furthermore, the organisational case studies highlighted the importance of preparatory work in prison to build trust, rapport and engagement. The case studies also prioritised the need to prepare clients for the end of the intervention as a positive step in a longer journey, including providing clients with a summary of their progress.

Finally, the initial prototype and the realist review highlighted the use of peers to support engagement and improve outcomes. The organisational case studies evidenced benefits for peers delivering support, but there was less evidence of benefit for the recipient. The Peer Researcher Group strongly asserted the importance of peer support. However, the research team reluctantly decided, following protracted discussions with the Peer Researcher Group, that this potential component was not logistically deliverable within the resources of this project. Instead, Engager practitioners would encourage and facilitate access to peer/mentoring services.

Focus groups

This work has been published. 40

The published work focuses on the methodological development of the focus groups. The aim of the focus groups was to explore the views of subgroups of the target population whose experiences were not represented by previous published data, the realist review and organisational case studies.

The following four focus groups were convened: (1) homelessness on release from prison, (2) young men who had served prison sentences, (3) people with a ‘loved one’ in prison and (4) men recently released from prison. Each group was recruited through a community-based service that already knew the participants and continued to support them afterwards.

Data were coded and analysed deductively using our theorical framework. This analysis consisted of four columns representing time points (i.e. initial meeting with the participant, actions in prison, actions in the community and preparations for endings) and six rows representing the main functions of the intervention (i.e. shared understanding of individual goals, shared action plan to achieve individual goals, therapeutic approach, family and community capabilities, peer or other volunteer mentor support, and liaison by practitioner and participant with other professionals/teams).

Conversations within the focus group predominantly related to the following areas within our framework.

Community (first meetings)

The men suggested that it can be hard to establish a routine in the first few weeks and this was a key factor in the likelihood of retuning to prison, alongside insecure accommodation and financial issues. This indicated to us that another role the Engager practitioner could have is working with the person to develop a new routine.

The data from the realist review, focus groups, organisational case studies and peer researcher meetings were synthesised into a prototype intervention (i.e. synthesis 1), which was then delivered and evaluated in the pilot trial and formative process evaluation. Figure 3 depicts the overarching structure of the Engager logic model theory. More detail of that synthesis process is detailed in Report Supplementary Material 2. During the synthesis, narratives were produced of the core components (see Report Supplementary Material 3 for details of the theory for shared understanding, a shared action plan, action in prison and action in the community).

FIGURE 3.

Engager logic model. Reproduced with permission from Brand et al. 41 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for non-commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by-nc/4.0/. The figure includes minor additions and formatting changes to the original figure.

Reproduced with prermission from Brand et al. 41 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for non-commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by-nc/4.0/. The figure includes minor additions and formatting changes to the original figure.

The peer researchers contributed to the discussions and challenged the academic researchers throughout the group meetings. The peer researchers required the academic researchers to prioritise the importance of ‘self-care’ and ‘family support’, even when the published data and financial capabilities suggested that these might not be achievable. Consequently, focus groups addressing these issues were held and a decision was made that Engager practitioners should work with participants’ families when appropriate.

Formative process evaluation

The formative process evaluation is published. 41

The formative process evaluation continued the realist approach. Realist approaches addressed the need to build theory prior to outcome evaluation33 and the need for greater attention to be paid to context during delivery and to effective scale-up during later implementation. 42

Face-to-face semistructured realist interviews were digitally audio-recorded and transcribed verbatim. Interviews were conducted with Engager practitioners, Engager supervisors, prison leavers and CJS, health and/or social care professionals. In addition, Engager practitioners used a pro forma to record notes about what practitioners had carried out in each session with, or on behalf of, participants, and any significant issues that had been discussed. Scanned copies of practitioner notes were examined using a structured pro forma to describe which components of the intervention were delivered, where they were delivered and over what time.

The findings presented in the published paper are both methodological and substantive. The paper provides a consolidated version of the core programme theory, with illustrative examples. A full overview of all the core programme theories examined and not included in the published paper are provided in Report Supplementary Material 4.

Key learning from the formative process evaluation led to direct modifications to the intervention and adjustments to IDP resources to support practitioner teams. The direct modifications included the following:

• Emphasising the importance of engagement and building a trusting relationship.

• Activating trust mechanisms (e.g. feeling cared for) as an important mechanism for undertaking meaningful goal-setting.

• A reinforcement of the importance of ‘quick wins’ for activating trust mechanisms (i.e. the practitioner delivering something for them that may seem small but is of significance to the participant and gives a concrete demonstration of help).

• The need for a more protocolised sharing of the written plan with the participant and other services at release to help galvanise resources to support personalised goals.

• Highlighting the difficulties of balancing the competing demands of immediate (often social, but sometimes emotional) crises and working towards longer-term goals.

• Practitioners needing to anticipate barriers and also respond flexibly when crises emerged.

Adjustments to IDP included the following:

• The addition of a ‘content of the manual’ session to the training to ensure consistent practice delivery.

• The need for clearer and more consistent risk assessment processes and support for practitioners in making risk assessments from team supervisors.

• The need to specify the expected content of the supervision process more clearly. The theory of supervision needed to focus on mechanisms that would develop practitioner competencies to deliver the intervention as intended.

• The need for a more robust team structure and management at each site, including re-emphasising the importance of joint decision-making and meeting together regularly to reflect on cases.

• The need to add a section to the manual about practitioners taking care of their own emotional well-being.

Intervention delivery platform: rapid realist review

In recognition of the importance of effective implementation and delivery of complex interventions in challenging contexts, an IDP was developed as a means of supporting practitioners to deliver the intervention as intended. The IDP incorporated training, a manual, supervision and organisational support. Having previously conducted the realist formative process evaluation41 with evidence from the organisational case studies, the research team acknowledged that they lacked adequate, relevant knowledge about intervention implementation. Rather than conducting a second realist review, we decided to use our existing realist review resource to deepen our understanding of relevant implementation issues and supportive strategies.

Studies were identified from the search conducted for the realist review. The flow of sources through the IDP review and information about the 29 included sources are shown in Report Supplementary Material 5. We used the Consolidated Framework for Implementation Research36 as a framework for structuring our identification and synthesis of evidence, and these findings are also shown in Report Supplementary Material 5.

This rapid realist review synthesised knowledge from a wider literature about complex implementation issues. This enabled us to go beyond simple descriptions of ‘practitioners’ experiences’ to provide a sounder, contextually refined foundation on which to base implementation activities. Although the review was not decisive on any one aspect of the implementation strategy, across the board it played a significant role in supporting emerging findings from other parts of the research programme. For example, working iteratively with the formative process evaluation, the review identified the importance of the manual catering for different learning styles and describing the intervention in ways that aligned with existing service design. The review also informed our understanding of how supervision should be delivered in a way that is theoretically consistent with the intervention. Some parts of the review simply played a supportive role, for example by alerting us to areas where there was scant existing research evidence or insufficient detail in the published evidence, and this was particularly the case for organisational agreements. The requirement for these organisational agreements became evident in discussions with practitioners and managers during set-up and delivery, and the agreements were necessary in order to put in place the formal clinical governance requirements that would enable teams to operate under research conditions but within NHS and voluntary sector services.

After the formative evaluation, the IDP was strengthened through acknowledging the need for top-up training and additional supervision for mentalisation. A decision was made to combine the role of Engager team leader and supervisor to create coherence and promote decisions in the local setting, taking into consideration the whole caseload and workload, as well as fidelity to the model for each individual (see Report Supplementary Material 3 for our developing theory of supervision).

The Engager model going into the trial

At this point, the results of the realist formative process evaluation and of the realist review of implementation literature, plus synthesis 1, were brought together in a second round of synthesis (i.e. synthesis 2). This synthesis was to inform the intervention theory (i.e. what practitioners do and why) and the IDP (i.e. training, manual and supervision), which would be then operationalised in the main trial.

Details of synthesis 2 are detailed in Report Supplementary Material 2.

There are several ways of gaining a description of the Engager intervention in addition to what is already presented:

• Box 2 describes the key elements and rationale behind the intervention theory going into the main trial.

• Report Supplementary Material 6 describes the details of the practitioners, training and supervision arrangements in place going into the trial.

• The Engager programme provides a link for requesting a copy of the trial version of the Engager manual (URL: www.plymouth.ac.uk/research/primarycare/criminal-justice/engager; accessed 9 June 2022).

Development of a set of outcomes for a randomised controlled trial to evaluate the effectiveness of the Engager intervention

Our aim was to select a set of outcome measures that captured the most important areas of outcome using measures that were acceptable to the target population and, as far as possible, met scientific validity criteria.

We adopted a four-stage approach, involving:

1. a single-round Delphi survey to identify the most important outcome domains

2. a focused review to identify potentially suitable measures within the three most highly rated outcome domains

3. testing of these measures in the target population to assess acceptability and the psychometric viability of the measures43

4. a consensus panel meeting to select the primary outcome measure for the RCT and key secondary outcome measures.

More detailed description of these stages can be found in Report Supplementary Material 7.

We actively sought the input of our Peer Research Group, with 10 members of the group completing the Delphi survey and four members of the group attending the consensus meeting.

In the single-round Delphi exercise, although the most important areas that people thought we should be capturing outcome data for were mental health symptoms, substance misuse and social inclusion, many of the other outcome domains were rated as important. Although the outcomes of this exercise were clear and, we believed, unlikely to change much in a second round, we recognised that not all outcome domains would be relevant to all participants or amenable to change through an intervention.

To address this, we tested using a measure that captured outcomes across multiple domains and two measures that captured personalised goals. Specifically, we included the Camberwell Assessment of Need – Forensic Version (CAN-FOR),44 which captured outcomes across multiple domains and has been used as a composite measure for offenders with mental health problems. We also included the PSYCHLOPS measure45 and the Goal Attainment Scale (GAS),46 both of which allow the participants to specify personalised goals and, therefore, enabled the capturing of idiographic outcomes that were not specific to one domain.

When we tested potential measures on men in prison who were close to release, we found that we were unable to identify a measure of social inclusion that had the psychometric properties necessary to be included as an outcome measure in the RCT. The use of PSYCHLOPS was problematic in that participants tended to identify problems that were primarily due to their situation of being in prison, and these problems no longer existed once they had been released. Similarly, the GAS was also problematic in that goals were often poorly specified and, therefore, measuring change in a systematic and standardised way at follow-up was difficult. Consequently, PSYCHLOPS and the GAS were not included in our considerations for the primary or secondary outcome measures.

At the consensus meeting, we first discussed measures by domain before focusing on the primary outcome. Of the measures tested within the mental health symptom domain, the Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM)47 was selected as the preferred measure over the General Health Questionnaire-1248 because of its wider range of constructs. The Patient Health Questionnaire-949 and General Anxiety Disorder-750 were not selected as many individuals were subthreshold on one or the other measure. The data we collected using the CAN-FOR also indicated that it would be a psychometrically viable option to be included as an outcome measure. No other composite measures were considered.

Two-thirds of participants reported having a substance misuse problem and, although it was decided that a substance misuse measure should not be the primary outcome, two short measures were included as secondary outcomes, with one capturing information on which substances were being used and the other capturing level of dependence.

After discussion about outcome measure criteria for trials and close reading of the measures, and with peer researchers supported to ask questions, the CORE-OM and CAN-FOR received the same number of votes to be the primary outcome measure. We opted for the CORE-OM as the primary outcome measure, as it had marginally superior psychometric properties and could be administered in a highly scripted fashion that would reduce researcher bias.

The four-stage process we conducted, incorporating the opinions of our Peer Research Group, enabled us to be confident that the outcome measures we selected focused on important areas of outcome and were acceptable to our target population. The outcome measures also demonstrated psychometric properties that indicated that they would be suitable for evaluating the effectiveness of the Engager intervention. However, some questions arise on this latter point. None of the selected instruments was specifically designed for, or validated on, prison populations and, therefore, may not accurately reflect the acutely stressful effects of custodial environments. Moreover, the transition from custody to community may itself have a significant impact on mental health, perhaps ‘swamping’ effects brought about by the intervention. As most of our data testing was undertaken when the participants were still in prison, we did not establish the efficacy of the measures in community settings. Although the above are clearly limitations of this study, it should be added that trials are usually expected to use validated and established instruments, which greatly restricts choice, and that any trial measuring change ‘through the gate’ is likely to be complicated by recovery among both arms simply as a consequence of leaving prison.

Finally, we considered using outcomes based on practitioner records, such as those from the Offender Assessment System (OASys) and other assessments entered by offender managers on nDelius, the Probation Service case management system (URL: https://data.gov.uk/dataset/8dae5fb2-82a2-4232-ae79-87e9c9fcfe46/ndelius; accessed 1 August 2022). However, it quickly became clear that these records were not recorded in a sufficiently consistent way to merit inclusion: they were not undertaken at set time points, were often subjective in terms of focus and they suffered from missing data. Above all, mental health was an issue that received relatively little attention.

Development and piloting procedures for a randomised controlled trial

This work is published. 43

Alongside the work undertaken in selecting a set of outcomes, we piloted RCT procedures to test the feasibility of a larger RCT. A key objective was to demonstrate that we could achieve a retention rate of > 50% when following up participants at 3 months post release from prison. Additional aims of the pilot RCT were to test out trial procedures, such as recruitment, consent and randomisation, to assess the levels of participation with the intervention, to test our ability to maintain research blinding and to model workforce requirements for the research team for a larger trial.

We reviewed the records of 864 individuals and identified 182 records of individuals who met the initial eligibility criteria. Of these individuals, we screened 110 potential participants to identify 60 eligible participants who were randomised at a ratio of 2 : 1 to receive either the Engager intervention plus usual care (i.e. the intervention group) or usual care alone (i.e. the control group). We achieved follow-up rates of 73% at 1 month and 47% at 3 months post release from prison.

No participants withdrew from the trial between consent and up to, and including, the point of randomisation, indicating that the trial procedures relating to recruitment, screening and randomisation were acceptable. However, maintaining researcher blinding was problematic and by the time of the 1-month follow-up the researchers were aware of the allocation of practically every participant. This was usually a consequence of participants sharing their allocation with the researchers who they frequently came across in the closed prison environment.

There were very high levels of data collection and completion across all the measures used at baseline and at follow-up, with few missing data. However, during the pilot trial we were still testing a range of potential outcome measures to use in the full trial and, therefore, not all participants completed the same set of outcome measures. Given the relatively small number of participants that completed each set of outcomes, we were unable to establish whether the intervention was able to bring about change on the measures, and whether or not such a change would be discernible over and above any change in scores that may have been due to whether the participants were in prison or the community. This issue was a key limitation of the pilot trial.

With regard to intervention acceptability, 90% of participants allocated to the intervention group received some of the intervention. Of the four participants who did not receive any intervention, three were either released or transferred to another prison before being seen by a practitioner and one decided the intervention was not for him prior to having contact with the practitioners. Of the 36 participants who did receive the intervention, 28 met with their practitioners in the community following their release from prison. There was strong indication that receiving support on the day of release led to ongoing contact in the community.

Overall, we found the trial procedures and intervention to be feasible to deliver, as well as acceptable to participants. With regard to contamination between the intervention and usual care, we found no evidence of this and, as the Engager practitioners were a stand-alone team, with many not working within the prison prior to the Engager intervention, there was little risk of contamination. The one major exception was in maintaining researcher blinding, which was a problem that was almost universal at both sites. We considered possible solutions to this problem, but it was felt that any solution created potentially more challenging problems. For example, we considered using a different researcher to collect data at follow-up, but felt that this might have a negative impact on follow-up rates, as participants may not be willing to meet a researcher they had not built up trust and rapport with. Ultimately, we opted to accept that unblinding would occur in the trial and to focus attention on reducing biases by training researchers to apply measures consistently, while continuing to allow flexibility for the whole schedule.

The retention rate for the 3-month follow-up was 46%, which was lower than hoped. To address this for the full trial, we broadened the window of time during which follow-ups could be completed. Participants often led chaotic lives and were very difficult to contact for periods of time and so it was felt that giving researchers longer to make contact with and meet participants in the community would increase the follow-up rate. In addition, we also decided to offer ‘thank you’ vouchers to compensate participants for their time when we interviewed them in the community, and we received approval from the Ministry of Justice to do this. Last, many of the participants worked with a range of services on their release from prison, and the introduction of the community rehabilitation companies (around the time of the pilot trial) meant that all people leaving prison were to be provided with support from probation for 12 months following their release. We developed closer working practices with services in the community, including establishing information-sharing agreements, to help researchers contact participants in the community.

The whole of the feasibility study also allowed us to test and develop the intervention and to model researcher workforce requirements and recruitment rates for small or more extensive geographical follow-up areas and different participant eligibility criteria, and this was critical for both assessing viability of and planning for the full trial.

Developing a process of care framework

In addition to developing a set of outcome measures for a RCT to evaluate the Engager intervention, we sought to develop a framework for capturing the care that prisoners received during their participation in the trial from the Engager intervention and standard services. A detailed description of the work we undertook in developing methods to capture the process of care is provided in Report Supplementary Material 8.

Economic modelling

This part of the economic analyses comprised conceptual model development, decision model specification and assessment of the feasibility of conducting estimated value of perfect information analysis (see Report Supplementary Material 10).

Randomised controlled trial

The results of the RCT have been published. 55 To date, there has been a dearth of research developing and evaluating mental health interventions for prison leavers. 27 Trials within prison settings are particularly challenging to undertake because of a range of factors, such as organisational difficulties, maintaining masking, poor follow-up rates and selecting appropriate outcomes measures. 1,17,28–30

Participants

Individuals recruited into the trial needed to be released to defined geographical areas and were required to score ≥ 10 points on the Patient Health Questionnaire-949 to indicate depression, ≥ 10 points on the General Anxiety Disorder-750 to indicate anxiety or score ≥ 3 points on a bespoke questionnaire to indicate likelihood of difficulties on release. Those individuals with psychosis under the care of prison in reach teams or part of the personality disorder service were excluded. All participants were assessed at six time points, that is, at baseline (before randomisation), during the week before release from prison, and then at 1, 3, 6 and 12 months post release from prison.

A total of 3102 prisoners received assessment for eligibility. Of these prisoners, 673 were identified as potentially eligible for the trial and approached for consent. One hundred and eighty-seven of the 673 prisoners declined involvement and a further 90 prisoners were found not to be eligible or were excluded for other reasons, leaving 396 prisoners to be screened for common mental health problems. Of these prisoners, 78% were found to be eligible and, therefore, selected to take part. After a small number of withdrawals, the 280 prisoners who remained were randomised into two groups of 140. Figure 4 depicts the CONSORT (Consolidated Standards of Reporting Trials) diagram.

FIGURE 4.

A CONSORT flow diagram. Reproduced with permission from Byng et al. 55 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original figure.

Reproduced with permission from Byng et al. 55 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original figure.

Results

There were some imbalances between the two groups at baseline. The Engager intervention group had a higher proportion of people with unstable accommodation [n = 76 (54%) vs. n = 58 (41%)], a higher proportion of people who were unemployed [n = 104 (75%) vs. n = 85 (61%)] and a higher proportion of people with physical health problems [n = 64 (45%) vs. n = 48 (34%)]. A higher proportion of people in the usual-care group had experienced relational trauma [n = 89 (64%) vs. n = 74 (53%)]. At 6 months, 184 (66%) participants were followed up, with 45% of participants followed up at 12 months.

There were between-group imbalances in participant characteristics at baseline for type of accommodation (people in the usual-care group had more stable accommodation before prison), employment (people in the usual-care group were more likely to be employed), previous trauma (people in the usual-care group had experienced more relational trauma) and physical health problems (people in the usual-care group had fewer problems). Therefore, these characteristics were included as covariates in all analyses.

Of 140 participants allocated to the intervention, 92% received at least one session in prison [mean 5.7 (SD 3.9)] and 108 (77%) participants received at least one post-release community session [mean 12.9 (SD 11.6)].

There were no significant differences in mean CORE-OM (primary outcome) scores between the groups at 6 months [Engager intervention group mean 12.6 (SD 6.9), n = 92; usual-care group mean 11.9 (SD = 7.7), n = 90; between-group difference 1.1 (95% CI –1.1 to 3.2); p-value 0.325]. Figure 5 depicts the change in CORE-OM score over the four time points.

FIGURE 5.

Graph of CORE-OM score over time. Reproduced with permission from Byng et al. 55 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original figure.

Reproduced with permission from Byng et al. 55 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original figure.

There were a small number of statistically significant differences between the two groups on the secondary outcomes [including CAN-FOR, Intermediate Outcomes Measurement Instrument, EuroQol-5 Dimensions, five-level version (EQ-5D-5L) and ICEpop CAPability measure for Adults (ICECAP-A)] for a variety of sensitivity analyses (i.e. complier-average causal effect and per protocol), but this is most likely due to the effects of multiple testing. At the time of writing, it had still not been possible to obtain Police National Computer data on reoffending.

Health economic analyses

We conducted a trial-based economic evaluation to identify the mean incremental cost per quality-adjusted life-year (QALY) gained with the Engager intervention compared with current practice. Report Supplementary Material 10 describes in detail the health economics modelling, and the results of the health economic analyses are published. 57

The cost of the Engager intervention included the cost of training and supervision based on practitioner-reported activities. As a conservative estimate, the cost per participant of training and supervision was calculated as the total cost of training and supervision for the Engager trial divided by the number of participants in the intervention arm of the trial.

Unit costs for accommodation-, education-, training-, employment-, money-, relationship- and criminal justice-related service use are reported in Hunter et al. 57 table 1. All costs are reported in 2017/18 GBP (i.e. the most recent year costing data were available), with costs for earlier years adjusted to 2017/18 values.

The trial primary outcome CORE-OM was converted to the Clinical Outcomes in Routine Evaluation – 6D (CORE-6D) utility to calculate QALYs. QALYs were calculated as the area under the curve using the CORE-6D responses at baseline and at 1, 3, 6 and 12 months post release. QALYs were also calculated and reported in a similar manner using responses to the EQ-5D-5L at baseline and at 3, 6 and 12 months post release and (1) the mapping algorithm and (2) the EQ-5D-5L value set. Years of full capability (YFCs) (equivalent) were calculated for the Engager intervention compared with usual care using patient-level responses to the ICECAP-A at baseline and at 3, 6 and 12 months post release.

We assumed that data missing at follow-up were missing at random. No predictors of ‘missingness’ were found. Costs, utility scores and the ICECAP-A tariff were imputed for the number of 30 data sets using chained equations [i.e. multiple imputation using chained equations (MICE)] and predictive mean matching.

For the incremental cost-effectiveness ratio, we used regression to account for the correlation between costs and outcomes to calculate the incremental mean cost per QALY or per YFC gained of the Engager intervention compared with usual care. The primary analysis was calculated using the multiple imputation data set and was bootstrapped. The incremental mean cost per QALY and per YFC were used to calculate cost-effectiveness acceptability curves and cost-effectiveness planes. A range of sensitivity analyses and a cost–consequences analysis were also conducted.

The total cost of training and supervision for the duration of the Engager trial was £59,303. If the total cost of the training and supervision is divided by the 140 participants randomised to the intervention, then the training and supervision cost was £424 per participant. The total average cost per participant of delivering all intervention sessions (i.e. prison, meeting at the gate and community) was £467 (SD £475). When the cost of training and supervision is added, then this results in an average cost per participant in the Engager arm of £891.

Descriptive statistics for CORE-6D, EQ-5D-5L (cross-walk and time trade-off tariff) and ICECAP-A tariff are reported. 57 There were no significant differences between trial arms.

The bias-corrected bootstrapped difference in health-care costs, adjusting for baseline, of the Engager intervention compared with usual care is £751 (95% CI –£1593 to £3096). When the cost of the Engager intervention is added (including the cost of training and supervision), the difference in costs is £1795 (95% CI –£575 to £4164). The cost difference for CJS costs including the cost of the intervention is £8166 (95% CI £1692 to £14,640). If productivity gains/losses are included, then the cost difference is £5344 (95% CI –£1228 to £11,916).

For the primary economic evaluation (i.e. a health and social care cost perspective, QALYs calculated from the CORE-6D and using MICE for missing data), the mean cost difference was £2133 (95% of iterations between £997 to £3374) and mean QALY was a difference of –0.017 (95% of iterations between –0.042 to 0.007) and, therefore, the Engager intervention is less effective and more costly than usual care. The cost-effectiveness plane is shown in Figure 6. There is a 0% probability that the intervention is cost-effective at the £20,000–30,000 willingness-to-pay threshold for a QALY gained (i.e. the standard willingness-to-pay threshold for recommending treatments for the NHS).

FIGURE 6.

Cost-effectiveness plane of the Engager intervention compared with usual care from a health and social care cost perspective over 12 months.

The Engager intervention had a very low probability of being cost-effective and this was the case across all secondary and sensitivity analyses. The Engager intervention group cost significantly more from a health service perspective, and had higher CJS costs. On the other hand, the Engager intervention group also showed greater productivity gains, although caution should be taken in interpreting these results, particularly given the number of analyses run. Very few cost-effectiveness analyses are carried out in CJS settings, with self-reported outcomes in this group being particularly hard to collect because of this population’s transient nature. This trial demonstrates the complexity of economic evaluations in this area and represents a significant contribution to the health economic evidence base for this population group.

Fidelity analysis

More detail on the fidelity analysis can be found in Report Supplementary Material 12.

The fidelity analysis aimed to quantify the extent to which the intervention was delivered as hypothesised. The primary objectives were to examine (1) adherence to delivery of the components of the intervention, as specified in the logic model, and (2) delivery of the team model throughout the trial. Data were extracted from practitioner logs and records for 129 of the 140 intervention participants. We were able to identify participants who had received the minimum dose of the intervention thought necessary for impact (i.e. two prison sessions and eight community sessions) and the extent of delivery for other participants.

Less than half (n = 62, 48%) of the participants received the minimum dose and just over one-third (n = 48, 36%) of the participants received any release day contact. Variations in intervention delivery were observed across sites. Information on the content of sessions was available for 45% (n = 332) of prison sessions and 47% (n = 701) of community sessions. Based on the content of records, just over two-thirds (67%) of the sessions were assessed as practically focused (e.g. focused on housing issues), 23% contained both practical and therapeutic content and just 10% were predominantly of a therapeutic nature (e.g. focus on thoughts, feelings and behaviours).

Overall, the fidelity analysis based on records highlighted that intervention delivery was not as therapeutically focused as was intended. Staff turnover, long-term sickness and the prison context (e.g. regime and lockdowns) presented barriers to the planned team model delivery of the intervention.

Thematic analysis of barriers and facilitators

This thematic analysis aimed to explore the individual- and organisational-level barriers to and facilitators of intervention delivery and implementation. A full description of the methods and results can be found in Report Supplementary Material 13 and 14.

Five key cross-cutting themes were identified.

Extent of delivery and impact of key intervention components

This component of the process evaluation provided more granularity as to the extent to which intervention components were delivered and whether or not these had an impact. The development of the practitioner and participant perspective checklists are reported in Report Supplementary Material 11. The two ‘if–then’ checklists were based on the realist-informed programme theory and were used to record ‘if’ individual components of the intervention had been delivered and, as a result of that delivery, whether or not the hypothesised outcome had ‘then’ been achieved.

Data from the practitioner perspective were available for 121 out of 140 intervention participants; however, because of late introduction of this measure, low follow-up rates at 12 months and participant burden, data from the participant perspective are reported for only 35 participants. The key findings were as follows.

Realist-informed case studies

Twenty-four longitudinal realist-informed in-depth case studies were conducted to examine how participants engaged and responded to intervention offers. Two papers reporting this part of the process evaluation have been published. 58,59 Report Supplementary Material 15 presents more details of the ‘if–then’ checklist and Report Supplementary Material 16 details the purposive sampling strategy that was used to select case study participants and provides an overview of the data collection strategy and interview schedules.

Synthesis 3

The five analyses from the parallel process evaluation were brought together, assessed and discussed by team members. Details of this informal synthesis and analysis can be found in Report Supplementary Material 17. The results were used to further develop the Engager intervention theory. The three main refinements identified were:

1. increased support for practitioners to understand fluctuating emotional states

2. making mentalisation more central

3. developing epistemic trust between the participant and the practitioners as a key mechanism to improve the effectiveness of the therapeutic work.

Overview of results and interpretation

The Engager research programme has run over 7 years and has incorporated several substudies within the two phases and across the four workstreams. The results of the RCT inevitably dominate the findings. The primary outcome showed no difference between arms at 3, 6 or 12 months. The secondary outcomes measured in the trial showed a pattern of null effect. The small number of statistically significant changes were most likely due to multiple testing. There was no evidence for the Engager intervention being cost-effective.

Despite the development of a substantive IDP, implementation of the Engager intervention was suboptimal. Reasons for this included some individuals becoming disengaged from the intervention and delivery of intervention being affected by illness among practitioners, staff changes, conflicts within team cultures and temporary gaps in the practitioners’ capacity to deliver the intervention. Challenges in delivering in the prison setting (e.g. lockdowns, violence and staff cuts) and the well-evidenced underperformance of community rehabilitation companies are also likely to have had an impact on outcomes achieved by the Engager intervention.

The in-depth case studies broadly supported these findings, with suboptimal fidelity to the model and most intervention participants not achieving positive outcomes. However, when Engager was delivered optimally, a significant minority of participants engaged well with the intervention and made important steps towards rehabilitation. However, the positive outcomes achieved by individuals did not correlate with the standard measures when the case study outcomes and trial outcomes were compared after both analyses had been completed. These individual-level case studies also provided evidence that, although most components of the intervention were helpful for at least some individuals, there were also weaknesses in the intervention theory in that it had not proposed specific practitioner activities in relation to individuals who were overoptimistic or resigned in hopelessness.

Overall, we found evidence for three contributors to the neutral results, that is, suboptimal implementation, weak delivery in certain areas of the intervention and the inability of standard trial outcome measures to detect small unpredictable steps in recovery resultant from the intervention for individuals with lifelong experiences of adversity.

Reflections on achievements and challenges

Although we succeeded in many areas, such as recruitment, retention and our iterative intervention development, we are particularly proud of the work the academic researchers produced in partnership with the peer researchers. 60

Implications

Conclusions

The Engager research programme allowed for substantial theoretical development and trial science work, building up to a fully powered trial, cost-effectiveness evaluation and an exemplar in-depth multimethod process evaluation in an area of health care that has very limited previous research and development. The Engager research programme saw the realist-informed development of a comprehensive evidence-based complex intervention for prison leavers with mental health problems, which was underpinned by a person-centred approach and supported by a flexible team-based delivery.

Although the Engager intervention, as delivered, was shown not to be effective using standard mental health trial outcome measures, conclusions are not straightforward. The weakness in measurement of improvement for personal goals is a weakness of current methodology for complex intervention evaluation. Our in-depth process evaluation showed that, although implementation problems may also have contributed to the neutral result, when delivered well, there was activation of mechanisms that produced short-term outcomes, such as engagement and emotional competencies, which we had hypothesised. The delivery of MBA and the ‘shared understanding’ were both particularly challenging to achieve, but were also both shown to be potentially critical for the generation of such outcomes. Other promising elements included the through-the-gate function and team-based supervision. Overall, although investing in new stand-alone Engager teams is not justified by the results, we conclude that it is worth testing whether or not core aspects of the intervention could be delivered by existing substance misuse, probation and homeless services, if supported by supervisors with skills in psychological therapy.

Contributions of authors

Richard Byng (https://orcid.org/0000-0001-7411-9467) (Professor in Primary Care Research) was responsible for programme design and management, intervention development and formative evaluation, trial science development, the RCT, process evaluation and report writing.

Charlotte Lennox (https://orcid.org/0000-0001-9014-9965) (Research Fellow and Lecturer) was responsible for programme design and management, intervention development and formative evaluation, trial science development, the RCT, process evaluation, report writing and health economics.

Tim Kirkpatrick (https://orcid.org/0000-0002-1693-0742) (Research Fellow, Complex Intervention Trial Development) was responsible for programme design and management, intervention development and formative evaluation, trial science development, the RCT, process evaluation, report writing and health economics.

Cath Quinn (https://orcid.org/0000-0003-4644-4603) (Senior Research Fellow, Complex Intervention Trial Development) was responsible for programme design and management, intervention development and formative evaluation, trial science development, process evaluation and report writing.

Rob Anderson (https://orcid.org/0000-0002-3523-8559) (Professor of Health Services and Implementation Research) was responsible for programme design and management, intervention development and formative evaluation, the RCT, report writing and health economics.

Sarah Louise Brand (https://orcid.org/0000-0001-5979-2442) (Research Fellow) was responsible for intervention development and formative evaluation, and report writing.

Lynne Callaghan (https://orcid.org/0000-0002-0766-645X) (Senior Research Fellow) was responsible for intervention development and formative evaluation, trial science development and report writing.

Lauren Carroll (https://orcid.org/0000-0003-1203-0672) (Research Assistant) was responsible for trial science development, the RCT and report writing.

Graham Durcan (https://orcid.org/0000-0001-7947-0651) (Associate Director, Centre for Mental Health) was responsible for intervention development and formative evaluation, process evaluation and report writing.

Laura Gill (https://orcid.org/0000-0001-6224-5693) (Research Group Co-ordinator) was responsible for programme design and management, intervention development and formative evaluation, trial science development and report writing.

Sara Goodier (https://orcid.org/0000-0003-1843-3915) (Research Assistant) was responsible for the RCT and report writing.

Jonathan Graham (https://orcid.org/0000-0002-3845-3289) (Research Assistant) was responsible for process evaluation and report writing.

Rebecca Greer (https://orcid.org/0000-0001-5552-2429) (Research Assistant) was responsible for the RCT and report writing.

Mark Haddad (https://orcid.org/0000-0002-4822-5482) (Senior Lecturer in Health Service Research) was responsible for trial science development, the RCT and report writing.

Tirril Harris (https://orcid.org/0000-0003-1769-665X) (Honorary Research Fellow, Psychology and Social Science) was responsible for intervention development and formative evaluation, trial science development, report writing and health economics.

William Henley (https://orcid.org/0000-0001-6273-2619) (Professor of Medical Statistics) was responsible for trial science development, process evaluation and health economics.

Rachael Hunter (https://orcid.org/0000-0002-7447-8934) (Associate Professor, Health Economics) was responsible for the RCT, report writing and health economics.

Mike Maguire (https://orcid.org/0000-0002-8379-6475) (Emeritus Professor of Criminology and Criminal Justice) was responsible for programme design and management, intervention development and formative evaluation, trial science development, the RCT, process evaluation, report writing and health economics.

Sarah Leonard (https://orcid.org/0000-0002-1729-0556) (Research Associate) was responsible for process evaluation and report writing.

Susan Michie (https://orcid.org/0000-0003-0063-6378) (Professor of Health Psychology) was responsible for intervention development and formative evaluation, process evaluation and report writing.

Christabel Owens (https://orcid.org/0000-0001-9846-0889) (Associate Professor of Public Mental Health) was responsible for intervention development and formative evaluation, process evaluation and report writing.

Mark Pearson (https://orcid.org/0000-0001-7628-7421) (Senior Lecturer in Implementation Science and Knowledge Mobilisation) was responsible for intervention development and formative evaluation, and report writing.

Sarah Rybczynska-Bunt (https://orcid.org/0000-0002-4284-1081) (Research Fellow) was responsible for process evaluation and report writing.

Caroline Stevenson (https://orcid.org/0000-0002-1176-5231) (Research Assistant) was responsible for trial science development, the RCT and report writing.

Amy Stewart (https://orcid.org/0000-0002-5324-2025) (Research Assistant) was responsible for trial science development, the RCT and report writing.

Alex Stirzaker (https://orcid.org/0000-0001-6755-7848) (Clinical Lead, IAPT Severe and Enduring Mental Illness) was responsible for intervention development and formative evaluation, the RCT, process evaluation and report writing.

Rod Taylor (https://orcid.org/0000-0002-3043-6011) (Professor of Health Services Research) was responsible for programme design and management, trial science development, process evaluation, report writing and health economics.

Roxanne Todd (https://orcid.org/0000-0001-5651-6549) (Research Assistant) was responsible for trial science development, the RCT and report writing.

Florian Walter (https://orcid.org/0000-0002-1877-2792) (Research Associate) was responsible for the RCT and report writing.

Fiona C Warren (https://orcid.org/0000-0002-3833-0182) (Senior Lecturer in Medical Statistics) was responsible for the RCT and report writing.

Lauren Weston (https://orcid.org/0000-0001-8735-2292) (Research Assistant) was responsible for intervention development and formative evaluation, trial science development, the RCT, process evaluation and report writing.

Nat Wright (https://orcid.org/0000-0003-3547-3724) (Clinical Research Director, Spectrum Community Health CIC) was responsible for trial science development, the RCT and report writing.

Jenny Shaw (https://orcid.org/0000-0003-2569-7687) (Professor of Forensic Psychiatry) was responsible for programme design and management, intervention development and formative evaluation, trial science development, the RCT, process evaluation, report writing and health economics.

Publications

Pearson M, Brand SL, Quinn C, Shaw J, Maguire M, Michie S, et al. Using realist review to inform intervention development: methodological illustration and conceptual platform for collaborative care in offender mental health. Implement Sci 2015;10:134. https://doi.org/10.1186/s13012-015-0321-2

Kirkpatrick T, Lennox C, Taylor R, Anderson R, Maguire M, Haddad M, et al. Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial. BMJ Open 2018;8:e017931. https://doi.org/10.1136/bmjopen-2017-017931

Lennox C, Kirkpatrick T, Taylor RS, Todd R, Greenwood C, Haddad M, et al. Pilot randomised controlled trial of the ENGAGER collaborative care intervention for prisoners with common mental health problems, near to and after release. Pilot Feasibility Stud 2018;4:15. https://doi.org/10.1186/s40814-017-0163-6

Owens C, Carter M, Shenton D, Byng R, Quinn C. Engaging without exposing: use of a fictional character to facilitate mental health talk in focus groups with men who have been subject to the criminal justice system. Qual Health Res 2018;28:2102–14. https://doi.org/10.1177/1049732318785359

Taylor C, Gill L, Gibson A, Byng R, Quinn C. Engaging ‘seldom heard’ groups in research and intervention development: offender mental health. Health Expect 2018;21:1104–10. https://doi.org/10.1111/hex.12807

Brand SL, Quinn C, Pearson M, Lennox C, Owens C, Kirkpatrick T, et al. Building programme theory to develop more adaptable and scalable complex interventions: realist formative process evaluation prior to full trial. Evaluation 2019;25:149–70. https://doi.org/10.1177/1356389018802134

Lennox C, Stevenson R, Owens C, Byng R, Brand SL, Maguire M, et al. Using multiple case studies of health and justice services to inform the development of a new complex intervention for prison-leavers with common mental health problems (Engager). Health Justice 2021;9:6. https://doi.org/10.1186/s40352-021-00131-z

Rybczynska-Bunt S, Weston L, Byng R, Stirzaker A, Lennox C, Pearson M, et al. Clarifying realist analytic and interdisciplinary consensus processes in a complex health intervention: a worked example of judgemental rationality in action. Evaluation 2021;27. https://doi.org/10.1177/13563890211037699

Hunter RM, Anderson R, Kirkpatrick T, Lennox C, Warren F, Taylor R, et al. Economic evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: a cost-utility and cost-consequences analysis. Eur J Health Econ 2022;22:193–210. https://doi.org/10.1007/s10198-021-01360-7

Byng R, Kirkpatrick T, Lennox C, Warren FC, Anderson R, Brand SL, et al. Evaluation of a complex intervention for prisoners with common mental health problems, near to and after release: The Engager randomised controlled trial [published online ahead of print August 18 2022]. Br J Psych 2022.

Weston L, Rybczynska-Bunt S, Quinn C, Lennox C, Maguire M, Pearson M, et al. Interrogating intervention delivery and participants’ emotional states to improve engagement and implementation: a realist informed multiple case study evaluation of Engager. PLOS ONE 2022;17:e0270691.

Data-sharing statement

All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.

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Disclaimers

This report presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, CCF, PGfAR or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the PGfAR programme or the Department of Health and Social Care.