Facilitators and Barriers to Recruitment and Engagement with a Randomised Controlled Trial in Mental Health Services: experiences of trial participants and intervention providers

BackgroundMany randomised control trials struggle to recruit and retain participants. Few previous studies explore participants experiences of recruitment and engagement in trials in secondary mental health care contexts, and few include the perspectives of control group participants. We addressed this knowledge gap in a sub-study of the Community Navigator trial, a multi-site UK trial of a novel, co-produced, social intervention for people with Treatment Resistant Depression (TRD) in secondary care community mental health teams. We used a mixed methods approach to explore barriers and facilitators to trial recruitment and retention, intervention engagement, and how these factors may persist and inter-relate. MethodsSemi structured interviews were conducted with 17 trial participants and with intervention providers: eight Community Navigators and one supervisor, across four UK sites. An online survey was sent to the first 100 trial participants, which could be completed anonymously. Collaborative framework analysis was used by the research team and lived experience advisory panel (LEAP) to analyse interview, focus group and survey data. ResultsFactors helping and hindering trial recruitment and engagement were described in three overarching themes: The Trial Context, Skilled Communication, and The Complexity of Depression and Anxiety. Facilitators included: maximising choice for participants at all stages, a kind and patient approach and striking the correct balance between too much and too little information about the trial. A novel finding was that researchers initiate a "virtuous cycle", where participants initial good experience generates optimism about future involvement in the trial and the experimental treatment. Barriers to recruitment and engagement included referring clinicians providing inaccurate initial information to service users, overwhelming volumes of information, concern about randomisation to the control group, and service users internal barriers regarding their mental health. ConclusionWe generated learning for future trials in mental health contexts. Consideration of how to minimise disappointment following allocation to a control group is important. A kind and patient approach from researchers is essential, and a good early experience of the research process can help trial retention and generate therapeutic optimism about the trial intervention. Trial registrationRegistered on 8 th July 2022: ISRCTN 13205972