Trial tribulations: Lessons learned from an unsuccessful pilot trial of Behavioural Activation in young people with early or emerging psychosis at a regional mental health service.

AimThe experience of conducting an unsuccessful pilot trial of behavioural activation (BA) to improve depressive symptoms in young clients with early or emerging psychosis is reported on. We aimed to identify barriers and enablers to inform the conduct of future trials with this client group.MethodsClinicians completed BA training with the aim of delivering this to suitable clients. Feasibility outcomes were calculated as proportions of feasibility targets. The various stages of the pilot randomised trial were examined, informed by interviews with five young people with early or emerging psychosis and four clinicians. Interviews were content analysed.ResultsClient recruitment and retention targets were not met, with proportions of 10% and 50%, respectively. Barriers included 'clinician self-efficacy in recruitment', 'staff turnover', the 'fragility of young people's engagement with the service', and 'workload incurred from study involvement'. The enablers were 'clients' and clinicians' perceived potential to contribute to new evidence', 'the clinician-client relationship', and 'opportunities to provide feedback to the research team'.ConclusionsRecommendations for future similar studies include pre-trial stakeholder consultation; offering multiple cycles of training; support to grow clinician confidence for recruitment; accounting for increased workload; and ongoing service-research team meetings to identify solutions to emerging issues.