Objectives To test the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate a Smartphone-based self-management tool in Early Intervention in Psychosis (EIP) services.
Design A two-arm unblinded feasibility RCT.
Setting Six NHS EIP services in England.
Participants Adults using EIP services who own an Android Smartphone. Participants were recruited until the recruitment target was met (n=40).
Interventions Participants were randomised with a 1:1 allocation to one of two conditions: (1) treatment as usual from EIP services (TAU) or (2) TAU plus access to My Journey 3 on their own Smartphone. My Journey 3 features a range of self-management components including access to digital recovery and relapse prevention plans, medication tracking and symptom monitoring. My Journey 3 use was at the users’ discretion and was supported by EIP service clinicians. Participants had access for a median of 38.1 weeks.
Primary and secondary outcome measures Feasibility outcomes included recruitment, follow-up rates and intervention engagement. Participant data on mental health outcomes were collected from clinical records and from research assessments at baseline, 4 months and 12 months.
Results 83% and 75% of participants were retained in the trial at the 4-month and 12-month assessments. All treatment group participants had access to My Journey 3 during the trial, but technical difficulties caused delays in ensuring timely access to the intervention. The median number of My Journey 3 uses was 16.5 (IQR 8.5 to 23) and median total minutes spent using My Journey 3 was 26.8 (IQR 18.3 to 57.3). No serious adverse events were reported.
Conclusions Recruitment and retention were feasible. Within a trial context, My Journey 3 could be successfully delivered to adults using EIP services, but with relatively low usage rates. Further evaluation of the intervention in a larger trial may be warranted, but should include attention to implementation.
Trial registration ISRCTN10004994.
- schizophrenia & psychotic disorders
- mental health
- clinical trials
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Contributors SJ is the chief investigator, based at University College London, DO the co-chief investigator and TS the project manager. The trial design was developed by SJ, DO, BL-E and PO. SA, HR, PO and ME have led on the development of the intervention. TS conducted the statistical analysis, with advice from RJ. TS wrote the draft of the paper, which was revised and approved by all authors. All authors approved the final manuscript.
Funding The research is funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care North Thames at Barts Health NHS Trust (NIHR CLAHRC North Thames). SJ, DO and BL-E are supported by the NIHR Mental Health Research Policy Unit, the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames and the UCLH Biomedical Research Centre.
Disclaimer The views expressed in this article are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval National Research Ethics Service Committee London—Brent (Research Ethics Committee reference: 15/LO/1453).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available. The datasets generated during and/or analysed during the current study will be available 2 years after the trial end.