Assessing feasibility and acceptability of web-based enhanced relapse prevention for bipolar disorder (ERPonline): a randomized controlled trial

Background: Interventions that teach people with Bipolar Disorder (BD) to recognise and respond to early warning signs of relapse are NICE recommended but implementation in clinical practice is poor. Objective: This study tests the feasibility and acceptability of a randomised controlled trial to evaluate an online enhanced relapse prevention intervention (ERPonline), and reports preliminary evidence of effectiveness. Methods: Single blind, parallel primarily online randomised controlled trial (n=96) over 48 weeks comparing ERPonline plus usual treatment to waitlist (WL) control plus usual treatment for people with BD recruited through National Health Services, voluntary organisations, and media. Randomisation was independent, minimised on number of previous episodes (<8,8-20,21+). Primary outcomes were feasibility and acceptability assessed by rates of study recruitment and retention, levels of intervention use, adverse events and participant feedback. Process and clinical outcomes were assessed by telephone and online and compared using linear models with intention-to-treat analysis. Results: Two hundred and eighty people registered interest online, from which ninety-six met inclusion criteria, consented and were randomised (49 to WL, 47 to ERPonline) over seventeen months, with 80% retention in telephone and online follow up, except week 48 online (76%). Acceptability was high for both ERPonline and trial methods. ERPonline cost approximately £19,340 to create, and £2176 per year to host and maintain the site. Qualitative data highlighted the importance of the relationship users have with online interventions and how this is created as an extension of the relationship with the humans perceived as offering and supporting its use. Differences between the group means suggested that access to ERPonline was associated with: a more positive model of bipolar disorder at 24 (10.70 (0.90-20.5 95%CIs)) and 48 weeks (13.1 (2.44-23.93 95%CIs)); increased monitoring of early