Integrated psychological therapy for people with bipolar disorder and co-morbid alcohol use:A feasibility and acceptability randomised controlled trial

Background Co-morbid substance misuse, particularly alcohol, is common in bipolar disorder (BD) and associated with worse treatment outcomes. Research into psychological interventions for substance misuse in BD is at an early stage and no studies have specifically targeted problematic alcohol use. This paper describes the context and protocol for a feasibility and acceptability randomised controlled trial (RCT) evaluating a novel intervention combining motivational interviewing and cognitive behavioural therapy (MI-CBT) for participants with BD and problematic alcohol use, developed in collaboration with people with lived experience of both issues. Methods and design: An RCT will assess the feasibility and acceptability of MI-CBT in addition to treatment as usual (TAU) with TAU alone. Participants will be recruited from across the North West of England through NHS services and self-referral. The primary outcomes will be the feasibility and acceptability of the intervention assessed by recruitment to target, adherence to intervention, retention rate at follow-up, absence of adverse events and qualitative analysis of participants' reported experiences of intervention. The effect size of the impact of the intervention on alcohol use and mood outcomes will also be estimated. In addition, we will explore number of potential process variables in therapy. Discussion This is the first RCT evaluating MI-CBT for BD and problematic alcohol use. Given the prevalence and impact of alcohol problems in BD this novel integrated intervention may have potential to offer important improvements in clinical and functional outcomes