The clinical and cost effectiveness of adapted dialectical behaviour therapy (DBT) for bipolar mood instability in primary care (ThrIVe-B programme): a feasibility study

• Published in: Current controlled trials in cardiovascular medicine 2018-10, Vol.19 (1), p.560-560, Article 560
• Main Authors: Wright, Kim, Dodd, Alyson, Warren, Fiona C, Medina-Lara, Antonieta, Taylor, Rod, Jones, Steven, Owens, Christabel, Javaid, Mahmood, Dunn, Barney, Harvey, Julie E, Newbold, Alexandra, Lynch, Tom
• Format: Article
• Language: English
• Subjects: Affect; Behavior modification; Bipolar disorder; Bipolar Disorder - diagnosis; Bipolar Disorder - economics; Bipolar Disorder - psychology; Bipolar Disorder - therapy; Clinical Trials, Phase II as Topic; Cost-Benefit Analysis; Cyclothymic disorder; Dialectical Behavior Therapy - economics; Dialectical Behavior Therapy - methods; Dialectical behaviour therapy; Feasibility Studies; Health Care Costs; Health services; Humans; Intervention; Mental depression; Mental disorders; Mental health care; Multicenter Studies as Topic; Primary care; Primary Health Care - economics; Primary Health Care - methods; Psychological therapy; Randomized Controlled Trials as Topic; Study Protocol; Time Factors; Treatment Outcome; United Kingdom
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-018-2926-7

In bipolar spectrum disorder, some individuals experience ongoing, frequent fluctuations in mood outside of affective episodes. There are currently no evidence-based psychological interventions designed to address this. This feasibility study is a phase II evaluation of a dialectical behavioural therapy-informed approach (Therapy for Inter-episode mood Variability in Bipolar [ThrIVe-B]). It seeks to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost effectiveness of the ThrIVe-B programme. Patients will be randomised 1:1 to either treatment as usual only (control arm) or the ThrIVe-B intervention plus treatment as usual (intervention arm). Follow-up points will be at 3, 6, 9 and 15 months after baseline, with 9 months as the primary end point for the candidate primary outcome measures. We aim to recruit 48 individuals meeting diagnostic criteria for a bipolar spectrum disorder and reporting frequent mood swings outside of acute episodes, through primary and secondary care services and self-referral. To evaluate feasibility and acceptability, we will examine recruitment and retention rates, completion rates for study measures and feedback from participants on their experience of study participation and therapy. Proceeding to a definitive trial will be indicated if the following criteria are met: (1) trial participation does not lead to serious negative consequences for our participants; (2) any serious concerns about the acceptability and feasibility of the trial procedures can be rectified prior to a definitive trial; (3) follow-up data at 9 months are available for at least 60% of participants; (4) at least 60% of patients in the ThrIVe-B arm complete treatment. ISRCTN, ISRCTN54234300 . Registered on 20 July 2017.