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

Wright, K. et al. (2018) The clinical and cost effectiveness of adapted dialectical behaviour therapy (DBT) for bipolar mood instability in primary care (ThrIVe-B programme): a feasibility study. Trials, 19(1), 560. (doi: 10.1186/s13063-018-2926-7) (PMID:30326960) (PMCID:PMC6192204)

Abstract

Background: 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. Methods/design: 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. Discussion: 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.

• Item Type: Articles
• Additional Information: The trial described by this protocol is funded by the National Institute for Health Research (NIHR) Research for Patient Benefit programme in the UK (grant number PB-PG-1215-20023).
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Taylor, Professor Rod
• Authors: Wright, K., Dodd, A., Warren, F. C., Medina-Lara, A., Taylor, R., Jones, S., Owens, C., Javaid, M., Dunn, B., Harvey, J. E., Newbold, A., and Lynch, T.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > MRC/CSO SPHSU
• Journal Name: Trials
• Publisher: BioMed Central
• ISSN: 1745-6215
• ISSN (Online): 1745-6215
• Published Online: 16 October 2018
• Copyright Holders: Copyright © 2018 The Authors
• First Published: First published in Trials 19(1):560
• Publisher Policy: Reproduced under a Creative Commons License