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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: Kim Wright, Alyson Dodd, Fiona C Warren, Antonieta Medina-Lara, Rod Taylor, Steven Jones, Christabel Owens, Mahmood Javaid, Barney Dunn, Julie E Harvey, Alexandra Newbold, Tom Lynch

Published in: Trials | Issue 1/2018

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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.

Trial registration

ISRCTN, ISRCTN54234300. Registered on 20 July 2017.
Appendix
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Metadata
Title
The clinical and cost effectiveness of adapted dialectical behaviour therapy (DBT) for bipolar mood instability in primary care (ThrIVe-B programme): a feasibility study
Authors
Kim Wright
Alyson Dodd
Fiona C Warren
Antonieta Medina-Lara
Rod Taylor
Steven Jones
Christabel Owens
Mahmood Javaid
Barney Dunn
Julie E Harvey
Alexandra Newbold
Tom Lynch
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2926-7

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