The clinical and cost effectiveness of adapted dialectical behaviour therapy (DBT) for bipolar mood instability in primary care (ThrIVe-B programme): a feasibility study
Posted on 2018-10-16 - 05:00
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 15Â months after baseline, with 9Â 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.
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Wright, Kim; Dodd, Alyson; Warren, Fiona; Medina-Lara, Antonieta; Taylor, Rod; Jones, Steven; 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. figshare. Collection. https://doi.org/10.6084/m9.figshare.c.4268855.v1
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AUTHORS (12)
KW
Kim Wright
AD
Alyson Dodd
FW
Fiona Warren
AM
Antonieta Medina-Lara
RT
Rod Taylor
SJ
Steven Jones
CO
Christabel Owens
MJ
Mahmood Javaid
BD
Barney Dunn
JH
Julie Harvey
AN
Alexandra Newbold
TL
Tom Lynch