| dc.creator |
Wright, K |
|
| dc.creator |
Dodd, A |
|
| dc.creator |
Warren, FC |
|
| dc.creator |
Medina-Lara, A |
|
| dc.creator |
Taylor, R |
|
| dc.creator |
Jones, S |
|
| dc.creator |
Owens, C |
|
| dc.creator |
Javaid, M |
|
| dc.creator |
Dunn, B |
|
| dc.creator |
Harvey, JE |
|
| dc.creator |
Newbold, A |
|
| dc.creator |
Lynch, T |
|
| dc.date |
2018-11-23T14:17:07Z |
|
| dc.date |
2018-10-16 |
|
| dc.date |
2018-11-23T14:17:07Z |
|
| dc.date.accessioned |
2022-05-27T01:03:07Z |
|
| dc.date.available |
2022-05-27T01:03:07Z |
|
| dc.identifier |
Vol. 19, article 560 |
|
| dc.identifier |
10.1186/s13063-018-2926-7 |
|
| dc.identifier |
http://hdl.handle.net/10871/34888 |
|
| dc.identifier |
Trials |
|
| dc.identifier.uri |
http://localhost:8080/xmlui/handle/CUHPOERS/241928 |
|
| dc.description |
This is the final version. Available on open access from BMC via the DOI in this record |
|
| dc.description |
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. |
|
| dc.description |
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). |
|
| dc.language |
en |
|
| dc.publisher |
BMC |
|
| dc.relation |
https://www.ncbi.nlm.nih.gov/pubmed/30326960 |
|
| dc.rights |
© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
|
| dc.subject |
Bipolar disorder |
|
| dc.subject |
Cyclothymic disorder |
|
| dc.subject |
Dialectical behaviour therapy |
|
| dc.subject |
Psychological therapy |
|
| dc.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 |
|
| dc.type |
Article |
|