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

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

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.

Bipolar disorder, Cyclothymic disorder, Dialectical behaviour therapy, Psychological therapy
1745-6215
Wright, Kim
d94dfa78-5c60-47e9-8b45-88afc44e1ddf
Dodd, Alyson
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Warren, Fiona C.
bab70ba8-cbd5-4419-a9b2-9b0d716d068e
Medina-Lara, Antonieta
13f802de-a5b7-46b2-a17b-55b57ea6a8a9
Taylor, Rod
12fb1379-fab8-4713-9c5d-2662b5b6ca14
Jones, Steven
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Owens, Christabel
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Javaid, Mahmood
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Dunn, Barney
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Harvey, Julie E.
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Newbold, Alexandra
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Lynch, Tom
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Wright, Kim
d94dfa78-5c60-47e9-8b45-88afc44e1ddf
Dodd, Alyson
18ef5376-b8ef-42e5-8d4b-fa5b92ae8c94
Warren, Fiona C.
bab70ba8-cbd5-4419-a9b2-9b0d716d068e
Medina-Lara, Antonieta
13f802de-a5b7-46b2-a17b-55b57ea6a8a9
Taylor, Rod
12fb1379-fab8-4713-9c5d-2662b5b6ca14
Jones, Steven
c903deb2-5c0f-4438-b9df-8da15ebe3c6b
Owens, Christabel
873d9aa6-699a-4e3e-80fd-0f1787ab05c4
Javaid, Mahmood
02186adc-3dbd-4c02-b0fb-c4c469807831
Dunn, Barney
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Harvey, Julie E.
cde23fac-3675-4007-9aaf-1145430585f6
Newbold, Alexandra
0187909f-aad2-428a-945e-c4395aea03e5
Lynch, Tom
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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 and Lynch, Tom (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).

Record type: Article

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.

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More information

Accepted/In Press date: 19 September 2018
e-pub ahead of print date: 16 October 2018
Published date: 16 October 2018
Keywords: Bipolar disorder, Cyclothymic disorder, Dialectical behaviour therapy, Psychological therapy

Identifiers

Local EPrints ID: 425656
URI: http://eprints.soton.ac.uk/id/eprint/425656
ISSN: 1745-6215
PURE UUID: 1f068ea0-d2c0-4b35-8c61-0b0620dc596f
ORCID for Tom Lynch: ORCID iD orcid.org/0000-0003-1270-6097

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Date deposited: 31 Oct 2018 17:30
Last modified: 07 Oct 2020 01:55

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Contributors

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

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