Randomised controlled trial investigating therapy for bipolar inter-episode symptoms

Not Applicable

• Conditions: Bipolar disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN18207465
• Lead Sponsor: niversity of Exeter

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-13
• Last Update Posted: 25 March 2024
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Participants will be adults who:
1. Meet research diagnostic criteria for Bipolar I or II Disorder, Other Specified Bipolar Disorder or Cyclothymic Disorder
2. Do not meet the criteria for a manic or severe depressive episode
3. Have IEBS, defined as at least mild depressive symptoms (Patient Health Questionnaire [PHQ9] >=5) or above-average bipolar mood instability defined as >=1.3 on the brief Affective Lability Scale (ALS) depression-elation scale
4. Are willing to engage in psychological work addressing IEBS or its impact on functioning
5. Sufficient English to complete questionnaires without translation
6. Have completed the intake measures
7. Are registered with a General Practice within the study site catchment area

Exclusion Criteria

1. Current substance dependence according to ICD-11 criteria (as this may interfere with the ability to engage in and use therapy; current substance abuse is not an exclusion criterion).
2. Risk of harm to self or others that cannot be safely managed in a community outpatient setting.
3. Currently engaged in another psychological therapy for bipolar disorder.
4. Participant anticipates they will be unable to regularly attend therapy sessions within the site area (e.g. planning to move out of the study area, work commitments prevent regular attendance, lengthy period of travel not mitigated by access to online therapy sessions).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Average recruitment rate recorded as the number of eligible participants recruited per site over 15 months to assess the feasibility of a future trial<br>2. Completion of the 30-week follow-up point