Group psychoeducation versus group support using expert patients and clinical staff in the management of bipolar disorder

Not Applicable

Completed

Conditions: Bipolar affective disorder
Bipolar disorder
Mental and Behavioural Disorders

Registration Number: ISRCTN62761948

Lead Sponsor: niversity of Nottingham (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 358

Inclusion Criteria

1. Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (SCID-DSM-IV) verified diagnosis of primary bipolar disorder
2. Increased risk of relapse (at least one episode in the last 24 months)
3. Age over 18 years, either sex

Exclusion Criteria

1. Presence of a current manic, hypomanic, mixed affective or major depressive episode currently or within the previous 8 weeks
2. Current suicide plans or high suicide intent
3. Inability or unwillingness to give written informed consent to the study
4. Participants would have to be able to communicate in written and verbal English to a sufficient level to allow them to complete the measures and take part in the groups

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Time to next bipolar episode and average weekly symptom score, both established using four monthly SCID LIFE interviews to generate weekly scores of mania and depression on 1 - 6 scale of severity<br>2. Primary economic measure of incremental cost per quality adjusted life year gained<br><br>Follow-up of each patient will be for 24 months from randomisation. Patients who had not relapsed at 24 months will be censored on the time to next episode outcome. The peak effect of psychoeducation on time to next bipolar episode have been observed at 24 months after randomisation. Baseline interview using the SCID will assess the presence of axis 1 and axis 2 comorbid psychopathology and the number of previous bipolar episodes.

Secondary Outcome Measures

Name	Time	Method
1. Assessment of weekly symptoms using the LIFE<br>2. Assessment of function using the Social Adjustment Scale, and Social and Occupational Functioning Assessment Scale (SOFAS)<br>3. Observer and self-rated measures of mood: 17-item Hamilton Depression Scale (HDRS), Bech-Raphaelson Mania Scale (MAS), Beck Depression Inventory (BDI) and PHQ-9 (Personal Health Questionnaire)<br>4. Medication adherence<br><br>Schedule of assessment:<br>At baseline, 12 and 24 months (face to face assessments): SAS, Economic Interview (CSRI), EuroQol<br>At 4, 8, 16, and 20 months (telephone assessments): LIFE, HDRS, MAS, SOFAS, MedAd, BDI version 1(by post), PHQ-9 (by post)