Efficacy of group psychoeducation and electronic diary in bipolar disorder – a multicenter, randomized, controlled trial

Phase 2

• Conditions: F31.7; F31.8; Bipolar affective disorder, currently in remission; Other bipolar affective disorders

• Registration Number: DRKS00017319
• Lead Sponsor: Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Carl Gustav Carus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2012-08-13
• Study Start: 2019-05-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

DSM-IV diagnosis of bipolar disorder (Type I or II)
- Remission for at least 2 months (YMRS <6 and HAMD-17 <8)
- Minimum age: 18 years
- Daily access to a computer (Windows)
- Psychotropic medication
- Recurrence/relapse (according to DSM-IV criteria) in the past 3 years
- Capacity to consent

Exclusion Criteria

- Current diagnosis of substance dependence, dementia or organic mental disorder
- Diagnosis of antisocial personality disorder
- Ultra-rapid cycling (12 or more episodes) in the past year
- Currently receiving psychotherapy
- Simultaneous participation in drug studies

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of manic, hypomanic, depressive or mixed episodes: intervention group < control group<br><br>Recurrences/relapses are recorded after the last group session and every 3 months until the end of the study (24 months after start of group sessions) per:<br>- Modules of affective disorders in Structured Clinical Interview for DSM-IV (SKID-I)<br>- Young Mania Rating Scale (YMRS)<br>- Hamilton Depression Scale (HAMD-17)<br><br>- A total score of = 20 on YMRS corresponds to a mania<br>- A total score of = 12 on YMRS corresponds to a hypomania<br>- A total score of = 17 on HAMD-17 corresponds to a depression<br>- A total score of = 20 on YMRS and of = 12 on HAMD-17 corresponds to a mixed episode

Secondary Outcome Measures

Name	Time	Method
- Time to recurrence: intervention group > control group<br>- Mood stability: intervention group > control group<br>- Quality of life: intervention group > control group<br>- Self-management skills: intervention group > control group<br>- Opportunities for participation: intervention group > control group<br><br>The following instruments will be applied after the last group meeting and every 3 months until the end of the study (24 months after start of group meetings):<br>- Time to recurrence: YMRS, HAMD-17, SKID-I<br>- Mood stability: YMRS, HAMD-17<br><br>The following instruments will be applied after the last group meeting and 6, 12, 15 and 24 months after the beginning of group meetings:<br>- Quality of life: 36-Item Short Form Survey (SF-36)<br>- Self-management skills: General Self-Efficacy Scale (GSE), Health Locus of Control Scale (HLOC)<br>- Opportunities for participation: Perceived Involvement in Care Scales (PICS)