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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00017319
Enrollment
150
Registered
2019-05-24
Start date
2006-02-07
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F31.7 F31.8

Interventions

Group 1: Group psychoeducation (6x 90 minutes, weekly) followed by electronic diary (ChronoRecord, daily, 54 weeks) Group 2: Unstructured group sessions (6x 90 minutes, weekly) followed by electronic

Sponsors

Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Carl Gustav Carus
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Frequency of manic, hypomanic, depressive or mixed episodes: intervention group < control group 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: - Modules of affective disorders in Structured Clinical Interview for DSM-IV (SKID-I) - Young Mania Rating Scale (YMRS) - Hamilton Depression Scale (HAMD-17) - A total score of = 20 on YMRS corresponds to a mania - A total score of = 12 on YMRS corresponds to a hypomania - A total score of = 17 on HAMD-17 corresponds to a depression - A total score of = 20 on YMRS and of = 12 on HAMD-17 corresponds to a mixed episode

Secondary

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

Countries

Germany

Contacts

Public ContactMichael Bauer

Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Carl Gustav Carus

michael.bauer@uniklinikum-dresden.de+49 351 458 2760

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 20, 2026