Bipolar Disorder
Conditions
Keywords
Bipolar I Disorder, Bipolar II Disorder, Relapse Prevention
Brief summary
This efficacy study compares an adjuvant specific psychotherapy and an active control intervention for Bipolar Disorder under mood stabilizer to prevent relapse an maintain remission. Patients should be in their early (18-30 yr.) phase of illness without having suffered of to many affective episodes (below 6), already. In addition, psychological, social, and neurobiological mediators and moderators well be identified.
Detailed description
There is still a lack of controlled outcome and follow-up studies about the role of adjuvant psychotherapy in Bipolar Disorder. By treating older subjects having suffered of multiple affective episodes, the potential benefit of psychotherapy to prevent relapse and help to adjust to this chronic illness might be underestimated. In addition, the investigators have no knowledge of mechanism (mediators) of positive changes by successful psychotherapy and of subjects with good outcome of adjuvant psychotherapy (moderators, indicators, predictors). Possible mediators and moderators can be sociodemographic, psychological (cognitive, interactional), and/or biological (neuronal, genetic). The planned study will address all three areas of questions. In a multi-center study, 300 younger subjects suffering of a Bipolar Disorder will be included and provide with one of two treatments in addition to stable medication. Moderators and mediators are selected on promising preliminary results and based on a psycho-biological understanding of Bipolar Disorder.
Interventions
BEHAVIORALSEKT - Cognitive-Behavioral-Emotional
This Bipolar Disorder specific psychotherapy has 4 modules: 1. psychoeducation, life chart, relapse experiences, personalized explanation, early symptoms and recognition of a new episode, self observation 2. Stress regulation, sleep-wake cycle, social rhythm, daily and weekly structure of life, life balance 3. dysfunctional cognitions, cognitive techniques, meta-cognitive techniques, emotion regulation methods 4. behavior changes, (social, problem solving) skill training, communication skills, crisis management
BEHAVIORALFEST - Clinical Supportive Educational
This active control psychotherapy has 2 modules: (a) psychoeducation about Bipolar Disorder, the etiology and development of this disorder, drug options, effects and side effects of medication, compliance, how to handle unwanted side effects (b) group discussion and exchange about disorder relevant and personal relevant topics related to Bipolar Disorder, therapist is passive, encouraging, listening, verbalizing feelings and emotion, strengthening subjects resources
Sponsors
University Hospital Dresden
University Hospital Goettingen
Ludwig-Maximilians - University of Munich
Universitätsklinikum Hamburg-Eppendorf
University Hospital Bergmannsheil Bochum
Charite University, Berlin, Germany
Philipps University Marburg
Goethe University
Ruppiner Clinic, Psychiatric Clinic, Neuruppin
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Bipolar I and Bipolar II Disorder, * 18 to 55 years of age, * giving informed consent to assessment, treatment, and randomization, * currently remitted (for at least 4 weeks) and taking medication, * less than 6 previous affective episodes
Exclusion criteria
* currently symptomatic (depressed, manic, hypomanic), * suicidal, * not taking medication, * schizo-affective, schizophrenic, borderline personality disorder, * not giving or withdrawing consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to new affective episode | 18 months | At baseline, subjects have to be remitted. Psychotherapies focus on maintenance and relapse prevention. Relapse will be assessed by LIFE interview every six month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qick-Inventory of Depressive Symptoms | 18 months | Clinician ratings of depressive symptoms |
| Social functioning | 18 months | Clinician rating social functioning (GAF) |
| Neurobiological changes (functional, genetic) (functional MRI) | 6 months | functional MRI at baseline and after six month |
| Young Mania Rating Scale | 18 months | Clinician ratings of manic symptoms |
Countries
Germany
Outcome results
None listed