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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
318
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
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
Eberhard Karls University
Tübingen, Germany
Time to new affective episode
At baseline, subjects have to be remitted. Psychotherapies focus on maintenance and relapse prevention. Relapse will be assessed by LIFE interview every six month
Time frame: 18 months
Qick-Inventory of Depressive Symptoms
Clinician ratings of depressive symptoms
Time frame: 18 months
Social functioning
Clinician rating social functioning (GAF)
Time frame: 18 months
Neurobiological changes (functional, genetic) (functional MRI)
functional MRI at baseline and after six month
Time frame: 6 months
Young Mania Rating Scale
Clinician ratings of manic symptoms
Time frame: 18 months
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