Adjuvant Psychotherapy for Relapse Prevention in Early Adulthood (< 35 yr.) of Bipolar Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Adjuvant Psychotherapy for Relapse Prevention in Early Adulthood (< 35 yr.) of Bipolar Disorder

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Behavioral: SEKT - Cognitive-Behavioral-Emotional
* Behavioral: FEST - Clinical Supportive Educational


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SEKT Cognitive-Behavioral-Emotional<br>Specific psychotherapy (SEKT - 4 modules) for typical problems of Bipolar patients to maintain remission and to prevent relapse. Including classical elements of self observation, psychoeducation, cognitive and behavioral interventions, social rhythm but also emotion regulation and meta-cognitive techniques. Delivered in a group setting in 4 one day treatment workshops, each one month apart. Homework assignment and electronical monitoring during time between sessions. | Behavioral: SEKT - Cognitive-Behavioral-Emotional<br>* This Bipolar Disorder specific psychotherapy has 4 modules: psychoeducation, life chart, relapse experiences, personalized explanation, early symptoms and recognition of a new episode, self observation Stress regulation, sleep-wake cycle, social rhythm, daily and weekly structure of life, life balance dysfunctional cognitions, cognitive techniques, meta-cognitive techniques, emotion regulation methods behavior changes, (social, problem solving) skill training, communication skills, crisis management<br>* Other names: Specific Psychotherapy for Bipolar Disorder;|
| Active Comparator: FEST Clinical Supportive Educational<br>This supportive, active control psychotherapy (FEST) is using general principals and non-specific interventions such as positive attitude, optimism, support, empathy, focus on emotion, self-help, strengthening and eliciting own resources, time and room for discussion of personal experiences. Psychoeducation about illness and drug treatment (mood stabilizer) to facilitate compliance. | Behavioral: FEST - Clinical Supportive Educational<br>* 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<br>* Other names: Supportive, non-specific psychotherapy for Bipolar Disorder;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qick-Inventory of Depressive Symptoms | Clinician ratings of depressive symptoms | 18 months | 
| Social functioning | Clinician rating social functioning (GAF) | 18 months | 
| Neurobiological changes (functional, genetic) (functional MRI) | functional MRI at baseline and after six month | 6 months | 
| Young Mania Rating Scale | Clinician ratings of manic symptoms | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar I Disorder, Bipolar II Disorder, Relapse Prevention