Adjuvant Psychotherapy for Relapse Prevention in Early Adulthood (< 35 yr.) of Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Recurrence; Bipolar Disorder
Study type: Interventional

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.
    

Intervention name(s): SEKT - Cognitive-Behavioral-Emotional; FEST - Clinical Supportive Educational
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; 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
Other intervention name(s): Specific Psychotherapy for Bipolar Disorder; Supportive, non-specific psychotherapy for Bipolar Disorder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar I Disorder; Bipolar II Disorder; Relapse Prevention