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

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.

Conditions

• Bipolar Disorder

Interventions

BEHAVIORAL

SEKT - 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

BEHAVIORAL

FEST - 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 & Collaborators

• University Hospital Dresden

  collaborator OTHER

• University Hospital Goettingen

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• University Hospital Bergmannsheil Bochum

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• Philipps University Marburg

  collaborator OTHER

• Goethe University

  collaborator OTHER

• Ruppiner Clinic, Psychiatric Clinic, Neuruppin

  collaborator UNKNOWN

• University Hospital Tuebingen

  lead OTHER

Principal Investigators

• Martin HAUTZINGER, PhD · Department Psychology University Tuebingen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-01

Primary Completion

2019-12-31

Completion

2020-03-31

Countries

• Germany

Study Locations