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Completed

NCT Number: NCT02506322

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eberhard Karls University

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SEKT - Cognitive-Behavioral-Emotional

Behavioral

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

Other names: Specific Psychotherapy for Bipolar Disorder

FEST - Clinical Supportive Educational

Behavioral

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 names: Supportive, non-specific psychotherapy for Bipolar Disorder

Primary outcomes

  1. Time to new affective episode

    Time frame: 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 outcomes

  1. Qick-Inventory of Depressive Symptoms

    Time frame: 18 months

    Clinician ratings of depressive symptoms

  2. Social functioning

    Time frame: 18 months

    Clinician rating social functioning (GAF)

  3. Neurobiological changes (functional, genetic) (functional MRI)

    Time frame: 6 months

    functional MRI at baseline and after six month

  4. Young Mania Rating Scale

    Time frame: 18 months

    Clinician ratings of manic symptoms

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Charite University, Berlin, Germany
  • Goethe University
  • Ludwig-Maximilians - University of Munich
  • Philipps University Marburg
  • Ruppiner Clinic, Psychiatric Clinic, Neuruppin
  • University Hospital Bergmannsheil Bochum
  • University Hospital Dresden
  • University Hospital Goettingen
  • Universitätsklinikum Hamburg-Eppendorf

Registry information

Acronym: A2BipoLife

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Jul 23, 2015
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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