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

Not Applicable

Completed

• Conditions: Bipolar Disorder
• Interventions: Behavioral: SEKT - Cognitive-Behavioral-Emotional; Behavioral: FEST - Clinical Supportive Educational

• Registration Number: NCT02506322
• Lead Sponsor: University Hospital Tuebingen

Brief 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.

Study Timeline

• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-23
• Study Start: 2015-08-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SEKT Cognitive-Behavioral-Emotional	SEKT - Cognitive-Behavioral-Emotional	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.
FEST Clinical Supportive Educational	FEST - Clinical Supportive Educational	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.

Primary Outcome Measures

Name	Time	Method
Time to new affective episode	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 Outcome Measures

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

Trial Locations

Locations (1)

Eberhard Karls University; 🇩🇪 Tuebingen, Germany