Adjuvant Psychotherapy for Relapse Prevention in Early Adulthood (< 35 yr.) of Bipolar Disorder (A2BipoLife)

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder
• Intervention / Treatment: Behavioral: SEKT - Cognitive-Behavioral-Emotional; Behavioral: FEST - Clinical Supportive Educational

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 Type: Interventional
• Enrollment (Actual): 318
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany, 72076
    • Eberhard Karls University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: SEKT - Cognitive-Behavioral-Emotional; 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
Active Comparator: 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.	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; Other Names: Supportive, non-specific psychotherapy for Bipolar Disorder

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Charite University, Berlin, Germany; Ludwig-Maximilians - University of Munich; Universitätsklinikum Hamburg-Eppendorf; Philipps University Marburg Medical Center; University Hospital Dresden; University Hospital Bergmannsheil Bochum; University Hospital Goettingen; University Hospital Frankfurt; Ruppiner Clinic, Psychiatric Clinic, Neuruppin
• Investigators: Principal Investigator: Martin HAUTZINGER, PhD, Department Psychology University Tuebingen

Publications and helpful links

General Publications

• Meyer TD, Hautzinger M. Cognitive behaviour therapy and supportive therapy for bipolar disorders: relapse rates for treatment period and 2-year follow-up. Psychol Med. 2012 Jul;42(7):1429-39. doi: 10.1017/S0033291711002522. Epub 2011 Nov 21.
• Stamm TJ, Zwick JC, O'Malley G, Sondergeld LM, Hautzinger M. Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial. Trials. 2020 Oct 13;21(1):845. doi: 10.1186/s13063-020-04755-8.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: December 19, 2014
• First Submitted That Met QC Criteria: July 22, 2015
• First Posted (Estimate): July 23, 2015

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Bipolar I Disorder; Bipolar II Disorder; Relapse Prevention
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Bipolar and Related Disorders; Disease; Recurrence; Bipolar Disorder
• Other Study ID Numbers: 01EE1404C