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

NCT ID: NCT02506322

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

318 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2020-03-31

Brief Summary

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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

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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.

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

SEKT - Cognitive-Behavioral-Emotional

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

FEST - Clinical Supportive Educational

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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Specific Psychotherapy for Bipolar Disorder Supportive, non-specific psychotherapy for Bipolar Disorder

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Dresden

OTHER

Sponsor Role collaborator

University Hospital Goettingen

OTHER

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role collaborator

University Hospital Bergmannsheil Bochum

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Philipps University Marburg

OTHER

Sponsor Role collaborator

Goethe University

OTHER

Sponsor Role collaborator

Ruppiner Clinic, Psychiatric Clinic, Neuruppin

UNKNOWN

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Martin Hautzinger

University Professor of Clinical Psychology an Psychotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin HAUTZINGER, PhD

Role: PRINCIPAL_INVESTIGATOR

Department Psychology University Tuebingen

Locations

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Eberhard Karls University

Tübingen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 22099722 (View on PubMed)

Hautzinger M; A2 BipoLife Consortium. Adjuvant Psychotherapies to Prevent Relapse in Bipolar Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Sep 1;81(9):855-862. doi: 10.1001/jamapsychiatry.2024.1310.

Reference Type DERIVED
PMID: 38837133 (View on PubMed)

Meyer K, Hindi Attar C, Fiebig J, Stamm T, Bassett TR, Bauer M, Dannlowski U, Ethofer T, Falkenberg I, Jansen A, Juckel G, Kircher T, Mulert C, Leicht G, Rau A, Ritter D, Ritter P, Trost S, Vogelbacher C, Walter H, Wolter S, Hautzinger M, Bermpohl F. Boosting the Theory of Mind Network: Specific Psychotherapy Increases Neural Correlates of Affective Theory of Mind in Euthymic Bipolar Disorder. Biol Psychiatry Cogn Neurosci Neuroimaging. 2023 May;8(5):572-580. doi: 10.1016/j.bpsc.2022.08.013. Epub 2022 Sep 8.

Reference Type DERIVED
PMID: 36087699 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33050952 (View on PubMed)

Other Identifiers

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01EE1404C

Identifier Type: -

Identifier Source: org_study_id