NCT02506322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

4.4 years

First QC Date

December 19, 2014

Last Update Submit

November 3, 2020

Conditions

Bipolar Disorder

Keywords

Bipolar I DisorderBipolar II DisorderRelapse Prevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Qick-Inventory of Depressive Symptoms

    18 months

  • Social functioning

    18 months

  • Neurobiological changes (functional, genetic) (functional MRI)

    6 months

  • Young Mania Rating Scale

    18 months

Study Arms (2)

SEKT Cognitive-Behavioral-Emotional

EXPERIMENTAL

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

FEST Clinical Supportive Educational

ACTIVE COMPARATOR

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

Interventions

SEKT - Cognitive-Behavioral-EmotionalBEHAVIORAL

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

Also known as: Specific Psychotherapy for Bipolar Disorder
SEKT Cognitive-Behavioral-Emotional
FEST - Clinical Supportive EducationalBEHAVIORAL

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

Also known as: Supportive, non-specific psychotherapy for Bipolar Disorder
FEST Clinical Supportive Educational

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Bipolar I and Bipolar II Disorder,
  • 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

You may not qualify if:

  • currently symptomatic (depressed, manic, hypomanic),
  • suicidal,
  • not taking medication,
  • schizo-affective, schizophrenic, borderline personality disorder,
  • not giving or withdrawing consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eberhard Karls University

Tübingen, 72076, Germany

Location

Related Publications (4)

  • 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.

    PMID: 22099722BACKGROUND

  • 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.

    PMID: 38837133DERIVED

  • 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.

    PMID: 36087699DERIVED

  • 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.

    PMID: 33050952DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

MD1Palliative Care

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Martin HAUTZINGER, PhD

    Department Psychology University Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Professor of Clinical Psychology an Psychotherapy

Study Record Dates

First Submitted

December 19, 2014

First Posted

July 23, 2015

Study Start

August 1, 2015

Primary Completion

December 31, 2019

Study Completion

March 31, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

DE(1)