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| Name | Class |
|---|---|
| University Hospital Dresden | OTHER |
| University Hospital Goettingen | OTHER |
| Ludwig-Maximilians - University of Munich | OTHER |
| Universitätsklinikum Hamburg-Eppendorf |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEKT - Cognitive-Behavioral-Emotional | Behavioral | This Bipolar Disorder specific psychotherapy has 4 modules:
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Qick-Inventory of Depressive Symptoms | Clinician ratings of depressive symptoms | 18 months |
| Social functioning | Clinician rating social functioning (GAF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin HAUTZINGER, PhD | Department Psychology University Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eberhard Karls University | Tübingen | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22099722 | Background | 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. | |
| 38837133 | Derived | 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. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C101544 | MD1 |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| OTHER |
| University Hospital Bergmannsheil Bochum | OTHER |
| Charite University, Berlin, Germany | OTHER |
| Philipps University Marburg | OTHER |
| Goethe University | OTHER |
| Ruppiner Clinic, Psychiatric Clinic, Neuruppin | UNKNOWN |
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| 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 |
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| 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 |
| 36087699 | Derived | 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. |
| 33050952 | Derived | 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. |