Clinical trial NCT02506322: Adjuvant Psychotherapy for Relapse Prevention in Early Adulthood (< 35 yr.) of Bipolar Disorder
Official title: Adjuvant Psychotherapy for Relapse Prevention in Early Adulthood (< 35 yr.) of Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Bipolar I Disorder
Bipolar II Disorder
Relapse Prevention
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: University Hospital Dresden
name: University Hospital Goettingen
name: Ludwig-Maximilians - University of Munich
name: Universitätsklinikum Hamburg-Eppendorf
name: University Hospital Bergmannsheil Bochum
name: Charite University, Berlin, Germany
name: Philipps University Marburg
name: Goethe University
name: Ruppiner Clinic, Psychiatric Clinic, Neuruppin
First posted: 2015-07-23
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to new affective episode
timeFrame: 18 months
Secondary outcomes:
measure: Qick-Inventory of Depressive Symptoms
timeFrame: 18 months
measure: Social functioning
timeFrame: 18 months
measure: Neurobiological changes (functional, genetic) (functional MRI)
timeFrame: 6 months
measure: Young Mania Rating Scale
timeFrame: 18 months
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Eberhard Karls University
Study officials:
affiliation: Department Psychology University Tuebingen
name: Martin HAUTZINGER, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.