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

Bipolar Disorder Clinical Trial

— A2BipoLife  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506322
• Other study ID #: 01EE1404C
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: March 31, 2020

Study information

• Verified date: November 2020
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Recurrence

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Eberhard Karls University	Tuebingen

Sponsors (10)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Charite University, Berlin, Germany, Ludwig-Maximilians - University of Munich, Philipps University Marburg Medical Center, Ruppiner Clinic, Psychiatric Clinic, Neuruppin, Universitätsklinikum Hamburg-Eppendorf, University Hospital Bergmannsheil Bochum, University Hospital Dresden, University Hospital Goettingen, University Hospital, Frankfurt

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Qick-Inventory of Depressive Symptoms	Clinician ratings of depressive symptoms	18 months
Secondary	Social functioning	Clinician rating social functioning (GAF)	18 months
Secondary	Neurobiological changes (functional, genetic) (functional MRI)	functional MRI at baseline and after six month	6 months
Secondary	Young Mania Rating Scale	Clinician ratings of manic symptoms	18 months