Adjuvant psychotherapy to prevent relapses in Bipolar Disorder (A2)
- Conditions
- F31Bipolar affective disorder
- Registration Number
- DRKS00006013
- Lead Sponsor
- Eberhard Karls UniversitätFachbereich PsychologieKlinische Psychologie und Psychotherapie
- Brief Summary
Objektive. Several psychotherapy protocols have been evaluated as adjuncts to pharmacotherapy for patients with bipolar disorder (BD). Little is known about their comparative effectiveness. We conducted a large randomized-controlled trial (N = 305) comparing two kinds of psychotherapy to prevent relapse in euthymic BD patients over 18 months. Methods. In addition to psychiatric „treatment as usual“ (including mood stabilizing medication), each participant received 24 hours of group psychotherapy over four full day sessions spread over 5 months. There were two forms of psychotherapy. SEKT intervention is a structured Cognitive Behavior Therapy integrating elements of Interpersonal Social Rhythm Therapy, and of Mindfullness basec Cognitive Therapy. FEST psychotherapy has its roots in emotion-focused, supportive and non-directive therapy. Main outcome over 18 moths was recurrence of either a new affective episode assessed by blinded interviewer with LIFE. Kaplan-Meier Survival curves were calculate for time to relapse. Cox Proportional Hazards statistics and Propensity Score Matching were calculated for multivariate analyses. Results. Both therapies were equally effective in preventing recurrence of a new episode. Outcome (higher rate of new episodes) was not predicted by kind of treatment but was predicted by Bipolar II, comorbidity, attenting all sessions, and the interaction of kind of treatment by Bipolar I/II. Conclusion. Currently we don’t have evidence that any one form of psychotherapy results in better outcomes versus another. It is possible that the provision of empathy, verbalizing emotions, and support are sufficient ingredients in relapse prevention. Additionally, there are baseline factors, in particular Bipolar II, that predict outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 305
Bipolar I and Bipolar II, remitted (symptom free for at least 4 weeks), on stable medication, 18 to 55 years of age, at least one previous affective episode in the last two years, giving informed consent
Patients with more than six previous episodes, rapid cycling, acute suicidal, schizo-affective disorder, schizophrenia, ADHD, substance use disorder (last 6 month), borderline personality disorder, informed consent, withdrawing informed consent, not taking medication
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of relapse (a new affective episode or re-hospitalization) assessed by Longitudial Follow-up Evaluaion interview at 6, 12, and 18 months after inclusion into study.
- Secondary Outcome Measures
Name Time Method Symptom Rating (Mania self ratings, Quick Depression Inventory self rating, Young Mania Scale and Quick Inventory of Depressive Symptoms clinician ratings); missed days at work/school, spent days in Hospital, health costs, improved compliance to medical treatment, social functioning, life Quality, normalized neurobiological functioning (net work of amygdala, striatum, medial prefrontal cortex, temporo-frontal cortex, subcortical structurs).