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Adjuvant psychotherapy to prevent relapses in Bipolar Disorder (A2) - A2BipoLife

Eberhard Karls UniversitätFachbereich PsychologieKlinische Psychologie und Psychotherapie0 个研究点目标入组 305 人开始时间: 2015年5月21日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
305

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 55 Years(—)
性别
All

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Eberhard Karls UniversitätFachbereich PsychologieKlinische Psychologie und Psychotherapie

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