Importance Several psychotherapy protocols have been evaluated as adjuncts to pharmacotherapy for patients with bipolar disorder (BD). Little is known about their comparative effectiveness. Objective To compare the effectiveness of 2 types of group psychotherapy, skill-oriented, material-based cognitive behavioral therapy (SEKT) and supportive, patient-centered, emotion-focused therapy (FEST), to prevent relapse in patients with euthymic BD. Design, Setting, and Participants This was a large, observer-blind, randomized clinical trial conducted over 18 months (posttreatment after 6 months; follow-up at 12 and 18 months). In addition to psychiatric care as usual (including mood-stabilizing medication), each participant at 9 clinical outpatient units in Germany received 24 hours of group psychotherapy over 4, full-day sessions spread over 5 months. Patients with euthymic BD type 1 (BD 1) or BD type 2 (BD 2) between the ages of 18 and 50 years were randomly assigned to 1 of 2 forms of psychotherapy, SEKT or FEST. Independent clinicians blinded to patient grouping performed assessments using structured interviews (Structured Clinical Interview for DSM Disorders and Longitudinal Interval Follow-Up Evaluation) and self-rating and clinician rating for inclusion criteria and outcome. Kaplan-Meier survival curves were calculated for time to relapse. Cox proportional hazards statistics and propensity score matching were calculated for the multivariate analysis. Study data were analyzed from March 2020 to September 2022. Interventions SEKT intervention is a structured cognitive behavioral therapy integrating elements of interpersonal social rhythm therapy, and of mindfulness-based cognitive therapy. FEST psychotherapy has its roots in emotion-focused, supportive, and nondirective therapy. Main Outcomes and Measures Recurrence of a new affective episode assessed by blinded interviewer with the LIFE interview. In addition, self-rating and clinician rating of depressive and mania symptoms as well as level of social functioning were assessed. Results Of 348 screened referrals, 305 patients (median [IQR] age, 34 [18-50] years; 162 male [53%]) with euthymic BD 1 or BD 2 were included in the study. A total of 207 patients (68%) had BD 1, 98 (32%) had BD 2, and 278 (91%) received psychiatric care. 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 (SEKT: 69 [49%] relapse; FEST: 63 [46%] relapse) but was predicted by BD 2, comorbidity, attending all sessions, and the interaction of type of treatment by BD 1 or 2. Patients with BD 2 had the highest rate of relapse (60 [61%] relapse), in particular, when treated by SEKT (39 [70%] relapse). Conclusions and Relevance Results of this randomized clinical trial revealed that a structured, skill-oriented, material-based cognitive behavioral therapy (SEKT) and a supportive, patient-centered, emotion-focused therapy (FEST) were equally effective in preventing relapse of affective episodes when delivered in a new, intensive group format. Additionally, there were baseline factors, in particular BD 2, that influenced outcomes. Trial Registration ClinicalTrials.gov Identifier: NCT02506322.

中文翻译：

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预防双相情感障碍复发的辅助心理疗法：一项随机临床试验。


重要性 一些心理治疗方案已被评估为双相情感障碍 (BD) 患者药物治疗的辅助手段。人们对它们的比较有效性知之甚少。目的 比较两种类型的团体心理治疗，即以技能为导向、基于材料的认知行为疗法 (SEKT) 和支持性、以患者为中心、以情绪为中心的疗法 (FEST)，对预防正常性双相情感障碍患者复发的有效性。设计、环境和参与者 这是一项为期 18 个月的大型、观察者盲法随机临床试验（6 个月后治疗后；12 个月和 18 个月随访）。除了照常进行精神科护理（包括情绪稳定药物）外，德国 9 个临床门诊单位的每位参与者在 5 个月内接受了超过 4 次全天疗程的 24 小时团体心理治疗。年龄在 18 至 50 岁之间的心境正常 BD 1 型 (BD 1) 或 BD 2 型 (BD 2) 患者被随机分配接受 2 种心理治疗形式 SEKT 或 FEST 中的一种。对患者分组不知情的独立临床医生使用结构化访谈（DSM 疾病结构化临床访谈和纵向间隔随访评估）以及自我评分和临床医生对纳入标准和结果的评分进行评估。计算卡普兰-迈耶生存曲线的复发时间。计算 Cox 比例风险统计和倾向评分匹配以进行多变量分析。研究数据的分析时间为 2020 年 3 月至 2022 年 9 月。 干预措施 SEKT 干预是一种结构化认知行为疗法，整合了人际社会节律疗法和基于正念的认知疗法的要素。 FEST 心理治疗源于以情感为中心的、支持性的、非指导性的治疗。主要成果和措施 LIFE 访谈中由盲法访谈者评估新情感发作的复发情况。此外，还评估了抑郁和躁狂症状的自我评分和临床医生评分以及社会功能水平。结果 在 348 名筛选转诊患者中，305 名患有正常 BD 1 或 BD 2 的患者（中位 [IQR] 年龄，34 [18-50] 岁；162 名男性 [53%]）纳入研究。共有 207 名患者 (68%) 患有 BD 1，98 名患者 (32%) 患有 BD 2，278 名患者 (91%) 接受了精神科护理。两种疗法在预防新发作复发方面同样有效。结果（新发作率较高）不是通过治疗类型预测的（SEKT：69 [49%] 复发；FEST：63 [46%] 复发），而是通过 BD 2、合并症、参加所有治疗以及相互作用来预测BD 1 或 2 的治疗类型。BD 2 患者的复发率最高（60 [61%] 复发），特别是在接受 SEKT 治疗时（39 [70%] 复发）。结论和相关性 这项随机临床试验的结果表明，结构化、以技能为导向、基于材料的认知行为疗法 (SEKT) 和支持性、以患者为中心、以情绪为中心的疗法 (FEST) 在预防情感障碍复发方面同样有效。以新的密集小组形式提供的剧集。此外，还有影响结果的基线因素，特别是 BD 2。试验注册 ClinicalTrials.gov 标识符：NCT02506322。