INTRODUCTION Schema therapy (ST) reduces depressive symptoms, but clinical trials have not investigated its effectiveness for patients suffering from severe forms of depression and high rates of comorbidities. There is high demand for exploring and improving treatments for this patient group. The objective of the current study was to evaluate whether ST is more effective than individual supportive therapy (IST) and noninferior compared with cognitive behavioral therapy (CBT) in treating depression. METHODS For this clinical trial, medicated patients were recruited in inpatient and day clinic settings. The major inclusion criteria were age between 18 and 75 years and primary diagnosis of depression without psychotic symptoms. A total of 292 participants were randomized to ST, CBT, or IST and received 7 weeks of psychotherapy (up to 14 individual and 14 group sessions). The primary outcome was change in depression severity after treatment measured by Beck Depression Inventory-II. Primary test for efficacy was superiority of ST over IST. Secondary test was noninferiority of ST compared with CBT. Multilevel modeling was conducted. The results at 6-month follow-up were explored. RESULTS Across treatment, ST was not superior to IST. Secondary outcome analyses and completer analyses showed similar results. However, ST showed clinically relevant noninferiority compared with CBT. CONCLUSION ST for depression as part of a psychiatric care program showed clinical noninferiority compared to CBT, without being superior to IST. ST represents a potentially useful addition to the therapeutic repertoire for the treatment of depression but its efficacy, including long-term efficacy, should be evaluated further.

中文翻译：

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图式疗法与认知行为疗法与支持疗法在住院和日间诊所治疗抑郁症的有效性：一项随机临床试验。


简介 图式疗法 (ST) 可减轻抑郁症状，但临床试验尚未研究其对患有严重抑郁症和高合并症的患者的有效性。对于探索和改进该患者群体的治疗方法有很高的需求。本研究的目的是评估 ST 在治疗抑郁症方面是否比个体支持疗法 (IST) 更有效，并且与认知行为疗法 (CBT) 相比是否不逊色。方法 在本临床试验中，招募了住院和日间诊所接受药物治疗的患者。主要纳入标准是年龄在 18 岁至 75 岁之间，初步诊断为抑郁症但无精神病症状。共有 292 名参与者被随机分配接受 ST、CBT 或 IST 组，并接受 7 周的心理治疗（最多 14 次个人治疗和 14 次小组治疗）。主要结局是通过贝克抑郁量表 II 测量治疗后抑郁严重程度的变化。功效的主要测试是 ST 相对 IST 的优越性。次要测试是 ST 与 CBT 相比的非劣效性。进行了多层次建模。对 6 个月随访的结果进行了探讨。结果 在整个治疗过程中，ST 并不优于 IST。次要结果分析和完整分析显示了相似的结果。然而，与 CBT 相比，ST 显示出临床相关的非劣效性。结论 ST 治疗抑郁症作为精神科护理计划的一部分，与 CBT 相比显示出临床非劣性，但并不优于 IST。 ST 代表了抑郁症治疗方案的潜在有用补充，但其疗效（包括长期疗效）应进一步评估。