Max Planck Institute of Psychiatry, Munich, Germany.
Department of Psychology, LMU Munich, Munich, Germany.
Psychother Psychosom. 2024;93(1):24-35. doi: 10.1159/000535492. Epub 2024 Jan 4.
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.
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.
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.
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.
图式治疗(ST)可减轻抑郁症状,但临床试验尚未研究其对患有严重形式的抑郁症和高共病率的患者的有效性。对于探索和改善这类患者群体的治疗方法存在巨大的需求。本研究的目的是评估 ST 是否比个体支持性治疗(IST)更有效,以及与认知行为治疗(CBT)相比是否不劣效,用于治疗抑郁症。
在这项临床试验中,我们在住院和日间诊所环境中招募了服用药物的患者。主要纳入标准为年龄在 18 至 75 岁之间,以及原发性无精神病症状的抑郁症诊断。共有 292 名参与者被随机分配到 ST、CBT 或 IST 组,并接受了 7 周的心理治疗(最多 14 次个体和 14 次团体治疗)。主要结局是治疗后抑郁严重程度的变化,通过贝克抑郁量表-II 进行评估。疗效的主要检验是 ST 优于 IST。次要检验是 ST 与 CBT 相比非劣效。采用多级模型进行分析。还探讨了 6 个月随访时的结果。
在所有治疗中,ST 均不优于 IST。二次结局分析和完成者分析显示出相似的结果。然而,ST 与 CBT 相比显示出具有临床意义的非劣效性。
作为精神科护理计划的一部分的 ST 治疗抑郁症显示出与 CBT 相比的临床非劣效性,而不优于 IST。ST 代表了一种对抑郁症治疗具有潜在有用的补充治疗方法,但应进一步评估其疗效,包括长期疗效。