Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, Freiburg, Germany.
J Clin Psychol. 2020 Jan;76(1):7-19. doi: 10.1002/jclp.22869. Epub 2019 Oct 1.
A recent trial comparing Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and supportive psychotherapy in chronic depression found CBASP to be more effective in treating depressive symptoms. We aimed to evaluate adverse events that occurred during this trial.
A randomized trial of chronically depressed outpatients was performed. The treatment included 32 sessions of CBASP or supportive psychotherapy. Therapists asked patients about adverse events and their intensity in each session using a standardized checklist. We analyzed the mean number of (severe) adverse events per patient up to Session 32 with gamma frailty recurrent event models.
Two hundred and sixty patients were included in the analyses (66% female, mean age 45 years). Patients in the supportive psychotherapy group reported less severe adverse events in general, and less severe adverse events related to personal life and to occupational life than patients in the CBASP group. Less adverse events related to suicidal thoughts were reported in the CBASP compared with the supportive psychotherapy group.
Differences in the adverse events profile may be explained by the treatment elements. Adverse events related to personal and occupational life for example might be considered a necessary and expected yet temporary adverse treatment outcome of an effective CBASP treatment.
最近一项比较认知行为分析系统疗法（CBASP）和支持性心理治疗慢性抑郁症的试验发现，CBASP 在治疗抑郁症状方面更有效。我们旨在评估该试验过程中发生的不良事件。
对慢性抑郁门诊患者进行了一项随机试验。治疗包括 32 节 CBASP 或支持性心理治疗。治疗师在每次治疗中使用标准化清单询问患者不良事件及其严重程度。我们使用伽马脆弱复发事件模型分析了第 32 次治疗前每位患者（严重）不良事件的平均数量。
260 名患者被纳入分析（66%为女性，平均年龄 45 岁）。支持性心理治疗组患者总体报告的不良事件较轻，与个人生活和职业生活相关的不良事件以及自杀意念相关的不良事件较 CBASP 组轻。
不良事件特征的差异可能与治疗元素有关。例如，与个人和职业生活相关的不良事件可能被认为是有效的 CBASP 治疗的一个必要且预期但暂时的不良治疗结果。
