Thoustrup Christine Lykke, Uhre Camilla, Uhre Valdemar, Ritter Melanie, Vangkilde Signe, Engstrøm Janus, Lindschou Jane, Gluud Christian, Pagsberg Anne Katrine, Olsen Markus Harboe
Child and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Gentofte Hospitalsvej 3A, 1. Sal, 2900, Hellerup, Denmark.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200, Copenhagen, Denmark.
Contemp Clin Trials Commun. 2024 Dec 4;43:101408. doi: 10.1016/j.conctc.2024.101408. eCollection 2025 Feb.
Research on improving psychotherapy for youths with obsessive-compulsive disorder (OCD), including cognitive behavioral therapy (CBT), should explore what works for whom and how by examining baseline moderators and potential mechanisms of change. Emotion dysregulation is proposed as an intermediate therapy factor in a transdiagnostic framework. This study investigates emotion dysregulation as an outcome, mechanism, and moderator of psychotherapy in youths aged 8-17 years with OCD.
Data are from a randomized clinical trial and a parallel prospective study of healthy controls. Participants with OCD (n = 130; 121 in this study) were randomized to 14 sessions of either family-based CBT with exposure and response prevention versus family-based psychoeducation and relaxation training. We will; 1) assess if emotion dysregulation, measured by the Difficulties in Emotion Regulation Scale (DERS), decreases from baseline to end-of-treatment; 2) compare the proportion of participants with normative emotion regulation to a 90% reference interval from healthy controls (n = 90); 3) use linear regression to examine if baseline emotion dysregulation moderates treatment effects measured by the Children's Yale-Brown Obsessive-Compulsive Scale; 4) investigate if changes in emotion dysregulation mediate treatment effects; and 5) investigate the stability of emotion regulation over time in the healthy controls. Analyses 1-4 will be conducted for all OCD participants and separately for the two treatment groups. Two independent investigators will perform the analyses.
This protocol and statistical analysis plan are presented to enhance analytical transparency and limit bias.
关于改善强迫症（OCD）青少年心理治疗的研究，包括认知行为疗法（CBT），应通过检查基线调节因素和潜在的变化机制来探索对谁有效以及如何有效。情绪调节障碍被认为是跨诊断框架中的一个中间治疗因素。本研究调查情绪调节障碍作为8至17岁OCD青少年心理治疗的结果、机制和调节因素。
数据来自一项随机临床试验和一项针对健康对照的平行前瞻性研究。OCD参与者（n = 130；本研究中为121名）被随机分配接受14节基于家庭的CBT（暴露与反应预防）或基于家庭的心理教育与放松训练。我们将：1）评估通过情绪调节困难量表（DERS）测量的情绪调节障碍从基线到治疗结束是否降低；2）将情绪调节正常的参与者比例与健康对照（n = 90）的90%参考区间进行比较；3）使用线性回归检查基线情绪调节障碍是否调节由儿童耶鲁-布朗强迫症量表测量的治疗效果；4）调查情绪调节障碍的变化是否介导治疗效果；以及5）调查健康对照中情绪调节随时间的稳定性。分析1-4将对所有OCD参与者进行，并分别对两个治疗组进行。两名独立研究人员将进行分析。
本方案和统计分析计划旨在提高分析透明度并限制偏差。
