基于家庭的认知行为疗法与基于家庭的心理教育和放松训练对儿童及青少年强迫症的疗效比较：一项随机临床试验（TECTO）
Family-based cognitive behavioral therapy versus family-based psychoeducation and relaxation training for obsessive-compulsive disorder in children and adolescents: a randomized clinical trial (TECTO).
作者信息
Pagsberg Anne Katrine, Lønfeldt Nicole Nadine, Thoustrup Christine Lykke, Korsbjerg Nicoline Løcke Jepsen, Uhre Camilla Funch, Christensen Sofie Heidenheim, Uhre Valdemar Funch, Mora-Jensen Anna-Rosa Cecilie, Ritter Melanie, Pretzmann Linea, Ingstrup Helga Kristensen, Moltke Birgitte Borgbjerg, Harboe Gitte Sommer, Thorsen Emilie Damløv, Clemmensen Line Katrine Harder, Lindschou Jane, Engstrøm Janus, Gluud Christian, Siebner Hartwig Roman, Thomsen Per Hove, Hybel Katja, Verhulst Frank, Baare William, Jeppesen Pia, Jepsen Jens Richardt Møllegaard, Vangkilde Signe, Olsen Markus Harboe, Hagstrøm Julie, Plessen Kerstin Jessica
机构信息
Child and Adolescent Mental Health Center, Copenhagen University Hospital - Mental Health Services CPH, Copenhagen, Denmark.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
出版信息
Eur Child Adolesc Psychiatry. 2025 Jul 31. doi: 10.1007/s00787-025-02797-4.
Few randomized clinical trials (RCTs) have compared cognitive behavioral therapy (CBT) versus active control interventions for pediatric obsessive-compulsive disorder (OCD), and the range of investigated outcomes has been limited. We investigated benefits and harms of family-based CBT with exposure and response prevention (FCBT) versus family-based psychoeducation and relaxation training (FPRT) in pediatric OCD. This single-center RCT was investigator-initiated, independently funded, including participants with OCD aged 8-17 years with a Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) entry score ≥ 16. We randomized participants 1:1 to 14 sessions of FCBT versus FPRT. Allocation was masked to assessors and statisticians. The primary outcome was CY-BOCS end-of-treatment-score (week-16) analyzed by intention-to-treat. Adverse events were reported by the Negative Effects Questionnaire (NEQ-20). One-hundred-and-thirty participants were randomized, 52.3% females; mean age 13.3 (SD = 2.9) years; mean CY-BOCS total score 25.8 (SD = 4.9); n = 64 to FCBT versus n = 66 to FPRT. Sixteen participants dropped out (four from FCBT, 12 from FPRT). The mean CY-BOCS total score at end-of-treatment was significantly lower for FCBT (15.9, SD = 8.7) versus FPRT (19.9, SD = 8.1), estimate - 3.89, 95%CI [-6.83, - 0.96), p = 0.01, effect size = 0.47, 95% CI [0.09, 0.85]. This difference was below our predefined minimal clinically important difference of four points. The average weekly NEQ frequency score showed no significant group differences. FCBT was associated with significantly larger symptom reduction than FPRT, but with a modest effect. FCBT and FPRT appeared comparably tolerable. A rigorous methodology enabled the counteraction of several biases. Limitations included missing self-reported data and inability of masking participants and treatment providers.
很少有随机临床试验（RCT）比较过认知行为疗法（CBT）与积极对照干预措施对儿童强迫症（OCD）的疗效，而且所研究的结果范围有限。我们调查了基于家庭的暴露与反应阻止认知行为疗法（FCBT）与基于家庭的心理教育和放松训练（FPRT）在儿童强迫症治疗中的益处和危害。这项单中心RCT由研究者发起，独立资助，纳入年龄在8至17岁、儿童耶鲁-布朗强迫症量表（CY-BOCS）初始评分≥16分的强迫症患者。我们将参与者按1:1随机分配至接受14节FCBT或FPRT治疗。评估者和统计人员对分组情况不知情。主要结局是按意向性分析的CY-BOCS治疗结束时（第16周）的评分。不良事件通过负性效应问卷（NEQ-20）进行报告。130名参与者被随机分组，其中52.3%为女性；平均年龄13.3（标准差=2.9）岁；CY-BOCS总分平均为25.8（标准差=4.9）；64人接受FCBT，66人接受FPRT。16名参与者退出（4名来自FCBT组，12名来自FPRT组）。治疗结束时，FCBT组的CY-BOCS总分（15.9，标准差=8.7）显著低于FPRT组（19.9，标准差=8.1），估计差值为-3.89，95%置信区间[-6.83，-0.96），p=0.01，效应量=0.47，95%置信区间[0.09，0.85]。这一差异低于我们预先定义的4分最小临床重要差异。平均每周NEQ频率评分在两组间无显著差异。FCBT组的症状减轻程度显著大于FPRT组，但效果中等。FCBT和FPRT的耐受性似乎相当。严谨的方法学能够抵消多种偏倚。局限性包括缺少自我报告数据以及无法对参与者和治疗提供者进行设盲。
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