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).

IF 4.9 2区 医学 Q1 PEDIATRICS
Anne Katrine Pagsberg, Nicole Nadine Lønfeldt, Christine Lykke Thoustrup, Nicoline Løcke Jepsen Korsbjerg, Camilla Funch Uhre, Sofie Heidenheim Christensen, Valdemar Funch Uhre, Anna-Rosa Cecilie Mora-Jensen, Melanie Ritter, Linea Pretzmann, Helga Kristensen Ingstrup, Birgitte Borgbjerg Moltke, Gitte Sommer Harboe, Emilie Damløv Thorsen, Line Katrine Harder Clemmensen, Jane Lindschou, Janus Engstrøm, Christian Gluud, Hartwig Roman Siebner, Per Hove Thomsen, Katja Hybel, Frank Verhulst, William Baare, Pia Jeppesen, Jens Richardt Møllegaard Jepsen, Signe Vangkilde, Markus Harboe Olsen, Julie Hagstrøm, Kerstin Jessica Plessen
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引用次数: 0

Abstract

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.

以家庭为基础的认知行为疗法与以家庭为基础的心理教育和放松训练治疗儿童和青少年强迫症:一项随机临床试验(TECTO)。
很少有随机临床试验(rct)比较认知行为疗法(CBT)和主动控制干预治疗儿童强迫症(OCD),而且研究结果的范围有限。我们研究了以家庭为基础的CBT加暴露和反应预防(FCBT)与以家庭为基础的心理教育和放松训练(FPRT)治疗儿童强迫症的利弊。该单中心随机对照试验由研究者发起,独立资助,包括8-17岁的强迫症患者,儿童耶鲁-布朗强迫症量表(CY-BOCS)评分≥16分。我们对参与者进行了1:1 - 14次FCBT和FPRT的随机分组。分配对评估人员和统计人员是隐瞒的。主要终点是CY-BOCS治疗结束评分(第16周),通过意向治疗分析。不良事件采用负面影响问卷(NEQ-20)进行报告。随机选取130名受试者,女性占52.3%;平均年龄13.3 (SD = 2.9)岁;CY-BOCS总分平均25.8分(SD = 4.9);ffcbt组n = 64, FPRT组n = 66。16名参与者退出(4名来自FCBT, 12名来自FPRT)。治疗结束时FCBT的CY-BOCS平均总分(15.9,SD = 8.7)显著低于FPRT (19.9, SD = 8.1),估计值- 3.89,95%CI [-6.83, - 0.96], p = 0.01,效应值= 0.47,95%CI[0.09, 0.85]。这一差异低于我们预定的最小临床重要差异4分。平均每周NEQ频率得分组间无显著差异。与FPRT相比,FCBT与显著更大的症状减轻相关,但效果一般。FCBT和FPRT表现出相当的可耐受性。严谨的方法使若干偏见得以抵消。局限性包括缺失自我报告数据和无法掩盖参与者和治疗提供者。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
12.80
自引率
4.70%
发文量
186
审稿时长
6-12 weeks
期刊介绍: European Child and Adolescent Psychiatry is Europe''s only peer-reviewed journal entirely devoted to child and adolescent psychiatry. It aims to further a broad understanding of psychopathology in children and adolescents. Empirical research is its foundation, and clinical relevance is its hallmark. European Child and Adolescent Psychiatry welcomes in particular papers covering neuropsychiatry, cognitive neuroscience, genetics, neuroimaging, pharmacology, and related fields of interest. Contributions are encouraged from all around the world.
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