Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.
Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.
JAMA. 2021 May 11;325(18):1863-1873. doi: 10.1001/jama.2021.3839.
In most countries, young people with obsessive-compulsive disorder have limited access to specialist cognitive behavioral therapy (CBT), a first-line treatment.
To investigate whether internet-delivered CBT implemented in a stepped-care model is noninferior to in-person CBT for pediatric obsessive-compulsive disorder.
DESIGN, SETTING AND PARTICIPANTS: A randomized clinical noninferiority trial conducted at 2 specialist child and adolescent mental health clinics in Sweden. Participants included 152 individuals aged 8 to 17 years with obsessive-compulsive disorder. Enrollment began in October 2017 and ended in May 2019. Follow-up ended in April 2020.
Participants randomized to the stepped-care group (n = 74) received internet-delivered CBT for 16 weeks. Nonresponders at the 3-month follow-up were then offered a course of traditional face-to-face treatment. Participants randomized to the control group (n = 78) immediately received in-person CBT for 16 weeks. Nonresponders at the 3-month follow-up received additional face-to-face treatment.
The primary outcome was the masked assessor-rated Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score at the 6-month follow-up. The scale includes 10 items rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total score range of 0 to 40, with higher scores indicating greater severity. Assessors were masked to treatment allocation at pretreatment, posttreatment, 3-month follow-up, and 6-month follow-up assessments. The predefined noninferiority margin was 4 points on the CY-BOCS.
Among the 152 randomized participants (mean age, 13.4 years; 94 [62%] females), 151 (99%) completed the trial. At the 3-month follow-up, 34 participants (46%) in the stepped-care group and 23 (30%) in the in-person CBT group were nonresponders. At the 6-month follow-up, the CY-BOCS score was 11.57 points in the stepped-care group vs 10.57 points in the face-to-face treatment group, corresponding to an estimated mean difference of 0.91 points ([1-sided 97.5% CI, -∞ to 3.28]; P for noninferiority = .02). Increased anxiety (30%-36%) and depressive symptoms (20%-28%) were the most frequently reported adverse events in both groups. There were 2 unrelated serious adverse events (1 in each group).
Among children and adolescents with obsessive-compulsive disorder, treatment with an internet-delivered CBT program followed by in-person CBT if necessary compared with in-person CBT alone resulted in a noninferior difference in symptoms at the 6-month follow-up. Further research is needed to understand the durability and generalizability of these findings.
ClinicalTrials.gov Identifier: NCT03263546.
在大多数国家，患有强迫症的年轻人获得专科认知行为疗法（CBT）的机会有限，而 CBT 是强迫症的一线治疗方法。
研究在阶梯式护理模式中实施的互联网提供的 CBT 是否不比面对面的 CBT 更适用于儿科强迫症。
设计、地点和参与者：在瑞典的 2 家专业儿童和青少年心理健康诊所进行的一项随机临床试验。参与者包括 152 名年龄在 8 至 17 岁之间的强迫症患者。招募于 2017 年 10 月开始，2019 年 5 月结束。随访于 2020 年 4 月结束。
随机分配到阶梯式护理组的参与者（n=74）接受了 16 周的互联网提供的 CBT。在 3 个月随访时无反应的患者随后接受了传统面对面治疗的疗程。随机分配到对照组的参与者（n=78）立即接受了 16 周的面对面 CBT。在 3 个月随访时无反应的患者接受了额外的面对面治疗。
主要结局是在 6 个月随访时评估者评定的儿童耶鲁-布朗强迫症量表（CY-BOCS）评分。该量表包含 10 个项目，从 0（无症状）到 4（极度症状）评分，总得分范围为 0 到 40，得分越高表示症状越严重。评估者在治疗前、治疗后、3 个月随访和 6 个月随访时均对治疗分配进行了盲法评估。预设的非劣效性边界为 CY-BOCS 的 4 分。
在 152 名随机参与者中（平均年龄 13.4 岁，94 [62%] 为女性），151 名（99%）完成了试验。在 3 个月随访时，阶梯式护理组有 34 名（46%）患者和面对面治疗组有 23 名（30%）患者无反应。在 6 个月随访时，阶梯式护理组的 CY-BOCS 评分为 11.57 分，面对面治疗组为 10.57 分，估计平均差异为 0.91 分（[1 侧 97.5%CI，-∞ 至 3.28]；P 值非劣效性=0.02）。两组中最常报告的不良事件是焦虑增加（30%-36%）和抑郁症状（20%-28%）。两组各有 1 例与治疗无关的严重不良事件。
在患有强迫症的儿童和青少年中，与单独面对面 CBT 相比，接受互联网提供的 CBT 方案治疗，如有必要再进行面对面 CBT，在 6 个月随访时症状改善程度无差异。需要进一步研究以了解这些发现的持久性和普遍性。
ClinicalTrials.gov 标识符：NCT03263546。
