Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm Health Care Services, Region Stockholm, Karolinska University Hospital, Stockholm, Sweden.
Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
JAMA Netw Open. 2022 Mar 1;5(3):e221967. doi: 10.1001/jamanetworkopen.2022.1967.
Cognitive behavioral therapy (CBT) for obsessive-compulsive disorder (OCD) is a highly specialized treatment that is in short supply worldwide.
To investigate whether both therapist-guided and unguided internet-based CBT (ICBT) are noninferior to face-to-face CBT for adults with OCD, to conduct a health economic evaluation, and to determine whether treatment effects were moderated by source of participant referral.
DESIGN, SETTING, AND PARTICIPANTS: This study is a single-blinded, noninferiority, randomized clinical trial, with a full health economic evaluation, conducted between September 2015 and January 2020, comparing therapist-guided ICBT, unguided ICBT, and individual face-to-face CBT for adults with OCD. Follow-up data were collected up to 12 months after treatment. The study was conducted at 2 specialist outpatient OCD clinics in Stockholm, Sweden. Participants included a consecutive sample of adults with a primary diagnosis of OCD, either self-referred or referred by a clinician. Data analysis was performed from June 2019 to January 2022.
Guided ICBT, unguided ICBT, and face-to-face CBT delivered over 14 weeks.
The primary end point was the change in OCD symptom severity from baseline to 3-month follow-up. The noninferiority margin was 3 points on the masked assessor-rated Yale-Brown Obsessive Compulsive Scale.
A total of 120 participants were enrolled (80 women [67%]; mean [SD] age, 32.24 [9.64] years); 38 were randomized to the face-to-face CBT group, 42 were randomized to the guided ICBT group, and 40 were randomized to the unguided ICBT group. The mean difference between therapist-guided ICBT and face-to-face CBT at the primary end point was 2.10 points on the Yale-Brown Obsessive Compulsive Scale (90% CI, -0.41 to 4.61 points; P = .17), favoring face-to-face CBT, meaning that the primary noninferiority results were inconclusive. The difference between unguided ICBT and face-to-face CBT was 5.35 points (90% CI, 2.76 to 7.94 points; P < .001), favoring face-to-face CBT. The health economic analysis showed that both guided and unguided ICBT were cost-effective compared with face-to-face CBT. Source of referral did not moderate treatment outcome. The most common adverse events were anxiety (30 participants [25%]), depressive symptoms (20 participants [17%]), and stress (11 participants [9%]).
The findings of this randomized clinical trial of ICBT vs face-to-face CBT for adults with OCD do not conclusively demonstrate noninferiority. Therapist-guided ICBT could be a cost-effective alternative to in-clinic CBT for adults with OCD in scenarios where traditional CBT is not readily available; unguided ICBT is probably less efficacious but could be an alternative when providing remote clinician support is not feasible.
ClinicalTrials.gov Identifier: NCT02541968.
针对强迫症（OCD）的认知行为疗法（CBT）是一种高度专业化的治疗方法，在全球范围内供应不足。
研究督导和非督导的基于互联网的认知行为疗法（ICBT）是否与面对面认知行为疗法（CBT）对强迫症成人患者同样有效，进行健康经济学评估，并确定治疗效果是否受患者转诊来源的影响。
设计、地点和参与者：这是一项单盲、非劣效性、随机临床试验，进行了全面的健康经济学评估，比较了督导的 ICBT、非督导的 ICBT 和个体面对面 CBT 对强迫症成人患者的治疗效果。治疗后随访数据收集长达 12 个月。研究在瑞典斯德哥尔摩的 2 个专科门诊强迫症诊所进行。参与者包括由临床医生转介或自我转诊的强迫症成人患者。数据分析于 2019 年 6 月至 2022 年 1 月进行。
接受为期 14 周的督导 ICBT、非督导 ICBT 和面对面 CBT。
主要结局是从基线到 3 个月随访时 OCD 症状严重程度的变化。无偏评估者评定的耶鲁-布朗强迫症量表的非劣效性边界为 3 分。
共有 120 名患者入组（80 名女性[67%]；平均[标准差]年龄为 32.24[9.64]岁）；38 名患者被随机分配到面对面 CBT 组，42 名患者被随机分配到督导的 ICBT 组，40 名患者被随机分配到非督导的 ICBT 组。在主要结局点，督导的 ICBT 与面对面 CBT 之间的平均差异为耶鲁-布朗强迫症量表 2.10 分（90%CI，-0.41 至 4.61 分；P=0.17），有利于面对面 CBT，这意味着主要的非劣效性结果不确定。非督导的 ICBT 与面对面 CBT 之间的差异为 5.35 分（90%CI，2.76 至 7.94 分；P<0.001），有利于面对面 CBT。健康经济学分析表明，与面对面 CBT 相比，督导和非督导的 ICBT 均具有成本效益。转诊来源并未影响治疗效果。最常见的不良事件是焦虑（30 名患者[25%]）、抑郁症状（20 名患者[17%]）和压力（11 名患者[9%]）。
这项针对 OCD 成人患者 ICBT 与面对面 CBT 的随机临床试验的结果并未明确证明非劣效性。在传统 CBT 不易获得的情况下，督导的 ICBT 可能是 OCD 成人患者的一种具有成本效益的替代治疗方法；非督导的 ICBT 可能效果较差，但在提供远程临床支持不可行时可能是一种替代方法。
ClinicalTrials.gov 标识符：NCT02541968。
