Kern Dorian, Ljótsson Brjánn, Lönndahl Louise, Hedman-Lagerlöf Erik, Molander Olof, Liliequist Björn, Bradley Maria, Lindefors Nils, Kraepelien Martin
Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden.
Centre for Psychiatry Research, Stockholm County Health Care Provision, Stockholm, Sweden.
JAMA Dermatol. 2025 Feb 1;161(2):183-190. doi: 10.1001/jamadermatol.2024.5044.
Clinician-guided online self-help based on cognitive behavioral therapy (CBT) has been shown to be effective at decreasing symptom severity for people with atopic dermatitis (AD). A brief online self-guided CBT intervention could be more cost-effective and allow for easy implementation and broader outreach compared with more comprehensive clinician-guided interventions.
To investigate whether a brief online self-guided CBT intervention is noninferior to a comprehensive online clinician-guided CBT treatment.
DESIGN, SETTING, AND PARTICIPANTS: This single-blind randomized clinical noninferiority trial was conducted at Karolinska Institutet, Stockholm, Sweden. Adult individuals with AD were enrolled from November 2022 to April 2023. The last postintervention data were collected in December 2023.
Participants randomized to the self-guided group had access to a self-guided online CBT intervention for 12 weeks without clinician support. Participants randomized to the clinician-guided group received online CBT for 12 weeks.
The primary outcome was change in score from baseline to postintervention to 12-week follow-up on the self-reported Patient-Oriented Eczema Measure (POEM). The predefined noninferiority margin was 3 points on POEM.
Of 168 randomized participants, 142 (84.5%) were female, and the mean (SD) age was 39 (10.5) years. A total of 86 participants were randomized to the self-guided group and 82 were randomized to the clinician-guided group. A total of 151 (90.0%) completed the main outcome postintervention assessment. Postintervention, the clinician-guided group had improved 4.20 points (95% CI, 1.94-6.05) on POEM and the self-guided group improved 4.60 points (95% CI, 2.57-6.64), corresponding to an estimated mean difference in change of 0.36 points (1-sided 97.5% CI, -∞ to 1.75), which was below the noninferiority margin of 3 points. No serious adverse events were reported. In the clinician-guided group, clinicians spent a mean (SD) of 36.0 (33.3) minutes (95% CI, 29.2-41.7) on treatment guidance and 14.0 (6.0) minutes (95% CI, 12.9-15.6) on assessments compared to 15.8 (6.4) minutes on assessments in the self-guided group.
In this randomized clinical noninferiority trial, a brief self-guided CBT intervention was noninferior to clinician-guided CBT. Given the limited clinical resources required to deliver self-guided CBT, this treatment might be a promising means to disseminate evidence-based psychological treatment for patients with AD.
ClinicalTrials.gov Identifier: NCT05517850.
基于认知行为疗法（CBT）的临床医生指导的在线自助已被证明能有效降低特应性皮炎（AD）患者的症状严重程度。与更全面的临床医生指导干预相比，简短的在线自我指导CBT干预可能更具成本效益，且易于实施和扩大推广范围。
研究简短的在线自我指导CBT干预是否不劣于全面的在线临床医生指导的CBT治疗。
设计、背景和参与者：这项单盲随机临床非劣效性试验在瑞典斯德哥尔摩的卡罗林斯卡学院进行。2022年11月至2023年4月招募了患有AD的成年个体。最后一次干预后数据于2023年12月收集。
随机分配到自我指导组的参与者可在无临床医生支持的情况下，进行为期12周的在线自我指导CBT干预。随机分配到临床医生指导组的参与者接受为期12周的在线CBT。
主要结局是从基线到干预后再到12周随访时，自我报告的以患者为导向的湿疹测量（POEM）得分的变化。预先定义的非劣效性界值为POEM上3分。
168名随机参与者中，142名（84.5%）为女性，平均（标准差）年龄为39（10.5）岁。共有86名参与者被随机分配到自我指导组，82名被随机分配到临床医生指导组。共有151名（90.0%）完成了干预后的主要结局评估。干预后，临床医生指导组的POEM得分提高了4.20分（95%置信区间，1.94 - 6.05），自我指导组提高了4.60分（95%置信区间，2.57 - 6.64），估计变化的平均差异为0.36分（单侧97.5%置信区间，-∞至1.75），低于3分的非劣效性界值。未报告严重不良事件。在临床医生指导组中，临床医生在治疗指导上平均（标准差）花费36.0（33.3）分钟（95%置信区间，29.2 - 41.7），在评估上花费14.0（6.0）分钟（95%置信区间，12.9 - 15.6），而自我指导组在评估上花费15.8（6.4）分钟。
在这项随机临床非劣效性试验中，简短的自我指导CBT干预不劣于临床医生指导的CBT。鉴于提供自我指导CBT所需的临床资源有限，这种治疗可能是为AD患者传播循证心理治疗的一种有前景的手段。
ClinicalTrials.gov标识符：NCT05517850。
