Dorian Kern, Brjánn Ljótsson, Louise Lönndahl, Erik Hedman-Lagerlöf, Olof Molander, Björn Liliequist, Maria Bradley, Nils Lindefors, Martin Kraepelien
{"title":"特应性皮炎的自我指导与医生指导在线认知行为疗法：随机临床试验","authors":"Dorian Kern, Brjánn Ljótsson, Louise Lönndahl, Erik Hedman-Lagerlöf, Olof Molander, Björn Liliequist, Maria Bradley, Nils Lindefors, Martin Kraepelien","doi":"10.1001/jamadermatol.2024.5044","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>To investigate whether a brief online self-guided CBT intervention is noninferior to a comprehensive online clinician-guided CBT treatment.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Interventions: </strong>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.</p><p><strong>Main outcomes and measures: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions and relevance: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT05517850.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5000,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Self-Guided vs Clinician-Guided Online Cognitive Behavioral Therapy for Atopic Dermatitis: A Randomized Clinical Trial.\",\"authors\":\"Dorian Kern, Brjánn Ljótsson, Louise Lönndahl, Erik Hedman-Lagerlöf, Olof Molander, Björn Liliequist, Maria Bradley, Nils Lindefors, Martin Kraepelien\",\"doi\":\"10.1001/jamadermatol.2024.5044\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>To investigate whether a brief online self-guided CBT intervention is noninferior to a comprehensive online clinician-guided CBT treatment.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Interventions: </strong>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.</p><p><strong>Main outcomes and measures: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions and relevance: </strong>In this randomized clinical noninferiority trial, a brief self-guided CBT intervention was noninferior to clinician-guided CBT. 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Self-Guided vs Clinician-Guided Online Cognitive Behavioral Therapy for Atopic Dermatitis: A Randomized Clinical Trial.
Importance: 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.
Objective: 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.
Interventions: 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.
Main outcomes and measures: 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.
Results: 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.
Conclusions and relevance: 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.
期刊介绍：
JAMA Dermatology is an international peer-reviewed journal that has been in continuous publication since 1882. It began publication by the American Medical Association in 1920 as Archives of Dermatology and Syphilology. The journal publishes material that helps in the development and testing of the effectiveness of diagnosis and treatment in medical and surgical dermatology, pediatric and geriatric dermatology, and oncologic and aesthetic dermatologic surgery.
JAMA Dermatology is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications. It is published online weekly, every Wednesday, and in 12 print/online issues a year. The mission of the journal is to elevate the art and science of health and diseases of skin, hair, nails, and mucous membranes, and their treatment, with the aim of enabling dermatologists to deliver evidence-based, high-value medical and surgical dermatologic care.
The journal publishes a broad range of innovative studies and trials that shift research and clinical practice paradigms, expand the understanding of the burden of dermatologic diseases and key outcomes, improve the practice of dermatology, and ensure equitable care to all patients. It also features research and opinion examining ethical, moral, socioeconomic, educational, and political issues relevant to dermatologists, aiming to enable ongoing improvement to the workforce, scope of practice, and the training of future dermatologists.
JAMA Dermatology aims to be a leader in developing initiatives to improve diversity, equity, and inclusion within the specialty and within dermatology medical publishing.
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