Therapist-guided vs Self-guided CBT for AD: Non-inferiority Trial

Comprehensive Therapist-guided Cognitive Behavioral Therapy for Atopic Dermatitis Versus a Shortened Digital Self-care Intervention: A Randomized Non-Inferiority Trial

The study aims to test the hypothesized non-inferiority of a self-guided digital intervention compared to a therapist-guided variant for people with atopic dermatitis (AD). Both interventions are based on Cognitive behavioral therapy. Participants will be recruited from advertisements in social media. Measurements of AD symptoms and psychological well-being will be conducted at pre-treatment, post-treatment as well as 6-month and one-year follow-up.

Background: Digital self-care based on Cognitive-behavioral therapy (CBT) could be an effective alternative to guided CBT for people with atopic dermatitis (AD) and has the theoretical potential to significantly increase access to psychological treatment for patients with AD, whilst being cost-effective for health care organizations.

Aim: To investigate whether a shortened digital self-care intervention is noninferior to, and cost-effective compared with, a comprehensive and therapist-guided CBT treatment for AD.

Intervention: Participants randomized to guided care will receive internet-delivered cognitive behavior therapy for 12 weeks. Participants randomized to digital self-care will have access to a self-guided intervention for 12 weeks_

Design, setting, and participants: This is a single-blind, randomized clinical non-inferiority trial at Karolinska Institutet, a medical university in Stockholm, Sweden. 174 adult participants with AD will be recruited through self-referral. Participants will be randomized 1:1 to the two experimental conditions. At post-treatment (primary endpoint), non-inferiority will be tested and resource use will be compared between the two treatment groups. Cost-effectiveness will be explored at 1-year follow-up. Potential mediators will be investigated. Data will be analyzed intention-to-treat.

Inclusion Criteria:

• Self-reported AD diagnosed by physician (potential participants will disclose the circumstances of their diagnosis)
• No new types of medications introduced for six months prior, with no intention of future change
• Able to understand Swedish
• Access to the internet and a smartphone

Exclusion Criteria:

• Other disease or condition that has immediate treatment priority over AD. This could be an ongoing demanding treatment of a severe somatic or psychiatric condition. No specific diagnoses are inevitably a cause for exclusion, as potential participants will rather be evaluated on a case-to-case basis.