NCT05517850

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
BEHAVIORAL	Therapist-guided cognitive behavioral therapy administered online	This intervention consists of 10 modules of education and interventions and lasts 12 weeks. An introduction provides information about CBT and AD. Step by step, the participants are introduced to the proposed active treatment components: mindfulness training, and exposure with response prevention. Through this whole process, the participant is guided by a therapist. The therapist may be contacted through a secure internet platform at any time and responds within 48 hours. Participants reads the education material, construct exercises to perform, describes their progress in homework assignments, and receives feedback from their therapist.
BEHAVIORAL	Self-guided digital intervention based on cognitive behavioral therapy	Participants will access a digital platform, read information, and perform exercises in their everyday life. The main treatment components are mindfulness and exposure with response prevention, with a specific focus on itch. Participants will be able to practice mindfulness with the help of instructions and examples. Participants will receive detailed instructions and guidance, and get to choose exposure exercises from a long list of examples. Participants will also be free to create their own relevant exposure situations within the intervention. Digital self-care consists of 8 modules. The only active interventions, mindfulness and exposure are introduced week 1 and 2, respectively. From week 3-7, no new interventions are introduced and participants are advised to continue practicing the interventions, but there is a new theme of education each week, to act as inspiration for exercises. The last 4 weeks, the participant is merely advised to continue practice.

Timeline

• Start date: 2022-11-29
• Primary completion: 2023-12-05
• Completion: 2024-10-01
• First posted: 2022-08-26
• Last updated: 2025-03-12

Locations

1 site across 1 country: Sweden