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

Karolinska Institute

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Behavioral: Self-guided digital intervention based on cognitive behavioral therapy; Behavioral: Therapist-guided cognitive behavioral therapy administered online

Study type: Interventional

Funder types: Other

Identifiers

NCT05517850

CBTADNI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups

Therapist-guided

Active Comparator group

Description:

12 weeks of therapist-guided, exposure-based intervention via tha internet, with comprehensive material

Treatment:

Behavioral: Therapist-guided cognitive behavioral therapy administered online

Self-guided

Experimental group

Description:

12 weeks of self-guided, exposure-based intervention via the internet, with shortened and improved material

Treatment:

Behavioral: Self-guided digital intervention based on cognitive behavioral therapy