Comprehensive Therapist-guided Cognitive Behavioral Therapy for Atopic Dermatitis Versus a Shortened Digital Self-care Intervention: A Randomized Non-Inferiority Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Change in atopic dermatitis symptoms
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participants will know about the randomization to one of two types of cognitive behavioral therapy. Participants will have no way to know their assignment beforehand, or the defining characteristics of either condition.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Therapist-guided
12 weeks of therapist-guided, exposure-based intervention via tha internet, with comprehensive material
Intervention: Therapist-guided cognitive behavioral therapy administered online (Behavioral)
Self-guided
12 weeks of self-guided, exposure-based intervention via the internet, with shortened and improved material
Intervention: Self-guided digital intervention based on cognitive behavioral therapy (Behavioral)
Outcomes
Primary Outcomes
Change in atopic dermatitis symptoms
Time Frame: Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)
Patient oriented eczema scale (POEM). 7 items. Higher scores indicate greater severity of eczemic symptoms. Scores range from 0 to 28.
Secondary Outcomes
- Intervention satisfaction(Post-treatment (12 weeks))
- Change in itching sensation(Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60))
- Change in stress reactivity(Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60))
- Change in depressive symptoms(Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60))
- Change in insomnia symptoms(Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60))
- Quality of life for health economy analysis(Post treatment (week 12) to one-year follow-up (week 60))
- Usability(Post-treatment (12 weeks))
- Change in skin-related quality of life(Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60))
- Treatment credibility(2 weeks after treatment start (baseline).)
- Health economics(Change from pre-treatment (baseline) to post-treatment (week 12); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60))
- Post-treatment adherence to exposure exercises(Post-treatment (12 weeks))
- Adverse events(Post-treatment (12 weeks))
- Time spent on treating(From week 1 to 12, throughout)
Investigators
Martin Kraepelien
Licensed clinical psychologist, Principal investigator, PhD
Karolinska Institutet