Clinical trial NCT05517850: Therapist-guided vs Self-guided CBT for AD: Non-inferiority Trial
Official title: Comprehensive Therapist-guided Cognitive Behavioral Therapy for Atopic Dermatitis Versus a Shortened Digital Self-care Intervention: A Randomized Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Cognitive behavioral therapy
Self-guided intervention
Digital intervention
Exposure therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2022-08-26
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in atopic dermatitis symptoms
timeFrame: 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)
Secondary outcomes:
measure: Change in itching sensation
timeFrame: 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)
measure: Change in stress reactivity
timeFrame: 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)
measure: Change in depressive symptoms
timeFrame: 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)
measure: Change in skin-related quality of life
timeFrame: 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)
measure: Change in insomnia symptoms
timeFrame: 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)
measure: Treatment credibility
timeFrame: 2 weeks after treatment start (baseline).
measure: Intervention satisfaction
timeFrame: Post-treatment (12 weeks)
measure: Quality of life for health economy analysis
timeFrame: Post treatment (week 12) to one-year follow-up (week 60)
measure: Health economics
timeFrame: 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)
measure: Post-treatment adherence to exposure exercises
timeFrame: Post-treatment (12 weeks)
measure: Usability
timeFrame: Post-treatment (12 weeks)
measure: Adverse events
timeFrame: Post-treatment (12 weeks)
measure: Time spent on treating
timeFrame: From week 1 to 12, throughout
Other outcomes:
measure: Telephone interview
timeFrame: Post treatment (12 weeks)
Locations:
city: Stockholm
country: Sweden
facility: Centre for psychatry research
state: Stockholms Län
Study officials:
References: