Therapist-guided vs Self-guided CBT for AD: Non-inferiority Trial
- Conditions
- Atopic Dermatitis
- Interventions
- Behavioral: Self-guided digital intervention based on cognitive behavioral therapyBehavioral: Therapist-guided cognitive behavioral therapy administered online
- Registration Number
- NCT05517850
- Lead Sponsor
- Karolinska Institutet
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 168
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Self-guided Self-guided digital intervention based on cognitive behavioral therapy 12 weeks of self-guided, exposure-based intervention via the internet, with shortened and improved material Therapist-guided Therapist-guided cognitive behavioral therapy administered online 12 weeks of therapist-guided, exposure-based intervention via tha internet, with comprehensive material
- Primary Outcome Measures
Name Time Method Change in atopic dermatitis 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) Patient oriented eczema scale (POEM). 7 items. Higher scores indicate greater severity of eczemic symptoms. Scores range from 0 to 28.
- Secondary Outcome Measures
Name Time Method Intervention satisfaction Post-treatment (12 weeks) Client Satisfaction Questionnaire (CSQ-8). Scores range from 8-32 with higher scores indicating greater satisfaction. An average Client Satisfaction Questionnaire-8 score of at least 22 will provide support for the acceptability and feasibility of this intervention.
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) Peak pruritus rating scale (NRS). 2 items. Higher scores indicate more severe itch. Scores range from 1-10
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) Perceived stress scale (PSS). 14 items. Higher scores indicate more stressed mood and greater reactivity. Score ranges from 0-56.
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) Patient Health Questionnaire.(PHQ-9). 9 items. Higher total scores indicate greater severity of depression. Scores range from 0 to 27.
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) Insomnia severity index (ISI). 7 items. Higher scores indicates more severe insomnia. Scores range from 0 to 28.
Quality of life for health economy analysis Post treatment (week 12) to one-year follow-up (week 60) Euro quality of life 5 dimensions (EQ5D). 5 items. Higher scored indicate higher quality of life. A calculation gives a total score from 0 to 100.
Usability Post-treatment (12 weeks) The System Usability Scale (SUS). The SUS consists of ten items, with a range of 0-4 points per item. The items are summed up and calculated with a formula resulting in a total score between 0 and 100, with a higher score reflecting better system usability.
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) Dermatological Life Quality Index (DLQI). 10 items. Higher score indicate lower quality of life related to skin symptoms.Scores range from 0 to 30.
Treatment credibility 2 weeks after treatment start (baseline). Credibility/expectancy questionnaire (CEQ). The CEQ ranges from 0 to 10 points per item and 0 to 50 points in total, where a higher score reflects better treatment credibility.
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) Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
Post-treatment adherence to exposure exercises Post-treatment (12 weeks) Time spent on exercises (ToE) Adherence to the exposure exercises will be determined by an online questionnaire where it will be stated on a four point Likert scale will state to what extent participants have worked with exposure: "not at all", "occasionally", "more than half of the days" and "daily". Acceptable level of adherence will be set to at least 50 % of participants working actively with exposure a majority of the days during a week for 4 weeks or more.
Adverse events Post-treatment (12 weeks) Adverse events (AE). Participants are asked if they have had an adverse event as a result of treatment, and if so to describe it. If they have experienced more than oneadverse event, the question is repeated.
Time spent on treating From week 1 to 12, throughout Time spent on treatment (ToT): Time in minutes spent by therapists on writing messeges, phone calls, etc.
Trial Locations
- Locations (1)
Centre for psychatry research
🇸🇪Stockholm, Stockholms Län, Sweden