An interventional study of Therapist-guided cognitive behavioral therapy administered online and Self-guided digital intervention based on cognitive behavioral therapy in Atopic Dermatitis, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 168 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Exclusion Criteria:
12 weeks of therapist-guided, exposure-based intervention via tha internet, with comprehensive material
Behavioral: Therapist-guided cognitive behavioral therapy administered online
12 weeks of self-guided, exposure-based intervention via the internet, with shortened and improved material
Behavioral: Self-guided digital intervention based on cognitive behavioral therapy
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.
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.
Change in atopic dermatitis symptoms
Patient oriented eczema scale (POEM). 7 items. Higher scores indicate greater severity of eczemic symptoms. Scores range from 0 to 28.
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)
Change in itching sensation
Peak pruritus rating scale (NRS). 2 items. Higher scores indicate more severe itch. Scores range from 1-10
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)
Change in stress reactivity
Perceived stress scale (PSS). 14 items. Higher scores indicate more stressed mood and greater reactivity. Score ranges from 0-56.
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)
Change in depressive symptoms
Patient Health Questionnaire.(PHQ-9). 9 items. Higher total scores indicate greater severity of depression. Scores range from 0 to 27.
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)
Change in skin-related quality of life
Dermatological Life Quality Index (DLQI). 10 items. Higher score indicate lower quality of life related to skin symptoms.Scores range from 0 to 30.
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)
Change in insomnia symptoms
Insomnia severity index (ISI). 7 items. Higher scores indicates more severe insomnia. Scores range from 0 to 28.
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)
Treatment credibility
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.
Time frame: 2 weeks after treatment start (baseline).
Intervention satisfaction
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.
Time frame: Post-treatment (12 weeks)
Quality of life for health economy analysis
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.
Time frame: Post treatment (week 12) to one-year follow-up (week 60)
Health economics
Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
Time frame: 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
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.
Time frame: Post-treatment (12 weeks)
Usability
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.
Time frame: Post-treatment (12 weeks)
Adverse events
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 frame: Post-treatment (12 weeks)
Time spent on treating
Time spent on treatment (ToT): Time in minutes spent by therapists on writing messeges, phone calls, etc.
Time frame: From week 1 to 12, throughout
Telephone interview
A semi-structured interview concerning the experience of the intervention and format will be conducted via telephone
Time frame: Post treatment (12 weeks)
Plan to share: No — Individual data will be available upon reasonable request.
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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