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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comprehensive Therapist-guided Cognitive Behavioral Therapy for Atopic Dermatitis Versus a Shortened Digital Self-care Intervention: A Randomized Non-Inferiority Trial

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Behavioral: Therapist-guided cognitive behavioral therapy administered online
* Behavioral: Self-guided digital intervention based on cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Therapist-guided<br>12 weeks of therapist-guided, exposure-based intervention via tha internet, with comprehensive material | Behavioral: Therapist-guided cognitive behavioral therapy administered online<br>* 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.<br>|
| Experimental: Self-guided<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in itching sensation | Peak pruritus rating scale (NRS). 2 items. Higher scores indicate more severe itch. Scores range from 1-10 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Post treatment (week 12) to one-year follow-up (week 60) | 
| Health economics | Treatment Inventory of Costs in Psychiatric Patients (TIC-P) | 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. | 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. | 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. | 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. | From week 1 to 12, throughout | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive behavioral therapy, Self-guided intervention, Digital intervention, Exposure therapy