Therapist-guided vs Self-guided CBT for AD: Non-inferiority Trial
NCT ID: NCT05517850
Last Updated: 2025-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
168 participants
INTERVENTIONAL
2022-11-29
2024-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Therapist-guided
12 weeks of therapist-guided, exposure-based intervention via tha internet, with comprehensive material
Therapist-guided cognitive behavioral therapy administered online
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.
Self-guided
12 weeks of self-guided, exposure-based intervention via the internet, with shortened and improved material
Self-guided digital intervention based on cognitive behavioral therapy
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.
Interventions
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Therapist-guided cognitive behavioral therapy administered online
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.
Self-guided digital intervention based on cognitive behavioral therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Martin Kraepelien
Licensed clinical psychologist, Principal investigator, PhD
Locations
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Centre for psychatry research
Stockholm, Stockholm County, Sweden
Countries
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References
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Kern D, Ljotsson B, Lonndahl L, Hedman-Lagerlof E, Molander O, Liliequist B, Bradley M, Lindefors N, Kraepelien M. Self-Guided vs Clinician-Guided Online Cognitive Behavioral Therapy for Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2025 Feb 1;161(2):183-190. doi: 10.1001/jamadermatol.2024.5044.
Kern D, Ljotsson B, Lonndahl L, Hedman-Lagerlof E, Bradley M, Lindefors N, Kraepelien M. Brief self-guided digital intervention versus a comprehensive therapist-guided online cognitive behavioural therapy for atopic dermatitis: a trial protocol for a randomised non-inferiority trial. BMJ Open. 2023 Feb 28;13(2):e068908. doi: 10.1136/bmjopen-2022-068908.
Other Identifiers
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CBTADNI
Identifier Type: -
Identifier Source: org_study_id
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