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

NCT05517850 | Completed

• 1 other identifier: CBTADNI
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Cognitive behavioral therapy; Self-guided intervention; Digital intervention; Exposure therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (1)

• Telephone interview

  Post treatment (12 weeks)

Study Arms (2)

Therapist-guided

ACTIVE COMPARATOR

12 weeks of therapist-guided, exposure-based intervention via tha internet, with comprehensive material

Behavioral: Therapist-guided cognitive behavioral therapy administered online

Self-guided

EXPERIMENTAL

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

Interventions

Therapist-guided cognitive behavioral therapy administered online BEHAVIORAL

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.

Therapist-guided

Self-guided digital intervention based on cognitive behavioral therapy BEHAVIORAL

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.

Self-guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Centre for psychatry research

Stockholm, Stockholm County, 11364, Sweden

Location

Related Publications (2)

• 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.

  PMID: 39693097 DERIVED

• 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.

  PMID: 36854583 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will know about the randomization to one of two types of cognitive behavioral therapy. Participants will have no way to know their assignment beforehand, or the defining characteristics of either condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Licensed clinical psychologist, Principal investigator, PhD

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: November 29, 2022
• Primary Completion: December 5, 2023
• Study Completion: October 1, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)