Digital Mindfulness Meditation in Adolescents With Atopic Dermatitis

NCT07746427 | Recruiting

• 1 other identifier: 25-12029628
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Atopic dermatitis is well reported to have a significant impact on well-being in adolescents with atopic dermatitis, without clear recommendations for intervention. The investigators aim to identify an accessible, effective digital health intervention for these patients. The investigators hypothesize that regular use of a digital mindfulness meditation app will improve disease control and quality of life in adolescents with moderate to severe atopic dermatitis based on validated survey measures.

Conditions

Eczema; Atopic Dermatitis

Keywords

Meditation; mindfulness; digital health

Outcome Measures

Primary Outcomes (2)

• Mean Atopic Dermatitis Control Tool (ADCT) score.

  Participants will complete the ADCT survey, a 6 question survey scoring between 0-24 points. Higher score indicates worse atopic dermatitis disease control.

  Pre and post 1 month study observation period.

• Mean Teenager Quality of Life (T-QoL) Index score

  Participants will complete the T-QoL index survey, an 18-question survey with scores between 0-36 points. Higher scores indicating worse quality of life in patients with dermatologic conditions.

  Pre and post 1 month study observation period.

Secondary Outcomes (1)

• Number of participants who found the digital app modality to be useful and accessible

  1 month post study observation period

Study Arms (2)

Mindfulness Meditation via Digital App

EXPERIMENTAL

Participants will use of a mindfulness meditation digital app.

Behavioral: Digital App Mindfulness Meditation

Mindfulness Meditation Sheet

ACTIVE COMPARATOR

Participants will read an information sheet on mindfulness meditation.

Behavioral: Mindfulness Meditation Sheet

Interventions

Digital App Mindfulness Meditation BEHAVIORAL

Regular use of a digital mindfulness meditation app 3-4 times per week for 10-15 minutes each session.

Mindfulness Meditation via Digital App

Mindfulness Meditation Sheet BEHAVIORAL

Participants will read an informational handout on mindfulness meditation at the start of the study.

Mindfulness Meditation Sheet

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents age 12-17 years.
• Atopic dermatitis refractory to standard topical treatment including topical steroids or topical calcineurin inhibitors.
• Moderate to severe atopic dermatitis via PO-SCORAD score on enrollment.

You may not qualify if:

• Started on a biologic agent (i.e. dupxient) within the past 3 months.
• Mild atopic dermatitis via PO-SCORAD score on enrollment.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Columbia University: collaborator

Study Sites (2)

Weill Cornell Medicine

New York, New York, 10021, United States

NOT YET RECRUITING

Columbia University Irving Medical Center

New York, New York, 10036, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

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 Officials

• Dana O'Toole, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Melissa Stockwell, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana A O'Toole, MD

CONTACT

646-962-3410; wcmallergy@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 5, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)