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NCT Number: NCT07746427

Digital Mindfulness Meditation in Adolescents With Atopic Dermatitis

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center, New York, United States

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About this study

Atopic dermatitis (AD) is a significant chronic, relapsing, remitting, disease affecting children and adolescents, in terms of prevalence and impact on patient quality of life. Ten percent of individuals in the United States have AD, with prevalence peaking during childhood and adolescence. Over the past 25 years, prevalence of AD in has increased from 8% to 12%. Atopic dermatitis is known to significantly impact patient quality of life. Pruritis is known to be among the most burdensome symptoms. Many patients report severe pruritis significantly affecting sleep. Children and adolescents with AD are more likely to have depression, anxiety, and decreased well-being.

While there are increasing options for medical therapy for AD including new topical agents (i.e. Ruxolitinib) and biological agents (i.e. Dupilumab), refractory cases resulting in pruritus and decreased sleep quality would benefit from yet to be identified accessible digital behavioral interventions to improve quality of life in patients with AD, especially in adolescents where AD is more likely to be associated with depression, anxiety, and decreased well-being.

Mindfulness and meditation are known tools that can improve sleep, stress, anxiety, depression, and physical symptoms including pain. Mindfulness is defined as the act of keeping one's attention to the present moment without judgement and with acceptance. Meditation is one way to practice mindfulness, using the breath or walking as a focal point. There are numerous studies showing the benefits of mindfulness and meditation in adults, but this data is more limited in children and adolescents.

There are digital mindfulness meditation apps that are readily accessible to the general population for learning mindfulness and incorporating a meditation practice into day-to-day life in a digitally accessible manner. There are multiple studies investigating psychological interventions in patients with AD, however to the investigators' knowledge none include mindfulness meditation or an accessible app-based intervention in adolescents. Digital mindfulness meditation apps have been shown to be effective in reducing stress, improving sleep, and decreasing physical symptoms such as pain. Users of digital mindfulness meditation apps have reported satisfaction with ease of use and overall enjoyment of the app.

Patients with AD, especially adolescents, have been reported to have a high psychological burden of disease and an easy to use, accessible digital app intervention designed to be used a few times a week for a short period of time has a potential to have a significant impact on anxiety, depression, pruritus, sleep, and disease outcomes in adolescents with AD.

Objective 1: To measure self-reported disease control before and after a digital mindfulness meditation app-based intervention in adolescents with moderate-to-severe atopic dermatitis (AD). The investigators will administer the Atopic Dermatitis Control Tool (ADCT), a brief, validated, and easily scored 6-question survey to adolescents age 12-17 with moderate-to-severe atopic dermatitis at the start and end of the one-month study period comparing intervention (digital mindfulness meditation) to control (receipt of a mindfulness meditation information sheet).

Objective 2: To evaluate the impact of a digital mindfulness meditation app-based intervention on quality of life in adolescents with moderate-to-severe AD. The investigators will administer the Teenager's Quality of Life Index (T-QoL) an 18-question, self-explanatory, validated survey on quality of life in dermatologic conditions for adolescents that evaluates self-image, physical well-being and future aspirations, and psychological impact and relationships to study participants at the start and end of the one-month study period comparing intervention (digital mindfulness meditation) to control (receipt of a mindfulness meditation information sheet).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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 Sheet

Behavioral

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

Primary outcomes

  1. Mean Atopic Dermatitis Control Tool (ADCT) score.

    Time frame: Pre and post 1 month study observation period.

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

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

    Time frame: Pre and post 1 month study observation period.

    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.

Secondary outcomes

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

    Time frame: 1 month post study observation period

    Open ended questions will be asked to each participant about how they felt about the ease of use and accessibility of digital format in the form of an informal interview focus group

Study contacts

Contact information is provided by the study sponsor or research team.

Dana A O'Toole, MD

CONTACT

[email protected]

646-962-3410

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Columbia University

Registry information

Official study title

Outcomes of a Digital Mindfulness Meditation App-Based Intervention in Adolescents With Moderate to Severe Atopic Dermatitis (MIND-AD)

Acronym: MIND-AD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 5, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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