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Atopic DermatitisMIND-ADNCT07746427

Digital Mindfulness Meditation in Adolescents With Atopic Dermatitis

A study testing Digital App Mindfulness Meditation and Mindfulness Meditation Sheet in people with Atopic Dermatitis and Eczema, run by Weill Medical College of Cornell University at 2 sites in United States.

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Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Atopic Dermatitis, Eczema
What is being tested?
Digital App Mindfulness Meditation and Mindfulness Meditation Sheet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
15 Nov 2026to Jul 2028
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Adolescents age 13-17 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting
  • Weill Cornell Medicine

    New York, New York, 10021

    Dana O'Toole, (646) 962-3410, wcmpedsallergy@med.cornell.edu

    Dana O'Toole, MD

    Recruiting
  • Columbia University Irving Medical Center

    New York, New York, 10036

    Melissa Stockwell, 2123052300, pedsallergy@cumc.columbia.edu

    Melissa Stockwell, MD, MPH

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

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 13-17 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).

Being tested
Digital App Mindfulness Meditation, Mindfulness Meditation Sheet
Keywords
Meditation, mindfulness, digital health
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital App Mindfulness MeditationBehavioural

    Regular use of a digital mindfulness meditation app at least 3 times per week for 10 minutes each session.

  • Mindfulness Meditation SheetBehavioural

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

Study groups in NCT07746427
Study groupRoleWhat they receive
Mindfulness Meditation via Digital AppExperimentalParticipants will use of a mindfulness meditation digital app.
Receives: Behavioral: Digital App Mindfulness Meditation
Mindfulness Meditation SheetActive comparatorParticipants will read an information sheet on mindfulness meditation.
Receives: Behavioral: Mindfulness Meditation Sheet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Pre and post 1 month study observation period.

Secondary outcomes (2)
  1. 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.

    Measured: Pre and post 1 month study observation period.

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

    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 interview.

    Measured: 1 month post study observation period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2026
  2. Study start15 Nov 2026 (estimated)
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07746427
Sponsor's protocol ID
25-12029628
Acronym
MIND-AD
Status last verified
Oct 2026
First submitted
30 Jul 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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