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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- 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
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).
- Conditions
- Atopic Dermatitis, Eczema
- 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 group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation via Digital App | Experimental | Participants will use of a mindfulness meditation digital app. Receives: Behavioral: Digital App Mindfulness Meditation |
| Mindfulness Meditation Sheet | Active comparator | Participants 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.
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)
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.
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.
- First posted5 Aug 2026
- Study start15 Nov 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Dana O'Toole, MD, Principal investigator, Weill Medical College of Cornell UniversityMelissa Stockwell, MD, MPH, Principal investigator, Columbia University
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