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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of a Digital Mindfulness Meditation App-Based Intervention in Adolescents With Moderate to Severe Atopic Dermatitis (MIND-AD)
- ClinicalTrials.gov ID
- NCT07746427
- Acronym / sponsor ID
- MIND-AD / 25-12029628
- Conditions
- Atopic Dermatitis, Eczema
- Keywords
- Meditation, mindfulness, digital health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation via Digital App | Experimental | Behavioral: Digital App Mindfulness MeditationParticipants will use of a mindfulness meditation digital app. |
| Mindfulness Meditation Sheet | Active comparator | Behavioral: Mindfulness Meditation SheetParticipants will read an information sheet on mindfulness meditation. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Started on a biologic agent (i.e. dupxient) within the past 3 months.
- Mild atopic dermatitis via PO-SCORAD score on enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital App Mindfulness MeditationRegular use of a digital mindfulness meditation app at least 3 times per week for 10 minutes each session. | Behavioural | Mindfulness Meditation via Digital App |
| Mindfulness Meditation SheetParticipants will read an informational handout on mindfulness meditation at the start of the study. | Behavioural | Mindfulness Meditation Sheet |
Primary outcome
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 secondary outcomes
Mean Teenager Quality of Life (T-QoL) Index score
Time frame: Pre and post 1 month study observation period.
Number of participants who found the digital app modality to be useful and accessible
Time frame: 1 month post study observation period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dana O'Toole, MD principal investigator
Weill Medical College of Cornell University
Melissa Stockwell, MD, MPH principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana A O'Toole, MD (646-962-3410, wcmpedsallergy@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Atopic Dermatitis Control Tool (ADCT) score. (time frame: Pre and post 1 month study observation period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.