Digital Mindfulness Meditation in Adolescents With Atopic Dermatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorWeill Medical College of Cornell University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Started on a biologic agent (i.e. dupxient) within the past 3 months.
Mild atopic dermatitis via PO-SCORAD score on enrollment.
Trial design
Design model
Parallel
Treatments tested in this trial
Digital App Mindfulness Meditation
BehavioralRegular use of a digital mindfulness meditation app at least 3 times per week for 10 minutes each session.
Mindfulness Meditation Sheet
BehavioralParticipants will read an informational handout on mindfulness meditation at the start of the study.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Mindfulness Meditation via Digital AppExperimental treatment 1 intervention
Group B: Mindfulness Meditation SheetActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Pre and post 1 month study observation period.Secondary outcomes
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.
Time frame
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.
Time frame
1 month post study observation periodSponsors and contacts
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Weill Medical College of Cornell University
Lead sponsor
Columbia University
Collaborator
Source ClinicalTrials.gov