Status:
RECRUITING
Mechanisms and Predictors of Change in App-Based Mindfulness Training for Adolescents
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Cambridge Health Alliance
Lawrence University
Conditions:
Rumination
Eligibility:
All Genders
13-18 years
Phase:
NA
Brief Summary
A growing body of research implicates rumination as being a transdiagnostic risk factor involved in the development of depression and anxiety in youth. Critically, mindfulness meditation has shown sig...
Detailed Description
Mindfulness-based smartphone apps have surged in popularity in recent years. Headspace - among the most popular of these platforms - has over 42 million users. Recent surveys indicate that 11% of U.S....
Eligibility Criteria
Inclusion
- Both genders, all ethnicities (see Section: Inclusion of Women and Minorities)
- Ages 13-18 years
- Written informed assent/consent from adolescent and parent/guardian
- English as a first language or English fluency
- Right-handed
- Personal iPhone or Android smartphone
- CRSQ rumination subscale score
- If on psychotropic medication, must be on stable dose for at least 2 months
Exclusion
- History or current diagnosis of any of the following DSM-5 disorders: schizophrenia spectrum or other psychotic disorder, bipolar disorder, substance/alcohol use disorder within the past 12 months or lifetime severe substance/alcohol use disorder.
- Systemic medical or neurological illness that could impact fMRI measures of cerebral blood flow
- Failure to meet standard exclusion criteria for fMRI scanning (e.g. pregnancy, claustrophobia, cardiac or neural pacemakers, surgically implanted metal devices, cochlear implants, metal objects in the body)
- History of seizure disorder, or head trauma with loss of consciousness \> 2 mins
- Serious or unstable medical illness (e.g., cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease)
- Participants with active suicidal ideation will be immediately referred to appropriate clinical treatment.
- Current or past treatment with mindfulness-based psychotherapy (e.g., MBCT, DBT or ACT)
- Exposure to in-person or app-based mindfulness/meditation course (at least 300 mins of past practice)
Key Trial Info
Start Date :
November 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT04697966
Start Date
November 16 2021
End Date
May 31 2026
Last Update
May 7 2025
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478