Mindfulness app training for adolescents to reduce rumination
Mechanisms and Predictors of Change in App-Based Mindfulness Training for Adolescents
This study is testing whether using a mindfulness app can help teenagers aged 13-18 feel less anxious and depressed by reducing their tendency to overthink.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 1 site (Belmont, Massachusetts) |
| Trial ID | NCT04697966 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a mindfulness app, specifically Headspace, in reducing rumination and improving symptoms of depression and anxiety in adolescents aged 13-18. Participants will be randomly assigned to either the mindfulness app or an active control condition and will undergo pre- and post-intervention fMRI scans to explore the neural mechanisms involved. The research aims to identify the cognitive processes that contribute to the benefits of app-based mindfulness training and determine which adolescents may benefit most from this approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 13-18 who are experiencing rumination and have access to a personal smartphone.
Not a fit: Patients with a history of severe mental health disorders or those who do not meet the eligibility criteria for fMRI scanning may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide adolescents with an effective tool to manage rumination and reduce symptoms of depression and anxiety.
How similar studies have performed: While mindfulness apps have gained popularity, this study addresses critical gaps in understanding their effectiveness and mechanisms, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where this trial is running
Belmont, Massachusetts
- McLean Hospital — Belmont, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Christian Webb, Phd
- Email: cwebb@mclean.harvard.edu
- Phone: 6178554429
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.