Clinical trial Recruiting at 1 site Interventional Ages 13 to 18

Mindfulness app training for adolescents to reduce rumination

Official title: Mechanisms and Predictors of Change in App-Based Mindfulness Training for Adolescents

Run by Mclean Hospital · NCT04697966 · Data updated 2026-11-12

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

Study typeInterventional
Ages13 Years to 18 Years
SexAll
Enrollment158 (estimated)
SponsorMclean Hospital
Academic / other
Locations1 site (Belmont, Massachusetts)
StatusRecruiting
StartedNovember 16, 2021
Main results expectedMay 31, 2027
Study endsSeptember 30, 2027
Registry record updatedJune 17, 2026
Trial IDNCT04697966 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adolescents aged 13-18 who are experiencing rumination and have access to a personal smartphone.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While mindfulness apps have gained popularity, this study addresses critical gaps in understanding their effectiveness and mechanisms, making it a novel approach.

Who can join: the full rules

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 it's running

  • McLean Hospital
    Belmont, Massachusetts, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.