Actively Recruiting

Phase Not Applicable
Age: 13Years - 18Years
All Genders
Healthy Volunteers
NCT04697966

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

Led by Mclean Hospital · Updated on 2026-04-16

158

Participants Needed

1

Research Sites

358 weeks

Total Duration

On this page

Sponsors

M

Mclean Hospital

Lead Sponsor

C

Cambridge Health Alliance

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 significant promise in targeting rumination, and ultimately improving depressive and anxiety symptoms. Mindfulness apps offer a convenient and cost-effective means for accessing mindfulness training, while being interactive and engaging for youth. Despite their growing popularity among teens, strikingly little research has been conducted on these apps. Two critical questions have yet to be addressed: (1) what are the underlying neural and cognitive mechanisms that account for the beneficial effects of these apps and (2) for whom is app-based mindfulness well-suited. To address these gaps, adolescents (ages 13-18) will be randomly assigned to an app-delivered mindfulness course vs. a control condition and will complete pre- and post-intervention resting state functional magnetic resonance imaging (fMRI) scans to probe static and dynamic functional connectivity within - and between - brain networks strongly implicated in mindfulness training and rumination. In addition, cognitive tasks will be administered at pre- and post-intervention to assess attentional control abilities putatively enhanced by mindfulness training. Finally, mindfulness skills and changes in rumination will be assessed via smartphone-based ecological momentary assessment (EMA). First, the investigators will test whether changes in (1) brain functional connectivity, (2) attentional control and (3) acquisition and use of mindfulness skills mediate between-group (i.e., app vs. control) differences in the reduction of rumination. Second, the investigators will test whether a machine learning model incorporating baseline clinical, demographic, and psychosocial characteristics can be used to identify which adolescents are predicted to benefit from app-based mindfulness training.

CONDITIONS

Official Title

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

Who Can Participate

Age: 13Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Both genders, all ethnicities
  • 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
Not Eligible

You will not qualify if you...

  • History or current diagnosis of schizophrenia spectrum, psychotic disorder, bipolar disorder, or substance/alcohol use disorder within past 12 months or severe lifetime substance/alcohol use disorder
  • Systemic medical or neurological illness that could affect fMRI cerebral blood flow
  • Failure to meet standard fMRI exclusion criteria (e.g., pregnancy, claustrophobia, pacemakers, metal implants)
  • History of seizure disorder or head trauma with loss of consciousness over 2 minutes
  • Serious or unstable medical illness (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease)
  • Active suicidal ideation requiring immediate clinical referral
  • Current or past mindfulness-based psychotherapy (e.g., MBCT, DBT, ACT)
  • Prior exposure to in-person or app-based mindfulness/meditation course totaling at least 300 minutes

AI-Screening

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Trial Site Locations

Total: 1 location

1

McLean Hospital

Belmont, Massachusetts, United States, 02478

Actively Recruiting

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Research Team

C

Christian Webb, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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