RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-11-16
Study Completion:2026-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04697966

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Both genders, all ethnicities (see Section: Inclusion of Women and Minorities)
  2. * Ages 13-18 years
  3. * Written informed assent/consent from adolescent and parent/guardian
  4. * English as a first language or English fluency
  5. * Right-handed
  6. * Personal iPhone or Android smartphone
  7. * CRSQ rumination subscale score
  8. * If on psychotropic medication, must be on stable dose for at least 2 months
  1. * 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.
  2. * Systemic medical or neurological illness that could impact fMRI measures of cerebral blood flow
  3. * 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)
  4. * History of seizure disorder, or head trauma with loss of consciousness \> 2 mins
  5. * Serious or unstable medical illness (e.g., cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease)
  6. * Participants with active suicidal ideation will be immediately referred to appropriate clinical treatment.
  7. * Current or past treatment with mindfulness-based psychotherapy (e.g., MBCT, DBT or ACT)
  8. * Exposure to in-person or app-based mindfulness/meditation course (at least 300 mins of past practice)

Contacts and Locations

Study Contact

Christian Webb, Phd
CONTACT
6178554429
cwebb@mclean.harvard.edu

Study Locations (Sites)

McLean Hospital
Belmont, Massachusetts, 02478
United States

Collaborators and Investigators

Sponsor: Mclean Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-16
Study Completion Date2026-05-31

Study Record Updates

Study Start Date2021-11-16
Study Completion Date2026-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Rumination