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NCT04697966 · ClinicalTrials.gov registry record · NA

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

A NA study of Rumination, sponsored by Mclean Hospital.

Recruiting
Registry status
NA
Development phase
158
Enrollment target
1
Study location

NCT04697966: Recruiting NA study of Rumination, sponsored by Mclean Hospital.

NCT04697966 is a NA study of Rumination that is actively recruiting participants, run by Mclean Hospital. The registered enrollment target is 158 participants, above the 37-participant average among 7 other Rumination trials with a reported enrollment target (327% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04697966, a NA study of Rumination, is actively recruiting participants, sponsored by Mclean Hospital.

RECRUITING
Registry status
NA
Development phase
158 participants
Enrollment target
1
Study location

Study 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 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 Studied

Interventions

  • BEHAVIORAL Mindfulness (Headspace) App
  • BEHAVIORAL Active Control Condition ("Recharge" condition delivered in Headspace app)

Study Locations (1)

Massachusetts

  • McLean Hospital - Belmont

Trial Details

FieldValue
Enrollment Target 158 participants
Start Date 2021-11-16
Est. Completion 2026-05-31
Phase NA
Mclean Hospital

140 total trials

What NCT04697966 shows while recruiting

NCT04697966 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, above the 37-participant average among 7 other Rumination trials with a reported enrollment target (327% higher).

The record links to 1 condition, with Rumination appearing as the primary indexed condition, and to 2 interventions - of which Mindfulness (Headspace) App is the first listed.

NCT04697966 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT04697966 about?

NCT04697966 is a clinical study titled "Mechanisms and Predictors of Change in App-Based Mindfulness Training for Adolescents". 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. ...

What is the current status of trial NCT04697966?

This trial is currently recruiting. It is a NA study. The enrollment target is 158 participants. The study started on 2021-11-16. Estimated completion is 2026-05-31.

What conditions does trial NCT04697966 study?

This clinical trial studies the following conditions: Rumination.

What interventions are being tested in trial NCT04697966?

The interventions under investigation include: Mindfulness (Headspace) App (BEHAVIORAL), Active Control Condition ("Recharge" condition delivered in Headspace app) (BEHAVIORAL).

Who is sponsoring clinical trial NCT04697966?

This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04697966 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04697966, the US trial registry maintained by the National Library of Medicine. NCT04697966 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.