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

StatusRecruiting
PhaseNot applicable
Started2021-11-16
View on ClinicalTrials.gov ↗

Amendment history

2026-06-15
minor
Study Status v9
Primary completion moved earlier: 2027-09-30 → 2027-05-31
Completion moved earlier: 2028-09-30 → 2027-09-30
2026-04-13
minor
Study Status, Oversight v8
Primary completion date2026-03-31→2027-09-30
Completion date2026-05-31→2028-09-30
2025-05-05
minor
Study Status, Oversight v7
Re-verified, no change to tracked fields
2024-03-19
minor
Study Status v6
Primary completion date2026-03→2026-03-31
Completion date2026-05→2026-05-31
2023-03-16
minor
Study Status v5
Start date2021-11-19→2021-11-16
Show 4 earlier versions
2022-05-11
minor
Study Status, Study Design v4
Primary completion date2025-11→2026-03
Start date2021-11-12→2021-11-19
2021-11-12
notable
Not Yet Recruiting→Recruiting Study Status, Study Description, Study Design, Arms and Interventions, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-11→confirmed 2021-11-12
Enrollment target157→158
Study sites0→1
InterventionsMindfulness (Headspace) App (Behavioral), Psychoeducational Active Control Condition (Behavioral)→Active Control Condition ("Recharge" condition delivered in Headspace app) (Behavioral), Mindfulness (Headspace) App (Behavioral)
Study description-59 characters
[...] nctional connectivity within - and between - brain networks strongly implicated in mindfulness training and rumination (i.e., Default Mode Network and Salience Network). In addition, cognitive tasks will be administered at pre- [...]
2021-08-31
minor
Study Status v2
Primary completion date2025-05→2025-11
Start date2021-05→2021-11
2021-02-09
minor
Study Status, Study Description, Outcome Measures v1
Primary endpoints1 entry, revised
[...] [unnamed] developed by Ruscio et al., J Abnorm Psychol, 2015 and used in Webb et al., J Am Acad Child Psy, 2021)
Study description+135 characters
[...] ll test whether changes in (1) brain functional connectivity (dynamic resting state functional connectivity via coactivation pattern analysis), (2) attentional control (Correct NoGo % on the SART task) and (3) acquisition and use of mindfulness skills (assessed via EMA) mediate between-group (i.e., app vs. control) differences i [...]
2021-01-05
minor
Original filing
53 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT04697966
Lead Sponsor Mclean Hospital
Collaborators: Cambridge Health Alliance, Lawrence University
Conditions Rumination
Enrollment 158 participants
Start Date 2021-11-16
Primary Completion 2027-05-31 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-17