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Mindfulness App Training for Rumination in Adolescents

N/A
Recruiting
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
English as a first language or English fluency
Ages 13-18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 weeks
Awards & highlights

Study Summary

This trial is testing whether an app-based mindfulness course can help reduce rumination in adolescents, and whether a machine learning model can be used to identify which adolescents are predicted to benefit from the course.

Who is the study for?
Adolescents aged 13-18, who are right-handed and fluent in English, can join this trial. They must have a personal smartphone and be on a stable dose of any psychotropic medication for at least two months. Those with certain psychiatric disorders, history of severe head trauma or substance abuse, or conditions that preclude fMRI scanning cannot participate.Check my eligibility
What is being tested?
The study is testing an app-based mindfulness training against an active control condition using the Headspace app to see if it reduces rumination linked to depression and anxiety in teens. It includes brain scans before and after the intervention to understand how it might work.See study design
What are the potential side effects?
Since this trial involves non-invasive mindfulness training through an app, there are no direct medical side effects expected from participation. However, participants will be monitored for any psychological discomfort during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fluent in English.
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I am between 13 and 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Slope of change in rumination scores (assessed via smartphone-delivered ecological momentary assessment items derived from rumination measure [unnamed] developed by Ruscio et al., J Abnorm Psychol, 2015 and used in Webb et al., J Am Acad Child Psy, 2021)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness (Headspace app)Experimental Treatment1 Intervention
Group II: Active Control ConditionActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor
213 Previous Clinical Trials
21,588 Total Patients Enrolled
Cambridge Health AllianceOTHER
59 Previous Clinical Trials
20,899 Total Patients Enrolled
Lawrence UniversityOTHER
2 Previous Clinical Trials
282 Total Patients Enrolled
1 Trials studying Rumination Syndrome
152 Patients Enrolled for Rumination Syndrome

Media Library

Mindfulness (Headspace) App Clinical Trial Eligibility Overview. Trial Name: NCT04697966 — N/A
Rumination Syndrome Research Study Groups: Mindfulness (Headspace app), Active Control Condition
Rumination Syndrome Clinical Trial 2023: Mindfulness (Headspace) App Highlights & Side Effects. Trial Name: NCT04697966 — N/A
Mindfulness (Headspace) App 2023 Treatment Timeline for Medical Study. Trial Name: NCT04697966 — N/A
~64 spots leftby Mar 2026
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