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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.
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I am between 13 and 18 years old.
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My gender and ethnicity do not limit my participation.
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I have been on the same dose of my mental health medication for at least 2 months.
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I am between 13 and 18 years old.
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My gender and ethnicity do not limit my participation.
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I am fluent in English.
Select...
I am fluent in English.

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
212 Previous Clinical Trials
21,442 Total Patients Enrolled
Cambridge Health AllianceOTHER
57 Previous Clinical Trials
20,499 Total Patients Enrolled
Lawrence UniversityOTHER
1 Previous Clinical Trials
152 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people of advanced age being included in this investigation?

"The eligibility criteria for this trial specify that the participants must be between 13 and 18 years old."

Answered by AI

Are there still opportunities to participate in this investigation?

"Indeed, the information on clinicaltrials.gov verifies that this medical trial is currently enlisting patients. The research was first advertised on November 19th 2021 and updated as recently as May 11th 2022. This endeavour requires 158 individuals to be recruited from a single site."

Answered by AI

Do I qualify for participation in this medical study?

"This investigation requires 158 participants, aged 13 to 18 years old who have been diagnosed with rumination syndrome. Furthermore, the application process necessitates that applicants: possess either an iPhone or Android phone; must be natively fluent in English; identify as any gender and ethnicity (as per inclusion of Women & Minorities policy); are right-handed individuals; can produce a CRSQ rumination subscale score if necessary; and have taken psychotropic medications for at least 2 months prior on a consistent dose."

Answered by AI

How many participants can enroll in this medical experiment?

"Affirmative. According to clinicaltrials.gov, this investigation is currently accepting applicants; the study was initially posted on November 19th 2021 and updated most recently on May 11th 2022. A total of 158 subjects are needed from 1 medical facility."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
McLean Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~73 spots leftby Mar 2026