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Behavioural Intervention

Mindfulness Program for Reducing Negative Affect in Youth (YMAP2 Trial)

N/A
Recruiting
Research Sponsored by Vanderbilt University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 12, 13, 14, 15, 16, 17
Be younger than 18 years old
Must not have
Current diagnosis of an anxiety or depressive disorder with significant clinical impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six-months
Awards & highlights

Summary

"This trial aims to see if an online mindfulness program can help reduce mood and anxiety symptoms in at-risk youth when compared to a support program and a no-intervention group. Adolescents aged 12 to

Who is the study for?
This trial is for at-risk youth aged 12 to 17 who often feel negative emotions like sadness or anxiety. They'll be randomly placed into one of three groups: an online mindfulness program, a supportive comparison condition, or no intervention.
What is being tested?
The study tests if the Youth Mindful Awareness Program can reduce feelings of negativity and anxiety in adolescents compared to other support methods or no treatment. Participants will be checked before and after the nine sessions, and again six months later.
What are the potential side effects?
Since this trial involves non-medical interventions such as mindfulness training, significant side effects are not expected. However, discussing personal issues during sessions could potentially cause temporary emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently diagnosed with anxiety or depression that significantly affects my daily life.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ecological Momentary Assessment of Momentary Negative Affect and Stress
Secondary study objectives
Diagnoses of Anxiety and Depressive Disorders
Internalizing symptoms factor

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness ProgramExperimental Treatment1 Intervention
The Mindfulness Program is an online, coached intervention that teaches mindfulness activities such as calm breathing, listening, acceptance, gratitude, and compassion. Participants meet with their coach weekly for nine 30-minute, weekly sessions in which they learn mindfulness skills and practice using the mindfulness exercises between sessions. Meetings are done remotely (e.g., Zoom).
Group II: ControlActive Control1 Intervention
This is an assessment only control condition. Participants complete all of the same measures as do youth in the other two conditions at the same time points (i.e., baseline, post-intervention (about 10 weeks after baseline) and at a six-month follow-up.
Group III: Supportive Active ComparisonActive Control1 Intervention
The Supportive Active condition involves participants meeting remotely (e.g., Zoom) with a coach for nine 30-minute, weekly sessions during which teens discuss their thoughts and feelings about things going on in their life. Coaches are instructed to use active listening, open-ended questions, empathy, reflection, and unconditional positive regard. Between sessions, teens use expressive writing to describe and understand their thoughts and feelings about situations in their life.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness Program
2016
N/A
~110

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,176 Total Patients Enrolled
1 Trials studying Prevention
250 Patients Enrolled for Prevention
Vanderbilt UniversityLead Sponsor
709 Previous Clinical Trials
6,143,348 Total Patients Enrolled
Megan M Saylor, PhDStudy ChairVanderbilt University
~240 spots leftby Mar 2027
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