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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ six-months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met