A Randomized Controlled Trial Testing the Effect of the Youth Mindful Awareness Program on Negative Affect (YMAP2).

NCT ID: NCT06526052

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2027-04-30

Brief Summary

The goal of this randomized clinical trial is to compare the effects of an online mindfulness program to an active supportive comparison condition and a no-intervention control group on reducing and preventing mood and anxiety symptoms in at-risk youth. Youth who are high on trait negative affect will be randomized to one of the three conditions. The primary outcomes of interest are reductions in momentary negative affect and internalizing problems in adolescents ages 12 to 17 years old. All participants will be evaluated prior to being randomized, after the 9-session intervention period, and at a 6-month follow-up.

The first hypothesis is that the mindfulness intervention will predict decreases in stressor-reactive momentary negative affect and internalizing symptoms. The second hypothesis is that changes in momentary negative affect will partially account for the effects of the mindfulness intervention on internalizing symptoms.

Detailed Description

Rates of anxiety and depression in youth are substantial, causing a major unmet need for effective prevention and treatment. A salient risk factor for anxiety and depression is negative affectivity - a partially heritable propensity to experience and express more frequent, intense, and enduring aversive emotional states. Prior longitudinal studies have shown that elevated trait negative affectivity (tNA) during mid-adolescence predicted internalizing disorders later in adolescence and early adulthood, and this relation was partially mediated by changes in momentary negative affect (mNA) measured with ecological momentary assessment (EMA). The conceptual rationale for this investigation is as follows: Trait negative affectivity (tNA) is a risk factor for internalizing symptoms and disorders. tNA also predicts higher levels of momentary negative affect (mNA), measured with EMA, which in turn partially accounts for the prospective association between tNA and symptoms of anxiety and depression. Mindfulness interventions reduce both mNA and internalizing symptoms. Given these empirical relations, this study will test whether in youth with high levels of tNA, an online, coached mindfulness program reduces mNA, as measured with EMA, and whether significantly reducing mNA via a mindfulness intervention then prevents the worsening or onset of internalizing problems.

Mindfulness-based interventions have been found to reduce negative affect and internalizing symptoms in children and adolescents. This study will evaluate changes in mNA as a transdiagnostic target of mindfulness-based training in youth at high risk (i.e., high tNA) for internalizing problems, and the degree to which reductions in such mNA partially account for the effects of mindfulness training on internalizing outcomes in youth. This randomized controlled prevention trial will test the extent to which youth assigned to an online, coached mindfulness program as compared to youth in a supportive attention comparison intervention and a no-intervention control condition will show reduced mNA and its two components -- stressor-independent and stressor-reactive momentary negative affect. The mindfulness training will be implemented through mobile technology (e.g., online program). Investigating the efficacy of an online mode of delivery of mindfulness with support of a coach can advance the prevention of internalizing psychopathology in a manner that could be disseminated broadly. Such technology would improve access to care for youth who can be easily identified as being vulnerable to internalizing problems due to having high levels of tNA.

Conditions

Prevention; Control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Mindfulness Program

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 Type: EXPERIMENTAL

Mindfulness Program

Intervention Type: BEHAVIORAL

Online, coached mindfulness training program

Supportive Active Comparison

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.

Group Type: ACTIVE_COMPARATOR

Active Comparator

Intervention Type: BEHAVIORAL

Remote meetings with a supportive coach

Control

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 Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness Program

Online, coached mindfulness training program

Intervention Type: BEHAVIORAL

Active Comparator

Remote meetings with a supportive coach

Intervention Type: BEHAVIORAL

Other Intervention Names

Supportive Active Comparison

Eligibility Criteria

Inclusion Criteria

• Ages 12, 13, 14, 15, 16, 17
• Parental Consent
• Participant Assent
• Live in Illinois, California, or Tennessee

Exclusion Criteria

• current diagnosis of an anxiety or depressive disorder with significant clinical impairment
• current alcohol or substance use disorder
• current serious suicidal ideation or behavior
• lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay
• reading level below 4th grade
• not English speaking at a level that would allow them to participate in the intervention and assessments

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Judith Garber

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Megan M Saylor, PhD

Role: STUDY_CHAIR

Vanderbilt University

Locations

University of California, Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Northwestern University

Evanston, Illinois, United States

Site Status: RECRUITING

Vanderbilt University

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Judith A Garber, PhD

Role: CONTACT

jgarber.vanderbilt@gmail.com

6153305605

Steven D Hollon, PhD

Role: CONTACT

steven.d.hollon@vanderbilt.edu

6153305604

Facility Contacts

Michelle G Craske, PhD

Role: primary

MCraske@mednet.ucla.edu

310-825-8403

Denise A Chavira, PhD

Role: backup

dchavira@psych.ucla.edu

310-825-8466

Richard E Zinbarg, PhD

Role: primary

rzinbarg@northwestern.edu

847-467-2290

Emma K Adam, PhD

Role: backup

ek-adam@northwestern.edu

847-467-2010

Judith A Garber, PhD

Role: primary

jgarber.vanderbilt@gmail.com

615-330-5605

Steven D Hollon, PhD

Role: backup

steven.d.hollon@vanderbilt.edu

6153305604

Other Identifiers

4R33MH119270-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R33MH119270

Identifier Type: NIH

Identifier Source: org_study_id

View Link