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Brain, Emotions, and Mind-Wandering

NCT05345392 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-06-05

No results posted yet for this study

Summary

Mood lability is an important transdiagnostic problem that is associated with poor psychosocial function and suicidal thoughts, and is a predictor of mood disorder onset, especially in youth at familial risk. Thus, particularly in youth with a family history of mood disorder, an intervention to target mood lability during a key period of development could improve outcomes. This study will allow us to test neurobehavioral mechanisms of a mindfulness-based intervention to target mood lability in early adolescents at high risk for developing mood disorders. Through this randomized controlled trial, the investigators will better understand how and for whom mindfulness interventions work, which will lead to more targeted interventions to improve emotion regulation during this key developmental period.

Conditions

  • Mood Disorders

Interventions

BEHAVIORAL

Mindfulness-Based Intervention (MBI)

The mindfulness-based intervention is based on mindfulness-based stress reduction and mindfulness-based cognitive therapy, borrowing publicly available materials from the Mindfulness in Schools Program and Acceptance and Commitment Therapy. The MBI consists of 8 weekly groups, 45-60 minutes in length, and include 3-8 youth.

BEHAVIORAL

Health and Wellness Intervention (HWI)

The control intervention is inspired by the Health Enhancement Program that has been adapted for youth 11-14 years old, using brief, engaging, and age-appropriate activities to address topics related to physical and mental health. HWI consists of 8 weekly groups, 45-60 minutes in length, and include 3-8 youth.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Danella Hafeman, MD, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05345392 on ClinicalTrials.gov