Actively Recruiting

Phase Not Applicable
Age: 11Years - 14Years
All Genders
NCT05345392

Brain, Emotions, and Mind-Wandering

Led by University of Pittsburgh · Updated on 2025-06-05

140

Participants Needed

1

Research Sites

231 weeks

Total Duration

On this page

Sponsors

U

University of Pittsburgh

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Brain, Emotions, and Mind-Wandering

Who Can Participate

Age: 11Years - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females between the ages of 11-14 years
  • Parent or full biological sibling with major depressive disorder and/or bipolar I/II disorder
  • Elevated mood lability, which is defined as >10 on the Children's Affective Lability Scale (averaging the child and parent score)
Not Eligible

You will not qualify if you...

  • IQ less than 70 or significant learning disability that makes participation difficult
  • Current or previous diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or autism spectrum disorder
  • Current diagnosis of major depressive disorder
  • Contraindications to MRI scanning, including metal in the body such as braces or planned braces within 8 months
  • Suicidal or homicidal ideation within the past month
  • Changed medications or doses, or started new therapy, within the past two months including psychotropic medications or hormonal contraceptives

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Western Psychiatric Hospital

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

Loading map...

Research Team

D

Danella Hafeman, MD, PhD

CONTACT

A

Ashley Harbaugh, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here