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Search / Trial NCT05345392

Brain, Emotions, and Mind-Wandering

Launched by UNIVERSITY OF PITTSBURGH · Apr 20, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Mindfulness Based Intervention Early Intervention Prevention Adolescent

ClinConnect Summary

This clinical trial, called "Brain, Emotions, and Mind-Wandering," is designed to study how mindfulness techniques can help young people manage their emotions, especially those who may be at risk for mood disorders like depression or bipolar disorder. The focus is on early adolescents, aged 11 to 14, who have a family history of these mood disorders and show signs of mood lability, which means their emotions can change quickly and unpredictably. By understanding how mindfulness practices affect their emotions, researchers hope to develop better ways to support these young individuals during a critical time in their development.

To participate in this study, young people need to be between 11 and 14 years old and have a parent or sibling who has been diagnosed with major depressive disorder or bipolar disorder. They also need to show elevated mood lability. If eligible, participants will take part in mindfulness sessions and provide feedback on their experiences. Parents may also join the study to help researchers understand the family background better. It’s important to note that certain conditions, like having a significant learning disability or recent changes in medication, could make someone ineligible for the trial. Overall, this study aims to find effective ways to help young people better manage their emotions and improve their mental health.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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).
  • Exclusion Criteria:
  • IQ\<70 or significant learning disability (which will make it difficult to participate in study procedures)
  • Current or previous diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or autism spectrum disorder
  • Current diagnosis of major depressive disorder
  • Contraindications to scanning, including metal in the body (e.g. has braces or planning to get braces within the next 8 months)
  • Suicidal or homicidal ideation within the past month
  • Changed medications or medication doses (including psychotropic medications and/or hormonal contraceptives), or have started a new therapy, within the past two months.
  • For each eligible youth, a parent (when possible, the parent with a mood disorder) will also be enrolled in the study, to provide a detailed account of family history. The only inclusion criterion for the parent participants is that they have an eligible child.

About University Of Pittsburgh

The University of Pittsburgh is a leading research institution known for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a robust infrastructure for research and a multidisciplinary approach, the university fosters collaboration among experts in various fields, facilitating the development of novel therapies and interventions. Its clinical trial programs emphasize ethical standards, patient safety, and the integration of cutting-edge technology, making the University of Pittsburgh a pivotal contributor to the landscape of clinical research and a trusted partner in the pursuit of health advancements.

Locations

Pittsburgh, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Danella Hafeman, MD, PhD

Principal Investigator

University of Pittsburgh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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