Status:
RECRUITING
Brain, Emotions, and Mind-Wandering
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Mood Disorders
Eligibility:
All Genders
11-14 years
Phase:
NA
Brief 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 famili...
Detailed Description
In a sample of 100 adolescents (11-14 years old) with mood lability and a parent or sibling with a major mood disorder, the investigators are comparing an 8-week mindfulness-based intervention (MBI) v...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05345392
Start Date
September 23 2022
End Date
February 28 2027
Last Update
June 5 2025
Active Locations (1)
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1
Western Psychiatric Hospital
Pittsburgh, Pennsylvania, United States, 15213