Brain, Emotions, and Mind-Wandering

Running, not enrolling · Not applicable

Conditions studied: Mood Disorders

In brief

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.

Key facts

Study ID

NCT05345392

Run by

University of Pittsburgh

People needed

224

Starts

2022-09-23

Expected to finish

2027-02-28

Last updated by the study team

2026-06-08

Who can join

Age: 11 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Western Psychiatric Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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