Mindfulness intervention for adolescents at risk of mood disorders
Neurobehavioral Targets of Mindfulness in Youth at Risk for Mood Disorders
This study is testing if an 8-week mindfulness program can help young teens with a family history of mood disorders manage their emotions better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 11 Years to 14 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05345392 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of an 8-week mindfulness-based intervention (MBI) aimed at reducing mood lability in adolescents aged 11-14 who have a family history of mood disorders. Participants will be randomly assigned to either the MBI or a health and wellness program (HWI) to assess the neurobehavioral mechanisms that contribute to changes in mood regulation. The study will involve intake assessments, MRI scans, and behavioral tasks to gather data on the participants' emotional responses and regulation. By understanding how mindfulness interventions work, the study aims to develop more targeted approaches for improving emotional health in at-risk youth.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 11-14 with elevated mood lability and a family history of major mood disorders.
Not a fit: Patients with a current diagnosis of major depressive disorder or significant learning disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve emotional regulation and reduce the risk of developing mood disorders in adolescents.
How similar studies have performed: Previous studies have shown promise in using mindfulness-based interventions for mood regulation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pittsburgh, Pennsylvania
- Western Psychiatric Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Danella Hafeman, MD, PhD — University of Pittsburgh
- Study coordinator: Danella Hafeman, MD, PhD
- Email: hafemand@upmc.edu
- Phone: 412-246-5820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.