Mindfulness may rewire brains of teens at risk for depression
NCT ID NCT05345392
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a mindfulness program can improve attention and brain connectivity in 11-14 year olds who have a family history of mood disorders and high mood swings. About 224 teens will be randomly assigned to mindfulness or a health education class. The goal is to understand how mindfulness works in the brain, not to cure or treat a disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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224 people
The number who actually took part.
- Started
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Sep 2022
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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11 to 14 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Western Psychiatric Hospital
Pittsburgh, Pennsylvania, 15213, United States
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Other studies related to the condition(s) this trial covers.
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