Brain, Emotions, and Mind-Wandering (NCT05345392) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Brain, Emotions, and Mind-Wandering
United States224 participantsStarted 2022-09-23
Plain-language 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 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.
Who can participate
Age range
11 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PCC-FPCN rsFC: Seed-based
Timeframe: PCC-FPCN rsFC will be assessed up to 3 months after completing the MBI/HWI group.
2
SART Accuracy
Timeframe: SART accuracy will be assessed up to 3 months after completing the MBI/HWI group.
3
SART: Mind-wandering Awareness Probe
Timeframe: Mind-wandering during the SART will be assessed up to 3 months after completing the MBI/HWI group.