Health-Enhancement Program (HEP) for Mood Disorders

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Western Psychiatric Hospital, Pittsburgh, PA
Mood Disorders
Mindfulness-Based Intervention (MBI) - Behavioral
Eligibility
< 18
All Sexes
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

0 Primary · 4 Secondary · Reporting Duration: The investigators will test specifically for early differences (prior to the MBI/HEP group to immediately following the MBI/HEP group) and assess whether these differences are sustained (immediately following the MBI/HEP group to 3 month follow-up).

SART reaction time variability will be assessed before the MBI/HEP group.
SART: Reaction Time Variability
Month 3
PCC-FPCN rsFC: Seed-based
SART Accuracy
SART: Mind-wandering Awareness Probe

Trial Safety

Trial Design

2 Treatment Groups

Health-Enhancement Program (HEP)
1 of 2
Mindfulness-Based Intervention (MBI)
1 of 2
Active Control

140 Total Participants · 2 Treatment Groups

Primary Treatment: Health-Enhancement Program (HEP) · No Placebo Group · N/A

Health-Enhancement Program (HEP)
Behavioral
ActiveComparator Group · 1 Intervention: Health-Enhancement Program (HEP) · Intervention Types: Behavioral
Mindfulness-Based Intervention (MBI)
Behavioral
ActiveComparator Group · 1 Intervention: Mindfulness-Based Intervention (MBI) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: the investigators will test specifically for early differences (prior to the mbi/hep group to immediately following the mbi/hep group) and assess whether these differences are sustained (immediately following the mbi/hep group to 3 month follow-up).
Closest Location: Western Psychiatric Hospital · Pittsburgh, PA
Photo of Pittsburgh 1Photo of Pittsburgh 2Photo of Pittsburgh 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Mood Disorders
0 CompletedClinical Trials

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,490 Previous Clinical Trials
1,765,931 Total Patients Enrolled
70 Trials studying Mood Disorders
45,843 Patients Enrolled for Mood Disorders
University of PittsburghLead Sponsor
1,595 Previous Clinical Trials
6,284,442 Total Patients Enrolled
6 Trials studying Mood Disorders
629 Patients Enrolled for Mood Disorders
Danella Hafeman, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh

Eligibility Criteria

Age < 18 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between the ages of 11 and 13 years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.