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In this study, we will conduct a pilot RCT of a yoga-based intervention (YBI) vs. group cognitive-behavioral therapy (gCBT) at two sites. We will recruit 48 adolescent participants each in Columbus, OH and Boston, MA (96 total). We have a priori targets for indices of feasibility and acceptability, including recruitment rate, retention for assessments, class attendance, interventionist fidelity to manuals, and participant satisfaction. We hypothesize that we will meet these metrics at both sites.
In this study, we will conduct a pilot RCT of a yoga-based intervention (YBI) vs. group cognitive-behavioral therapy (gCBT) at two sites. We will recruit 48 adolescent participants each in Columbus, OH and Boston, MA (96 total). We have a priori targets for indices of feasibility and acceptability, including recruitment rate, retention for assessments, class attendance, interventionist fidelity to manuals, and participant satisfaction. We hypothesize that we will meet these metrics at both sites. We will examine preliminary outcomes of depression, functional impairment, and anxiety, as well as engagement of hypothesized mechanisms of self-compassion, and metacognitive awareness. Participants will be adolescents with depression who will receive their assigned intervention for 3 months and be followed for 3 additional months. Parents will also be invited to participate in assessments regarding their child. Adolescent participants will be comprised of Set A (n=72) vs. Set B (where Set B participants do not meet Set A criteria for severity of depression symptoms or stability of other depression treatment. For both sets, in-person CBT groups and the yoga intervention will occur on the campus of the study hospital site. Randomization will be stratified by site and by set (A/B). Masked evaluators will assess depression symptom severity, which will be the primary outcome in a future fully-powered effectiveness trial.
Age
12 - 18 years
Sex
ALL
Healthy Volunteers
No
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Start Date
March 1, 2026
Primary Completion Date
December 1, 2027
Completion Date
December 1, 2027
Last Updated
March 17, 2026
96
ESTIMATED participants
Yoga-Based Intervention
BEHAVIORAL
group CBT
BEHAVIORAL
Lead Sponsor
Butler Hospital
Collaborators
NCT05329441
NCT06523439
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06668688