An interventional study of Yoga-Based Intervention and group CBT in Depression in Adolescence, sponsored by Butler Hospital. Recruiting at 2 sites in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Butler Hospital · Not applicable, Interventional, and Other
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.
Set A Inclusion Criteria. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Set A Exclusion criteria: Adolescents will be excluded if they:
Set B Eligibility criteria
Participants who are not eligible for Set A may be enrolled in Phase 2 Set B, such that they will be eligible to attend classes but their data will not be considered in our main analyses.
Set B Inclusion Criteria. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Set B Exclusion criteria: Adolescents will be excluded if they:
Yoga-based intervention
Behavioral: Yoga-Based Intervention
group CBT
Behavioral: group CBT
This intervention consists of twice-weekly yoga classes. Classes will be led by trained yoga teachers. Each week for 12 weeks, classes will occur once in person (55 mins) and once virtually (30 mins).
This intervention consists of twice-weekly group CBT sessions. Sessions will be led by trained behavioral health specialists. Each week for 12 weeks, sessions will occur once in person (55 mins) and once virtually (30 mins).
Credibility
Assessed by Credibility scale of Credibility Expectancy Questionnaire
Time frame: Start of treatment
Expectancy
Assessed by Expectancy scale of Credibility Expectancy Questionnaire
Time frame: Start of treatment
Program Satisfaction
Assessed by the Client Satisfaction Questionnaire (CSQ-8)
Time frame: 12 weeks
Class Attendance
Assessed via staff observation
Time frame: Week 0-12
Plan to share: Yes — De-identified data reflecting demographics, primary, and secondary outcomes.
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Butler Hospital