NCT07475845

Teenthrive 2: Treatments for Improving Mood in Teens

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Butler Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Depression in Adolescence

Interventions

Type	Name	Description
BEHAVIORAL	Yoga-Based Intervention	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).
BEHAVIORAL	group CBT	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).

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

2 sites across 1 country: United States