Recruiting

YBI vs. gCBT

Sponsor:

Butler Hospital

Code:

NCT07475845

Conditions

Depression in Adolescence

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

Yoga-Based Intervention

group CBT

Study Details

Brief 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.

Conditions

Depression in Adolescence

Study ID

NCT07475845

Start date

Jun 15, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Set A Inclusion Criteria. In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Have elevated depressive symptoms, defined by: a) a score of 1 or greater on the PHQ-2 and 5 or greater on the PHQ-8 at screening; and b) a score of 10 or higher on the Quick Inventory of Depression-Adolescent Version-Clinician Rating (QIDS-A-CR), including either sad mood or anhedonia;
2. Be aged 12-18;
3. Be allowed to participate in gym class or sports at school (or, if not, medically cleared by their primary care provider or other relevant healthcare provider);
4. Be able to read and write in English;
5. Provide consent/assent appropriate to age;
6. Be able to attend group session times:
7. Have access to a private space once per week that is suitable for synchronous intervention sessions.

Set A Exclusion criteria: Adolescents will be excluded if they:

1. Meet criteria for lifetime bipolar I disorder, a current psychotic disorder, or current anorexia or bulimia; or currently be in treatment for anorexia or bulimia;
2. Meet criteria for substance use disorder (SUD) in the previous 12 months, with current symptoms of sufficient severity to interfere with study participation;
3. Have severe depression (QIDS-A-CR score > = 16);
4. Have moderate or high risk for suicide (Response of "yes" on CSSRS-Screener item 3,4,5,6 with regard to the past 3 months).
5. Have suicide ideation (Response of "yes" on CSSRS- Screener item 2) and do not currently have other mental health treatment (pharmacotherapy or psychotherapy)
6. Are pregnant;
7. Are currently (past 4 weeks) engaged in yoga classes or in gCBT;
8. Have had substantive changes in other psychiatric treatment in the previous 4 weeks (e.g., started a new depression medication; stopped or started attending psychotherapy).
9. Have a sibling or other household member active in a study intervention (for this study) at the same time.

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:

1. Have elevated depressive symptoms, defined by: a) a score of 1 or greater on the PHQ-2 and 5 or greater on the PHQ-8 at screening; and b) a score of 6 or higher on the Quick Inventory of Depression-Adolescent Version-Clinician Rating (QIDS-A-CR), including either sad mood or anhedonia;
2. Be aged 12-18;
3. Be allowed to participate in gym class or sports at school (or, if not, medically cleared by their primary care provider or other relevant healthcare provider);
4. Be able to read and write in English;
5. Provide consent/assent appropriate to age;
6. Be able to attend group session times:
7. Have access to a private space once per week that is suitable for synchronous intervention sessions.

Set B Exclusion criteria: Adolescents will be excluded if they:

1. Meet criteria for lifetime bipolar I disorder, a current psychotic disorder, or current anorexia or bulimia; or currently be in treatment for anorexia or bulimia;
2. Meet criteria for substance use disorder (SUD) in the previous 12 months, with current symptoms of sufficient severity to interfere with study participation;
3. Have severe depression (QIDS-A-CR score > = 16);
4. Have moderate or high risk for suicide (Response of "yes" on CSSRS-Screener item 3,4,5,6 with regard to the past 3 months).
5. Have suicide ideation (Response of "yes" on CSSRS- Screener item 2) and do not currently have other mental health treatment (pharmacotherapy or psychotherapy)
6. Are pregnant;
7. Are currently (past 4 weeks) engaged in yoga classes or in gCBT;
8. Have a sibling or other household member active in a study intervention (for this study) at the same time.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Yoga arm

Yoga-based intervention

active comparator: gCBT arm

group CBT

Interventions

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).

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).

Primary outcome measure

  • Credibility [ Time Frame: Start of treatment ]
  • Expectancy [ Time Frame: Start of treatment ]
  • Program Satisfaction [ Time Frame: 12 weeks ]
  • Class Attendance [ Time Frame: Week 0-12 ]

Central Contacts and Locations

Central contacts

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Shirley Yen, PhD

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43215

Contacts

Principal Investigator:

Jennifer Hughes, PhD

More Information

Sponsor

Butler Hospital

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • depression
  • yoga
  • cognitive-behavioral therapy
  • adolescent

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Butler Hospital on 2026-06-10.