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RecruitingNCT07475845Updated Jun 10, 2026

Teenthrive 2: Treatments for Improving Mood in Teens

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

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depression in Adolescence

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Keywords

  • depression
  • yoga
  • cognitive-behavioral therapy
  • adolescent
03

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    Yoga arm

    Yoga-based intervention

    Behavioral: Yoga-Based Intervention

  • Active comparator
    gCBT arm

    group CBT

    Behavioral: group CBT

Interventions

  • BehavioralYoga-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).

  • Behavioralgroup 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).

05

What researchers measure

Primary outcomes

  1. Credibility

    Assessed by Credibility scale of Credibility Expectancy Questionnaire

    Time frame: Start of treatment

  2. Expectancy

    Assessed by Expectancy scale of Credibility Expectancy Questionnaire

    Time frame: Start of treatment

  3. Program Satisfaction

    Assessed by the Client Satisfaction Questionnaire (CSQ-8)

    Time frame: 12 weeks

  4. Class Attendance

    Assessed via staff observation

    Time frame: Week 0-12

06

Study locations

2 of 2 sites recruiting
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02115, United States
    Recruiting
  • Nationwide Children's Hospital
    Columbus, Ohio 43215, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — De-identified data reflecting demographics, primary, and secondary outcomes.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07475845
Lead sponsor
Butler Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Beth Israel Deaconess Medical Center, Nationwide Children's Hospital
Responsible party
Sponsor
First posted
Mar 17, 2026
Start date
Jun 15, 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 10, 2026

Study contacts

Bailey O'Keeffe, MA
Contact
bokeeffe@butler.org
401-455-6219
Julie Desaulniers
Contact
jdesaulniers@butler.org
401-455-6219
Lisa Uebelacker, PhD
principal investigator · Butler Hospital
Shirley Yen, PhD
principal investigator · Beth Israel Deaconess Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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