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Depression in AdolescenceNCT07475845

Teenthrive 2: Treatments for Improving Mood in Teens

A study testing Yoga-Based Intervention and group CBT in people with Depression in Adolescence, run by Butler Hospital at 2 sites in United States.

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Sites and contacts
Official record

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Trial 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). Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Depression in Adolescence
What is being tested?
Yoga-Based Intervention and group CBT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
2 sitesUnited States
Study dates
7 Jul 2026to Dec 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bailey O'Keeffe, MA contact

401-455-6219

bokeeffe@butler.org

Julie Desaulniers contact

401-455-6219

jdesaulniers@butler.org

United States2 sites, 2 recruiting
  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

    Shirley Yen, PhD, 617-626-9370, syen1@bidmc.harvard.edu

    Shirley Yen, PhD

    Recruiting
  • Nationwide Children's Hospital

    Columbus, Ohio, 43215

    Jenny Hughes, PhD, 614-722-6811, Jennifer.Hughes@nationwidechildrens.org

    John Psurney, 614-355-4132, John.Psurny@nationwidechildrens.org

    Recruiting

Other trials in United States

About this study

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.

Being tested
Yoga-Based Intervention, group CBT
Keywords
depression, yoga, cognitive-behavioral therapy, adolescent
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga-Based InterventionBehavioural

    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 CBTBehavioural

    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).

Study groups in NCT07475845
Study groupRoleWhat they receive
Yoga armExperimentalYoga-based intervention
Receives: Behavioral: Yoga-Based Intervention
gCBT armActive comparatorgroup CBT
Receives: Behavioral: group CBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Credibility

    Assessed by Credibility scale of Credibility Expectancy Questionnaire

    Measured: Start of treatment

  2. Expectancy

    Assessed by Expectancy scale of Credibility Expectancy Questionnaire

    Measured: Start of treatment

  3. Program Satisfaction

    Assessed by the Client Satisfaction Questionnaire (CSQ-8)

    Measured: 12 weeks

  4. Class Attendance

    Assessed via staff observation

    Measured: Week 0-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2026
  2. Study start7 Jul 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07475845
Sponsor's protocol ID
2312-001
Other IDs
R01AT012238
Status last verified
Sep 2026
First submitted
13 Mar 2026
Last updated
2 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data reflecting demographics, primary, and secondary outcomes.

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