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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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:
- 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;
- Be aged 12-18;
- 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);
- Be able to read and write in English;
- Provide consent/assent appropriate to age;
- Be able to attend group session times:
- 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:
- 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;
- Meet criteria for substance use disorder (SUD) in the previous 12 months, with current symptoms of sufficient severity to interfere with study participation;
- Have severe depression (QIDS-A-CR score > = 16);
- 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).
- Have suicide ideation (Response of "yes" on CSSRS- Screener item 2) and do not currently have other mental health treatment (pharmacotherapy or psychotherapy)
- Are pregnant;
- Are currently (past 4 weeks) engaged in yoga classes or in gCBT;
- 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).
- 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:
- 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;
- Be aged 12-18;
- 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);
- Be able to read and write in English;
- Provide consent/assent appropriate to age;
- Be able to attend group session times:
- 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:
- 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;
- Meet criteria for substance use disorder (SUD) in the previous 12 months, with current symptoms of sufficient severity to interfere with study participation;
- Have severe depression (QIDS-A-CR score > = 16);
- 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).
- Have suicide ideation (Response of "yes" on CSSRS- Screener item 2) and do not currently have other mental health treatment (pharmacotherapy or psychotherapy)
- Are pregnant;
- Are currently (past 4 weeks) engaged in yoga classes or in gCBT;
- 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.
United States2 sites, 2 recruiting
- 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
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.
- Conditions
- Depression in Adolescence
- 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 group | Role | What they receive |
|---|---|---|
| Yoga arm | Experimental | Yoga-based intervention Receives: Behavioral: Yoga-Based Intervention |
| gCBT arm | Active comparator | group CBT Receives: Behavioral: group CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Credibility
Assessed by Credibility scale of Credibility Expectancy Questionnaire
Measured: Start of treatment
Expectancy
Assessed by Expectancy scale of Credibility Expectancy Questionnaire
Measured: Start of treatment
Program Satisfaction
Assessed by the Client Satisfaction Questionnaire (CSQ-8)
Measured: 12 weeks
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.
- First posted17 Mar 2026
- Study start7 Jul 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Beth Israel Deaconess Medical Center, Nationwide Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Lisa Uebelacker, PhD, Principal investigator, Butler HospitalShirley Yen, PhD, Principal investigator, Beth Israel Deaconess Medical Center
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.