NCT07475845 · Butler Hospital
Teenthrive 2: Treatments for Improving Mood in Teens
What this study is about
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).
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Boston, Massachusetts
- Columbus, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations