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Teenthrive 2: Treatments for Improving Mood in Teens

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be adolescents with depression who will receive their assigned intervention for 3 months and be followed for 3 additional months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares a yoga program with group talk therapy that helps teens change unhelpful thoughts and behaviors. It is for teens ages 12–18 with depression symptoms in Columbus, Ohio, and Boston, Massachusetts. Researchers want to see if the programs are practical to run and whether teens are satisfied with them.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 12–18 years old.
  • Have depression symptoms, including sadness or loss of interest. Screening scores must be at least 1 on the PHQ-2 and 5 on the PHQ-8.
  • For Set A, score at least 10 on the clinician-rated teen depression test (QIDS-A-CR). For Set B, score at least 6.
  • Teens who do not qualify for Set A may join Phase 2 Set B classes, but their data will not be part of the main study analysis.
  • Be allowed to join school gym or sports, or have approval from a health care provider.
  • Be able to read and write in English and give permission to join as required for your age.
  • Be able to attend the group sessions.
  • Have a private space for live sessions once a week.

Who can't join

  • Have ever had bipolar I disorder, which causes extreme mood changes; currently have a psychotic disorder, which affects your sense of reality; or have or receive treatment for anorexia or bulimia, which are eating disorders.
  • Have had a substance use disorder in the past 12 months, with current symptoms that would make joining the study difficult.
  • Have severe depression, with a QIDS-A-CR score of 16 or higher.
  • Have moderate or high suicide risk based on a screening about the past 3 months, or have thoughts of suicide without currently receiving mental health medicine or talk therapy.
  • Be pregnant.
  • Have taken yoga classes or group cognitive-behavioral therapy in the past 4 weeks.
  • For Set A only: Have had major changes in mental health treatment in the past 4 weeks, such as starting a depression medicine or starting or stopping talk therapy.
  • Have a sibling or someone else in your home taking part in this study's treatment sessions at the same time.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

MA

OH