Teenthrive 2: Treatments for Improving Mood in Teens

NCT07475845 | Recruiting

• 2 other identifiers: 2312-001R01AT012238
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Depression in Adolescence

Keywords

depression; yoga; cognitive-behavioral therapy; adolescent

Outcome Measures

Primary Outcomes (4)

• Credibility

  Assessed by Credibility scale of Credibility Expectancy Questionnaire

  Start of treatment

• Expectancy

  Assessed by Expectancy scale of Credibility Expectancy Questionnaire

  Start of treatment

• Program Satisfaction

  Assessed by the Client Satisfaction Questionnaire (CSQ-8)

  12 weeks

• Class Attendance

  Assessed via staff observation

  Week 0-12

Study Arms (2)

Yoga arm

EXPERIMENTAL

Yoga-based intervention

Behavioral: Yoga-Based Intervention

gCBT arm

ACTIVE COMPARATOR

group CBT

Behavioral: group CBT

Interventions

Yoga-Based Intervention BEHAVIORAL

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).

Yoga arm

group CBT BEHAVIORAL

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).

gCBT arm

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Butler Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Nationwide Children's Hospital: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43215, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Lisa Uebelacker, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

• Shirley Yen, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bailey O'Keeffe, MA

CONTACT

401-455-6219; bokeeffe@butler.org

Julie Desaulniers

CONTACT

401-455-6219; jdesaulniers@butler.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 17, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (2)