ClinicalTrials.gg
RecruitingNCT07475845Updated Oct 26, 2026

Teenthrive 2: Treatments for Improving Mood in Teens

An interventional study of Yoga-Based Intervention and group CBT in Depression in Adolescence, sponsored by Butler Hospital. Recruiting at 2 sites in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Butler Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Updated Oct 2, 2026Start date movedGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 25 studies in Depression by Butler Hospital — 1 open to participants now, 2 under way, none of them phase 3. Depression · Butler Hospital.

Planned enrollment
11th of 24
96 · median 62
Started
2026
the only one that year
No phase
14 of 25
1 open now
Registered
25th of 25
by date

Among the 25 studies in Depression by Butler Hospital, this one is the 11th largest by planned enrollment of the 24 interventional ones that give a count, is the only one that started in 2026, is one of 14 with no phase, and was the 25th registered.

Depression

8,590 studies on the registry are indexed under Depression; 1,728 are open to participants now.

Browse Depression studies →

Open to participants now

1 of the 25 studies in Depression by Butler Hospital is open now, in 1 country.

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 1,090 Depression studies recruiting now, 470 (43%) set no upper age limit and 520 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.

This study: 12 Years to 18 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

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.

03

Conditions studied

  • Depression in Adolescence

Browse trials for

Keywords

  • depression
  • yoga
  • cognitive-behavioral therapy
  • adolescent
04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    Yoga arm

    Yoga-based intervention

    Behavioral: Yoga-Based Intervention

  • Active comparator
    gCBT arm

    group CBT

    Behavioral: group CBT

Interventions

  • BehavioralYoga-Based Intervention

    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).

  • Behavioralgroup CBT

    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).

06

What researchers measure

Primary outcomes

  1. Credibility

    Assessed by Credibility scale of Credibility Expectancy Questionnaire

    Time frame: Start of treatment

  2. Expectancy

    Assessed by Expectancy scale of Credibility Expectancy Questionnaire

    Time frame: Start of treatment

  3. Program Satisfaction

    Assessed by the Client Satisfaction Questionnaire (CSQ-8)

    Time frame: 12 weeks

  4. Class Attendance

    Assessed via staff observation

    Time frame: Week 0-12

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — De-identified data reflecting demographics, primary, and secondary outcomes.

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Dec 2027, 17 months after the start.

Of 3,476 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 17 months is below that.

Counting every sponsor, half of 3,574 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

Start moved once since we started tracking on Sep 25, 2026: Jun 2026 → Jul 2026, on Oct 2, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2026
First posted
Mar 17, 2026
StartActual
Jul 7, 2026was Jun 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Jun 15, 2026→Jul 7, 2026 (actual)
Oct 2, 2026
Show all 2 updates
  1. Oct 26, 2026
    Minor edits only
    + 1 other change: date precision
  2. Oct 2, 2026
    Start date Jun 15, 2026→Jul 7, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07475845
Lead sponsor
Butler Hospital
Responsible party
Sponsor
First posted
Mar 17, 2026
Start date
Jul 7, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

Bailey O'Keeffe, MA
Contact
bokeeffe@butler.org
401-455-6219
Julie Desaulniers
Contact
jdesaulniers@butler.org
401-455-6219
Lisa Uebelacker, PhD
principal investigator · Butler Hospital
Shirley Yen, PhD
principal investigator · Beth Israel Deaconess Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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