CompletedNCT03831347TeenThriveUpdated Mar 23, 2022Results posted

Treatments for Improving Mood in Depressed Teens-2

An interventional study of Hatha Yoga in Depression, sponsored by Brown University. Completed at 1 site in United States. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-03-23.

Sponsored by Brown University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 11
Allocation: Not applicable
Ages: 13 Years to 18 Years
Sex: All

Study summary

Phase 2: Open Trial N=12 adolescents will be enrolled into a single-arm pilot trial to test the adapted hatha yoga intervention

Read the detailed description

In Phase 2, the investigators will conduct an open single-arm pilot trial of our 12 week adapted hatha yoga intervention.

the investigators will enroll 12 adolescents in the open pilot trial.

Conditions studied

Depression

Browse trials for

Depression 8,245

In context

Depression

8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 11 is below the median of 84 across 6,869 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Brown University is the lead sponsor of 288 studies on the registry; 38 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.

Browse Brown University studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 13 Years to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Adolescents must have elevated depressive symptoms, defined by a score of 11 or higher on the Quick Inventory of Depression -Adolescent Version-- Clinician Rating (QIDS-A-CR), including endorsement of either sad mood or anhedonia on the QIDS.
Other treatment for depression must be stable at baseline. Adolescents do not have to be in other treatment for depression, but, if they are, it must be stable for the past 12 weeks.
Adolescents must be aged 13-18.
Adolescents must be medically cleared for moderate physical activity by their primary care physician. This criterion may be met by a current (dated in the past year) statement from their pediatrician that the adolescent may participate in school or camp programs including physical education.
Adolescents must be able to read and write English sufficient to complete informed consent and engage in interventions.
Adolescents aged 13-17 must assent to be in the study, and their parent or legal guardian must consent to their participation. Adolescents aged 18 must consent to be in the study.
Able to attend one of the class times.

Exclusion criteria

Exclusion Criteria:

QIDS- A-CR may not be higher than a score of 21. This ensures that adolescents are not severely depressed.
Adolescents who meet criteria for:
- Current (past year) autism spectrum disorder (AS), if of sufficient severity to interfere with study treatment per clinician judgment;
- Schizophrenia;
- Bipolar disorder;
- Clinically significant psychotic symptoms in the past month;
- Anorexia or Bulimia in past 3 months
- Substance use disorders in the past 12 months and symptoms are of sufficient severity to interfere with study treatment per clinician judgment These will be assessed with the Mini-International Neuropsychiatric Interview (MINI).
Adolescents may not have current suicide ideation or behavior that warrants immediate treatment. They may have passive ideation (i.e., thoughts that life is not worth living), but may not have active suicide ideation, intent, plan, or an attempt within the previous 6 months.
Adolescents cannot currently be engaged in or yoga classes, as this is the study intervention.
Adolescents cannot be pregnant as yoga should be modified for pregnancy

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 11 participants (actual)

Study arms

Experimental
Hatha Yoga
12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.
Behavioral: Hatha Yoga

Interventions

BehavioralHatha Yoga
12 weeks of Hatha Yoga

What researchers measure

Primary outcomes

Acceptability
Acceptability assessed based on number of participants who remained in the intervention (retention).
Time frame: Post intervention (month 3)
Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale
Credibility assessed with Credibility Expectancy Questionnaire (CEQ), credibility subscale. The credibility subscale of the CEQ, is a 3 item subscale of the 6 item CEQ. The 3 items are scored on a range of 0-1. Higher scores indicate greater credibility.
Time frame: Week 1
Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale
Patient expectations assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. Score ranges from 0-1 with higher scores indicating greater expectations.
Time frame: Week 1
The Client Satisfaction Questionnaire (CSQ-8)
Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction.
Time frame: Post intervention (month 3)
Home Practice Questionnaire
Number of participants who met criteria for home practice (target of two practices per week) as assessed with a home practice questionnaire.
Time frame: Post intervention (month 3)
Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.
Time frame: Post intervention (month 3)

Secondary outcomes

Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)
Depression symptom severity at Month 3. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms.
Time frame: post intervention (month 3)

Results

Posted Mar 23, 2022

Participant flow

Participant flow — Overall Study
Milestone	Hatha Yoga
Started	11
Completed	9
Not completed	2

Outcome measures

PrimaryAcceptability

Acceptability assessed based on number of participants who remained in the intervention (retention).

Time frame:: Post intervention (month 3)
Reported as:: Count of participants · Participants

Acceptability
Participants	Hatha Yoga
Acceptability	9

PrimaryCredibility Expectancy Questionnaire (CEQ) - Credibility Subscale

Credibility assessed with Credibility Expectancy Questionnaire (CEQ), credibility subscale. The credibility subscale of the CEQ, is a 3 item subscale of the 6 item CEQ. The 3 items are scored on a range of 0-1. Higher scores indicate greater credibility.

Time frame:: Week 1
Reported as:: Mean · score on a scale

Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale
score on a scale	Hatha Yoga
Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale	0.76 ± 0.25

PrimaryCredibility Expectancy Questionnaire (CEQ) - Expectancy Subscale

Patient expectations assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. Score ranges from 0-1 with higher scores indicating greater expectations.

Time frame:: Week 1
Reported as:: Mean · score on a scale

Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale
score on a scale	Hatha Yoga
Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale	0.66 ± 0.29

PrimaryThe Client Satisfaction Questionnaire (CSQ-8)

Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction.

Time frame:: Post intervention (month 3)
Reported as:: Mean · score on a scale

The Client Satisfaction Questionnaire (CSQ-8)
score on a scale	Hatha Yoga
The Client Satisfaction Questionnaire (CSQ-8)	26.2 ± 6.1

PrimaryHome Practice Questionnaire

Number of participants who met criteria for home practice (target of two practices per week) as assessed with a home practice questionnaire.

Time frame:: Post intervention (month 3)
Reported as:: Count of participants · Participants

Home Practice Questionnaire
Participants	Hatha Yoga
Home Practice Questionnaire	6

PrimarySystematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)

Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.

Time frame:: Post intervention (month 3)
Reported as:: Number · adverse events

Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
adverse events	Hatha Yoga
Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)	6

SecondaryQuick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)

Depression symptom severity at Month 3. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms.

Time frame:: post intervention (month 3)
Reported as:: Mean · score on a scale

Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)
score on a scale	Hatha Yoga
Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)	4.11 ± 2.66

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Hatha Yoga	0/11 (0%)	0/11 (0%)	2/11 (18.2%)

Most frequent other events

Most frequent other events
Event	Hatha Yoga
InfectionBlood and lymphatic system disorders	1/11
CeliacGastrointestinal disorders	1/11
GI distressGastrointestinal disorders	1/11
Gynecological issueGeneral disorders	1/11

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Hatha Yoga
Mean	15.8 ± 1.8

Sex: Female, Male
Sex: Female, Male(Participants)	Hatha Yoga
Female	10
Male	1

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Hatha Yoga
White	9
Multiracial and Other	2

Region of Enrollment
Region of Enrollment(Participants)	Hatha Yoga
United States	11

Study locations

1 site

Butler Hospital
Providence, Rhode Island 02906, United States

References and documents

Study documents

Protocol and statistical analysis plan · Dec 10, 2020
Informed consent form · Apr 17, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — All IPD underlying publication if required by journal.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: One year after study collection.

Access criteria: Information available upon request, please send to PIs Lisa Uebelacker or Shirley Yen.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03831347
Lead sponsor: Brown University
Collaborators: Butler Hospital, National Center for Complementary and Integrative Health (NCCIH)
Responsible party: Sponsor
First posted: Feb 5, 2019
Start date: Mar 1, 2019
Primary completion: Aug 14, 2019
Completion: Aug 29, 2019
Results posted: Mar 23, 2022
Last update: Mar 23, 2022

Study contacts

Lisa Uebelacker, PhD

principal investigator · Butler Hospital

Shirley Yen, PhD

principal investigator · Brown University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Depression →

Other studies from this sponsor

Brown University →

Start the discussion