NCT03831347: TeenThrive

Treatments for Improving Mood in Depressed Teens-2

Completed NA Results posted Last updated 23 March 2022

What this trial tests

NA trial testing Hatha Yoga in Depression in 11 participants. Completed in 29 August 2019.

Timeline

1 March 2019

Primary endpoint
14 August 2019

29 August 2019

Quick facts

Lead sponsor	Brown University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	1 March 2019
Primary completion	14 August 2019
Estimated completion	29 August 2019
Sites	1 location across United States

Drugs / interventions tested

• Hatha Yoga

Conditions studied

• Depression — all drugs for Depression →

Sponsor

Brown University

Who can join

Adults 13 to 18, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acceptability Primary · Post intervention (month 3)

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

Group	Value	95% CI
Hatha Yoga	9

Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale Primary · Week 1

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.

Group	Value	95% CI
Hatha Yoga	0.76	± 0.25

Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale Primary · Week 1

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.

Group	Value	95% CI
Hatha Yoga	0.66	± 0.29

The Client Satisfaction Questionnaire (CSQ-8) Primary · Post intervention (month 3)

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.

Group	Value	95% CI
Hatha Yoga	26.2	± 6.1

Home Practice Questionnaire Primary · Post intervention (month 3)

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

Group	Value	95% CI
Hatha Yoga	6

Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) Primary · Post intervention (month 3)

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.

Group	Value	95% CI
Hatha Yoga	6

Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR) Secondary · post intervention (month 3)

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.

Group	Value	95% CI
Hatha Yoga	4.11	± 2.66

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Hatha Yoga

Serious: 0/11 (0%)

Deaths: 0/11

Other adverse events (4 terms — click to expand)

Reaction	System	Hatha Yoga
Infection	Blood and lymphatic system disorders	—
Celiac	Gastrointestinal disorders	—
GI distress	Gastrointestinal disorders	—
Gynecological issue	General disorders	—

Data from ClinicalTrials.gov NCT03831347 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.