Trial Outcomes & Findings for Treatments for Improving Mood in Depressed Teens-2 (NCT NCT03831347)

NCT ID: NCT03831347

Last Updated: 2022-03-23

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: Post intervention (month 3)
• Results posted on: 2022-03-23

Participant Flow

Participant milestones

Measure	Hatha Yoga 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression. Hatha Yoga: 12 weeks of Hatha Yoga
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatments for Improving Mood in Depressed Teens-2

Baseline characteristics by cohort

Measure	Hatha Yoga n=11 Participants 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression. Hatha Yoga: 12 weeks of Hatha Yoga
Age, Continuous	15.8 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants
Race/Ethnicity, Customized Multiracial and Other	2 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Post intervention (month 3)

Population: Entire sample

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

Outcome measures

Measure	Hatha Yoga n=11 Participants 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression. Hatha Yoga: 12 weeks of Hatha Yoga
Acceptability	9 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Hatha Yoga n=11 Participants 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression. Hatha Yoga: 12 weeks of Hatha Yoga
Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale	0.76 score on a scale Standard Deviation 0.25

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Hatha Yoga n=11 Participants 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression. Hatha Yoga: 12 weeks of Hatha Yoga
Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale	0.66 score on a scale Standard Deviation 0.29

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Hatha Yoga n=9 Participants 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression. Hatha Yoga: 12 weeks of Hatha Yoga
The Client Satisfaction Questionnaire (CSQ-8)	26.2 score on a scale Standard Deviation 6.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Hatha Yoga n=10 Participants 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression. Hatha Yoga: 12 weeks of Hatha Yoga
Home Practice Questionnaire	6 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Hatha Yoga n=11 Participants 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression. Hatha Yoga: 12 weeks of Hatha Yoga
Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)	6 adverse events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hatha Yoga n=9 Participants 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression. Hatha Yoga: 12 weeks of Hatha Yoga
Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)	4.11 score on a scale Standard Deviation 2.66

Adverse Events

Hatha Yoga

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hatha Yoga n=11 participants at risk 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression. Hatha Yoga: 12 weeks of Hatha Yoga
Blood and lymphatic system disorders Infection	9.1% 1/11 • Number of events 2 • 3 months
Gastrointestinal disorders Celiac	9.1% 1/11 • Number of events 2 • 3 months
Gastrointestinal disorders GI distress	9.1% 1/11 • Number of events 1 • 3 months
General disorders Gynecological issue	9.1% 1/11 • Number of events 1 • 3 months

Additional Information

Dr. Lisa Uebelacker

Butler Hospital

Phone: 401-455-6200

Email: LUebelacker@butler.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place