Trial Outcomes & Findings for Treatments for Improving Mood in Depressed Teens-3 (NCT NCT03831360)

NCT ID: NCT03831360

Last Updated: 2022-06-02

Results Overview

Acceptability is operationalized by the number of participants who attended 8 or more classes out of possible 12. Target was 70% or greater.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2022-06-02

Participant Flow

Participant milestones

Measure	Hatha Yoga 12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	Group CBT 12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Overall Study STARTED	15	15
Overall Study COMPLETED	12	14
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatments for Improving Mood in Depressed Teens-3

Baseline characteristics by cohort

Measure	Hatha Yoga n=15 Participants 12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	Group CBT n=15 Participants 12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents	Total n=30 Participants Total of all reporting groups
Age, Continuous	15.00 years STANDARD_DEVIATION 1.41 • n=5 Participants	15.00 years STANDARD_DEVIATION 1.46 • n=7 Participants	15.00 years STANDARD_DEVIATION 1.40 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Acceptability is operationalized by the number of participants who attended 8 or more classes out of possible 12. Target was 70% or greater.

Outcome measures

Measure	Hatha Yoga n=15 Participants 12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	Group CBT n=15 Participants 12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Acceptability	11 Participants	13 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 each scored on a range of 0-1, and the mean of thise is used in analyses. Higher scores indicate greater credibility.

Outcome measures

Measure	Hatha Yoga n=14 Participants 12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	Group CBT n=14 Participants 12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale	0.72 score on a scale Standard Deviation .18	0.71 score on a scale Standard Deviation .17

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 and the mean of those scores are analyzed, with higher scores indicating greater expectations.

Outcome measures

Measure	Hatha Yoga n=14 Participants 12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	Group CBT n=14 Participants 12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale	0.57 score on a scale Standard Deviation .20	0.55 score on a scale Standard Deviation .24

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 hatha yoga Yoga: Hatha yoga for depressed adolescents	Group CBT n=13 Participants 12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
The Client Satisfaction Questionnaire (CSQ-8)	26.8 score on a scale Standard Deviation 4.18	26.1 score on a scale Standard Deviation 5.00

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=14 Participants 12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	Group CBT n=15 Participants 12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Home Practice Questionnaire	3 Participants	8 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=14 Participants 12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	Group CBT n=14 Participants 12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to post intervention (month 3)

Change in depression symptom severity will be assessed via blind evaluator using the the QIDS. 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=12 Participants 12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	Group CBT n=13 Participants 12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)	6.92 score on a scale Standard Deviation 5.20	8.23 score on a scale Standard Deviation 3.17

Adverse Events

Hatha Yoga

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group CBT

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=15 participants at risk 12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents	Group CBT n=15 participants at risk 12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents
Immune system disorders flu	6.7% 1/15 • Number of events 1 • Three months	13.3% 2/15 • Number of events 2 • Three months

Additional Information

Dr. Lisa Uebelacker

Butler Hospital

Phone: 401-455-6381

Email: LUebelacker@butler.org

Results disclosure agreements

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