Trial Outcomes & Findings for Hyperthermic Yoga for Depressive Symptoms (NCT NCT02607514)
NCT ID: NCT02607514
Last Updated: 2025-11-20
Results Overview
Acceptability Interview: A 19-question qualitative interview assesses perception of ease of participation, program likeability, and perceived benefits of the yoga program. Adapted from DeBoer et al. It was a 1-10 likert scale with 1 = lowest, 10 = highest to rate acceptability of the yoga intervention. These are the items we used: 1) how much did you enjoy the yoga itself?; 2) how much did you enjoy the aftereffects of the yoga?; and 3) how reasonable did you find the time commitment to be?
COMPLETED
NA
80 participants
at the end of 8-weeks or early termination.
2025-11-20
Participant Flow
Participant milestones
| Measure |
Immediate Yoga Arm
participants will immediately start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
Delayed Yoga Arm
participants will wait 8 weeks to start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
22
|
26
|
|
Overall Study
NOT COMPLETED
|
18
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hyperthermic Yoga for Depressive Symptoms
Baseline characteristics by cohort
| Measure |
Immediate Yoga Arm
n=33 Participants
participants will immediately start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
Delayed Yoga Arm
n=32 Participants
participants will wait 8 weeks to start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=39 Participants
|
32 Participants
n=29 Participants
|
65 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 11.65 • n=39 Participants
|
33.12 years
STANDARD_DEVIATION 11.93 • n=29 Participants
|
32.71 years
STANDARD_DEVIATION 11.7 • n=60 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=39 Participants
|
28 Participants
n=29 Participants
|
53 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=39 Participants
|
4 Participants
n=29 Participants
|
12 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
5 Participants
n=29 Participants
|
7 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=39 Participants
|
27 Participants
n=29 Participants
|
58 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
4 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=39 Participants
|
4 Participants
n=29 Participants
|
8 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=39 Participants
|
21 Participants
n=29 Participants
|
45 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=39 Participants
|
3 Participants
n=29 Participants
|
6 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=39 Participants
|
32 Participants
n=29 Participants
|
65 Participants
n=60 Participants
|
|
IDS-CR
|
36.86 units on a scale
STANDARD_DEVIATION 8.80 • n=39 Participants
|
34.38 units on a scale
STANDARD_DEVIATION 6.68 • n=29 Participants
|
35.63 units on a scale
STANDARD_DEVIATION 7.87 • n=60 Participants
|
|
HAMD-17
|
22.21 units on a scale
STANDARD_DEVIATION 5.42 • n=39 Participants
|
20.78 units on a scale
STANDARD_DEVIATION 4.02 • n=29 Participants
|
21.51 units on a scale
STANDARD_DEVIATION 4.80 • n=60 Participants
|
PRIMARY outcome
Timeframe: 8-week primary endpointPopulation: The number of baseline participants reported is the sample that we analyzed in our a priori Modified Intent-to-Treat (MITT) primary analysis.
Inventory of Depressive Symptomatology - Clinician Rated. Scale range: 0-84 (higher = greater depressive symptoms)
Outcome measures
| Measure |
Delayed Yoga Arm
n=32 Participants
participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
Immediate Yoga Arm
n=33 Participants
participants will immediately start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
|---|---|---|
|
Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)
|
29.63 units on a scale
Standard Deviation 9.58
|
17.93 units on a scale
Standard Deviation 12.70
|
PRIMARY outcome
Timeframe: 8-week primary end pointMeasured by percent of the yoga group who complete a week 8 assessment
Outcome measures
| Measure |
Delayed Yoga Arm
n=32 Participants
participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
Immediate Yoga Arm
n=33 Participants
participants will immediately start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
|---|---|---|
|
Feasibility and Tolerability Measured by Percent of the Yoga Group Who Complete a Week 8 Assessment
|
32 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: at the end of 8-weeks or early termination.Population: we analyzed participants who finished the trial in the immediate yoga arm, delayed yoga arm, or terminated early from the intervention. \*we only published and analyzed results from the immediate yoga arm
Acceptability Interview: A 19-question qualitative interview assesses perception of ease of participation, program likeability, and perceived benefits of the yoga program. Adapted from DeBoer et al. It was a 1-10 likert scale with 1 = lowest, 10 = highest to rate acceptability of the yoga intervention. These are the items we used: 1) how much did you enjoy the yoga itself?; 2) how much did you enjoy the aftereffects of the yoga?; and 3) how reasonable did you find the time commitment to be?
Outcome measures
| Measure |
Delayed Yoga Arm
n=27 Participants
participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
Immediate Yoga Arm
n=27 Participants
participants will immediately start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
|---|---|---|
|
Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination
Enjoyment of yoga
|
7.52 likert scale units
Standard Deviation 1.99
|
7.17 likert scale units
Standard Deviation 2.28
|
|
Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination
Enjoyment of aftereffects of yoga
|
8.59 likert scale units
Standard Deviation 1.67
|
8.33 likert scale units
Standard Deviation 1.74
|
|
Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination
Reasonable time commitment
|
7 likert scale units
Standard Deviation 2
|
6.90 likert scale units
Standard Deviation 2.38
|
SECONDARY outcome
Timeframe: 8-weeks end pointQuality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Range 0-70 with higher scores indicating greater life satisfaction and enjoyment
Outcome measures
| Measure |
Delayed Yoga Arm
n=32 Participants
participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
Immediate Yoga Arm
n=33 Participants
participants will immediately start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
|---|---|---|
|
Quality of Life as Measured by the Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Over 8 Weeks.
|
41.34 units on a scale
Standard Deviation 8.24
|
51.33 units on a scale
Standard Deviation 7.90
|
SECONDARY outcome
Timeframe: 8 weeksMedical Outcomes Study 36-item short-form survey (SF-36): Assesses bodily pain, general health perception, vitality, social functioning, physical and emotional impediments to role functioning, mental health, and includes an overall physical component scale (PCS) and mental component scale (MCS). scores range from 0-100 with 100 being the best.
Outcome measures
| Measure |
Delayed Yoga Arm
n=32 Participants
participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
Immediate Yoga Arm
n=33 Participants
participants will immediately start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
|---|---|---|
|
General Health as Measured by the Medical Outcomes Study 36-item Short-form Survey (SF-36)
|
53.5 units on a scale
Standard Deviation 18.72
|
61.67 units on a scale
Standard Deviation 23.15
|
SECONDARY outcome
Timeframe: 8 weeksMedical Outcomes Study 36-item short-form survey (SF-36)86: Assesses bodily pain, general health perception, vitality, social functioning, physical and emotional impediments to role functioning, mental health, and includes an overall physical component scale (PCS) and mental component scale (MCS). Scores range from 0-100 with 100 being the best.
Outcome measures
| Measure |
Delayed Yoga Arm
n=32 Participants
participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
Immediate Yoga Arm
n=33 Participants
participants will immediately start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
|---|---|---|
|
Physical Functioning as Measured by the Physical Component Scale (PCS) of the Medical Outcomes Study 36-item Short-form Survey (SF-36) Over 8 Weeks.
|
53.33 units on a scale
Standard Deviation 16
|
47.62 units on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 8 weeksThe Perceived Stress Scale (PSS): Measures perceived level of stress. Scale range: 0-40 (higher = more perceived stress)
Outcome measures
| Measure |
Delayed Yoga Arm
n=32 Participants
participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
Immediate Yoga Arm
n=33 Participants
participants will immediately start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
|---|---|---|
|
Perceived Stress as Measured by the Perceived Stress Scale (PSS) Over 8 Weeks.
|
22.33 units on a scale
Standard Deviation 5.84
|
17.42 units on a scale
Standard Deviation 8.22
|
SECONDARY outcome
Timeframe: 8 weeksSpielberger State-Trait Anxiety Inventory (STAI), State. A 40-item commonly used measure that distinguishes between state vs. trait anxiety. Ranges from 0-63 with higher scores indicating more anxiety.
Outcome measures
| Measure |
Delayed Yoga Arm
n=32 Participants
participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
Immediate Yoga Arm
n=33 Participants
participants will immediately start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
|---|---|---|
|
Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), State, Over 8 Weeks.
|
48.43 units on a scale
Standard Deviation 9.66
|
40.69 units on a scale
Standard Deviation 10.74
|
SECONDARY outcome
Timeframe: 8-weeksPittsburg Sleep Quality Index (PSQI): A commonly used and well-validated self-rated measure of sleep-quality and disturbance. total score ranges from 0-21 with higher score indicating worse sleep quality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: one month post interventionsee all primary and secondary outcome measures listed here.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksSpielberger State-Trait Anxiety Inventory (STAI), Trait. A 40-item commonly used measure that distinguishes between state vs. trait anxiety. Ranges from 0-63 with higher scores indicating more anxiety.
Outcome measures
| Measure |
Delayed Yoga Arm
n=32 Participants
participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
Immediate Yoga Arm
n=33 Participants
participants will immediately start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
|---|---|---|
|
Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), Trait, Over 8 Weeks.
|
54.1 units on a scale
Standard Deviation 8.25
|
46.70 units on a scale
Standard Deviation 11.80
|
Adverse Events
Immediate Yoga Arm
Delayed Yoga Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Immediate Yoga Arm
n=33 participants at risk
participants will immediately start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
Delayed Yoga Arm
n=32 participants at risk
participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
3/33 • Number of events 3 • 8 weeks
|
3.1%
1/32 • Number of events 1 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place