Trial Outcomes & Findings for Online Yoga for Individuals With Mood Disorders (NCT NCT02610725)

Last Updated: 2019-09-30

Results Overview

The PANAS is a 20-item questionnaire that contains two 10-item subscales for positive and negative affect, respectively. The positive affect subscale assesses domains of excitement, enthusiasm, and attentiveness, whereas the negative subscale measures domains of distress, guilt, and irritability. Each subscale score can range from 10-50 where higher scores indicate greater levels of affect.

Recruitment status

COMPLETED

Study phase

Target enrollment

281 participants

Primary outcome timeframe

Pre- and post-intervention, 40 min

Results posted on

2019-09-30

Participant Flow

Participant milestones

Participant milestones
Measure	Yoga Class A 30 minute online Hatha yoga video intervention will be administered to participants.Participants will only participate in one yoga class and complete follow-up questionnaires. Hatha yoga: Participants will be shown a 30 minute video of a yoga class that they will be invited to follow along with.
Overall Study STARTED	281
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	206

Reasons for withdrawal

Reasons for withdrawal
Measure	Yoga Class A 30 minute online Hatha yoga video intervention will be administered to participants.Participants will only participate in one yoga class and complete follow-up questionnaires. Hatha yoga: Participants will be shown a 30 minute video of a yoga class that they will be invited to follow along with.
Overall Study Lost to Follow-up	197
Overall Study self-reported contraindication	9

Baseline Characteristics

Online Yoga for Individuals With Mood Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Yoga Class n=272 Participants A 30 minute online Hatha yoga video intervention will be administered to participants.Participants will only participate in one yoga class and complete follow-up questionnaires. Hatha yoga: Participants will be shown a 30 minute video of a yoga class that they will be invited to follow along with.
Age, Continuous	40.22 years STANDARD_DEVIATION 13.38 • n=5 Participants
Sex/Gender, Customized Gender : Male	31 Participants n=5 Participants
Sex/Gender, Customized Gender : Female	238 Participants n=5 Participants
Sex/Gender, Customized Gender : Unknown or Not Reported	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	235 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	227 Participants n=5 Participants
Race (NIH/OMB) More than one race	25 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre- and post-intervention, 40 min

Population: 140 participants completed the PANAS at pre-intervention. 52 had valid data at post-intervention

Outcome measures

Outcome measures
Measure	Yoga Class n=140 Participants A 30 minute online Hatha yoga video intervention will be administered to participants.Participants will only participate in one yoga class and complete follow-up questionnaires. Hatha yoga: Participants will be shown a 30 minute video of a yoga class that they will be invited to follow along with.
Positive and Negative Affect Scale Positive Affect Pre-Intervention	23.39 units on a scale Standard Deviation 7.95
Positive and Negative Affect Scale Positive Affect Post-Intervention	25.38 units on a scale Standard Deviation 9.40
Positive and Negative Affect Scale Negative Affect Pre-Intervention	22.99 units on a scale Standard Deviation 8.83
Positive and Negative Affect Scale Negative Affect Post-Intervention	15.21 units on a scale Standard Deviation 7.04

SECONDARY outcome

Timeframe: Post-Intervention

This measure was developed for this study. It includes a Likert Scale item assessing how much participants liked the class (1 "Disliked it very much" to 10 "Liked it very much"). It also collects qualitative feedback on what they liked, disliked, as well as any other commentary. Quantitative data from Likert items are the secondary outcome reported.

Outcome measures

Outcome measures
Measure	Yoga Class n=50 Participants A 30 minute online Hatha yoga video intervention will be administered to participants.Participants will only participate in one yoga class and complete follow-up questionnaires. Hatha yoga: Participants will be shown a 30 minute video of a yoga class that they will be invited to follow along with.
Feasibility/Acceptability Questionnaire	7.40 units on a scale Standard Deviation 2.27

SECONDARY outcome

Timeframe: Post-Intervention

A free response survey asking for detail on any pain or injuries that may be relevant or related to the online yoga class

Outcome measures

Outcome measures
Measure	Yoga Class n=50 Participants A 30 minute online Hatha yoga video intervention will be administered to participants.Participants will only participate in one yoga class and complete follow-up questionnaires. Hatha yoga: Participants will be shown a 30 minute video of a yoga class that they will be invited to follow along with.
Adverse Event Questionnaire No reported pain or discomfort	41 Participants
Adverse Event Questionnaire Pain or discomfort as a result of participating	4 Participants
Adverse Event Questionnaire Limitations from previously existing conditions	4 Participants
Adverse Event Questionnaire Soreness unrelated to study intervention or health	1 Participants

Adverse Events

Yoga Class

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Yoga Class n=281 participants at risk A 30 minute online Hatha yoga video intervention will be administered to participants.Participants will only participate in one yoga class and complete follow-up questionnaires. Hatha yoga: Participants will be shown a 30 minute video of a yoga class that they will be invited to follow along with.
Musculoskeletal and connective tissue disorders Pain or discomfort as a result of participation	2.1% 6/281 • 40 minutes
Musculoskeletal and connective tissue disorders Limitations from previously existing conditions	1.8% 5/281 • 40 minutes
Musculoskeletal and connective tissue disorders Soreness unrelated to study intervention or health	0.36% 1/281 • 40 minutes

Additional Information

Louisa G. Sylvia, Ph.D.

Massachusetts General Hospital

Phone: 617-643-4804

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place