Bipolar Disorder, Depression, Mood Disorders
Conditions
Brief summary
We are seeking to understand the acceptability of an online yoga class for individuals with mood disorders. MoodNetwork members who are 18 years old or over who have experienced depression, mania, or hypomania are invited to participate. About 200 MoodNetwork participants will take part in this study.
Detailed description
Yoga practitioners view yoga as a way to promote good physical and mental health, rather than as a treatment for poor health. This world view may be appealing to patients, especially those concerned with the stigma of conventional mental health treatment, or with the narrow focus on decreasing symptoms (instead of a broader focus on living to one's full potential) that defines much of conventional mental health treatment. Yoga classes are widely available and relatively inexpensive compared to other depression treatments. Yoga can be practiced at home with the aid of video recordings or books. We propose to examine the acceptability and feasibility of online yoga practice for individuals with depression, mania, or hypomania.
Interventions
OTHERHatha yoga
Participants will be shown a 30 minute video of a yoga class that they will be invited to follow along with.
Sponsors
Massachusetts General Hospital
Brown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fluent in English * Over age 18 * Self-report of having experienced depression, mania, or hypomania in their lifetime
Exclusion criteria
* Any contraindication to exercise (e.g., pregnant, physical injuries or any other reason prohibiting exercise).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Affect Scale | Pre- and post-intervention, 40 min | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility/Acceptability Questionnaire | 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. |
| Adverse Event Questionnaire | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 272 |
| Total | 272 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 197 |
| Overall Study | self-reported contraindication | 9 |
Baseline characteristics
| Characteristic | Yoga Class |
|---|---|
| Age, Continuous | 40.22 years STANDARD_DEVIATION 13.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 235 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 25 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 227 Participants |
| Sex/Gender, Customized Gender : Female | 238 Participants |
| Sex/Gender, Customized Gender : Male | 31 Participants |
| Sex/Gender, Customized Gender : Unknown or Not Reported | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 281 |
| other Total, other adverse events | 12 / 281 |
| serious Total, serious adverse events | 0 / 281 |
Outcome results
Primary
Positive and Negative Affect Scale
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.
Time frame: Pre- and post-intervention, 40 min
Population: 140 participants completed the PANAS at pre-intervention. 52 had valid data at post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Yoga Class | Positive and Negative Affect Scale | Positive Affect Pre-Intervention | 23.39 units on a scale | Standard Deviation 7.95 |
| Yoga Class | Positive and Negative Affect Scale | Positive Affect Post-Intervention | 25.38 units on a scale | Standard Deviation 9.4 |
| Yoga Class | Positive and Negative Affect Scale | Negative Affect Pre-Intervention | 22.99 units on a scale | Standard Deviation 8.83 |
| Yoga Class | Positive and Negative Affect Scale | Negative Affect Post-Intervention | 15.21 units on a scale | Standard Deviation 7.04 |
Comparison: Paired-samples t-tests were used to analyze change in affect after participating in the yoga class. Analyses were conducted to measure changes in both positive affect and negative affect. This entry describes positive affect analysis.p-value: 0.01395% CI: [-3.73, -0.46]t-test, 2 sided
Comparison: Paired-samples t-tests were used to analyze change in affect after participating in the yoga class. Analyses were conducted to measure changes in both positive affect and negative affect. This entry describes negative affect analysis.p-value: <0.00195% CI: [4.1, 8.02]t-test, 2 sided
Secondary
Adverse Event Questionnaire
A free response survey asking for detail on any pain or injuries that may be relevant or related to the online yoga class
Time frame: Post-Intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Yoga Class | Adverse Event Questionnaire | Pain or discomfort as a result of participating | 4 Participants |
| Yoga Class | Adverse Event Questionnaire | Limitations from previously existing conditions | 4 Participants |
| Yoga Class | Adverse Event Questionnaire | Soreness unrelated to study intervention or health | 1 Participants |
| Yoga Class | Adverse Event Questionnaire | No reported pain or discomfort | 41 Participants |
Secondary
Feasibility/Acceptability Questionnaire
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.
Time frame: Post-Intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga Class | Feasibility/Acceptability Questionnaire | 7.40 units on a scale | Standard Deviation 2.27 |