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| Name | Class |
|---|---|
| Brown University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga class | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hatha yoga | Other | Participants will be shown a 30 minute video of a yoga class that they will be invited to follow along with. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre- and post-intervention, 40 min |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-Intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louisa G Sylvia, Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who consented and were not screened out for medical contraindications.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 140 participants completed the PANAS at pre-intervention. 52 had valid data at post-intervention | Posted | Mean | Standard Deviation | units on a scale | Pre- and post-intervention, 40 min |
|
40 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain or discomfort as a result of participation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Any amount of pain or soreness associated breathing or stretching when following along with the yoga class. |
This study utilized a single online yoga class as a pilot to assess feasibility. Results may not fully reflect changes associated with long-term yoga practice.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Louisa G. Sylvia, Ph.D. | Massachusetts General Hospital | 617-643-4804 | lsylvia2@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2015 | May 21, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 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 | Post-Intervention |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Post-Intervention |
|
|
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| 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 | Posted | Count of Participants | Participants | Post-Intervention |
|
|
|
| 0 |
| 281 |
| 0 |
| 281 |
| 12 |
| 281 |
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| Limitations from previously existing conditions | Musculoskeletal and connective tissue disorders | Systematic Assessment | Any pain or discomfort that is the product of exacerbating any previously existing medical conditions that were minor enough so as not to be deemed ineligible at consent |
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| Soreness unrelated to study intervention or health | Musculoskeletal and connective tissue disorders | Systematic Assessment | Any pain or discomfort related to circumstances beyond the scope of study procedures or other health conditions |
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| Soreness unrelated to study intervention or health |
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