- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02610725
Online Yoga for Individuals With Mood Disorders
September 5, 2019 updated by: Louisa Grandin Sylvia, Massachusetts General Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
281
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive and Negative Affect Scale
Time Frame: 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.
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Pre- and post-intervention, 40 min
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility/Acceptability Questionnaire
Time Frame: Post-Intervention
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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.
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Post-Intervention
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Adverse Event Questionnaire
Time Frame: Post-Intervention
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A free response survey asking for detail on any pain or injuries that may be relevant or related to the online yoga class
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Post-Intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Louisa G Sylvia, Ph.D., Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2015
Primary Completion (Actual)
February 20, 2018
Study Completion (Actual)
February 20, 2018
Study Registration Dates
First Submitted
November 19, 2015
First Submitted That Met QC Criteria
November 19, 2015
First Posted (Estimate)
November 20, 2015
Study Record Updates
Last Update Posted (Actual)
September 30, 2019
Last Update Submitted That Met QC Criteria
September 5, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015P001362
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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