- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05431166
Virtual Yoga for Social Isolation and Loneliness in Rural Veterans
September 20, 2023 updated by: Oregon Health and Science University
The overarching goal of this project is to decrease social isolation and loneliness through increased awareness and uptake of virtual yoga group classes among rural Veterans.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
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
-
-
Oregon
-
Portland, Oregon, United States, 97239
- VA Portland Health Care System
-
-
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 to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Enrolled in VA Healthcare
- Residential address associated with VA Portland Health Care System that is "rural" or "highly rural; except among Collaborative Aging Research using Technology (CART) participants
- Valid contact info (mailing address, email, and phone number)
- High speed Internet access
- Positive screen for loneliness (NIH Toolbox Loneliness Scale Score greater or equal to 13)
Exclusion Criteria:
- Any VA or non-VA yoga visit in the preceding 12 months
- Visually or hearing impaired, or any mobility limitation that would impact computer/mobile device use, without availability of appropriate assistive devices
- Cognitive impairment, upcoming medical procedures, or significant unstable medical and psychiatric conditions that may limit study participation
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Treatment Group
8 weeks of Yoga Classes during first 8 weeks of study
|
1 hour per week of virtual yoga delivered by an active movement therapist at the VA during the first 8 weeks of the study
|
|
Active Comparator: Waitlist Control
8 weeks of Yoga Classes during second 8 weeks of study
|
1 hour per week of virtual yoga delivered by an active movement therapist at the VA during the second 8 weeks of the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
UCLA Loneliness Scale, Version 3
Time Frame: 10 Weeks
|
Loneliness, higher scores indicate greater loneliness
|
10 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NIH Toolbox Loneliness Scale
Time Frame: 10 Weeks
|
Loneliness, higher scores indicate greater loneliness
|
10 Weeks
|
|
Modified Duke Social Support Index, Social Interaction Subscale
Time Frame: 10 Weeks
|
Social Interaction Subscale
|
10 Weeks
|
|
Modified Duke Social Support Index, Social Interaction by Relationship Subscale
Time Frame: 10 Weeks
|
Social Interaction by Relationship Subscale
|
10 Weeks
|
|
Promis Social Roles and Activities
Time Frame: 10 Weeks
|
Measure on ability to participate in social roles and activities
|
10 Weeks
|
|
Promis Satisfaction with Social Roles and Activities
Time Frame: 10 Weeks
|
Measure on satisfaction with social roles and activities
|
10 Weeks
|
|
PHQ-9
Time Frame: 10 Weeks
|
Depression measure
|
10 Weeks
|
|
PC-PTSD-5
Time Frame: 10 Weeks
|
Post Traumatic Stress Disorder Measure
|
10 Weeks
|
|
NIH CoRonavIruS Health Impact Survey (CRISIS)
Time Frame: 10 Weeks
|
Selected items from this measure
|
10 Weeks
|
|
CSQ-8
Time Frame: 10 Weeks
|
Adaption of CSQ-8, a Satisfaction measure
|
10 Weeks
|
|
Treatment Delivery
Time Frame: 10 Weeks
|
Treatment Delivery (Veteran Assessed)
|
10 Weeks
|
|
Treatment Fidelity Checklist
Time Frame: 10 Weeks
|
Treatment Fidelity Checklist (Assessed by Provider
|
10 Weeks
|
|
Attitudes Toward Yoga
Time Frame: 10 Weeks
|
Survey items on familiarity with yoga, reasons for participation in yoga, and expectations regarding yoga.
|
10 Weeks
|
|
Sociodemographic Characteristics
Time Frame: 10 Weeks
|
Items on age, race/ethnicity, sex, gender, military background, household cohabitation status, zip code, employment status, education, household income, spirituality
|
10 Weeks
|
|
PEG (Pain, Enjoyment, General Activity) Scale
Time Frame: 10 Weeks
|
Assessing Pain Intensity and Interference
|
10 Weeks
|
|
SF-12
Time Frame: 10 Weeks
|
Assesses pain
|
10 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 1, 2021
Primary Completion (Estimated)
September 30, 2023
Study Completion (Estimated)
September 30, 2023
Study Registration Dates
First Submitted
March 29, 2022
First Submitted That Met QC Criteria
June 21, 2022
First Posted (Actual)
June 24, 2022
Study Record Updates
Last Update Posted (Actual)
September 22, 2023
Last Update Submitted That Met QC Criteria
September 20, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Study00023836
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.