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

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.

Subscribe