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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Alan R Teo, MD
  • Phone Number: 52461 503-220-8262
  • Email: alan.teo@va.gov

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate Treatment Group
8 weeks of Yoga Classes during first 8 weeks of study
Behavioral: Virtual Yoga at First 8 weeks
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
Behavioral: Virtual Yoga at Second 8 weeks
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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