LonelinessNCT05431166
Virtual Yoga for Social Isolation and Loneliness in Rural Veterans
A study testing Virtual Yoga at First 8 weeks and Virtual Yoga at Second 8 weeks in people with Loneliness and Social Isolation, run by Oregon Health and Science University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Loneliness, Social Isolation
- What is being tested?
- Virtual Yoga at First 8 weeks and Virtual Yoga at Second 8 weeks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System
Portland, Oregon, 97239
About this study
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.
- Conditions
- Loneliness, Social Isolation
- Being tested
- Virtual Yoga at First 8 weeks, Virtual Yoga at Second 8 weeks
- Keywords
- Veterans
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Yoga at First 8 weeksBehavioural
1 hour per week of virtual yoga delivered by an active movement therapist at the VA during the first 8 weeks of the study
Virtual Yoga at Second 8 weeksBehavioural
1 hour per week of virtual yoga delivered by an active movement therapist at the VA during the second 8 weeks of the study
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment Group | Experimental | 8 weeks of Yoga Classes during first 8 weeks of study Receives: Behavioral: Virtual Yoga at First 8 weeks |
| Waitlist Control | Active comparator | 8 weeks of Yoga Classes during second 8 weeks of study Receives: Behavioral: Virtual Yoga at Second 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA Loneliness Scale, Version 3
Loneliness, higher scores indicate greater loneliness
Measured: 10 Weeks
Secondary outcomes (15)
NIH Toolbox Loneliness Scale
Loneliness, higher scores indicate greater loneliness
Measured: 10 Weeks
Modified Duke Social Support Index, Social Interaction Subscale
Social Interaction Subscale
Measured: 10 Weeks
Modified Duke Social Support Index, Social Interaction by Relationship Subscale
Social Interaction by Relationship Subscale
Measured: 10 Weeks
Promis Social Roles and Activities
Measure on ability to participate in social roles and activities
Measured: 10 Weeks
Promis Satisfaction with Social Roles and Activities
Measure on satisfaction with social roles and activities
Measured: 10 Weeks
PHQ-9
Depression measure
Measured: 10 Weeks
PC-PTSD-5
Post Traumatic Stress Disorder Measure
Measured: 10 Weeks
NIH CoRonavIruS Health Impact Survey (CRISIS)
Selected items from this measure
Measured: 10 Weeks
CSQ-8
Adaption of CSQ-8, a Satisfaction measure
Measured: 10 Weeks
Treatment Delivery
Treatment Delivery (Veteran Assessed)
Measured: 10 Weeks
Treatment Fidelity Checklist
Treatment Fidelity Checklist (Assessed by Provider
Measured: 10 Weeks
Attitudes Toward Yoga
Survey items on familiarity with yoga, reasons for participation in yoga, and expectations regarding yoga.
Measured: 10 Weeks
Sociodemographic Characteristics
Items on age, race/ethnicity, sex, gender, military background, household cohabitation status, zip code, employment status, education, household income, spirituality
Measured: 10 Weeks
PEG (Pain, Enjoyment, General Activity) Scale
Assessing Pain Intensity and Interference
Measured: 10 Weeks
SF-12
Assesses pain
Measured: 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Oct 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Wait list Control
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431166
- Sponsor's protocol ID
- Study00023836
- Status last verified
- Aug 2023
- First submitted
- 29 Mar 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Teo AR, Benton MC, Hooker ER, Zaccari B, Hidalgo NJ, Newell S, Tuepker A, Greaves DW, Nicosia FM. Effect of telehealth yoga on loneliness and social isolation among rural older adults: a randomized controlled trial. Aging Ment Health. 2025 May;29(5):824-832. doi: 10.1080/13607863.2024.2449126. Epub 2025 Jan 10.
PubMed 39791606
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Yoga for Social Isolation and Loneliness in Rural Veterans
- ClinicalTrials.gov ID
- NCT05431166
- Acronym / sponsor ID
- Study00023836
- Conditions
- Loneliness, Social Isolation
- Keywords
- Veterans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Wait list Control
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment Group | Experimental | Behavioral: Virtual Yoga at First 8 weeks8 weeks of Yoga Classes during first 8 weeks of study |
| Waitlist Control | Active comparator | Behavioral: Virtual Yoga at Second 8 weeks8 weeks of Yoga Classes during second 8 weeks of study |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Yoga at First 8 weeks1 hour per week of virtual yoga delivered by an active movement therapist at the VA during the first 8 weeks of the study | Behavioural | Immediate Treatment Group |
| Virtual Yoga at Second 8 weeks1 hour per week of virtual yoga delivered by an active movement therapist at the VA during the second 8 weeks of the study | Behavioural | Waitlist Control |
Primary outcome
UCLA Loneliness Scale, Version 3
Time frame: 10 Weeks
Loneliness, higher scores indicate greater loneliness
15 secondary outcomes
NIH Toolbox Loneliness Scale
Time frame: 10 Weeks
Modified Duke Social Support Index, Social Interaction Subscale
Time frame: 10 Weeks
Modified Duke Social Support Index, Social Interaction by Relationship Subscale
Time frame: 10 Weeks
Promis Social Roles and Activities
Time frame: 10 Weeks
Promis Satisfaction with Social Roles and Activities
Time frame: 10 Weeks
PHQ-9
Time frame: 10 Weeks
PC-PTSD-5
Time frame: 10 Weeks
NIH CoRonavIruS Health Impact Survey (CRISIS)
Time frame: 10 Weeks
CSQ-8
Time frame: 10 Weeks
Treatment Delivery
Time frame: 10 Weeks
Treatment Fidelity Checklist
Time frame: 10 Weeks
Attitudes Toward Yoga
Time frame: 10 Weeks
Sociodemographic Characteristics
Time frame: 10 Weeks
PEG (Pain, Enjoyment, General Activity) Scale
Time frame: 10 Weeks
SF-12
Time frame: 10 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 39791606Teo AR, Benton MC, Hooker ER, Zaccari B, Hidalgo NJ, Newell S, Tuepker A, Greaves DW, Nicosia FM. Effect of telehealth yoga on loneliness and social isolation among rural older adults: a randomized controlled trial. Aging Ment Health. 2025 May;29(5):824-832. doi: 10.1080/13607863.2024.2449126. Epub 2025 Jan 10.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Yoga at First 8 weeks and Virtual Yoga at Second 8 weeks in people with Loneliness and Social Isolation, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCLA Loneliness Scale, Version 3 (time frame: 10 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05431166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.