Virtual Yoga for Social Isolation and Loneliness in Rural Veterans

Loneliness Clinical Trial

Official title:

Virtual Yoga for Social Isolation and Loneliness in Rural Veterans

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05431166
• Other study ID #: Study00023836
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Loneliness
• Social Isolation

Intervention

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
• 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

Locations

Country	Name	City	State
United States	VA Portland Health Care System	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UCLA Loneliness Scale, Version 3	Loneliness, higher scores indicate greater loneliness	10 Weeks
Secondary	NIH Toolbox Loneliness Scale	Loneliness, higher scores indicate greater loneliness	10 Weeks
Secondary	Modified Duke Social Support Index, Social Interaction Subscale	Social Interaction Subscale	10 Weeks
Secondary	Modified Duke Social Support Index, Social Interaction by Relationship Subscale	Social Interaction by Relationship Subscale	10 Weeks
Secondary	Promis Social Roles and Activities	Measure on ability to participate in social roles and activities	10 Weeks
Secondary	Promis Satisfaction with Social Roles and Activities	Measure on satisfaction with social roles and activities	10 Weeks
Secondary	PHQ-9	Depression measure	10 Weeks
Secondary	PC-PTSD-5	Post Traumatic Stress Disorder Measure	10 Weeks
Secondary	NIH CoRonavIruS Health Impact Survey (CRISIS)	Selected items from this measure	10 Weeks
Secondary	CSQ-8	Adaption of CSQ-8, a Satisfaction measure	10 Weeks
Secondary	Treatment Delivery	Treatment Delivery (Veteran Assessed)	10 Weeks
Secondary	Treatment Fidelity Checklist	Treatment Fidelity Checklist (Assessed by Provider	10 Weeks
Secondary	Attitudes Toward Yoga	Survey items on familiarity with yoga, reasons for participation in yoga, and expectations regarding yoga.	10 Weeks
Secondary	Sociodemographic Characteristics	Items on age, race/ethnicity, sex, gender, military background, household cohabitation status, zip code, employment status, education, household income, spirituality	10 Weeks
Secondary	PEG (Pain, Enjoyment, General Activity) Scale	Assessing Pain Intensity and Interference	10 Weeks
Secondary	SF-12	Assesses pain	10 Weeks