Recruiting

Social Engagement

Sponsor:

VA Office of Research and Development

Code:

NCT06467214

Conditions

Social Isolation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CONNECTED

VET BEFRIENDING

Study Details

Brief summary:

Social isolation is a negative social determinant of health that affects 1-in-5 adults in the U.S. and 43% of Veterans. Social isolation is estimated to cost the nation $6.7 billion annually in federal healthcare spending. Yet, social isolation has rarely been the direct focus of healthcare interventions. The proposed project is a randomized controlled trial that seeks to test the effectiveness of the Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention on social isolation among diverse Veteran groups in primary care clinics. Increasing Veterans' Social Engagement and Connectedness involves three key services delivered by peers via telehealth through individual and group sessions over 8 weeks: 1) peer support, which includes person-centered assessment for social isolation, 2) psychosocial interventions to address social isolation, and 3) navigation (i.e., connecting Veterans to social resources). Findings from this study will contribute to the VA's efforts to address social determinants of health among Veterans and to provide high quality, person-centered, and equitable care to all Veterans.

Conditions

Social Isolation

Study ID

NCT06467214

Start date

Oct 4, 2024

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Eligible participants for Aim 1 \& Aim 2

1. Must be Veterans at the Roudebush Veterans Affairs Medical Center or its Community-Based Outpatient Clinics who had a primary care encounter in the prior 6 months and
2. Veteran obtained a score 12, indicating social isolation, on the Lubben Social Isolation Scale (LSNS-6), a validated, 6-item social isolation measure, at the time of screening in Aim 1.

Exclusion Criteria:

For Aim 1 and Aim 2, the investigators will exclude Veterans with

1. Active suicidal ideation needing immediate mental health treatment
2. severe cognitive, hearing or speech impairment,
3. current exacerbation of severe psychiatric symptoms (e.g., active psychosis), or
4. severe illness that makes study participation not feasible.

Study Design

Enrollment

264 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CONNECTED

CONNECTED integrates two evidence-based care models--peer support and patient navigation--and involves the delivery of three services by peers: 1) peer support, which includes person-centered assessment for drivers of social isolation; 2) group-based interventions to address Veterans' social isolation and 3) navigation, which involves connecting Veterans to social resources to facilitate social participation. CONNECTED is delivered through individual and group sessions over 8 weeks. All sessions will be delivered via videoconference. Veterans may choose to receive some peer support sessions in person when feasible, to facilitate engagement and retention.

active comparator: VET BEFRIENDING

VET BEFRIENDING (attention control arm) consists of weekly social interactions with a research assistant (RA). It will match the number of social contacts (12 contacts), frequency (weekly), intervention expectancy (positive treatment expectations), and working alliance (rapport with interventionist) in the intervention arm. The control condition has no overlap with CONNECTED in terms of content and therapeutic elements (e.g., goal setting, navigation).

Interventions

CONNECTED

CONNECTED is a manualized, peer-led, group-based social isolation intervention for diverse Veteran populations in VA primary care settings. It is delivered via videoconference through individual and group sessions over 8 weeks.

VET BEFRIENDING

VET BEFRIENDING (attention control arm) consists of weekly social interactions with a research assistant (RA) over videoconference or phone.

Primary outcome measure

  • Lubben Social Network Scale-6 [ Time Frame: Baseline, 2, 4, 8 months ]

Central Contacts and Locations

Central contacts

Johanne Eliacin, PhD

(317) 988-5298johanne.eliacin@va.gov

Jared Ferguson, BS CRA

(317) 988-9833Jared.Ferguson2@va.gov

Locations

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Recruiting

Indianapolis, Indiana, United States, 46202-2884

Contacts

Jasma Adams, BA MPH

jasma.adams2@va.gov

Principal Investigator:

Johanne Eliacin, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Veterans
  • Peer specialists
  • Loneliness
  • Navigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-08-19.