CONNECTED Program for Social Isolation

(CONNECTED Trial)

Overseen By Carrie Ballard, BA AS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Suicidal ideation, Severe cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

264 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to assist Veterans experiencing social isolation. It examines whether a program called CONNECTED, which involves peer support and group sessions, can enhance feelings of connection among Veterans. Another group will engage in regular conversations with a research assistant for comparison. Veterans who have felt socially isolated and visited a primary care clinic in the last six months may be suitable for this trial. The goal is to determine if these approaches can improve social connections and overall well-being for Veterans. As an unphased trial, this study provides Veterans the chance to contribute to innovative solutions for social isolation and enhance their own well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on social support and engagement, so it's unlikely that medication changes are required.

What prior data suggests that the CONNECTED and VET BEFRIENDING interventions are safe for addressing social isolation among Veterans?

Research has shown that the CONNECTED program is practical and well-received by veterans experiencing social isolation. Studies suggest it effectively reduces these feelings. The program includes peer support, group sessions, and connects veterans to social resources. Reports have not indicated any negative effects from these activities, which are designed to safely increase social interaction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CONNECTED program because it combines peer support and patient navigation to tackle social isolation among veterans, which is quite different from current options. Unlike traditional treatments that might focus solely on counseling or medication, CONNECTED uses peer support to help veterans identify and address the root causes of their social isolation. Additionally, it facilitates group-based interventions and connects veterans with social resources, promoting active participation in their communities. This method is delivered via videoconferencing, offering flexibility and accessibility that can enhance engagement and retention. Meanwhile, VET BEFRIENDING provides a unique control by offering consistent social interaction, which helps to address the social needs of participants while maintaining a clear distinction from the therapeutic elements of CONNECTED.

What evidence suggests that the CONNECTED program is effective for reducing social isolation among Veterans?

Research has shown that the CONNECTED program, one of the treatments in this trial, reduces feelings of loneliness among veterans. This program includes support from fellow veterans, group activities, and guidance to social resources. Participants find it easy to use and respond positively. The goal is to help veterans form more social connections, which can improve overall health. Early results suggest that veterans in the CONNECTED program become more socially active, making it a promising way to combat loneliness. The program's flexibility allows sessions to be held online or in person, helping veterans stay connected. Meanwhile, the VET BEFRIENDING arm, another treatment option in this trial, provides weekly social interactions with a research assistant to match the social contact frequency of the CONNECTED program. ^{1 2 3 4 5}

Who Is on the Research Team?

Johanne Eliacin, PhD

Principal Investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Are You a Good Fit for This Trial?

This trial is for U.S. Veterans experiencing social isolation. It's designed to help them connect with others and improve their social health. To join, they must be receiving care at a participating primary clinic and feel socially isolated.

Inclusion Criteria

Must be Veterans at the Roudebush VAMC or its CBOCs who had a primary care encounter in the prior 6 months

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

I do not have severe problems with thinking, hearing, or speaking.

I am currently experiencing thoughts of harming myself and need urgent mental health support.

Severe illness that makes study participation not feasible

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CONNECTED intervention, which includes peer support, psychosocial interventions, and navigation services delivered via telehealth over 8 weeks

8 weeks

Weekly sessions (telehealth), optional in-person sessions

Follow-up

Participants are monitored for social isolation and health-related outcomes at 2, 4, and 8 months from baseline

8 months

Assessments at 2, 4, and 8 months

What Are the Treatments Tested in This Trial?

Interventions

• CONNECTED
• VET BEFRIENDING

Trial Overview The CONNECTED intervention is being tested, which includes peer support, psychosocial interventions, and resource navigation via telehealth over 8 weeks to reduce social isolation among Veterans.

How Is the Trial Designed?

Group I: CONNECTED Experimental Treatment 1 Intervention

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.

Group II: VET BEFRIENDING Active Control 1 Intervention

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).

CONNECTED is already approved in United States for the following indications:

Approved in United States as CONNECTED for:

• Social isolation among veterans

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A study of 1,683 older military veterans revealed that those aged 85 and older, particularly White males who are unmarried or have lower education and income levels, are at a higher risk for severe social isolation.

The findings highlight the need for targeted interventions to enhance social connections among older veterans, addressing the specific risk factors that contribute to their social isolation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social isolation among older veterans: findings from the National Health and Aging Trends Study. Suntai, Z., White, B.[2022]

A study on a telephone-based social connectedness intervention for older adults found that individuals with disabilities, depression, and arthritis were more likely to participate, highlighting the importance of targeting these groups for such programs.

Using advanced machine learning techniques, the study achieved over 95% accuracy in predicting participation, indicating that understanding these predictors can help improve engagement in social interventions for isolated seniors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Predictors of Participation in Telephone-Based Social-Connectedness Interventions for Older Adults: A Dual Machine-Learning and Regression Approach. Chae, M., Chavez, A., Singh, M., et al.[2023]

Engaging veterans in research is crucial for identifying modifiable suicide risk factors and developing effective public health interventions, as highlighted by the contributions of the Veterans Engagement Board to the ASCEND project.

Veteran engagement not only improves communication and sensitivity around topics like firearms and suicide in surveys but also enhances the relevance of research to current events, making it a vital part of suicide prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Veteran Engagement in Survey Research to Prevent Suicide. Wendleton, L., Hoffmire, CA., Drop, S., et al.[2023]

A survey of 105 veterans and 112 staff at a VA medical center revealed that social distancing during COVID-19 led to a decline in therapeutic alliances and clinical status, with both groups rating their treatment experience as 'not as good' compared to before the pandemic.

Both veterans and staff expressed a strong preference for returning to face-to-face service delivery, while still wanting to incorporate some telehealth options, highlighting the importance of personal interaction in mental health treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of COVID-19-Related Social Distancing on Delivery of Intensive Case Management. Rosenheck, R., Johnson, B., Deegan, D., et al.[2023]

In a survey of 200 veterans, 39% reported being socially isolated, with a significant interest (over 61%) in programs aimed at reducing social isolation, highlighting a critical need for interventions like CONNECTED.

The pilot study of the CONNECTED intervention with 19 veterans showed high feasibility and acceptability, with significant improvements in social isolation, social support, anxiety, and depression, indicating its potential effectiveness in addressing social isolation among veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Findings from a Peer-Facilitated, Social Isolation Intervention in the Veterans Health Administration Healthcare System: A Mixed-Methods, Pilot Feasibility Study. Eliacin, J., Patterson, SM., Mendez, DM., et al.[2023]

Veterans experience unique challenges related to social isolation and loneliness, particularly during their transition out of the military, highlighting the need for targeted support during this period.

Integrating veterans into community services and utilizing social prescribing can effectively connect them to resources, suggesting that tailored programs are essential for addressing their social isolation and loneliness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social isolation and loneliness of UK veterans: a Delphi study. Leslie, C., McGill, G., Kiernan, MD., et al.[2021]

The VOICES intervention, which organizes community-based Veterans Socials, has shown high levels of acceptability and demand among veterans, indicating that they find it valuable and are likely to participate.

This program may enhance social connections and increase the use of VA services, potentially contributing to a reduction in suicide rates among U.S. veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Veterans Socials to Build a Community: Feasibility of the VOICES Intervention. Gorman, JA., Chamberlin, ES., Stevenson, BJ., et al.[2023]

Veteran Coffee Socials, held weekly in local coffee shops, successfully engaged an average of 8.5 veterans per meeting over 9 months, totaling 2236 interactions, which helped combat social isolation among veterans transitioning to civilian life.

These gatherings not only fostered relationships among veterans but also connected them with community organizations and healthcare resources, demonstrating a positive impact on building social support networks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Veteran Coffee Socials: A Community-Building Strategy for Enhancing Community Reintegration of Veterans. Gorman, JA., Scoglio, AAJ., Smolinsky, J., et al.[2019]

Veterans recently discharged from psychiatric hospitalization expressed a strong desire for community engagement to enhance their social connectedness, but faced barriers such as low self-confidence and lack of information about available activities.

To improve participation in community activities, veterans suggested the need for centralized information and active support systems to help them connect after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Veteran community engagement and social connection needs following inpatient psychiatric hospitalization. Chen, JI., Ono, SS., Laliberte, AZ., et al.[2023]

In a study of 262 veterans over one year, higher levels of loneliness were linked to a decrease in depression severity and suicidal thoughts, suggesting that loneliness may have a complex relationship with mental health outcomes.

Conversely, having more confidants was associated with increased depression symptoms, while greater emotional support correlated with fewer mental health visits, indicating that emotional support may help reduce the need for mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social connectedness, depression symptoms, and health service utilization: a longitudinal study of Veterans Health Administration patients. Chen, JI., Hooker, ER., Niederhausen, M., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06467214

Study Details | NCT06467214 | Increasing Veterans' Social ... The proposed project is a randomized controlled trial that seeks to test the effectiveness of the Increasing Veterans' Social Engagement and Connectedness ( ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06467214/increasing-veterans-social-engagement-and-connectedness

Increasing Veterans' Social Engagement and ... The proposed project is a randomized controlled trial that seeks to test the effectiveness of the Increasing Veterans' Social Engagement and Connectedness ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10713941/

Findings from a Peer-Facilitated, Social Isolation ... CONNECTED is a feasible and acceptable intervention and is likely to be an effective tool to intervene on social isolation among veterans.

4. va.gov va.gov/indiana-health-care/programs/connected/

CONNECTED | VA Indiana Health Care | Veterans Affairs The goal of the CONNECTED project is to support Veterans who are experiencing social isolation to become more socially connected, which will improve their ...

5. research.va.gov research.va.gov/about/funded_research/proj-details-FY2025.cfm?pid=794631

I01HX003741-01A2 - Increasing Veterans' Social ... Increasing Veterans' Social Engagement and Connectedness (CONNECTED). Principal Investigator: Johanne Eliacin. Location: Indianapolis, IN.