CONNECTED Program for Social Isolation

(CONNECTED Trial)

Overseen By Ai-Nghia L Do, BA

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

Trial Summary

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 data supports the effectiveness of the CONNECTED treatment for increasing veterans' social engagement and connectedness?

Research shows that community-based social activities, like Veteran Coffee Socials and the VOICES intervention, help veterans build social connections and access healthcare services, which can improve their overall well-being and reduce feelings of isolation. ^{1 2 3 4 5}

Is the CONNECTED Program for Social Isolation safe for humans?

The research articles do not provide specific safety data for the CONNECTED Program for Social Isolation, but they suggest that similar interventions, like Veteran Coffee Socials and VOICES, are well-received and help build social connections without mentioning any safety concerns. ^{1 3 6 7 8}

How is the CONNECTED treatment for social isolation unique compared to other treatments?

The CONNECTED treatment is unique because it focuses on increasing social engagement and connectedness among veterans through peer-facilitated interventions, which is different from traditional medical or psychological treatments. This approach leverages the shared experiences of veterans to build community and reduce social isolation, a method not commonly used in other treatments for this condition. ^{2 3 7 9 10}

What is the purpose of this trial?

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.

Research Team

Johanne Eliacin, PhD

Principal Investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Veteran Coffee Socials: A Community-Building Strategy for Enhancing Community Reintegration of Veterans. [2019]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Using Veterans Socials to Build a Community: Feasibility of the VOICES Intervention. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Social connectedness, depression symptoms, and health service utilization: a longitudinal study of Veterans Health Administration patients. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of COVID-19-Related Social Distancing on Delivery of Intensive Case Management. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Veteran Engagement in Survey Research to Prevent Suicide. [2023]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Veteran community engagement and social connection needs following inpatient psychiatric hospitalization. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Social isolation among older veterans: findings from the National Health and Aging Trends Study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Social isolation and loneliness of UK veterans: a Delphi study. [2021]