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Behavioral Intervention

CONNECTED Program for Social Isolation (CONNECTED Trial)

N/A

Recruiting

Led By Johanne Eliacin, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Severe cognitive, hearing or speech impairment

Active suicidal ideation needing immediate mental health treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2, 4, 8 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a program called CONNECTED that helps Veterans combat social isolation. The program involves peer support, psychosocial interventions, and connecting Veterans to social resources through telehealth sessions over

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on social engagement rather than medication or medical procedures, traditional physical side effects are not expected; however, participants may experience emotional discomfort.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I do not have severe psychiatric symptoms right now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2, 4, 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2, 4, 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2, 4, 8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lubben Social Network Scale-6

Secondary study objectives

Columbia Suicide Severity Rating Scale Screener

General Anxiety Disorder

Life Engagement Test

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CONNECTEDExperimental Treatment1 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 BEFRIENDINGActive Control1 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).

0 / 3Eligibility criteria met