Caring Connections: a Program to Alleviate Social Isolation and Loneliness in Individuals Living with Spinal Cord Injury

Not Applicable

Completed

• Conditions: Spinal Cord Injuries and Disorders (SCI/D)

• Registration Number: NCT05295108
• Lead Sponsor: Chicago Association for Research and Education in Science

Brief Summary

This study will use a randomized controlled design with an active attention control group to evaluate an intervention intended to reduce social isolation and loneliness in persons with SCI/D. The intervention, Caring Connections, is a peer-based intervention which is important because peers with SCI/D play an important role in improving quality of life, mental health, and social health in persons with SCI/D.

Detailed Description

The overall study objective is to conduct and evaluate a fully powered randomized control trial (RCT) to assess changes in loneliness and social isolation outcomes between the Caring Connections intervention and attention control condition in community-dwelling individuals with SCI/D. The Caring Connections intervention (described in detail below) is a peer-based, facilitated, letter writing program designed to provide feelings of social connectedness and moments of positivity to reduce loneliness and social isolation in persons with SCI/D.

Study Timeline

• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-24
• Study Start: 2023-06-22
• Primary Completion: 2024-08-21
• Study Completion: 2025-01-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Our target population will include adult Veterans with chronic SCI/D (duration of injury > 1 year); this may include those with traumatic and non-traumatic SCI/D, and may include SCI, nonmalignant neoplasms resulting in neurologic deficit; vascular insults of a thromboembolic, hemorrhagic, or ischemic nature; cauda equina syndrome producing neurologic deficit; inflammatory disease of the spine, spinal cord, or cauda equina resulting in non-progressive neurologic deficit; and demyelinating disease of the spinal cord.

Exclusion Criteria

• Veterans with SCI/D under the age of 18 will be excluded. Individuals with new injuries (injury duration less than one year) will be excluded as it is plausible that social isolation and loneliness may more likely occur after the first year of injury when individuals have transitioned to the community and may no longer be surrounded by people consistently for help with their acute care needs (Dickson 2011). There are no SCI/D level or severity exclusions, as we wish to reach a diverse group of individuals.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
loneliness	change from baseline to post-RCT (6 months)	UCLA 3-item Loneliness Scale

Secondary Outcome Measures

Name	Time	Method
social isolation	change from baseline to post-RCT (6 months)	PROMIS Social Isolation 8-item

Trial Locations

Locations (1)

Hines VA; 🇺🇸 Hines, Illinois, United States