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OpenTrials
Completed

NCT Number: NCT05295108

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

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.

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Key information

Conditions

Spinal Cord Injuries and Disorders (SCI/D) Central Nervous System Diseases Disease Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hines VA

Hines, Illinois, 60141, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caring Connections

Other

peer-based letter writing social connectedness intervention to improve social health outcomes

Attention Control

Other

informational materials provided to educate on life domains that are important to social health

Primary outcomes

  1. loneliness

    Time frame: change from baseline to post-RCT (6 months)

    UCLA 3-item Loneliness Scale

Secondary outcomes

  1. social isolation

    Time frame: change from baseline to post-RCT (6 months)

    PROMIS Social Isolation 8-item

Other outcomes

  1. social contact with friends/family

    Time frame: change from baseline to post-RCT (6 months)

    frequency: Once a week, Several times a week, About once a month, Several times a year, About once or twice a year, Less than once a year, Never)

  2. social contact with organized groups (Examples include: a choir, a committee or board, a support group, a sports or exercise group, a hobby group, or a professional society.)

    Time frame: change from baseline to post-RCT (6 months)

    frequency: Once a week, Several times a week, About once a month, Several times a year, About once or twice a year, Less than once a year, Never)

  3. perceived benefit from the intervention

    Time frame: post-RCT at 6 months

    5-point Likert scale (No benefit, Minor benefit, Neutral, Moderate benefit, Major benefit)

  4. perceived negative impacts from the intervention

    Time frame: post-RCT at 6 months

    5-point Likert scale (No negative impacts, Minor negative impacts, Neutral, Moderate negative impacts, Major negative impacts)

  5. satisfaction with the intervention

    Time frame: post-RCT at 6 months

    5-point Likert scale (Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied)

Sponsors and collaborators

Lead sponsor

Chicago Association for Research and Education in Science

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 24, 2022
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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