Caring Connections for Spinal Cord Injury

Overseen By Sherri LaVela, PhD, MPH, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Chicago Association for Research and Education in Science

Disqualifiers: Under 18, New injuries, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with spinal cord injury or disorder (SCI/D) feel less isolated and lonely. The study tests a program called Caring Connections, where participants receive monthly letters from peers with SCI/D, offering support and positivity. Another group will receive informational materials about improving quality of life. Veterans with SCI/D for more than a year who experience feelings of isolation or loneliness are ideal candidates for this study.

As an unphased trial, this study offers a unique opportunity to connect with others and enhance quality of life through shared experiences.

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 rather than medication changes.

What prior data suggests that the Caring Connections intervention is safe for individuals with SCI/D?

Research shows that the Caring Connections program is generally safe for people with spinal cord injuries or disorders (SCI/D). This program reduces feelings of loneliness and social isolation by sending personalized letters containing caring and positive messages from others with SCI/D.

Previous studies found that participants did not report any major negative effects from receiving these letters. The program offers emotional support and improves social well-being, both crucial for mental health. Because the communication is simple and not demanding, participants generally receive it well.

Overall, evidence suggests that the Caring Connections program is safe for people with SCI/D, as it primarily involves supportive letters to enhance emotional and social health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Caring Connections intervention for spinal cord injury and disorders (SCI/D) because it offers a unique approach to addressing social isolation and loneliness, which are common challenges for those with SCI/D. Unlike traditional treatments that focus on physical rehabilitation or medication management, this intervention uses personalized letters filled with care and positivity, sent consistently by a peer who also has SCI/D. This method not only provides emotional support but also fosters a lasting connection, aiming to improve the overall quality of life in a way that current standard treatments do not address.

What evidence suggests that the Caring Connections intervention could be effective for reducing social isolation and loneliness in individuals with SCI/D?

Research has shown that the Caring Connections program, which participants in this trial may receive, reduces feelings of loneliness and social isolation in people with spinal cord injuries and disorders (SCI/D). In one study, 76% of participants in the Caring Connections group found the program helpful, compared to 45% in the attention control group, which did not receive the program. Additionally, 79% of those in the program expressed satisfaction with it. The program involves sending personalized, caring letters from a peer with SCI/D to help build connections and improve social well-being. These results suggest that Caring Connections can enhance the quality of life for people with SCI/D. ^{1 2 3 6 7}

Who Is on the Research Team?

Sherri LaVela, PhD, MPH, MBA

Principal Investigator

Department of Veterans Affairs, Hines VA

Are You a Good Fit for This Trial?

This trial is for adult Veterans with chronic spinal cord injury/disorder (SCI/D) that's lasted more than a year. It includes various causes of SCI/D like trauma, non-cancerous tumors causing nerve issues, blood vessel problems in the spine, inflammation or demyelinating diseases affecting the spinal cord.

Inclusion Criteria

I am a veteran with a long-term spinal cord injury or condition.

I am a veteran with a spinal cord injury or disease for over a year.

Exclusion Criteria

Individuals with new injuries (injury duration less than one year)

I am a veteran under 18 with a spinal cord injury or disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly letters from peers as part of the Caring Connections intervention to reduce social isolation and loneliness

6 months

Monthly mailings

Follow-up

Participants are monitored for changes in loneliness and social isolation outcomes after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attention control
• Caring Connections

Trial Overview The study tests 'Caring Connections,' a peer-based program aimed at reducing loneliness and social isolation among individuals with SCI/D. Participants are randomly placed into either this program or an active control group to compare outcomes.

How Is the Trial Designed?

Group I: Caring Connections intervention Experimental Treatment 1 Intervention

The Caring Connections intervention will consist of non-demanding, messages of care and concern delivered to individuals with SCI/D who had moderate to high social isolation and/or loneliness scores on the baseline survey. The caring messages will be in the form of structured, yet personalized mailed letters from one consistent peer with SCI/D, providing long-term and steady contact. Intervention participants will receive a letter every month over a 6-month period. Following a standardized set of principles, letters will contain cheerful expressions of care and micro-moments of positivity. The PI/Co-Is will provide a brief training and work with volunteer peers with SCI/D to write the letters.

Group II: Attention control Active Control 1 Intervention

We will mail informational materials to individuals with SCI/D in our control group at the same timepoints over 6 months as our intervention letter mailings. The informational materials will discuss life domains that are important to a good quality of life. Topics include community living, physical/healthy living, safety and security, social/spirituality, advocacy/engagement, and employment/volunteering. We will draw information for each topic from the Knowledge Translation Center SCI Factsheets (MSKTC 2021) and the LifeCourse Nexus library (2021).

Who Is Running the Clinical Trial?

Chicago Association for Research and Education in Science

Lead Sponsor

Trials

1

Recruited

60+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9677023/

Randomised controlled trial of the Caring Connections ... We developed an intervention called Caring Connections (CC) aimed at reducing loneliness and perceived social isolation in persons with SCI/D.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05295108

Caring Connections: A Program to Alleviate Social ... 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 ...

3. researchgate.net researchgate.net/publication/395990032_A_randomized_controlled_trial_of_the_caring_connections_intervention_to_reduce_loneliness_in_persons_with_spinal_cord_injuries_and_disorders

A Randomized Controlled Trial of the Caring Connections ... A greater proportion of the treatment versus control group found the program to be beneficial (76% vs. 45%, p = .02) and satisfactory (79% vs.

4. awspntest.apa.org awspntest.apa.org/record/2026-69149-001

A randomized controlled trial of the caring connections ... A randomized controlled trial of the caring connections intervention to reduce loneliness in persons with spinal cord injuries and disorders. Publication Status.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36400737/

Randomised controlled trial of the Caring Connections ... We developed an intervention called Caring Connections (CC) aimed at reducing loneliness and perceived social isolation in persons with SCI/D.

6. bmjopen.bmj.com bmjopen.bmj.com/content/12/11/e063246.abstract

Randomised controlled trial of the Caring Connections ... We will conduct and evaluate a randomised controlled trial (RCT) to assess changes in loneliness and social isolation outcomes between the CC intervention and ...

7. psycnet.apa.org psycnet.apa.org/fulltext/2026-69149-001.html?sr=1

A randomized controlled trial of the caring connections intervention ... Results: Both groups showed within-group improvements in loneliness from baseline to post-RCT, but no statistically significant differences in change scores ...