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Clinical Trials/NCT04827095
NCT04827095
Unknown
Not Applicable

Comparison of Two Web-Based Education/Support Programs for Partner Caregivers of People With Spinal Cord Injury

Kessler Foundation1 site in 1 country40 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
Kessler Foundation
Enrollment
40
Locations
1
Primary Endpoint
Change in Behavioral Inhibition/ Behavioral Activation Scale (BIS/BAS) score
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this research study is to compare the effect of two different types of education and support programs for partner caregivers of people with spinal cord injury (SCI).

Detailed Description

SCI particularly affects partners (spouses or other types of significant others), as they face changes in relationship dynamics and identity as they take on a caregiver role. The purpose of this research study is to compare the effect of two different types of education and support programs for partner caregivers of people with spinal cord injury (SCI).

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
April 29, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • At least 18 years old
  • Fluent in English (reading and writing)
  • Romanic partner of a person with SCI (regardless of martial status) for at least one year prior to injury
  • Live in a private residence with their partner with SCI
  • Partner is at least 3 months post discharge from inpatient rehabilitation
  • At least 6 months since their partner's injury
  • Provide care to their partner with SCI on a daily basis
  • Have access to the internet in a private location

Exclusion Criteria

  • Participant reports a diagnosis of a schizoaffective disorder, bipolar personality disorder, or severe depression
  • History of hospitalization for depression treatment

Outcomes

Primary Outcomes

Change in Behavioral Inhibition/ Behavioral Activation Scale (BIS/BAS) score

Time Frame: Average scores obtained during baseline (pre-program) compared to scores obtained immediately after program completion.

Change in behavior and emotion, measured by the Behavioral Inhibition/ Behavioral Activation Scale. The extent to which behavior and emotions change over time will be measured with the Behavioral Inhibition/ Behavioral Activation Scale. The BIS/BAS scale is composed of three subscales; (1) drive, which measures the persistent pursuit of goals, (2) fun seeking, which measures the desire for new rewards and the willingness to approach a potentially rewarding event, and (3) reward responsiveness, which measures positive responses to rewarding outcomes.

Secondary Outcomes

  • Change in Marit-Meuser Caregiver Grief Inventory (CGI) scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Change in Zarit Burden Interview (ZBI) scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Change in NIH Toolbox Loneliness Survey (Fixed Form) scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Change in Connor-Davidson Resilience Scale scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Change in Couples Satisfaction Index scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Change in Satisfaction with Life Scale scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Changs in Duke Social Support Index (DSSI) scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Change in Patient Health Questionnaire scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Long-Term Change in Behavioral Inhibition/ Behavioral Activation Scale (BIS/BAS) score(3-months post intervention versus baseline, 6-months post intervention versus baseline)

Study Sites (1)

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