Clinical trial NCT04964362: The Impact of Injustice Appraisals on Psychosocial Outcomes Following Spinal Cord Injury: A Longitudinal Study
Official title: The Impact of Injustice Appraisals on Psychosocial Outcomes Following Spinal Cord Injury: A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injuries
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans and civilians who have recently acquired a spinal cord injury and are hospitalized for inpatient rehabilitation through the University of Minnesota Health System, Jefferson-affiliated rehabilitation hospitals, the Minneapolis VA Health Care System, and the Richmond VA Medical Center.

Brief summary: The primary objectives of this study are to: (1) determine the longitudinal course and impact of injury-related injustice appraisals among civilians and Veterans who have recently acquired a spinal cord injury (SCI), and (2) use qualitative inquiry to gain a rich, contextual understanding of appraisals of injustice during the first year after acquired SCI. The long-term goal of this research is to inform the development of new treatment approaches targeting appraisals of injustice.

Detailed description: At present, there are no interventions that specifically target appraisals of injustice, and there is limited research upon which to recommend clinical interventions to mitigate the impact of injustice appraisals on rehabilitation outcomes. Treatment techniques currently being used within multidisciplinary rehabilitation programs do not yield clinically meaningful reductions in perceptions of injustice. Findings from the proposed study will inform the development of interventions targeting injustice appraisals and associated sequelae. Given the lack of research in this domain, as well as the absence of interventions to address injustice appraisals following injury, the proposed study will make a significant contribution to our current understanding of mechanisms that impact psychosocial and functional outcomes following spinal cord injury to inform future interventions.

Eligibility criteria: Inclusion Criteria:

* Have acquired a spinal cord injury (SCI) in the past 6 months
* Admitted for first inpatient rehabilitation hospitalization

Exclusion Criteria:

* SCI without neurological impairment

Primary outcomes:
measure: Injustice Experience Questionnaire (IEQ) Score
timeFrame: 12 months
measure: The Appraisals of Disability Primary and Secondary Scale- Short Form (ADAPSSsf) Score
timeFrame: 12 months
measure: Patient Health Questionnaire-8 (PHQ-8) Score
timeFrame: 12 months
measure: Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Score
timeFrame: 12 months
measure: Spinal Cord Injury-Functional Index/Assistive Technology Short Forms (SCI-FI/AT) Score
timeFrame: 12 months
measure: International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS)
timeFrame: 12 months
measure: The International Spinal Cord Injury Quality of Life Basic Data Set (ISCIQOLBDS)
timeFrame: 12 months
measure: State-Trait Anger Expression Inventory-2 (STAXI-II) Score
timeFrame: 12 months
measure: Qualitative Interview
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota Medical School Department of Rehabilitation Medicine
name: Kimberley Monden, PhD
role: PRINCIPAL_INVESTIGATOR
References: