- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04964362
The Impact of Injustice Appraisals on Psychosocial Outcomes Following Spinal Cord Injury: A Longitudinal Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kimberley Monden, PhD
- Phone Number: (612)-625-2661
- Email: kmonden@umn.edu
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Individuals with Spinal Cord Injury
Individuals with recent spinal cord injuries, both veterans and civilians, will be followed for 1 year for inquiry into injustice appraisals.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Injustice Experience Questionnaire (IEQ) Score
Time Frame: 12 months
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Injustice appraisals will be measured via the IEQ.
The IEQ asks participants to rate 12 statements describing different thoughts and feelings they may experience when they think about their injuries on a 5-point scale from 0 (never) to 4 (all the time).
Scores range from 0 to 48; higher scores represent greater appraisals of injustice.
The IEQ has strong psychometric properties among individuals with persistent musculoskeletal pain, among an acute trauma sample, and within rehabilitation settings.
The IEQ will be collected at inpatient rehabilitation/acute phase (baseline), 6 months post-discharge/sub-acute phase (T1), and 12 months post- discharge/chronic phase (T2).
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12 months
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The Appraisals of Disability Primary and Secondary Scale- Short Form (ADAPSSsf) Score
Time Frame: 12 months
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The ADAPSSsf will be used to assess appraisals of disability. The ADAPSSsf is a 6-item self-report survey of people's thoughts about their spinal cord injuries. Each item on the ADAPSSsf represents a subscale: Fearful Despondency, Overwhelming Disbelief, Determined Resolve, Growth and Resilience, Negative Perceptions, and Personal Agency. Items are rated on a 6-point scale (strongly disagree to strongly agree) and summed (items 3, 5, and 6 are reverse coded), with higher scores representing less adaptive appraisals. The ADAPSS was developed and validated for use in the spinal cord injury population. The ADAPSSsf will be collected at inpatient rehabilitation/acute phase (baseline), 6 months post-discharge/sub-acute phase (T1), and 12 months post- discharge/chronic phase (T2). |
12 months
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Patient Health Questionnaire-8 (PHQ-8) Score
Time Frame: 12 months
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The PHQ-8 asks participants to rate how often they have been bothered by eight symptoms of depression over the past two weeks on a 0 (not at all) to 3 (nearly every day) scale.
Scores on the PHQ-8 are summed to indicate the severity of depression symptoms, with higher scores indicating increasing severity.
The PHQ-8 is a valid and reliable measure to assess depression in persons with spinal cord injury.
The PHQ-8 will be collected at inpatient rehabilitation/acute phase (baseline), 6 months post-discharge/sub-acute phase (T1), and 12 months post- discharge/chronic phase (T2).
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12 months
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Score
Time Frame: 12 months
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The PCL-5 is a 20- item self-report measure assessing symptoms of PTSD.
Participants rate how bothered they have been by each of the 20 items in the past month on a 5-point scale ranging from 0 (not at all) to 4 (extremely).
Scores range from 0-80, with higher scores indicating greater severity of PTSD symptoms.
The PCL-5 is psychometrically sound in civilians and veterans.
The PCL-5 will be collected at inpatient rehabilitation/acute phase (baseline), 6 months post-discharge/sub-acute phase (T1), and 12 months post- discharge/chronic phase (T2).
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12 months
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Spinal Cord Injury-Functional Index/Assistive Technology Short Forms (SCI-FI/AT) Score
Time Frame: 12 months
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The SCI-FI/AT assesses functional impairment in four domains: basic mobility (9 items), self-care (9 items), fine motor (9 items), and ambulation (8 items). For each item, participants select the response that best describes their ability to do each activity without help from another person but using the equipment or devices they usually use. Items are rated from 0 (unable to do so) to 4 (without any difficulty). Summed raw scores are transformed into T scores in each domain. The SCI-FI/AT has excellent psychometric properties. The SCI-FI/AT will be collected at inpatient rehabilitation/acute phase (baseline), 6 months post-discharge/sub-acute phase (T1), and 12 months post- discharge/chronic phase (T2). |
12 months
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International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS)
Time Frame: 12 months
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The ISCIPBDS asks participants if they have experienced pain in the past seven days.
If pain was experienced, three 11-point Likert scale questions pertaining to pain interference are asked, ranging from no interference to extreme interference.
Total scores range from 0 to 30, and higher scores indicate greater interference due to pain.The ISCIPBDS is appropriate for the evaluation of pain among community-dwelling individuals with SCI.
The ISCIPBDS will be collected at inpatient rehabilitation/acute phase (baseline), 6 months post-discharge/sub-acute phase (T1), and 12 months post- discharge/chronic phase (T2).
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12 months
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The International Spinal Cord Injury Quality of Life Basic Data Set (ISCIQOLBDS)
Time Frame: 12 months
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The ISCIQOLBDS assesses three aspects of QoL: satisfaction with general QoL (overall well-being), satisfaction with physical health, and satisfaction with psychological health.
Each factor is rated on a 0-10 scale from 0 (completely dissatisfied) to 10 (completely satisfied).
Higher scores on each factor indicate higher QoL in that domain.
The ISCIQOLBDS demonstrates good psychometric populations.
The ISCIQOLBDS will be collected at inpatient rehabilitation/acute phase (baseline), 6 months post-discharge/sub-acute phase (T1), and 12 months post- discharge/chronic phase (T2).
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12 months
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State-Trait Anger Expression Inventory-2 (STAXI-II) Score
Time Frame: 12 months
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The STAXI-II includes four subscales: state (7 items), trait (5 items), expression (4 items), and anger inhibition (4 items).
The state subscale reflects the intensity of an individual's feelings of anger at the time of testing; the trait subscale assesses a person's general predisposition to become angry.
Anger inhibition items reflect the frequency with which individuals attempt to suppress feelings of anger, whereas anger expression items gauge how often anger is outwardly expressed.
The STAXI-II has been used in previous spinal cord injury research and demonstrates excellent psychometric properties across use with outpatient, inpatient, and rehabilitation populations.
The STAXI-II will be collected at inpatient rehabilitation/acute phase (baseline), 6 months post-discharge/sub-acute phase (T1), and 12 months post- discharge/chronic phase (T2).
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12 months
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Qualitative Interview
Time Frame: 12 months
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Qualitative interviews will be conducted with a subset of individuals to explore injustice appraisals during inpatient rehabilitation and 12 months post-rehabilitation.
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kimberley Monden, PhD, University of Minnesota Medical School Department of Rehabilitation Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PMR-2021-30041
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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