Spinal Cord InjuriesNCT04964362
The Impact of Injustice Appraisals on Psychosocial Outcomes Following Spinal Cord Injury: A Longitudinal Study
An observational study of Spinal Cord Injuries, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2022to 7 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Have acquired a spinal cord injury (SCI) in the past 6 months
- Admitted for first inpatient rehabilitation hospitalization
Who cannot join
- SCI without neurological impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injustice Experience Questionnaire (IEQ) Score
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).
Measured: 12 months
The Appraisals of Disability Primary and Secondary Scale- Short Form (ADAPSSsf) Score
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).
Measured: 12 months
Patient Health Questionnaire-8 (PHQ-8) Score
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).
Measured: 12 months
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Score
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).
Measured: 12 months
Spinal Cord Injury-Functional Index/Assistive Technology Short Forms (SCI-FI/AT) Score
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).
Measured: 12 months
International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS)
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).
Measured: 12 months
The International Spinal Cord Injury Quality of Life Basic Data Set (ISCIQOLBDS)
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).
Measured: 12 months
State-Trait Anger Expression Inventory-2 (STAXI-II) Score
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).
Measured: 12 months
Qualitative Interview
Qualitative interviews will be conducted with a subset of individuals to explore injustice appraisals during inpatient rehabilitation and 12 months post-rehabilitation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start29 Apr 2022
- Primary completion7 May 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberley Monden, PhD, Principal investigator, University of Minnesota Medical School Department of Rehabilitation Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964362
- Sponsor's protocol ID
- PMR-2021-30041
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2021
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Injustice Appraisals on Psychosocial Outcomes Following Spinal Cord Injury: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT04964362
- Acronym / sponsor ID
- PMR-2021-30041
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Have acquired a spinal cord injury (SCI) in the past 6 months
- Admitted for first inpatient rehabilitation hospitalization
Key exclusion criteria (1 listed)
- SCI without neurological impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Injustice Experience Questionnaire (IEQ) Score
Time frame: 12 months
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).
The Appraisals of Disability Primary and Secondary Scale- Short Form (ADAPSSsf) Score
Time frame: 12 months
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).
Patient Health Questionnaire-8 (PHQ-8) Score
Time frame: 12 months
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).
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Score
Time frame: 12 months
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).
Spinal Cord Injury-Functional Index/Assistive Technology Short Forms (SCI-FI/AT) Score
Time frame: 12 months
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).
International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS)
Time frame: 12 months
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).
The International Spinal Cord Injury Quality of Life Basic Data Set (ISCIQOLBDS)
Time frame: 12 months
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).
State-Trait Anger Expression Inventory-2 (STAXI-II) Score
Time frame: 12 months
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).
Qualitative Interview
Time frame: 12 months
Qualitative interviews will be conducted with a subset of individuals to explore injustice appraisals during inpatient rehabilitation and 12 months post-rehabilitation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberley Monden, PhD principal investigator
University of Minnesota Medical School Department of Rehabilitation Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injustice Experience Questionnaire (IEQ) Score (time frame: 12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.