Psychological Well-BeingPhase 1/2SCISM-DNCT05800717
Self-Management Program for AIS D SCI
A Phase 1/2 study testing SCI Self-Management for AIS D in people with Psychological Well-Being and Spinal Cord Injuries, run by VA Office of Research and Development at 1 site in United States.
Trial summary
About 25-51% of adults with acquired spinal cord injury (SCI) have "AIS D" SCI, the lowest severity grade of neurologic injury. Veterans with AIS D SCI generally have better outcomes in mobility, community integration, and employment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psychological Well-Being, Spinal Cord Injuries
- What is being tested?
- SCI Self-Management for AIS D
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 31 Dec 2025
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- VA clinician-confirmed diagnosis of tetraplegia or paraplegia with an ASIA rating of AIS D [Veterans with AIS D SCI];
- Interest and ability (e.g., reliable video telehealth equipment and WiFi) to participate in the focus groups.
Who cannot join
- Currently participating in a comprehensive, inpatient rehabilitation program;
- Diagnosis of a psychotic disorder;
- At high risk for suicidal/homicidal behavior;
- Active substance dependence;
- Lack of capacity to consent to participation;
- Any medical condition that could affect results such as advanced cancer or neurologic disease such as Parkinson's disease; and
- Mental disorders such as posttraumatic stress disorder and depressive disorder will not be exclusions, but any medications must have been stable for at least 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Richmond VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001
About this study
Official title: A Self-Management Program for Improving the Well-Being of Veterans With AIS D Incomplete Spinal Cord Injury
About 25-51% of adults with acquired spinal cord injury (SCI) have "AIS D" SCI, the lowest severity grade of neurologic injury. Veterans with AIS D SCI generally have better outcomes in mobility, community integration, and employment. However, counterintuitively, they are also at higher risk of poor subjective well-being (SWB) and related psychosocial outcomes. Preliminary evidence suggests that poorer SWB in this group is associated with distinctive, modifiable factors such as less intensity of acute rehabilitation services, limited development of instrumental and social support networks, and underdeveloped disability identity. A significant gap in the care of Veterans with AIS D SCI is that they are unlikely to receive rehabilitation that is responsive to their specific experiences and needs. The proposed study will develop a novel, self-management based program to help Veterans with AIS D SCI. This study is highly significant, as creation of the proposed program is expected to improve SWB and lifetime psychosocial functioning for Veterans with AIS D SCI.
Read the detailed description
Background and Significance: Spinal cord injury (SCI) is a life-altering event that often results in permanent paralysis and sensory loss, with subsequent loss of physical function and independence and risk for negative psychosocial outcomes. About 25-51% of adults with acquired SCI have AIS D SCI and have an excellent prognosis for ambulation, are less visibly disabled, and generally have better objective well-being, such as community integration and mobility. However, counterintuitively, military Veterans with AIS D SCI are at higher risk of poor subjective well-being (SWB) including higher rates of depression and suicidal ideation. Several factors that may explain the disparity in well-being have been proposed, including less acute rehabilitation services, limited development of instrumental and social support networks, greater prevalence of comorbid health issues, and underdeveloped disability identity. Given that SWB is central to quality of life, it is essential to understand and foster those skills, perspectives, and resources that best support SWB after SCI.
Specific Aims: This study will develop the first intervention targeting the well-being of Veterans with AIS D SCI by attending to their specific needs using a self-management approach. Self-management (SM) programs are differentiated by fostering engagement, knowledge, and authority to direct care to the patient. An SM-oriented program that is tailored to the needs and treatment preferences of Veterans with AIS D SCI has great promise to improve well-being. For this reason, the proposed study will develop the SCI Self- Management for AIS D (SCISM-D) Program, an individually administered, personalized support and skills training intervention via the VA's video telehealth-to-home technology, to improve well-being among Veterans with AIS D SCI. This study is highly significant for Veteran health care, as creation of the proposed SCISM-D program is expected to fill a critical health care gap and improve lifetime psychosocial functioning for Veterans with AIS D SCI. This study has three aims: (Aim 1) Develop SCISM-D to enhance the SWB of military Veterans with AIS D SCI using preliminary research and focus groups. (Aim 2) Conduct a pilot study to improve SCISM-D and test the feasibility and acceptability of SCISM-D to prepare for a future randomized controlled trial. (Aim 3) Finalize the SCISM-D program manual and consumer handbook.
Research Plan: For Aim 1, two focus groups of 4-6 Veterans with AIS D SCI and two focus groups of 4-6 SCI providers will be recruited to review, rate, and discuss proposed components of SCISM-D during two meetings each. Informed by the focus group ratings and feedback, the SCISM-D program manual and consumer handbook will be developed. Individual program components will be adapted from extant SM manuals with others developed by the investigators. The completed program manual and consumer handbook will then be presented to the focus groups and expert panel for feedback, followed by a final round of revisions. Criteria for success include completion of the focus groups and materials according to the study timeline.
Next, a pilot study will be conducted to examine the feasibility of SCISM-D and a subsequent randomized controlled trial (Aim 2). A target of 20 Veterans with AIS D SCI will complete the study. SCISM-D is anticipated to involve 5-7, 45-60-minute sessions conducted via the VA's telehealth system. Several measures and interviews will be administered during the program to assess treatment gains and mediators. Criteria for success include the ability to recruit at least 2 participants per month, at least 75% retention, at least 75% patient satisfaction, and an average change of "minimally improved" in confidence and life satisfaction, among others. After the pilot study, the focus group members will be asked to review the draft SCISM-D program manual and consumer handbook to inform final revisions to content by the team of investigators and layout by professional designers (Aim 3).
- Conditions
- Psychological Well-Being, Spinal Cord Injuries
- Being tested
- SCI Self-Management for AIS D
- Keywords
- Spinal Cord Injuries, Psychological Well-Being, Clinical trial
- Medical subject headings
- Psychological Well-Being, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCI Self-Management for AIS DBehavioural
An individually administered, self-management intervention for Veterans with AIS D spinal cord injury.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Receives SCISM-D. Receives: Behavioral: SCI Self-Management for AIS D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire
An 8-item measure of patient satisfaction with the intervention. Each item is rated on a 4-point scale. The full scale has a range of 8-32 with higher scores indicating more satisfaction.
Measured: 6 weeks
Patient Global Impression of Change
A one-item measure of self-reported change as a result of the intervention. Each item is rated on a 7-point scale: "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 May 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Why it stopped: Staffing unavailable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Well-BeingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group, successive cohort design
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Scott D McDonald, PhD, Principal investigator, Richmond VA Medical Center, Richmond, VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800717
- Sponsor's protocol ID
- D4417-P
- Other IDs
- 1I21RX004417-01A1
- Acronym
- SCISM-D
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2023
- Last updated
- 13 Mar 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-Management Program for Improving the Well-Being of Veterans With AIS D Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05800717
- Acronym / sponsor ID
- SCISM-D / D4417-P
- Conditions
- Psychological Well-Being, Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, Psychological Well-Being, Clinical trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Staffing unavailable.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Apr 2023 (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.
About 25-51% of adults with acquired spinal cord injury (SCI) have "AIS D" SCI, the lowest severity grade of neurologic injury. Veterans with AIS D SCI generally have better outcomes in mobility, community integration, and employment. However, counterintuitively, they are also at higher risk of poor subjective well-being (SWB) and related psychosocial outcomes. Preliminary evidence suggests that poorer SWB in this group is associated with distinctive, modifiable factors such as less intensity of acute rehabilitation services, limited development of instrumental and social support networks, and underdeveloped disability identity. A significant gap in the care of Veterans with AIS D SCI is that they are unlikely to receive rehabilitation that is responsive to their specific experiences and needs. The proposed study will develop a novel, self-management based program to help Veterans with AIS D SCI. This study is highly significant, as creation of the proposed program is expected to improve SWB and lifetime psychosocial functioning for Veterans with AIS D SCI.
Detailed description
Background and Significance: Spinal cord injury (SCI) is a life-altering event that often results in permanent paralysis and sensory loss, with subsequent loss of physical function and independence and risk for negative psychosocial outcomes. About 25-51% of adults with acquired SCI have AIS D SCI and have an excellent prognosis for ambulation, are less visibly disabled, and generally have better objective well-being, such as community integration and mobility. However, counterintuitively, military Veterans with AIS D SCI are at higher risk of poor subjective well-being (SWB) including higher rates of depression and suicidal ideation. Several factors that may explain the disparity in well-being have been proposed, including less acute rehabilitation services, limited development of instrumental and social support networks, greater prevalence of comorbid health issues, and underdeveloped disability identity. Given that SWB is central to quality of life, it is essential to understand and foster those skills, perspectives, and resources that best support SWB after SCI.
Specific Aims: This study will develop the first intervention targeting the well-being of Veterans with AIS D SCI by attending to their specific needs using a self-management approach. Self-management (SM) programs are differentiated by fostering engagement, knowledge, and authority to direct care to the patient. An SM-oriented program that is tailored to the needs and treatment preferences of Veterans with AIS D SCI has great promise to improve well-being. For this reason, the proposed study will develop the SCI Self- Management for AIS D (SCISM-D) Program, an individually administered, personalized support and skills training intervention via the VA's video telehealth-to-home technology, to improve well-being among Veterans with AIS D SCI. This study is highly significant for Veteran health care, as creation of the proposed SCISM-D program is expected to fill a critical health care gap and improve lifetime psychosocial functioning for Veterans with AIS D SCI. This study has three aims: (Aim 1) Develop SCISM-D to enhance the SWB of military Veterans with AIS D SCI using preliminary research and focus groups. (Aim 2) Conduct a pilot study to improve SCISM-D and test the feasibility and acceptability of SCISM-D to prepare for a future randomized controlled trial. (Aim 3) Finalize the SCISM-D program manual and consumer handbook.
Research Plan: For Aim 1, two focus groups of 4-6 Veterans with AIS D SCI and two focus groups of 4-6 SCI providers will be recruited to review, rate, and discuss proposed components of SCISM-D during two meetings each. Informed by the focus group ratings and feedback, the SCISM-D program manual and consumer handbook will be developed. Individual program components will be adapted from extant SM manuals with others developed by the investigators. The completed program manual and consumer handbook will then be presented to the focus groups and expert panel for feedback, followed by a final round of revisions. Criteria for success include completion of the focus groups and materials according to the study timeline.
Next, a pilot study will be conducted to examine the feasibility of SCISM-D and a subsequent randomized controlled trial (Aim 2). A target of 20 Veterans with AIS D SCI will complete the study. SCISM-D is anticipated to involve 5-7, 45-60-minute sessions conducted via the VA's telehealth system. Several measures and interviews will be administered during the program to assess treatment gains and mediators. Criteria for success include the ability to recruit at least 2 participants per month, at least 75% retention, at least 75% patient satisfaction, and an average change of "minimally improved" in confidence and life satisfaction, among others. After the pilot study, the focus group members will be asked to review the draft SCISM-D program manual and consumer handbook to inform final revisions to content by the team of investigators and layout by professional designers (Aim 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group, successive cohort design
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Behavioral: SCI Self-Management for AIS DReceives SCISM-D. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- VA clinician-confirmed diagnosis of tetraplegia or paraplegia with an ASIA rating of AIS D [Veterans with AIS D SCI];
- Interest and ability (e.g., reliable video telehealth equipment and WiFi) to participate in the focus groups.
Key exclusion criteria (7 listed)
- Currently participating in a comprehensive, inpatient rehabilitation program;
- Diagnosis of a psychotic disorder;
- At high risk for suicidal/homicidal behavior;
- Active substance dependence;
- Lack of capacity to consent to participation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCI Self-Management for AIS DAn individually administered, self-management intervention for Veterans with AIS D spinal cord injury. | Behavioural | Treatment |
Primary outcome
Client Satisfaction Questionnaire
Time frame: 6 weeks
An 8-item measure of patient satisfaction with the intervention. Each item is rated on a 4-point scale. The full scale has a range of 8-32 with higher scores indicating more satisfaction.
Patient Global Impression of Change
Time frame: 6 weeks
A one-item measure of self-reported change as a result of the intervention. Each item is rated on a 7-point scale: "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 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.
Scott D McDonald, PhD principal investigator
Richmond VA Medical Center, Richmond, VA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SCI Self-Management for AIS D in people with Psychological Well-Being and Spinal Cord Injuries, run by VA Office of Research and Development 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 7 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: withdrawn, as of the sponsor's last update on 13 Mar 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Client Satisfaction Questionnaire (time frame: 6 weeks). The study lists 2 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 13 Mar 2026.