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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-20-1-0786 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| Kessler Foundation | OTHER |
| Department of Veterans Affairs, New Jersey | FED |
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The availability of symptom monitoring and self-management (SMSM) interventions is especially important for civilians and military populations with spinal cord injuries (SCI). High rates of depressive disorders (20-40%) and anxiety disorders (20-25%) have been found in both civilian and military populations and are significant contributors to both quality of life and well-being after SCI. Previous self-management interventions targeting physical activity and self-reliance in individuals with SCI have demonstrated significant health and lifestyle benefits. However, it has been shown that the injured individual's psychological outlook and mood can either enable or hinder self-management efforts and that currently available SCI-specific self-management programs may be inadequate. Developing interventions to reduce mental health symptoms following SCI is therefore critical to improve the lives of individuals, alleviate resource strain on military and civilian health care systems, and potentially reduce the rate of mortality by suicide in Veterans and civilians living with SCI. The current study will build on prior work developing an intervention platform to assess the effectiveness of this eHealth SMSM system and will test the feasibility and effectiveness of the intervention platform.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eHeatlh Intervention Arm | Experimental | The intervention platform is an interactive, web-based self-management program comprised of computer-adaptive tests (CATs) to assess depression, anxiety, and resilience and multimedia-assisted components. Participants will access the system once a week for 6 weeks, complete the symptom monitoring CATs, receive score reports, and watch a system-assigned self-management strategy video (which is selected by the system based on the participant's current level of depression/anxiety symptoms). |
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| Active Control Arm | Active Comparator | The active control condition is a static web-based program which also includes computer-adaptive tests (CATs) to assess depression, anxiety, and resilience, but does not provide score reports and plays a predetermined educational video (related to health promotion after SCI) each week. Participants will access the system once a week for 6 weeks, complete the symptom monitoring CATs and watch the educational video. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eHealth Intervention | Other | The intervention platform is interactive, and uses multimedia-assisted components. The system uses three SCI-QOL computer-adaptive tests (CATs) to assess depression, anxiety, and resilience; cut scores are used to tailor multi-media content that specifically addresses users' emotional health concerns. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weekly depression symptoms as measured by the Spinal Cord Injury - Quality of Life (SCI-QOL) Depression computer adaptive test (CAT) | Patient-reported outcome measure of current depressive symptoms which is included in the intervention and control conditions each week. | Weeks 1-6 |
| Change in weekly anxiety symptoms as measured by the Spinal Cord Injury - Quality of Life (SCI-QOL) Anxiety computer adaptive test (CAT) | Patient-reported outcome measure of current anxiety symptoms which is included in the intervention and control conditions each week. | Weeks 1-6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Current Depressive Symptoms as assessed by the Patient Health Questionnaire (PHQ)-8 | Patient-reported measure of depression | Change from Baseline to Week 6. Also used for screening. |
| Change in Current Symptoms of anxiety as assessed by the Generalized Anxiety Disorder (GAD-7) |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative information on the usability of the system as measured by a System Usability Survey | Participants will complete a usability survey following the final session to provide information on the usability of the system. | At the end of the final (6th) system session. Each system session is open for 4 days or until the participant completes the session, whichever comes first. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Delaware College of Health Sciences | Newark | Delaware | 19716 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Active Control Condition | Other | The active control condition is a static site that displays symptom assessments followed by one educational video each week. These videos, which play in a predetermined order, provide education about managing physical health in individuals with SCI. |
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Patient-reported measure of depression |
| Change from Baseline to Week 6. Also used for screening. |
| Change in weekly resilience levels as measured by the Spinal Cord Injury - Quality of Life (SCI-QOL) resilience computer adaptive test (CAT) | Patient-reported outcome measure of current resilience which is included in the intervention and control conditions each week. | Weeks 1-6 |
| D014947 | Wounds and Injuries |