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| Name | Class |
|---|---|
| Virginia Commonwealth University | OTHER |
| University of Tennessee | OTHER |
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This three-year randomized clinical trial will evaluate a behavioral intervention for caregivers of Veterans with traumatic brain injury (TBI) and Alzheimer's dementia or mixed Dementia (AD/MD) to reduce caregiver depression, anxiety and burden, and improve veterans' health management. The study will combine and deliver two award-winning behavioral interventions - REACH VA (Resources for Enhancing All Caregivers Health in Department of Veterans Affairs) and the DoD's Virtual Hope Box, which we call REACH Hope. Both REACH and Hope Box have evidence of effectiveness individually but have not been delivered together for caregivers supporting veterans with complex neurodegenerative diagnoses and health conditions. Our primary hypothesis is that REACH Hope will improve caregivers' quality of life as measured by reduced burden.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REACH Hope | Experimental | Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app. |
|
| Wait list control | Active Comparator | Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REACH Hope | Other | REACH VA (Resources for Enhancing All Caregivers Health in Department of Veterans Affairs) and the DoD's Virtual Hope Box. For REACH Hope, as the caregiver and interventionist work on strategies one-on-one, these will be integrated into the Hope Box for the caregiver to use between and after sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Burden at three months | Measured by the Zarit Burden Inventory- 12 | three months |
| Change from baseline Burden at six months | Measured by the Zarit Burden Inventory- 12 | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Depression at three months | As measured with the Patient Health Questionnaire-9 | Three months |
| Change from baseline Depression at six months | As measured with the Patient Health Questionnaire-9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda O Nichols, PhD | US Department of Veterans Affairs | Principal Investigator |
| Paul Perrin, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caregiver Center, VA Medical Center | Memphis | Tennessee | 38104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40742769 | Derived | Nichols LO, Martindale-Adams J, Seel RT, Zuber JK, Perera R, Perrin PB. Reducing burden and anxiety for caregivers of veterans with traumatic brain injury and dementia: Randomized controlled trial of the resources for enhancing all caregivers' health-Hope intervention. Rehabil Psychol. 2025 Jul 31:10.1037/rep0000632. doi: 10.1037/rep0000632. Online ahead of print. |
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| ID | Term |
|---|---|
| D000093902 | Mixed Dementias |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The study is a wait list control design.
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|
| Six months |
| Change from baseline Anxiety at three months | As measured with the General Anxiety Disorders-7 | Three months |
| Change from baseline Anxiety at six months | As measured with the General Anxiety Disorders-7 | six months |
| Change from baseline Caregiving self-efficacy at three months | As measured with the Caregiving Self-Efficacy scale | three months |
| Change from baseline Caregiving self-efficacy at six months | As measured with the Caregiving Self-Efficacy scale | six months |
| D019965 |
| Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |