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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The goal of this clinical trial is to find out if a 9 week group therapy using video from home will help veterans with Mild Cognitive Impairment (MCI). The main questions it aims to answer are:
Veterans will be asked to attend nine 1 hour small group video sessions and will complete questionnaires before and after the sessions.
Researchers will compare the group of veterans that starts the video sessions right away with a group that waits before starting the video sessions.
The study will be achieved by conducting a two-arm, single-blind, pilot randomized controlled trial at two VA medical centers. Eighty participants at each site will be randomized in a 1:1 ratio to either the MiND-MCI group or waitlist control group. Participants will be Veterans ages 60 and older with a diagnosis of MCI, at least one cardiovascular risk factor, self-reported cognitive complaint, and self-reported difficulty adjusting to MCI diagnosis or symptoms. MiND-MCI will be delivered in nine weekly 60-minute sessions via telehealth in groups of 5 to 7 Veterans. Feasibility and acceptability process data will be tracked throughout the study. Acceptability measures pertaining to participants' perceptions of MiND-MCI will be collected at post-treatment using quantitative and qualitative assessment methods. Outcome measures collected at baseline, post-treatment, and 12-week follow-up will assess global QoL, MCI-related QoL, MCI-related self-efficacy, depression, anxiety, loneliness, coping, and cognitive functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group therapy delivered via video telehealth | Experimental | Nine sessions of 60 min each group therapy delivered via telehealth |
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| Group therapy delivered via video telehealth - wait list control | Other | Nine sessions of 60 min each group therapy delivered via telehealth after a waiting period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group psychotherapy delivered via video telehealth | Behavioral | Small group psychotherapy using psychoeducation and skills training aimed at addressing modifiable factors in MCI. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of a group video-telehealth intervention for veterans with MCI | percentage of screened, eligible subjects that enroll in intervention | At Week 0 (randomization) |
| Acceptability of a group video-telehealth intervention for veterans with MCI | percentage of subjects that attend 70% or more of scheduled sessions | At Week 10 (one week after completion of the 9 video-telehealth sessions) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Quality of Life in Alzheimers Disease (QOL-AD, range of 13-52) scale in Veterans with Mild Cognitive Impairment following participation in a 9-week video-telehealth intervention. | change in the Quality of Life in Alzheimers Disease (QOL-AD) Scale | baseline to 12 week post-treatment follow-up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Pilkinton, MD | Contact | 205-554-20944 | patricia.pilkinton@va.gov | |
| Lindsay Jacobs, PhD | Contact | 205-554-2337 | jacob008@ua.edu |
| Name | Affiliation | Role |
|---|---|---|
| Patricia Pilkinton, MD | Tuscaloosa Veterans Affairs Medical Center | Principal Investigator |
| Lindsay Jacobs, PhD | Tuscaloosa Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tuscaloosa VA Medical Center | Recruiting | Tuscaloosa | Alabama | 35404 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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two-arm, single-blind, pilot randomized controlled trial with 1:1 randomization. Wait List Control.
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Assessor and fidelity monitor will be blinded to treatment group.
| Salem VA Medical Center | Recruiting | Salem | Virginia | 24153 | United States |
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