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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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The proposed project is a 24-week prospective randomized controlled trial (RCT) evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=41) vs. enhanced waitlist (eWL, N=41) control in young (<50 years) African American women who are depressed or suffering from stress, and at risk for hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEAM-Red | Experimental | Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference |
|
| Enhanced Waitlist (eWL) | Other | After the week 12 follow up visit, subjects in the Waitlist group will receive the TEAM Red intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEAM-Red | Behavioral | Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up | PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression | Baseline to 12 weeks |
| Phase 1 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up | PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression | Baseline to 24 weeks |
| Phase 2 TEAM-Red vs eWL 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up | PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression | Baseline to 12 weeks |
| Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow-up | PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression | Baseline to 24 weeks |
| Phase 2 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up | PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress | Baseline to 12 weeks |
| Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up | PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress | Baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up | PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress | Baseline to 12 weeks |
| Phase 1 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up |
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Phase 1 Inclusion Criteria:
Phase 1 Exclusion Criteria:
Phase 2 Inclusion Criteria
Phase 2 Exclusion Criteria
participant eligibility is based on self-representation of gender identity.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Levin | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
Deidentified data with the data dictionary and protocol will be made available to other researchers via the American Heart Association (AHA) Precision Medicine Platform
Data will be available by one year following the funding
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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41 participants are assigned to receive TEAM, and 41 participants are assigned to wait list
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| Waitlist | Other | After the week 12 follow up visits subjects in the Waitlist group will receive the TEAM Red intervention |
|
PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress |
| Baseline to 24 weeks |
| Phase 1 TEAM-Red vs eWL 12-item Short Form Survey (SF-12) mental component score at 12-week follow up | SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health | Baseline to 12 weeks |
| Phase 1 TEAM-Red vs eWL 12-item Short Form Survey (SF-12) physical component score at 12-week follow up | SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health | Baseline to 12 weeks |
| Phase 1 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up | SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health | Baseline to 24 weeks |
| Phase 1 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up | SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health | Baseline to 24 weeks |
| Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) mental component score at 12-week follow-up | SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health | Baseline to 12 weeks |
| Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) physical component score at 12-week follow-up | SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health | Baseline to 12 weeks |
| Phase 2 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up | SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health | Baseline to 24 weeks |
| Phase 2 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up | SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health | Baseline to 24 weeks |
| Phase 1 and Phase 2 TEAM-Red vs eWL change in 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up | PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression | Baseline to 12 weeks |
| Phase 1 and Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up | PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression | Baseline to 24 weeks |
| Phase 1 and Phase 2 TEAM-Red vs eWL change in 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up | PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress | Baseline to 12 weeks |
| Phase 1 and Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up | PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress | Baseline to 24 weeks |
| Phase 1 and Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) mental component score at 12-week follow-up | SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health | Baseline to 12 weeks |
| Phase 1 and Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) physical component score at 12-week follow-up | SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health | Baseline to 12 weeks |
| Phase 1 and Phase 2 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up | SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health | Baseline to 24 weeks |
| Phase 1 and Phase 2 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up | SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health | Baseline to 24 weeks |