TEAM-Red, a Remotely Delivered Self-management Program for Depressed Black Women at Risk for Hypertension
Purpose
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.
Condition
- Depression
Eligibility
- Eligible Ages
- Between 18 Years and 49 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Registered on Research Goes Red; 2. Self-identified African American female ages 18-49; 3. current depression as measured by a score of ≥10 on the 9-item Patient Health Questionnaire (PHQ-9), 4. Have at least one of the following self or chart-recorded HTN risk factors: body mass index (BMI) greater ≥ 30, HbA1c >5.75, at least one outpatient reading of systolic blood pressure (BP) ≥ 130 mm Hg or diastolic ≥90 mmHg, current smoker, or LDL ≥100 mg/dl in the last 12 months; 5. Are able to participate in study procedures. Phase 1
Exclusion Criteria
- Unwilling/unable to provide informed consent; 2. Pregnancy; 3. Imminent suicide risk, 4. A current diagnosis of hypertension or use of antihypertensive medications. Phase 2 Inclusion Criteria 1. Self-identified AA female ages 18-49; 2. Endorses either: a past or current history of depression, current depression as measured by a score of at least a 5 on the 9-item Patient Health Questionnaire (PHQ-9), or indicate feelings of stress or discrimination that impact their functioning 3. Have at least one of the following self or chart-recorded HTN risk factors: BMI greater ≥ 30,26 HbA1c >5.75,27 at least one outpatient reading of systolic BP ≥ 130 mm Hg or diastolic ≥90 mmHg, current smoker, or LDL ≥100 mg/dl in the last 12 months; 4. Are able to participate in study procedures. Phase 2 Exclusion Criteria 1. Unwilling/unable to provide informed consent; 2. Pregnancy; 3. Imminent suicide risk, 4. A current diagnosis of HTN or use of antihypertensive medications.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- 41 participants are assigned to receive TEAM, and 41 participants are assigned to wait list
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TEAM-Red |
Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference |
|
|
Other Enhanced Waitlist (eWL) |
After the week 12 follow up visit, subjects in the Waitlist group will receive the TEAM Red intervention |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Jennifer B. Levin
