TEAM-Red, a Remotely Delivered Self-management Program for Depressed Black Women at Risk for Hype… (NCT05488782) | Clinical Trial Compass
CompletedNot Applicable
TEAM-Red, a Remotely Delivered Self-management Program for Depressed Black Women at Risk for Hypertension
United States83 participantsStarted 2023-01-30
Plain-language summary
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.
Who can participate
Age range18 Years – 49 Years
SexFEMALE
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Inclusion criteria
✓. Registered on Research Goes Red;
✓. Self-identified African American female ages 18-49;
✓. current depression as measured by a score of ≥10 on the 9-item Patient Health Questionnaire (PHQ-9),
✓. 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;
✓. Are able to participate in study procedures.
Exclusion criteria
✕. Unwilling/unable to provide informed consent;
✕. Pregnancy;
✕. Imminent suicide risk,
✕. A current diagnosis of hypertension or use of antihypertensive medications.
✕. Self-identified AA female ages 18-49;
✕. 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
✕. 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;
What they're measuring
1
Phase 1 TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up
Timeframe: Baseline to 12 weeks
2
Phase 1 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up
Timeframe: Baseline to 24 weeks
3
Phase 2 TEAM-Red vs eWL 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up
Timeframe: Baseline to 12 weeks
4
Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow-up
Timeframe: Baseline to 24 weeks
5
Phase 2 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up
Timeframe: Baseline to 12 weeks
6
Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up