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 range
18 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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;