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Self-Management Program for Depression and High Blood Pressure Risk (TEAM-Red Trial)
N/A
Waitlist Available
Led By Jennifer Levin
Research Sponsored by Jennifer B. Levin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self-identified AA female ages 18-49;
Self-identified African American female ages 18-49
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights
TEAM-Red Trial Summary
This trial will compare the effects of a targeted management intervention against an enhanced wait-list control in depressed African-American women at risk for hypertension.
Who is the study for?
This trial is for young African-American women under 50 with depression and at risk for high blood pressure, but not yet diagnosed with it. Participants must have a BMI ≥30, HbA1c >5.75, a recent BP reading of ≥130/90 mmHg, be current smokers or have LDL levels ≥100 mg/dl.Check my eligibility
What is being tested?
The study compares the TEAM-Red self-management program against an enhanced waitlist control over 24 weeks to see if it helps manage risks associated with hypertension in depressed Black women who are predisposed to high blood pressure.See study design
What are the potential side effects?
Since this is a non-medical intervention focusing on self-management and lifestyle changes rather than medication or procedures, significant physical side effects are not expected.
TEAM-Red Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an African American woman aged 18-49.
Select...
I am an African American woman aged 18-49.
TEAM-Red Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score
TEAM-Red Trial Design
2Treatment groups
Experimental Treatment
Group I: TEAM-RedExperimental Treatment1 Intervention
Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference
Group II: Enhanced Waitlist (eWL)Experimental Treatment1 Intervention
After the week 12 follow up visit, subjects in the Waitlist group will receive the TEAM Red intervention
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Who is running the clinical trial?
American Heart AssociationOTHER
333 Previous Clinical Trials
4,933,954 Total Patients Enrolled
3 Trials studying Depression
212 Patients Enrolled for Depression
Jennifer B. LevinLead Sponsor
Jennifer LevinPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an African American woman aged 18-49.I am an African American woman aged 18-49.I have high blood pressure risk due to factors like being overweight, high blood sugar, high blood pressure readings, smoking, or high cholesterol.I can follow the study's required procedures.You have a score of 10 or more on the 9-item Patient Health Questionnaire (PHQ-9), which measures depression.I can follow the study's required procedures.I have high blood pressure, am overweight, smoke, or have high cholesterol or blood sugar.You are registered on Research Goes Red.You currently have a score of 10 or more on the depression questionnaire.I have high blood pressure or am taking medication for it.You are at high risk of attempting suicide.
Research Study Groups:
This trial has the following groups:- Group 1: TEAM-Red
- Group 2: Enhanced Waitlist (eWL)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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