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Self-Management Program for Depression and High Blood Pressure Risk (TEAM-Red Trial)

N/A
Recruiting
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
Must not have
A current diagnosis of hypertension or use of antihypertensive medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am an African American woman aged 18-49.
Select...
I am an African American woman aged 18-49.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have high blood pressure or am taking medication for it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1 TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up
Phase 1 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up
Phase 2 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up
+3 more
Secondary study objectives
Phase 1 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up
Phase 1 TEAM-Red vs eWL 12-item Short Form Survey (SF-12) mental component score at 12-week follow up
Phase 1 TEAM-Red vs eWL 12-item Short Form Survey (SF-12) physical component score at 12-week follow up
+15 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,105 Total Patients Enrolled
3 Trials studying Depression
212 Patients Enrolled for Depression
Jennifer B. LevinLead Sponsor
Jennifer LevinPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Media Library

TEAM-Red Clinical Trial Eligibility Overview. Trial Name: NCT05488782 — N/A
Depression Research Study Groups: TEAM-Red, Enhanced Waitlist (eWL)
Depression Clinical Trial 2023: TEAM-Red Highlights & Side Effects. Trial Name: NCT05488782 — N/A
TEAM-Red 2023 Treatment Timeline for Medical Study. Trial Name: NCT05488782 — N/A
~27 spots leftby Jan 2026
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