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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 24 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 below
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I am an African American woman aged 18-49.
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I am an African American woman aged 18-49.
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I have high blood pressure risk due to factors like being overweight, high blood sugar, high blood pressure readings, smoking, or high cholesterol.
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I can follow the study's required procedures.

TEAM-Red Trial 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

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

Find a Location

Who is running the clinical trial?

American Heart AssociationOTHER
319 Previous Clinical Trials
4,932,372 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does my profile meet the qualifications to partake in this experiment?

"The current trial is open for enrollment to 50 self-identifying African American women between 18 and 49 who have been diagnosed with depression, as gauged by a score of 10 or higher on the 9-item Patient Health Questionnaire (PHQ-9). Furthermore, they must be registered in Research Goes Red and meet at least one criteria from an elevated body mass index (BMI) ≥30, HbA1c >5.75, systolic blood pressure (BP) ≥ 130 mmHg or diastolic BP≥90 mmHg , smoking status, LDL cholesterol levels ≥100 mg/dl within"

Answered by AI

Are there any vacancies available for potential participants in this research endeavor?

"According to clinicaltrials.gov, this research endeavour which debuted on December 1st 2022 is not currently accepting applicants. However, there are 1878 other trials recruiting new participants as we speak."

Answered by AI

Is eligibility for this medical evaluation limited to persons under 45 years of age?

"This trial is open to patients aged between 18 and 49. For those younger than 18 or older than 65, additional clinical trials are available with 230 for the former group and 1508 for the latter."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
University Hospitals Cleveland Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~13 spots leftby Sep 2024