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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05488782
Other study ID # STUDY20220976
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 30, 2023
Est. completion date September 1, 2024

Study information

Verified date March 2024
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed project is a 24-week prospective randomized controlled trial (RCT) evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=25) vs. enhanced wait-list (eWL, N=25) control in depressed young (<50 years) African-American (AA) women at risk for hypertension.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date September 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: 1. Registered on Research Goes Red; 2. Self-identified African American female ages 18-49; 3. current depression as measured by a score of =10 on the 9-item Patient Health Questionnaire (PHQ-9), 4. 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; 5. Are able to participate in study procedures. Exclusion Criteria: 1. Unwilling/unable to provide informed consent; 2. Pregnancy; 3. Imminent suicide risk, 4. A current diagnosis of hypertension or use of antihypertensive medications.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
TEAM-Red
Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference
Other:
Waitlist
After the week 12 follow up visits subjects in the Waitlist group will receive the TEAM Red intervention

Locations

Country Name City State
United States University Hospitals Cleveland Medical Center Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
Jennifer B. Levin American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression Baseline to 12 weeks
Primary TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression Baseline to 24 weeks
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