TEAM-Red, a Remotely Delivered Self-management Program for Depressed Black Women at Risk for Hypertension

Depression Clinical Trial

— TEAM-Red  

Official title:

A Pilot RCT of a Remotely Delivered Self-management Program (TEAM-Red) for Depressed Young African American Women at Risk for Hypertension (HTN)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05488782
• Other study ID #: STUDY20220976
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Depression
• Hypertension

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