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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: TEAM-Red; Other: Waitlist

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taylor Maniglia; Phone Number: 888-819-0004; Email: Taylor.Maniglia@UHhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
      • Contact: Taylor Maniglia; Phone Number: 888-819-0004
      • Principal Investigator: Jenniger Levin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEAM-Red; Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference	Behavioral: TEAM-Red; Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference
Other: Enhanced Waitlist (eWL); After the week 12 follow up visit, subjects in the Waitlist group will receive the TEAM Red intervention	Other: Waitlist; After the week 12 follow up visits subjects in the Waitlist group will receive the TEAM Red intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Jennifer B. Levin
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Jennifer Levin, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: STUDY20220976

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data with the data dictionary and protocol will be made available to other researchers via the American Heart Association (AHA) Precision Medicine Platform
• IPD Sharing Time Frame: Data will be available by one year following the funding
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No