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=41) vs. enhanced waitlist (eWL, N=41) control in young (<50 years) African American women who are depressed or suffering from stress, and at risk for hypertension.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: TEAM-Red; Other: Waitlist

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

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

Description

Phase 1 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.

Phase 1 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.

Phase 2 Inclusion Criteria

1. Self-identified AA female ages 18-49;
2. Endorses either: a past or current history of depression, current depression as measured by a score of at least a 5 on the 9-item Patient Health Questionnaire (PHQ-9), or indicate feelings of stress or discrimination that impact their functioning
3. Have at least one of the following self or chart-recorded HTN risk factors: BMI greater ≥ 30,26 HbA1c >5.75,27 at least one outpatient reading of systolic BP ≥ 130 mm Hg or diastolic ≥90 mmHg, current smoker, or LDL ≥100 mg/dl in the last 12 months;
4. Are able to participate in study procedures.

Phase 2 Exclusion Criteria

1. Unwilling/unable to provide informed consent;
2. Pregnancy;
3. Imminent suicide risk,
4. A current diagnosis of HTN 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
Phase 1 TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up	PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression	Baseline to 12 weeks
Phase 1 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up	PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression	Baseline to 24 weeks
Phase 2 TEAM-Red vs eWL 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up	PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression	Baseline to 12 weeks
Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow-up	PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression	Baseline to 24 weeks
Phase 2 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up	PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress	Baseline to 12 weeks
Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up	PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress	Baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up	PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress	Baseline to 12 weeks
Phase 1 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up	PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress	Baseline to 24 weeks
Phase 1 TEAM-Red vs eWL 12-item Short Form Survey (SF-12) mental component score at 12-week follow up	SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health	Baseline to 12 weeks
Phase 1 TEAM-Red vs eWL 12-item Short Form Survey (SF-12) physical component score at 12-week follow up	SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health	Baseline to 12 weeks
Phase 1 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up	SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health	Baseline to 24 weeks
Phase 1 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up	SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health	Baseline to 24 weeks
Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) mental component score at 12-week follow-up	SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health	Baseline to 12 weeks
Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) physical component score at 12-week follow-up	SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health	Baseline to 12 weeks
Phase 2 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up	SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health	Baseline to 24 weeks
Phase 2 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up	SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health	Baseline to 24 weeks
Phase 1 and Phase 2 TEAM-Red vs eWL change in 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up	PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression	Baseline to 12 weeks
Phase 1 and Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up	PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression	Baseline to 24 weeks
Phase 1 and Phase 2 TEAM-Red vs eWL change in 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up	PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress	Baseline to 12 weeks
Phase 1 and Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up	PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress	Baseline to 24 weeks
Phase 1 and Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) mental component score at 12-week follow-up	SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health	Baseline to 12 weeks
Phase 1 and Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) physical component score at 12-week follow-up	SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health	Baseline to 12 weeks
Phase 1 and Phase 2 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up	SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health	Baseline to 24 weeks
Phase 1 and Phase 2 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up	SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health	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 (Actual): September 18, 2025
• Study Completion (Actual): September 18, 2025

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 (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression; Organization and Administration; Health Services Administration; Appointments and Schedules; Waiting Lists
• 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
• product manufactured in and exported from the U.S.: No