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

NCT05488782 | Active Not Recruiting

• 1 other identifier: STUDY20220976
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (18)

• Phase 1 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up

  Baseline to 12 weeks

• Phase 1 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up

  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

  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

  Baseline to 12 weeks

• Phase 1 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up

  Baseline to 24 weeks

Study Arms (2)

TEAM-Red

EXPERIMENTAL

Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference

Behavioral: TEAM-Red

Enhanced Waitlist (eWL)

OTHER

After the week 12 follow up visit, subjects in the Waitlist group will receive the TEAM Red intervention

Other: Waitlist

Interventions

TEAM-Red BEHAVIORAL

Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference

TEAM-Red

Waitlist OTHER

After the week 12 follow up visits subjects in the Waitlist group will receive the TEAM Red intervention

Enhanced Waitlist (eWL)

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Registered on Research Goes Red;
• Self-identified African American female ages 18-49;
• current depression as measured by a score of ≥10 on the 9-item Patient Health Questionnaire (PHQ-9),
• 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;
• Are able to participate in study procedures.

You may not qualify if:

• Unwilling/unable to provide informed consent;
• Pregnancy;
• Imminent suicide risk,
• A current diagnosis of hypertension or use of antihypertensive medications.
• Self-identified AA female ages 18-49;
• 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
• 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;
• Are able to participate in study procedures.
• Unwilling/unable to provide informed consent;
• Pregnancy;
• Imminent suicide risk,
• A current diagnosis of HTN or use of antihypertensive medications.

Sponsors & Collaborators

• Jennifer B. Levin: lead
• American Heart Association: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Jennifer Levin

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investiagator

Model Details: 41 participants are assigned to receive TEAM, and 41 participants are assigned to wait list

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 5, 2022
• Study Start: January 30, 2023
• Primary Completion: January 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available by one year following the funding

Locations

US (1)