A program to help manage depression in young Black women at risk for hypertension

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

This study is testing a new program to help young Black women manage their depression and reduce their risk of high blood pressure over six months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 18 Years to 49 Years
• Sex: Female
• Sponsor: University Hospitals Cleveland Medical Center (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT05488782 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the TargEted MAnageMent Intervention (TEAM) over a 24-week period in young African American women who are experiencing depression and are at risk for hypertension. Participants will be randomly assigned to receive the TEAM intervention or be placed on an enhanced waitlist control. The study aims to assess improvements in mental health and hypertension risk factors through a remotely delivered self-management program. The trial will include 82 participants aged 18-49 who meet specific eligibility criteria related to depression and hypertension risk.

Who should consider this trial

Good fit: Ideal candidates are self-identified African American women aged 18-49 who are currently experiencing depression and have at least one risk factor for hypertension.

Not a fit: Patients who are pregnant, at imminent risk of suicide, or currently diagnosed with hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve mental health outcomes and reduce hypertension risk in young Black women.

How similar studies have performed: While similar interventions targeting mental health in specific demographics have shown promise, this particular approach is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Cleveland, Ohio

• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Jennifer Levin — University Hospitals Cleveland Medical Center
• Study coordinator: Taylor Maniglia

Conditions Depression