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

Jennifer B. Levin

Status: Active, not recruiting

Conditions: Depression

Treatments: Other: Waitlist; Behavioral: TEAM-Red

Study type: Interventional

Funder types: Other

Identifiers

NCT05488782

STUDY20220976

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

82 participants in 2 patient groups

TEAM-Red

Experimental group

Description:

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

Treatment:

Behavioral: TEAM-Red

Enhanced Waitlist (eWL)

Other group

Description:

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

Treatment:

Other: Waitlist