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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: TEAM-Red
* Other: Waitlist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Unwilling/unable to provide informed consent; Pregnancy; Imminent suicide risk, A current diagnosis of hypertension or use of antihypertensive medications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 25 participants are assigned to receive TEAM, and 25 participants are assigned to wait list
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |