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

N/AActive Not RecruitingNCT05488782

Jennifer B. Levin82 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Depression

Interventions

TEAM-RedBEHAVIORAL

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

WaitlistOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline to 24 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline to 24 weeks