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

Not Applicable

Recruiting

• Conditions: Depression

• Registration Number: NCT05488782
• Lead Sponsor: Jennifer B. Levin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-05
• Study Start: 2023-01-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2026-01-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Phase 1 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up	Baseline to 24 weeks	PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow-up	Baseline to 24 weeks	PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Phase 2 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up	Baseline to 12 weeks	PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up	Baseline to 24 weeks	PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Phase 1 TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up	Baseline to 12 weeks	PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Phase 2 TEAM-Red vs eWL 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up	Baseline to 12 weeks	PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression

Secondary Outcome Measures

Name	Time	Method
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	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
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	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
Phase 1 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up	Baseline to 24 weeks	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
Phase 1 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up	Baseline to 24 weeks	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
Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) mental component score at 12-week follow-up	Baseline to 12 weeks	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
Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) physical component score at 12-week follow-up	Baseline to 12 weeks	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
Phase 1 and Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up	Baseline to 24 weeks	PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
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	Baseline to 12 weeks	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
Phase 1 and Phase 2 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up	Baseline to 24 weeks	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
Phase 1 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up	Baseline to 12 weeks	PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Phase 1 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up	Baseline to 24 weeks	PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Phase 2 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up	Baseline to 24 weeks	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
Phase 2 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up	Baseline to 24 weeks	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
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	Baseline to 12 weeks	PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Phase 1 and Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up	Baseline to 24 weeks	PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
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	Baseline to 12 weeks	PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
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	Baseline to 12 weeks	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
Phase 1 and Phase 2 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up	Baseline to 24 weeks	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

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States