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

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Behavioral: TEAM-Red; Other: Waitlist

• 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

Arm && Interventions

Group	Intervention	Description
TEAM-Red	TEAM-Red	Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference
Enhanced Waitlist (eWL)	Waitlist	After the week 12 follow up visit, subjects in the Waitlist group will receive the TEAM Red intervention

Primary Outcome Measures

Name	Time	Method
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 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 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
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

Secondary Outcome Measures

Name	Time	Method
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 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 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 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 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
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

Trial Locations

Locations (1)

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