Clinical trial NCT05488782: TEAM-Red, a Remotely Delivered Self-management Program for Depressed Black Women at Risk for Hypertension
Official title: A Pilot RCT of a Remotely Delivered Self-management Program (TEAM-Red) for Depressed Young African American Women at Risk for Hypertension (HTN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2022-08-05
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 41 participants are assigned to receive TEAM, and 41 participants are assigned to wait list
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Phase 1 TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up
timeFrame: Baseline to 12 weeks
measure: Phase 1 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up
timeFrame: Baseline to 24 weeks
measure: Phase 2 TEAM-Red vs eWL 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up
timeFrame: Baseline to 12 weeks
measure: Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow-up
timeFrame: Baseline to 24 weeks
measure: Phase 2 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up
timeFrame: Baseline to 12 weeks
measure: Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up
timeFrame: Baseline to 24 weeks
Secondary outcomes:
measure: Phase 1 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up
timeFrame: Baseline to 12 weeks
measure: Phase 1 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up
timeFrame: Baseline to 24 weeks
measure: Phase 1 TEAM-Red vs eWL 12-item Short Form Survey (SF-12) mental component score at 12-week follow up
timeFrame: Baseline to 12 weeks
measure: Phase 1 TEAM-Red vs eWL 12-item Short Form Survey (SF-12) physical component score at 12-week follow up
timeFrame: Baseline to 12 weeks
measure: Phase 1 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up
timeFrame: Baseline to 24 weeks
measure: Phase 1 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up
timeFrame: Baseline to 24 weeks
measure: Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) mental component score at 12-week follow-up
timeFrame: Baseline to 12 weeks
measure: Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) physical component score at 12-week follow-up
timeFrame: Baseline to 12 weeks
measure: Phase 2 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up
timeFrame: Baseline to 24 weeks
measure: Phase 2 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up
timeFrame: Baseline to 24 weeks
measure: 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
timeFrame: Baseline to 12 weeks
measure: Phase 1 and Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up
timeFrame: Baseline to 24 weeks
measure: 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
timeFrame: Baseline to 12 weeks
measure: Phase 1 and Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up
timeFrame: Baseline to 24 weeks
measure: 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
timeFrame: Baseline to 12 weeks
measure: 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
timeFrame: Baseline to 12 weeks
measure: Phase 1 and Phase 2 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up
timeFrame: Baseline to 24 weeks
measure: Phase 1 and Phase 2 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up
timeFrame: Baseline to 24 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Jennifer Levin
role: PRINCIPAL_INVESTIGATOR
References: