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
82
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
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
Phase 1 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up
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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