Depression
Conditions
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.
Interventions
BEHAVIORALTEAM-Red
Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference
OTHERWaitlist
After the week 12 follow up visits subjects in the Waitlist group will receive the TEAM Red intervention
Sponsors
Jennifer B. Levin
American Heart Association
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
41 participants are assigned to receive TEAM, and 41 participants are assigned to wait list
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer Levin
University Hospitals Cleveland Medical Center
Outcome results
None listed