A Pilot RCT of a Remotely Delivered Self-management Program (TEAM-Red) for Depressed Young African American Women at Risk for Hypertension (HTN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Phase 1 TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Phase 1 Inclusion Criteria:
- •Registered on Research Goes Red;
- •Self-identified African American female ages 18-49;
- •current depression as measured by a score of ≥10 on the 9-item Patient Health Questionnaire (PHQ-9),
- •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;
- •Are able to participate in study procedures.
排除标准
- •Unwilling/unable to provide informed consent;
- •Imminent suicide risk,
- •A current diagnosis of hypertension or use of antihypertensive medications.
- •Phase 2 Inclusion Criteria
- •Self-identified AA female ages 18-49;
- •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
- •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;
- •Are able to participate in study procedures.
- •Phase 2 Exclusion Criteria
- •Unwilling/unable to provide informed consent;
- •Imminent suicide risk,
- •A current diagnosis of HTN or use of antihypertensive medications.
研究组 & 干预措施
TEAM-Red
Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference
干预措施: TEAM-Red (Behavioral)
Enhanced Waitlist (eWL)
After the week 12 follow up visit, subjects in the Waitlist group will receive the TEAM Red intervention
干预措施: Waitlist (Other)
结局指标
主要结局
Phase 1 TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline to 24 weeks
PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
次要结局
- Phase 1 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up(Baseline to 12 weeks)
- Phase 1 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up(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(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(Baseline to 12 weeks)
- Phase 1 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up(Baseline to 24 weeks)
- Phase 1 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up(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(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(Baseline to 12 weeks)
- Phase 2 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up(Baseline to 24 weeks)
- Phase 2 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up(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(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(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(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(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(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(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(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(Baseline to 24 weeks)
研究者
Jennifer B. Levin
Principal Investiagator
University Hospitals Cleveland Medical Center