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临床试验 NCT07010133 针对抑郁症，身体不活动目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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圣地亚哥州立大学Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3) 60 随机化
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临床试验NCT07010133是一项针对抑郁症，身体不活动的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年2月15日开始，预计招募60名患者。该研究由圣地亚哥州立大学主导，计划于2027年1月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月11日。
简要概括
This small randomized controlled trial will evaluate a workplace-based depression intervention that is tailored to the specific social and behavioral needs of low-wage hospital service workers. The intervention involves assessment of depression-related work impairment, work-focused cognitive behavioral therapy, work coaching, social needs screening and referral, and text message support for mood and physical activity...显示更多
详细描述
Depression and physical inactivity are leading contributors to cardiometabolic diseases such as obesity, diabetes, and cardiovascular disease. Low-wage workers, who comprise one third of all workers in the U.S. and are essential to many industries, are more likely to be physically inactive and to have cardiometabolic conditions and depression, yet the participants are half as likely as higher wage workers to utilize ...显示更多
官方标题
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3).
疾病
抑郁症身体不活动其他研究标识符
- IRB-24-0260
- K23HL157763 (美国 NIH 拨款/合同)
NCT编号
实际开始日期
2026-02-15
最近更新发布
2026-02-11
预计完成日期
2027-01-31
计划入组人数
60
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
Depression
Physical Activity
Employees
Worker Health
Low-income
Social needs
Physical Activity
Employees
Worker Health
Low-income
Social needs
主要目的
治疗方法
分配方式
随机
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Immediate Intervention The intervention consists of assessment of depression and work impairment, work-focused cognitive behavioral therapy, work coaching, social needs screening and referral, and text message support for mood and physical activity. | A workplace-based depression intervention for low-wage hospital workers This intervention is a remotely delivered workplace-based depression intervention that is tailored to the specific social and behavioral needs of low-wage hospital service workers. The intervention involves assessment of depression-related work impairment, work-focused cognitive behavioral therapy, work coaching, social needs screening and referral, and text message support for mood and physical activity. |
阳性对照Waitlist Control Delivered after a 4-month waitlist period, the intervention consists of assessment of depression and work impairment, work-focused cognitive behavioral therapy, work coaching, social needs screening and referral, and text message support for mood and physical activity. | A workplace-based depression intervention for low-wage hospital workers This intervention is a remotely delivered workplace-based depression intervention that is tailored to the specific social and behavioral needs of low-wage hospital service workers. The intervention involves assessment of depression-related work impairment, work-focused cognitive behavioral therapy, work coaching, social needs screening and referral, and text message support for mood and physical activity. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Intervention feasibility | Feasibility will be assessed by the number of intervention sessions completed. The intervention will be considered feasible if the majority of participants complete 75% (6 of 8) or more phone sessions. | From enrollment to end of treatment (approximately 4 months after enrollment). |
Depression symptoms | Depression symptoms will be measured with the Patient Health Questionnaire - 9 item version (range 0-27, higher = worse depression symptoms) | From baseline through end of treatment (approximately 4 months after enrollment). |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Work limitations | Work limitations (range: 0-100%, higher = more limitation) will be measured by the Work Limitations Questionnaire. | From baseline to end of treatment (approximately 4 months after enrollment) |
Perceived stress | Perceived stress measured by the Perceived Stress Scale (range 0-40, higher = more perceived stress). | From baseline to end of treatment (approximately 4 months after enrollment) |
Sleep quality | Sleep quality and duration as measured by the Pittsburgh Sleep Quality Index (range: 0-21, higher scores indicate worse sleep quality). | Baseline, follow-up (4 months) |
Physical activity - step count | Weekly step count as measured by wrist-worn FitBit watch | Baseline, follow-up (4 months) |
Body Mass Index | A weight-to-height ratio, calculated by dividing participant's weight in kilograms by height in meters squared. | Baseline, follow-up (4 months) |
Blood pressure | Resting systolic and diastolic blood pressures | Baseline, Follow-up (4 months) |
Physical Activity (self-report) | Self-reported physical activity using the Global Physical Activity Questionnaire | Baseline, Follow-up (4 months) |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- part-time or full-time employment (at least 20 hours per week);
- ≥18 years old;
- employed in low-wage-earning jobs in the Environmental Services or Food & Nutrition Services Departments;
- presence of depression symptoms as measured by the Patient Health Questionnaire-9 item version; individuals who score ≥5 (indicating mild depression symptoms or higher) will be eligible;
- presence of impairment in work functioning, as measured by the Work Limitations Questionnaire; individuals who score ≥5% (indicating mild work productivity loss) will be eligible;
- possession of a cell phone with ability to receive text-messages;
- Fluent in either English or Spanish.
- plan to leave Scripps employment in <6 months;
- severe mental illness or substance use condition (e.g., bipolar disorder, schizophrenia, active alcohol use disorder)
圣地亚哥州立大学国家心脏、肺和血液研究所747 个活跃的临床试验可供探索研究中心联系人
联系人: Jessica L McCurley, PhD, MPH, 619-594-2132, [email protected]
1 位于 1 个国家/地区的研究中心
California
San Diego State University, San Diego, California, 92115, United States
Jessica L McCurley, PhD, MPH, 联系人, 619-594-2132, [email protected]
Jessica L McCurley, PhD, MPH, 主要研究者