Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Intervention feasibility
研究概览
简要总结
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.
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 preventive care. Targeted workplace initiatives have been successful in improving employee health, but low-wage workers are difficult to engage, in part due to a high burden of social disadvantage (e.g., food and housing insecurity, time and financial constraints). There are few, if any, workplace interventions for depression that specifically target low-wage workers and the participants unique social risk factors. This study was designed using a planned adaptation approach that involved low-wage workers in the design of the intervention to increase engagement and feasibility. The study will test an evidence-based 8-session telephone-delivered depression intervention for working adults, Be Well at Work, and critical adaptations for low-wage workers: assessment and referrals for social determinants of health (e.g., food and housing insecurity, financial stress), physical activity promotion, and personalized text message behavioral support. The adapted intervention, Be Well at Work-PLUS, will be evaluated through a pilot randomized controlled trial comparing Be Well at Work-PLUS to a waitlist condition. The primary objectives are to assess acceptability, feasibility, and preliminary clinical outcomes. The primary preliminary clinical outcome is depression symptom severity, and secondary outcomes are physical activity, sleep quality, blood pressure, and BMI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •plan to leave Scripps employment in <6 months;
- •severe mental illness or substance use condition (e.g., bipolar disorder, schizophrenia, active alcohol use disorder)
研究组 & 干预措施
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.
干预措施: A workplace-based depression intervention for low-wage hospital workers (Behavioral)
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.
干预措施: A workplace-based depression intervention for low-wage hospital workers (Behavioral)
结局指标
主要结局
Intervention feasibility
时间窗: From enrollment to end of treatment (approximately 4 months after enrollment).
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.
Depression symptoms
时间窗: From baseline through end of treatment (approximately 4 months after enrollment).
Depression symptoms will be measured with the Patient Health Questionnaire - 9 item version (range 0-27, higher = worse depression symptoms)
次要结局
- Work limitations(From baseline to end of treatment (approximately 4 months after enrollment))
- Sleep quality(Baseline, follow-up (4 months))
- Perceived stress(From baseline to end of treatment (approximately 4 months after enrollment))
- Physical activity - step count(Baseline, follow-up (4 months))
- Body Mass Index(Baseline, follow-up (4 months))
- Blood pressure(Baseline, Follow-up (4 months))
- Physical Activity (self-report)(Baseline, Follow-up (4 months))