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临床试验/NCT06753123
NCT06753123
尚未招募
不适用

Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers.

San Diego State University2 个研究点 分布在 1 个国家目标入组 10 人2026年4月21日

概览

阶段
不适用
干预措施
A workplace-based depression intervention for low-wage hospital workers
疾病 / 适应症
Depression
发起方
San Diego State University
入组人数
10
试验地点
2
主要终点
Intervention Feasibility
状态
尚未招募
最后更新
16天前

概览

简要总结

This study develops and tests a dynamic 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 conceptualized using a planned adaptation approach that involves 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 tested first in a single-arm open pilot (N=10) with exit interviews to refine the intervention content and delivery. Later, a pilot randomized controlled trial comparing Be Well at Work-PLUS to a waitlist condition (N=60) will be conducted (separate ClinicalTrials.gov study). 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).

注册库
clinicaltrials.gov
开始日期
2026年4月21日
结束日期
2026年7月31日
最后更新
16天前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

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

Single Arm: Open Pilot of 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

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.

Acceptability

时间窗: From enrollment to end of treatment (approximately 4 months after enrollment)

Acceptability will be assessed by the average of participants' ratings of intervention components on a 0-10 scale. Participants will rate each counseling session independently and will rate text messages on a monthly basis. The intervention will be considered acceptable if mean ratings are ≥ 7/10.

次要结局

  • Depression symptoms(From baseline through end of treatment (approximately 4 months after enrollment).)
  • Work limitations(From baseline to end of treatment (approximately 4 months after enrollment))
  • Perceived stress(From baseline to end of treatment (approximately 4 months after enrollment))
  • Sleep quality(From baseline to end of treatment (approximately 4 months after enrollment))
  • Physical activity - step count(From baseline to end of treatment (approximately 4 months after enrollment))
  • Body mass index (BMI)(From baseline to end of treatment (approximately 4 months after enrollment))
  • Blood pressure(From baseline to end of treatment (approximately 4 months after enrollment))
  • Physical activity - self report(From baseline to end of treatment (approximately 4 months after enrollment))

研究点 (2)

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