Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)

Официальное название

Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3).

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Intervention feasibility [Срок оценки: From enrollment to end of treatment (approximately 4 months after enrollment).]
• Depression symptoms [Срок оценки: From baseline through end of treatment (approximately 4 months after enrollment).]

Вторичные конечные точки (7)

• Work limitations [Срок оценки: From baseline to end of treatment (approximately 4 months after enrollment)]
• Perceived stress [Срок оценки: From baseline to end of treatment (approximately 4 months after enrollment)]
• Sleep quality [Срок оценки: Baseline, follow-up (4 months)]
• Physical activity - step count [Срок оценки: Baseline, follow-up (4 months)]
• Body Mass Index [Срок оценки: Baseline, follow-up (4 months)]
• Blood pressure [Срок оценки: Baseline, Follow-up (4 months)]
• Physical Activity (self-report) [Срок оценки: Baseline, Follow-up (4 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• plan to leave Scripps employment in <6 months;
• severe mental illness or substance use condition (e.g., bipolar disorder, schizophrenia, active alcohol use disorder)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• San Diego State University — San Diego

Идентификаторы

NCT: NCT07010133 · IRB-24-0260 · K23HL157763

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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