Clinical trial NCT06753123: Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 2)
Official title: Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Physical Inactivity
Keywords: Depression
Physical Activity
Employees
Low-income
Social needs
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-12-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm open pilot study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Intervention Feasibility
timeFrame: From enrollment to end of treatment (approximately 4 months after enrollment).
measure: Acceptability
timeFrame: From enrollment to end of treatment (approximately 4 months after enrollment)
Secondary outcomes:
measure: Depression symptoms
timeFrame: From baseline through end of treatment (approximately 4 months after enrollment).
measure: Work limitations
timeFrame: From baseline to end of treatment (approximately 4 months after enrollment)
measure: Perceived stress
timeFrame: From baseline to end of treatment (approximately 4 months after enrollment)
measure: Sleep quality
timeFrame: From baseline to end of treatment (approximately 4 months after enrollment)
measure: Physical activity - step count
timeFrame: From baseline to end of treatment (approximately 4 months after enrollment)
measure: Body mass index (BMI)
timeFrame: From baseline to end of treatment (approximately 4 months after enrollment)
measure: Blood pressure
timeFrame: From baseline to end of treatment (approximately 4 months after enrollment)
measure: Physical activity - self report
timeFrame: From baseline to end of treatment (approximately 4 months after enrollment)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: San Diego State University
name: Jessica L McCurley, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: