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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07010133
Enrollment
60
Registered
2025-06-08
Start date
2026-06-01
Completion date
2027-01-31
Last updated
2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Physical Inactivity

Keywords

Depression, Physical Activity, Employees, Worker Health, Low-income, Social needs

Brief summary

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.

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 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).

Interventions

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.

Sponsors

San Diego State University
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This is a pilot randomized controlled trial with a waitlist control group.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Intervention feasibilityFrom 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 symptomsFrom 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)

Secondary

MeasureTime frameDescription
Work limitationsFrom baseline to end of treatment (approximately 4 months after enrollment)Work limitations (range: 0-100%, higher = more limitation) will be measured by the Work Limitations Questionnaire.
Perceived stressFrom baseline to end of treatment (approximately 4 months after enrollment)Perceived stress measured by the Perceived Stress Scale (range 0-40, higher = more perceived stress).
Sleep qualityBaseline, follow-up (4 months)Sleep quality and duration as measured by the Pittsburgh Sleep Quality Index (range: 0-21, higher scores indicate worse sleep quality).
Physical activity - step countBaseline, follow-up (4 months)Weekly step count as measured by wrist-worn FitBit watch
Body Mass IndexBaseline, follow-up (4 months)A weight-to-height ratio, calculated by dividing participant's weight in kilograms by height in meters squared.
Blood pressureBaseline, Follow-up (4 months)Resting systolic and diastolic blood pressures
Physical Activity (self-report)Baseline, Follow-up (4 months)Self-reported physical activity using the Global Physical Activity Questionnaire

Countries

United States

Contacts

CONTACTJessica L McCurley, PhD, MPH
jlmccurley@sdsu.edu619-594-2132
PRINCIPAL_INVESTIGATORJessica L McCurley, PhD MPH

San Diego State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026