Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 2)

Not Applicable

Not yet recruiting

• Conditions: Depression; Physical Inactivity

• Registration Number: NCT06753123
• Lead Sponsor: San Diego State University

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).

Study Timeline

• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-21
• Study First Posted: 2024-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Study Start: 2025-07-01
• Primary Completion: 2026-01-30
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Intervention Feasibility	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	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.

Secondary Outcome Measures

Name	Time	Method
Body mass index (BMI)	From baseline to end of treatment (approximately 4 months after enrollment)	A weight-to-height ratio, calculated by dividing participant's weight in kilograms by height in meters squared.
Depression symptoms	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 symtpoms)
Work limitations	From 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.
Blood pressure	From baseline to end of treatment (approximately 4 months after enrollment)	Resting systolic and diastolic blood pressures
Physical activity - self report	From baseline to end of treatment (approximately 4 months after enrollment)	Self-reported physical activity using the International Physical Activity Questionnaire \[low/medium/high activity; metabolic equivalents (METs) per week\]
Perceived stress	From 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 quality	From baseline to end of treatment (approximately 4 months after enrollment)	Sleep quality and duration as measured by the Pittsburgh Sleep Quality Index (range: 0-21, higher scores indicate worse sleep quality).
Physical activity - step count	From baseline to end of treatment (approximately 4 months after enrollment)	Weekly step count as measured by wrist-worn FitBit watch

Trial Locations

Locations (1)

San Diego State University; 🇺🇸 San Diego, California, United States