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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Physical Inactivity
• Intervention / Treatment: Behavioral: A workplace-based depression intervention for low-wage hospital workers

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica L McCurley, PhD, MPH; Phone Number: 619-594-2132; Email: jlmccurley@sdsu.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92115
      • Recruiting
      • San Diego State University
      • Contact: Jessica L McCurley, PhD, MPH; Phone Number: 619-594-2132; Email: jlmccurley@sdsu.edu
      • Principal Investigator: Jessica L McCurley, PhD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.; Other Names: Be Well at Work-PLUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Feasibility	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.	From enrollment to end of treatment (approximately 4 months after enrollment).
Acceptability	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.	From enrollment to end of treatment (approximately 4 months after enrollment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression symptoms	Depression symptoms will be measured with the Patient Health Questionnaire - 9 item version (range 0-27, higher = worse depression symtpoms)	From baseline through end of treatment (approximately 4 months after enrollment).
Work limitations	Work limitations (range: 0-100%, higher = more limitation) will be measured by the Work Limitations Questionnaire.	From baseline to end of treatment (approximately 4 months after enrollment)
Perceived stress	Perceived stress measured by the Perceived Stress Scale (range 0-40, higher = more perceived stress).	From baseline to end of treatment (approximately 4 months after enrollment)
Sleep quality	Sleep quality and duration as measured by the Pittsburgh Sleep Quality Index (range: 0-21, higher scores indicate worse sleep quality).	From baseline to end of treatment (approximately 4 months after enrollment)
Physical activity - step count	Weekly step count as measured by wrist-worn FitBit watch	From baseline to end of treatment (approximately 4 months after enrollment)
Body mass index (BMI)	A weight-to-height ratio, calculated by dividing participant's weight in kilograms by height in meters squared.	From baseline to end of treatment (approximately 4 months after enrollment)
Blood pressure	Resting systolic and diastolic blood pressures	From baseline to end of treatment (approximately 4 months after enrollment)
Physical activity - self report	Self-reported physical activity using the International Physical Activity Questionnaire [low/medium/high activity; metabolic equivalents (METs) per week]	From baseline to end of treatment (approximately 4 months after enrollment)

Collaborators and Investigators

• Sponsor: San Diego State University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Jessica L McCurley, PhD, MPH, San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 21, 2024
• First Posted (Actual): December 31, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Physical Activity; Employees; Low-income; Social needs
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression; Motor Activity; Sedentary Behavior
• Other Study ID Numbers: HS-2024-0219; K23HL157763 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share data as this is an open pilot study with a very small number of participants (N=10), and it would be too easy to identify individuals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No