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

NCT ID: NCT06753123

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-07-31

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).

Conditions

Depression; Physical Inactivity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

A workplace-based depression intervention for low-wage hospital workers

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Be Well at Work-PLUS

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

San Diego State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica L McCurley, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Locations

San Diego State University

San Diego, California, United States

Countries

United States

Central Contacts

Jessica L McCurley, PhD, MPH

Role: CONTACT

jlmccurley@sdsu.edu

619-594-2132

Facility Contacts

Jessica L McCurley, PhD, MPH

Role: primary

jlmccurley@sdsu.edu

619-594-2132

Other Identifiers

K23HL157763

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HS-2024-0219

Identifier Type: -

Identifier Source: org_study_id