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

NCT ID: NCT07010133

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-01-31

Brief Summary

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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

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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).

Conditions

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Depression Physical Inactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate 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.

Waitlist Control

Delivered after a 4-month waitlist period, 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 ACTIVE_COMPARATOR

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

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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

Eligibility Criteria

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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

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

San Diego State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica L McCurley, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Locations

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San Diego State University

San Diego, California, United States

Site Status

Countries

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United States

Central Contacts

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Jessica L McCurley, PhD, MPH

Role: CONTACT

619-594-2132

Facility Contacts

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Jessica L McCurley, PhD, MPH

Role: primary

619-594-2132

Other Identifiers

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K23HL157763

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-24-0260

Identifier Type: -

Identifier Source: org_study_id