Menu
Recruiting NCT06753123

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

No phase Interventional Depression Physical Inactivity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A workplace-based depression intervention for low-wage hospital workers.
Who it may be relevant to
Registry conditions: Depression, Physical Inactivity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • Intervention Feasibility [Time frame: From enrollment to end of treatment (approximately 4 months after enrollment).]
  • Acceptability [Time frame: From enrollment to end of treatment (approximately 4 months after enrollment)]
Secondary outcome measures (8)
  • Depression symptoms [Time frame: From baseline through end of treatment (approximately 4 months after enrollment).]
  • Work limitations [Time frame: From baseline to end of treatment (approximately 4 months after enrollment)]
  • Perceived stress [Time frame: From baseline to end of treatment (approximately 4 months after enrollment)]
  • Sleep quality [Time frame: From baseline to end of treatment (approximately 4 months after enrollment)]
  • Physical activity - step count [Time frame: From baseline to end of treatment (approximately 4 months after enrollment)]
  • Body mass index (BMI) [Time frame: From baseline to end of treatment (approximately 4 months after enrollment)]
  • Blood pressure [Time frame: From baseline to end of treatment (approximately 4 months after enrollment)]
  • Physical activity - self report [Time frame: From baseline to end of treatment (approximately 4 months after enrollment)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • San Diego State University — San Diego

Identifiers

NCT: NCT06753123 · HS-2024-0219 · K23HL157763

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗