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NCT Number: NCT07010133

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Diego State University

San Diego, California, 92115, United States

Location contact

Jessica L McCurley, PhD, MPH

CONTACT

[email protected]

619-594-2132

Jessica L McCurley, PhD, MPH

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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.

Primary outcomes

  1. Intervention feasibility

    Time frame: 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.

  2. Depression symptoms

    Time frame: 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 symptoms)

Secondary outcomes

  1. Work limitations

    Time frame: 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.

  2. Perceived stress

    Time frame: 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).

  3. Sleep quality

    Time frame: Baseline, follow-up (4 months)

    Sleep quality and duration as measured by the Pittsburgh Sleep Quality Index (range: 0-21, higher scores indicate worse sleep quality).

  4. Physical activity - step count

    Time frame: Baseline, follow-up (4 months)

    Weekly step count as measured by wrist-worn FitBit watch

  5. Body Mass Index

    Time frame: Baseline, follow-up (4 months)

    A weight-to-height ratio, calculated by dividing participant's weight in kilograms by height in meters squared.

  6. Blood pressure

    Time frame: Baseline, Follow-up (4 months)

    Resting systolic and diastolic blood pressures

  7. Physical Activity (self-report)

    Time frame: Baseline, Follow-up (4 months)

    Self-reported physical activity using the Global Physical Activity Questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica L McCurley, PhD, MPH

CONTACT

[email protected]

619-594-2132

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 8, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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