DepressionNCT06753123
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 2)
A study testing A workplace-based depression intervention for low-wage hospital workers in people with Depression and Physical Inactivity, run by San Diego State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Physical Inactivity
- What is being tested?
- A workplace-based depression intervention for low-wage hospital workers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- plan to leave Scripps employment in <6 months;
- severe mental illness or substance use condition (e.g., bipolar disorder, schizophrenia, active alcohol use disorder)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Diego State University
San Diego, California, 92115
Jessica L McCurley, PhD, MPH, 619-594-2132, jlmccurley@sdsu.edu
Jessica L McCurley, PhD, MPH
About this study
Official title: 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.
Read the 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
- Being tested
- A workplace-based depression intervention for low-wage hospital workers
- Keywords
- Depression, Physical Activity, Employees, Low-income, Social needs
- Medical subject headings
- Depression, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A workplace-based depression intervention for low-wage hospital workersBehavioural
Also called Be Well at Work-PLUS
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: Open Pilot of Intervention | Experimental | 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. Receives: Behavioral: A workplace-based depression intervention for low-wage hospital workers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to end of treatment (approximately 4 months after enrollment)
Secondary outcomes (8)
Depression symptoms
Depression symptoms will be measured with the Patient Health Questionnaire - 9 item version (range 0-27, higher = worse depression symtpoms)
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: From baseline to end of treatment (approximately 4 months after enrollment)
Blood pressure
Resting systolic and diastolic blood pressures
Measured: 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]
Measured: From baseline to end of treatment (approximately 4 months after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start28 May 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm open pilot study.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jessica L McCurley, PhD, MPH, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753123
- Sponsor's protocol ID
- HS-2024-0219
- Other IDs
- K23HL157763
- Status last verified
- Oct 2026
- First submitted
- 18 Dec 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers.
- ClinicalTrials.gov ID
- NCT06753123
- Acronym / sponsor ID
- HS-2024-0219
- Conditions
- Depression, Physical Inactivity
- Keywords
- Depression, Physical Activity, Employees, Low-income, Social needs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 28 May 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm open pilot study.
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Open Pilot of Intervention | Experimental | Behavioral: A workplace-based depression intervention for low-wage hospital workersThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (2 listed)
- plan to leave Scripps employment in <6 months;
- severe mental illness or substance use condition (e.g., bipolar disorder, schizophrenia, active alcohol use disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A workplace-based depression intervention for low-wage hospital workersAlso: Be Well at Work-PLUSThis 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. | Behavioural | Single Arm: Open Pilot of Intervention |
Primary outcome
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.
Acceptability
Time frame: From enrollment to end of treatment (approximately 4 months after enrollment)
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.
8 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica L McCurley, PhD, MPH principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A workplace-based depression intervention for low-wage hospital workers in people with Depression and Physical Inactivity, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica L McCurley, PhD, MPH (619-594-2132, jlmccurley@sdsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility (time frame: From enrollment to end of treatment (approximately 4 months after enrollment).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.