DepressionNCT07010133
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
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 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. 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 Jan 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
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 (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.
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 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
- Depression, Physical Inactivity
- Being tested
- A workplace-based depression intervention for low-wage hospital workers
- Keywords
- Depression, Physical Activity, Employees, Worker Health, 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
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 |
|---|---|---|
| Immediate 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 |
| Waitlist Control | Active comparator | 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. 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).
Depression symptoms
Depression symptoms will be measured with the Patient Health Questionnaire - 9 item version (range 0-27, higher = worse depression symptoms)
Measured: From baseline through end of treatment (approximately 4 months after enrollment).
Secondary outcomes (7)
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: Baseline, follow-up (4 months)
Physical activity - step count
Weekly step count as measured by wrist-worn FitBit watch
Measured: Baseline, follow-up (4 months)
Body Mass Index
A weight-to-height ratio, calculated by dividing participant's weight in kilograms by height in meters squared.
Measured: Baseline, follow-up (4 months)
Blood pressure
Resting systolic and diastolic blood pressures
Measured: Baseline, Follow-up (4 months)
Physical Activity (self-report)
Self-reported physical activity using the Global Physical Activity Questionnaire
Measured: Baseline, Follow-up (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 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
- Randomised
- Intervention model
- Single group
- Model description
- This is a pilot randomized controlled trial with a waitlist control group.
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT07010133
- Sponsor's protocol ID
- IRB-24-0260
- Other IDs
- K23HL157763
- Status last verified
- Apr 2026
- First submitted
- 30 May 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently we do not plan to share data as this is an open pilot study with a small number of participants (N=60), and thus it could be possible identify individuals.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 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 (Aim 3).
- ClinicalTrials.gov ID
- NCT07010133
- Acronym / sponsor ID
- IRB-24-0260
- Conditions
- Depression, Physical Inactivity
- Keywords
- Depression, Physical Activity, Employees, Worker Health, Low-income, Social needs
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 8 Jun 2025 (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 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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pilot randomized controlled trial with a waitlist control group.
| Arm | Type | Receives |
|---|---|---|
| Immediate 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. |
| Waitlist Control | Active comparator | Behavioral: A workplace-based depression intervention for low-wage hospital workersDelivered 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. |
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 workersThis 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 | Immediate Intervention, Waitlist Control |
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.
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)
7 secondary outcomes
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: Baseline, follow-up (4 months)
Physical activity - step count
Time frame: Baseline, follow-up (4 months)
Body Mass Index
Time frame: Baseline, follow-up (4 months)
Blood pressure
Time frame: Baseline, Follow-up (4 months)
Physical Activity (self-report)
Time frame: Baseline, Follow-up (4 months)
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 16 Apr 2026.
- Individual participant dataSharing planned: No. Currently we do not plan to share data as this is an open pilot study with a small number of participants (N=60), and thus it could be possible 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: opening soon, as of the sponsor's last update on 16 Apr 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 16 Apr 2026.