San Diego State University
San Diego, California, 92115, United States
Location status: Recruiting
Location contact
Jessica L McCurley, PhD, MPH
CONTACT
Jessica L McCurley, PhD, MPH
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06753123
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
San Diego, California, 92115, United States
Location status: Recruiting
Jessica L McCurley, PhD, MPH
CONTACT
Jessica L McCurley, PhD, MPH
PRINCIPAL_INVESTIGATOR
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Be Well at Work-PLUS
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.
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.
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 symtpoms)
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.
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).
Time frame: From baseline to end of treatment (approximately 4 months after enrollment)
Sleep quality and duration as measured by the Pittsburgh Sleep Quality Index (range: 0-21, higher scores indicate worse sleep quality).
Time frame: From baseline to end of treatment (approximately 4 months after enrollment)
Weekly step count as measured by wrist-worn FitBit watch
Time frame: From baseline to end of treatment (approximately 4 months after enrollment)
A weight-to-height ratio, calculated by dividing participant's weight in kilograms by height in meters squared.
Time frame: From baseline to end of treatment (approximately 4 months after enrollment)
Resting systolic and diastolic blood pressures
Time frame: From baseline to end of treatment (approximately 4 months after enrollment)
Self-reported physical activity using the International Physical Activity Questionnaire [low/medium/high activity; metabolic equivalents (METs) per week]
Contact information is provided by the study sponsor or research team.
San Diego State University
Other
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers.
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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