רדאר קליני AI | ||
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הניסוי הקליני NCT07010133 עבור דיכאון, חוסר פעילות גופנית הוא גיוס בקרוב. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
ניסוי אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'קבל הסבר' כדי לצפות ולשוחח על מידע מהניסוי בשפה המועדפת עליך.
הניסוי הקליני NCT07010133 הוא מחקר מסוג מתערב עבור דיכאון, חוסר פעילות גופנית, שנמצא במצב גיוס בקרוב. גיוס המשתתפים צפוי להתחיל ב-1 בנובמבר 2025, במטרה לכלול 60 משתתפים. המחקר ינוהל על ידי אוניברסיטת סן-דייגו וצפוי להסתיים ב-31 בינואר 2027. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-22 ביוני 2025.
סיכום קצר
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.
תיאור מפורט
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).
כותרת רשמית
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3).
מצבים רפואיים
דיכאוןחוסר פעילות גופניתמזהי מחקר נוספים
- IRB-24-0260
- K23HL157763 (מענק/חוזה של NIH בארה"ב)
מספר NCT
תחילת המחקר (בפועל)
2025-11-01
עדכון אחרון שפורסם
2025-06-22
סיום המחקר (מוערך)
2027-01-31
השתתפות (מוערכת)
60
סוג המחקר
מתערב
שלב
לא זמין
סטטוס
גיוס בקרוב
מילות מפתח
Depression
Physical Activity
Employees
Worker Health
Low-income
Social needs
Physical Activity
Employees
Worker Health
Low-income
Social needs
מטרה ראשית
טיפול
הקצאת טיפול
מחקר אקראי
דגם מתערב
שיוך קבוצתי בודד
עיוורון
אין (תווית פתוחה)
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיImmediate Intervention 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. | 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. |
משווה פעילWaitlist Control 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. | 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. |
תוצאה ראשית
תוצאה משנית
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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. | 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) | From baseline through end of treatment (approximately 4 months after enrollment). |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Work limitations | Work limitations (range: 0-100%, higher = more limitation) will be measured by the Work Limitations Questionnaire. | 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). | 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). | Baseline, follow-up (4 months) |
Physical activity - step count | Weekly step count as measured by wrist-worn FitBit watch | 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. | Baseline, follow-up (4 months) |
Blood pressure | Resting systolic and diastolic blood pressures | Baseline, Follow-up (4 months) |
Physical Activity (self-report) | Self-reported physical activity using the Global Physical Activity Questionnaire | Baseline, Follow-up (4 months) |
קריטריוני זכאות
גילאים מוערכים למחקר
מבוגר, מבוגר יותר
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
- 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.
- plan to leave Scripps employment in <6 months;
- severe mental illness or substance use condition (e.g., bipolar disorder, schizophrenia, active alcohol use disorder)
איש קשר מרכזי למחקר
צור קשר: Jessica L McCurley, PhD, MPH, 619-594-2132, [email protected]
1 מיקומי המחקר ב-1 מדינות
California
San Diego State University, San Diego, California, 92115, United States
Jessica L McCurley, PhD, MPH, צור קשר, 619-594-2132, [email protected]
Jessica L McCurley, PhD, MPH, חוקר ראשי