- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07791563
Digital Intervention for Healthcare Workers
Enhancing Sustained Engagement in Digital Mental Health Interventions (DMHIs)
The goal of this clinical trial is to test which engagement strategies lead to more participation in a digital mental health program among healthcare workers. The main questions it aims to answer is:
- Does content tailoring increase engagement with the digital program?
- Does human support increase engagement with the digital program?
Researchers will compare the general intervention to a tailored intervention and to the tailored intervention with human support coaching to see what leads to more engagement with/use of the program.
Participants will:
- Use a digital program weekly for 6 weeks
- Complete questionnaires at 5 times: Start of study, Week 2, Week 3 (mid-program), Week 6 (end of program), and Week 10 (follow-up)
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Jennifer Duffecy, PhD
- Telefonszám: 312-413-1225
- E-mail: jduffecy@uic.edu
Tanulmányi helyek
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Illinois
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Chicago, Illinois, Egyesült Államok, 60612
- Neuropsychiatric Institute
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Kapcsolatba lépni:
- Jennifer Duffecy, PhD
- Telefonszám: 312-413-1225
- E-mail: jduffecy@uic.edu
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-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria:
- Age 18 years or older, all sexes
- Currently working in healthcare in the US with at least 4 hours per week of direct patient contact
- Stable access to internet
- Have a total score between 3-14 on the PHQ-9 (Patient Health Questionnaire-9), suggestive of mild to moderate depressive symptoms
Exclusion Criteria:
- Have a total score of ≥15 on the PHQ-9, indicating Severe Depressive symptoms.
- Currently diagnosed with a psychotic disorder or bipolar disorder, based on self-report.
- Currently receiving psychotherapy for depression or anxiety based on self-report; If on medications for depression or anxiety, must be on a stable dose of medication for at least 2 weeks.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Tényező hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Aktív összehasonlító: Control Group
Infographic onboarding and the Cognitive Behavioral Therapy (CBT)-based 6-week digital mental health intervention.
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The digital mental health intervention is based on Cognitive Behavioral Therapy principles and consists of learning modules covering basic skills (e.g., behavioral activation) and interactive tools to assist in learning and implementing the skills associated with the learning modules.
Interactive tools are designed to support implementation of cognitive behavioral skills including activity scheduling and monitoring, cognitive restructuring, goal setting, relaxation, and mood tracking.
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Kísérleti: Content Tailoring Group
Healthcare-worker-tailored infographic onboarding and the Cognitive Behavioral Therapy (CBT)-based 6-week digital mental health intervention with healthcare worker tailoring.
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The digital mental health intervention is based on Cognitive Behavioral Therapy principles and consists of learning modules covering basic skills (e.g., behavioral activation) and interactive tools to assist in learning and implementing the skills associated with the learning modules.
Interactive tools are designed to support implementation of cognitive behavioral skills including activity scheduling and monitoring, cognitive restructuring, goal setting, relaxation, and mood tracking.
This version of the intervention contains content tailored specifically for healthcare workers, based on findings from a co-design, qualitative focus group process.
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Kísérleti: Content Tailoring Plus Human Support Group
An onboarding engagement call with a human coach and the Cognitive Behavioral Therapy (CBT)-based 6-week digital mental health intervention with healthcare worker tailoring, plus human support via messaging (coaching).
|
The digital mental health intervention is based on Cognitive Behavioral Therapy principles and consists of learning modules covering basic skills (e.g., behavioral activation) and interactive tools to assist in learning and implementing the skills associated with the learning modules.
Interactive tools are designed to support implementation of cognitive behavioral skills including activity scheduling and monitoring, cognitive restructuring, goal setting, relaxation, and mood tracking.
This version of the intervention contains content tailored specifically for healthcare workers, based on findings from a co-design, qualitative focus group process.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Engagement with the intervention (subjective)
Időkeret: From start of intervention to end of intervention period at 6 weeks.
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The primary outcome is engagement with intervention.
Subjective engagement will be measured via the TWente Engagement with Ehealth Technologies Scale (TWEETS), a 9-item measure aimed at assessing behavioral engagement, cognitive engagement, and affective engagement.
A higher total score reflects a greater, more positive engagement with the digital health intervention.
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From start of intervention to end of intervention period at 6 weeks.
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Engagement - Number of Lessons
Időkeret: From start of intervention to end of intervention period at 6 weeks.
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An objective measure of engagement with the digital intervention is number of lessons read (i.e., module completion).
More lessons read reflects more engagement with the intervention.
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From start of intervention to end of intervention period at 6 weeks.
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Engagement - Number of Tools
Időkeret: From start of intervention to end of intervention period at 6 weeks.
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An objective measure of engagement with the digital intervention is number of tools completed (i.e., tool usage).
More tools completed reflects more engagement with the intervention.
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From start of intervention to end of intervention period at 6 weeks.
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Engagement - Duration of Time
Időkeret: From start of intervention to end of intervention period at 6 weeks.
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An objective measure of engagement with the digital intervention is the duration of time participants spend on the digital intervention site.
More time on the site reflects more engagement with the intervention.
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From start of intervention to end of intervention period at 6 weeks.
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Burnout
Időkeret: From baseline to follow-up at 10 weeks.
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Burnout is measured via the Oldenburg Burnout Inventory, a validated 16-item survey with positively and negatively framed items that cover 2 areas: exhaustion (physical, cognitive, and affective aspects) and disengagement from work (negative attitudes toward work objects, work content, or work in general).
Scores on the Oldenburg Burnout Inventory can be presented as an overall total (range 16 to 64).
Higher total scores indicate a higher level of burnout.
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From baseline to follow-up at 10 weeks.
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Depressive Symptoms
Időkeret: From baseline to follow-up at 10 weeks.
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Depressive symptoms are measured via the Patient Health Questionnaire (PHQ-9), a validated 9-item multipurpose instrument for screening, monitoring, and measuring depression, asking participants to rate their frequency of DSM symptoms over the past 2 weeks.
PHQ-9 scores are obtained by adding score for each question (total points).
Total scores of 5, 10, 15, and 20 represent cut-points for mild, moderate, moderately severe and severe depression, respectively.
Higher scores reflect more depressive symptoms.
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From baseline to follow-up at 10 weeks.
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Anxiety symptoms
Időkeret: From baseline to follow-up at 10 weeks.
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The Generalized Anxiety Disorder Screener (GAD-7) is a validated 7-item practical self-report anxiety questionnaire, asking participants to rate their frequency of symptoms over the past 2 weeks.
GAD-7 score obtained by adding score for each question (total points).
Total scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety.
Higher scores reflect more anxiety.
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From baseline to follow-up at 10 weeks.
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 2025-0594
- UM1TR005438 (Az Egyesült Államok NIH támogatása/szerződése)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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