Digital Intervention for Healthcare Workers
27 août 2026 mis à jour par: University of Illinois at Chicago
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)
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
201
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jennifer Duffecy, PhD
- Numéro de téléphone: 312-413-1225
- E-mail: jduffecy@uic.edu
Lieux d'étude
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Illinois
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Chicago, Illinois, États-Unis, 60612
- Neuropsychiatric Institute
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Contact:
- Jennifer Duffecy, PhD
- Numéro de téléphone: 312-413-1225
- E-mail: jduffecy@uic.edu
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Expérimental: 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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Expérimental: 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).
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Engagement with the intervention (subjective)
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Burnout
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 novembre 2026
Achèvement primaire (Estimé)
1 janvier 2028
Achèvement de l'étude (Estimé)
1 mars 2028
Dates d'inscription aux études
Première soumission
24 août 2026
Première soumission répondant aux critères de contrôle qualité
27 août 2026
Première publication (Réel)
28 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-0594
- UM1TR005438 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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