Digital Intervention for Healthcare Workers
27 de agosto de 2026 actualizado por: 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)
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
201
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jennifer Duffecy, PhD
- Número de teléfono: 312-413-1225
- Correo electrónico: jduffecy@uic.edu
Ubicaciones de estudio
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60612
- Neuropsychiatric Institute
-
Contacto:
- Jennifer Duffecy, PhD
- Número de teléfono: 312-413-1225
- Correo electrónico: jduffecy@uic.edu
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Control Group
Infographic onboarding and the Cognitive Behavioral Therapy (CBT)-based 6-week digital mental health intervention.
|
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.
|
|
Experimental: 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.
|
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.
|
|
Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Engagement with the intervention (subjective)
Periodo de tiempo: From start of intervention to end of intervention period at 6 weeks.
|
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.
|
From start of intervention to end of intervention period at 6 weeks.
|
|
Engagement - Number of Lessons
Periodo de tiempo: From start of intervention to end of intervention period at 6 weeks.
|
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.
|
From start of intervention to end of intervention period at 6 weeks.
|
|
Engagement - Number of Tools
Periodo de tiempo: From start of intervention to end of intervention period at 6 weeks.
|
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.
|
From start of intervention to end of intervention period at 6 weeks.
|
|
Engagement - Duration of Time
Periodo de tiempo: From start of intervention to end of intervention period at 6 weeks.
|
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.
|
From start of intervention to end of intervention period at 6 weeks.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Burnout
Periodo de tiempo: From baseline to follow-up at 10 weeks.
|
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.
|
From baseline to follow-up at 10 weeks.
|
|
Depressive Symptoms
Periodo de tiempo: From baseline to follow-up at 10 weeks.
|
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.
|
From baseline to follow-up at 10 weeks.
|
|
Anxiety symptoms
Periodo de tiempo: From baseline to follow-up at 10 weeks.
|
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.
|
From baseline to follow-up at 10 weeks.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de noviembre de 2026
Finalización primaria (Estimado)
1 de enero de 2028
Finalización del estudio (Estimado)
1 de marzo de 2028
Fechas de registro del estudio
Enviado por primera vez
24 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de agosto de 2026
Publicado por primera vez (Actual)
28 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-0594
- UM1TR005438 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .