Digital Intervention for Healthcare Workers

August 27, 2026 updated by: 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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
201

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jennifer Duffecy, PhD
  • Phone Number: 312-413-1225
  • Email: jduffecy@uic.edu

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Neuropsychiatric Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group
Infographic onboarding and the Cognitive Behavioral Therapy (CBT)-based 6-week digital mental health intervention.
Behavioral: Engage
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.
Behavioral: HCW-Tailored Engage
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).
Behavioral: HCW-Tailored Engage
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Engagement with the intervention (subjective)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Burnout
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Advancing Translational Sciences (NCATS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-0594
  • UM1TR005438 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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