NCT07791563

Brief Summary

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)

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Nov 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

1.2 years

First QC Date

August 24, 2026

Last Update Submit

August 27, 2026

Conditions

Keywords

digital mental health interventionsengagementhealthcare workers

Outcome Measures

Primary Outcomes (4)

  • Engagement with the intervention (subjective)

    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

    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

    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

    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 Outcomes (3)

  • Burnout

    From baseline to follow-up at 10 weeks.

  • Depressive Symptoms

    From baseline to follow-up at 10 weeks.

  • Anxiety symptoms

    From baseline to follow-up at 10 weeks.

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Infographic onboarding and the Cognitive Behavioral Therapy (CBT)-based 6-week digital mental health intervention.

Behavioral: Engage

Content Tailoring Group

EXPERIMENTAL

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

Content Tailoring Plus Human Support Group

EXPERIMENTAL

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

Interventions

EngageBEHAVIORAL

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.

Control Group

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.

Content Tailoring GroupContent Tailoring Plus Human Support Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuropsychiatric Institute

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

engage 8200

Central Study Contacts

Jennifer Duffecy, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 28, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations