Health TrialsbyHealthPanel

Digital Intervention for Healthcare Workers

ConditionHealthcare Workforce Well-Being
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Engage

    Behavioral

    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.

  • HCW-Tailored Engage

    Behavioral

    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.

Treatment groups

201 Participants
are divided into 3 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: Content Tailoring GroupExperimental treatment 1 intervention
Group C: Content Tailoring Plus Human Support GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From start of intervention to end of intervention period at 6 weeks.
2

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.

Time frame
From start of intervention to end of intervention period at 6 weeks.
3

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.

Time frame
From start of intervention to end of intervention period at 6 weeks.
4

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.

Time frame
From start of intervention to end of intervention period at 6 weeks.

Secondary outcomes

1

Burnout

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.

Time frame
From baseline to follow-up at 10 weeks.
2

Depressive Symptoms

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.

Time frame
From baseline to follow-up at 10 weeks.
3

Anxiety symptoms

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.

Time frame
From baseline to follow-up at 10 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: