Clinical trial NCT06336967: Testing a Wellness App for First Responders, Military Personnel and Veterans
Official title: A Randomized Controlled Trial of a Wellness App for First Responders, Military Personnel and Veterans
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Wellness
Keywords: first responders
veterans
soldiers
social connectedness
burnout
wellbeing
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Nlyten Corp
First posted: 2024-03-29
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the research study is to trial a smart phone application, the GUIDE App, to better understand its impact on social connectedness, personal growth and mental health/wellness among first responders, soldiers, and veterans. The research team will also investigate workplace metrics (e.g., engagement and burnout), implementation outcomes and technical merit. The investigators plan to run a three-armed randomized waitlist pilot feasibility trial with up to 150 participants.

Detailed description: There is an urgent need to address mental wellbeing, isolation, and burnout among first responders, military personnel and veterans. Research shows that these groups are at a greater risk for suicide, depression, and post-traumatic stress disorder (PTSD) than the general civilian population, and that their occupations make them more likely to feel isolation and burnout. Despite these risks, first responders, soldiers and veterans tend not to seek help due to stigma, time burden and other barriers to entry. The GUIDE App was designed with this population in mind. The lessons and exercises take only minutes to complete, and the group chats are anonymous, so users can share their thoughts with likeminded peers, without the stigma. In a 4-week pilot study with 16 participants from the Wilkes Barre Police Department, the GUIDE App showed promising results in promoting wellbeing, reducing anxiety and encouraging personal growth. This clinical trial builds off the pilot study. The investigators will use a three-armed randomized waitlist pilot feasibility trial with 150 participants (first responders, soldiers, and veterans) to test whether use of the GUIDE App will lead to increased social connectedness, personal growth, and mental health/wellbeing; and whether these outcomes will in turn increase work engagement and reduce burnout. The investigators will also investigate implementation outcomes (e.g., the feasibility of using the app) and technical merit (e.g., how user-friendly the app is).

Eligibility criteria: Inclusion Criteria:

* Law enforcement, military personnel, or veteran.
* Employed (part-time, full-time, self-employed).
* Owns compatible smartphone.
* Not paid by the GUIDE App/Nlyten Corp.
* No previous use of GUIDE App.

Exclusion Criteria:

* Not law enforcement, military personnel, or veteran.
* Not employed.
* Paid by GUIDE App/Nlyten Corp.
* Previous use of GUIDE App.

Primary outcomes:
measure: PERMA-Profiler Overall Wellbeing Score
timeFrame: Baseline and post-trial, over 4 weeks
measure: Patient Health Questionnaire for depression symptoms (PHQ-8)
timeFrame: Baseline and post-trial, over 4 weeks
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline and post-trial, over 4 weeks
measure: WHO Well-being Index (WHO-5)
timeFrame: Baseline and post-trial, over 4 weeks
measure: Personal Wellbeing Score (PWS)
timeFrame: Baseline and post-trial, over 4 weeks
measure: Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
timeFrame: Baseline and post-trial, over 4 weeks
Secondary outcomes:
measure: Positive Emotion (Positive emotion subscale of the PERMA-Profiler)
timeFrame: Baseline and post-trial, over 4 weeks
measure: Social Connectedness (Engagement and Relationship subscales of PERMA-Profiler)
timeFrame: Baseline and post-trial, over 4 weeks
measure: Social Connectedness (Number of posts/comments in the app)
timeFrame: Week 1 vs Week 4 of app usage period
measure: Personal Growth (Meaning and Accomplishment subscales of the PERMA-Profiler)
timeFrame: Baseline and post-trial, over 4 weeks
measure: Personal Growth (Total GUIDE lessons and courses completed)
timeFrame: Aggregated over 28 days
measure: Utrecht Work Engagement Scale (UWES-17)
timeFrame: Baseline and post-trial, over 4 weeks
measure: Maslach Burnout Inventory (MBI)
timeFrame: Baseline and post-trial, over 4 weeks
measure: Job Retention (Employment status)
timeFrame: Baseline and post-trial, over 4 weeks
Other outcomes:
measure: Feasibility of Intervention Measure (FIM)
timeFrame: 4 weeks post-trial
measure: Acceptability of Intervention Measure (AIM)
timeFrame: 4 weeks post-trial
measure: Intervention Appropriateness Measure (IAM)
timeFrame: 4 weeks post-trial
measure: System Usability Scale (SUS)
timeFrame: 4 weeks post-trial
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Heather J Nuske, PhD
role: PRINCIPAL_INVESTIGATOR
References: