A Randomized Controlled Trial of a Wellness App for First Responders, Military Personnel and Veterans
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Mental Health Wellness
- Sponsor
- University of Pennsylvania
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- PERMA-Profiler Overall Wellbeing Score
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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).
Investigators
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.
Outcomes
Primary Outcomes
PERMA-Profiler Overall Wellbeing Score
Time Frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
The PERMA-Profiler is designed to measure the general wellbeing of adults; specifically this questionnaire measures positive and negative emotions, engagement, relationships, meaning, accomplishment, and health. Participants respond to 23 items on an 11-point Likert scale, from 0 to 10. Scores are calculated as the average of the items comprising each factor. Lower scores indicate lower flourishing, and higher scores indicate higher flourishing.
Patient Health Questionnaire for Depression Symptoms (PHQ-8)
Time Frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
The PHQ-8 is a self-reported measure of depressive symptoms composed of 8 Likert type items with a response scale ranging from 0 (Not at all) to 3 (Nearly every day), that refer to the presence of that symptom during the previous 2 weeks. Each item corresponds to the first 8 symptoms of the 4th edition of the DSM-IV diagnostic criteria for major depressive disorder. The PHQ-8 final score is obtained by adding the score for each of the items, ranging from 0 to 24 (higher scores corresponding to higher levels of depression).
Generalized Anxiety Disorder (GAD-7)
Time Frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
GAD-7 consists of seven items measuring worry and anxiety symptoms. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity. Scores above 10 are considered to be in the clinical range. The GAD-7 has shown good reliability and construct validity.
WHO Well-being Index (WHO-5)
Time Frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing. The WHO-5 consists of five statements, which respondents rate according to the scale below (in relation to the past two weeks). All of the time = 5 Most of the time = 4 More than half of the time = 3 Less than half of the time = 2 Some of the time = 1 At no time = 0. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Personal Wellbeing Score (PWS)
Time Frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
The Personal Wellbeing Score (PWS) is based on the Office of National Statistics (ONS) four subjective well-being questions (ONS4) and thresholds. It evaluates life satisfaction, sense of purpose, happiness, and anxiety. Each PWS item is scored as follows: Disagree=0, Neutral=1, Agree=2 and Strongly Agree=3. Summary scores are calculated by aggregating all items and transforming to a scale of 0 to 100, with higher scores indicating greater well-being.
Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
Time Frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
The Difficulties in Emotion Regulation Scale Short Form (DERS-SF) is an 18-item measure used to identify emotional regulation issues in adults. The measure uses 6 subscales to measure 4 dimensions of emotional regulation: awareness; acceptance; the ability to engage in goal-directed behavior and refrain from impulsive behavior when experiencing negative emotions; and access to emotion regulation strategies perceived as effective. Respondents indicate how often each statement applies to them on a 5 point scale, where 1=Almost Never (0-10%), 2=Sometimes (11-35%), About Half of the Time (36-65%), Most of the Time (66-90%), Almost Always (91-100%). Scores range from 18 to 90, with higher scores indicating greater difficulties in emotion regulation. The DERS-SF Total Score is computed by summing responses across all items. Lower scores represent better emotion regulation outcomes.
Secondary Outcomes
- Positive Emotion (Positive Emotion Subscale of the PERMA-Profiler)(assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported)
- Social Connectedness (Engagement Subscale of PERMA-Profiler)(assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported)
- Social Connectedness (Relationship Subscale of PERMA-Profiler)(assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported)
- Personal Growth (Meaning Subscale of the PERMA-Profiler)(assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported)
- Personal Growth (Accomplishment Subscale of the PERMA-Profiler)(assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported)
- Utrecht Work Engagement Scale (UWES-17)(assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported)
- Maslach Burnout Inventory (MBI) - Emotional Exhaustion(assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported)
- Maslach Burnout Inventory (MBI) - Personal Accomplishment(assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported)
- Maslach Burnout Inventory (MBI) - Depersonalization(assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported)
- Number of Participants Still Employed(assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported)
- Feasibility of Intervention Measure (FIM)(assessed at post-trial (4 weeks))
- Acceptability of Intervention Measure (AIM)(4 weeks post-trial)
- Intervention Appropriateness Measure (IAM)(4 weeks post-trial)
- System Usability Scale (SUS)(4 weeks post-trial)