Testing a Wellness App for First Responders, Military Personnel and Veterans

Not Applicable

Completed

Conditions: Mental Health Wellness

Registration Number: NCT06336967

Lead Sponsor: University of Pennsylvania

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 115

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PERMA-Profiler Overall Wellbeing Score	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)	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)	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)	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)	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)	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 Outcome Measures

Name	Time	Method
Social Connectedness (Engagement Subscale of PERMA-Profiler)	assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported	The PERMA-Profiler is a 23-item measure that assesses wellbeing across five domains (positive emotion, engagement, relationships, meaning, accomplishment). The instrument was constructed so that each domain can be defined and measured as separate but correlated constructs. This study will use the Engagement and Relationship subscales of the PERMA. These subscales include 3 items each, ranked on an 11-point Likert scale, from 0 to 10. Scores are calculated as an average of these items for each subscale, with lower scores indicating less flourishing in respect to engagement/relationships and high scores indicating better engagement/relationships.
Social Connectedness (Relationship Subscale of PERMA-Profiler)	assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported	The PERMA-Profiler is a 23-item measure that assesses wellbeing across five domains (positive emotion, engagement, relationships, meaning, accomplishment). The instrument was constructed so that each domain can be defined and measured as separate but correlated constructs. This study will use the Engagement and Relationship subscales of the PERMA. These subscales include 3 items each, ranked on an 11-point Likert scale, from 0 to 10. Scores are calculated as an average of these items for each subscale, with lower scores indicating less flourishing in respect to engagement/relationships and high scores indicating better engagement/relationships.
Personal Growth (Meaning Subscale of the PERMA-Profiler)	assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported	The PERMA-Profiler is a 23-item measure that assesses wellbeing across five domains (positive emotion, engagement, relationships, meaning, accomplishment). The instrument was constructed so that each domain can be defined and measured as separate but correlated constructs. This study will use the Meaning and Accomplishment subscales of the PERMA. These subscales include 3 items each, ranked on an 11-point Likert scale, from 0 to 10. Scores are calculated as an average of these items for each subscale, with lower scores indicating less flourishing in respect to meaning/accomplishment and high scores indicating more meaning/accomplishment.
Personal Growth (Accomplishment Subscale of the PERMA-Profiler)	assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported	The PERMA-Profiler is a 23-item measure that assesses wellbeing across five domains (positive emotion, engagement, relationships, meaning, accomplishment). The instrument was constructed so that each domain can be defined and measured as separate but correlated constructs. This study will use the Meaning and Accomplishment subscales of the PERMA. These subscales include 3 items each, ranked on an 11-point Likert scale, from 0 to 10. Scores are calculated as an average of these items for each subscale, with lower scores indicating less flourishing in respect to meaning/accomplishment and high scores indicating more meaning/accomplishment.
Utrecht Work Engagement Scale (UWES-17)	assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported	The Utrecht Work Engagement Scale-17 assesses work engagement, or a positive, fulfilling, work-related state of mind characterized by vigor, dedication, and absorption. It is intended to measure the 'opposite' of burnout in both university students and employees. Items were developed to reflect three underlying dimensions: "Vigor" (VI); "Dedication" (DE), and "Absorption" (AB). The subscales were found to be internally consistent but relatively strongly correlated. Items are scored along a 6-point Likert-type scale (0 = Never to 6 = Always or Every day). Scores are calculated by summing item scores. The total score ranges from 0 to 102 points. A higher score indicates greater worker engagement.
Maslach Burnout Inventory (MBI) - Emotional Exhaustion	assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported	The Maslach Burnout Inventory - Emotional Exhaustion (MBI-EE) is a validated self-report measure assessing feelings of emotional depletion and fatigue due to work-related stress. It is part of the Maslach Burnout Inventory (MBI), which evaluates burnout across three domains. Scores range from 0 to 54, with higher scores indicating greater emotional exhaustion. The Emotional Exhaustion Score is computed by summing responses to nine Likert-type items. Lower scores represent better well-being outcomes.
Maslach Burnout Inventory (MBI) - Personal Accomplishment	assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported	The Maslach Burnout Inventory - Personal Accomplishment (MBI-PA) is a validated self-report measure assessing feelings of competence and achievement in one's work. It is part of the Maslach Burnout Inventory (MBI), which evaluates burnout across three domains. Scores range from 0 to 48, with higher scores indicating greater personal accomplishment and lower scores suggesting burnout-related inefficacy. The Personal Accomplishment Score is computed by summing responses to eight Likert-type items.
Positive Emotion (Positive Emotion Subscale of the PERMA-Profiler)	assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported	The PERMA-Profiler is a 23-item measure that assesses wellbeing across five domains (positive emotion, engagement, relationships, meaning, accomplishment). The instrument was constructed so that each domain can be defined and measured as separate but correlated constructs. This study will use the Positive Emotion subscale of the PERMA. This subscale includes 3 items on an 11-point Likert scale, from 0 to 10. Scores are calculated as an average of these items, with lower scores indicating less positive emotion and high scores indicating more positive emotion.
Maslach Burnout Inventory (MBI) - Depersonalization	assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported	The Maslach Burnout Inventory - Depersonalization (MBI-DP) is a validated self-report measure assessing feelings of detachment and impersonal responses toward others in a work setting. It is part of the Maslach Burnout Inventory (MBI), which evaluates burnout across three domains. Scores range from 0 to 30, with higher scores indicating greater depersonalization and emotional distancing. The Depersonalization Score is computed by summing responses to five Likert-type items. Lower scores represent better well-being outcomes.
Number of Participants Still Employed	assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported	Whether the participant still has their job at the end of the 4-week trial period.
Feasibility of Intervention Measure (FIM)	assessed at post-trial (4 weeks)	The Feasibility of Intervention Measure (FIM) is used to measure the feasibility of an intervention. The scale consists of 4 items rated on a 5-point Likert Scale from 1 ("Completely disagree") to 5 ("Completely agree"). The score consists of the average of the items, ranging from 1 to 5, with higher scores indicating greater feasibility of the intervention.
Acceptability of Intervention Measure (AIM)	4 weeks post-trial	The Acceptability of Intervention Measure (AIM) is used to measure the acceptability of an intervention. The scale consists of 4 items rated on a 5-point Likert Scale from 1 ("Completely disagree") to 5 ("Completely agree"). The score consists of the average of the items, ranging from 1 to 5, with higher scores indicating greater acceptability of the intervention.
Intervention Appropriateness Measure (IAM)	4 weeks post-trial	The Intervention Appropriateness Measure (IAM) is used to measure the appropriateness of an intervention. The scale consists of 4 items rated on a 5-point Likert Scale from 1 ("Completely disagree") to 5 ("Completely agree"). The score consists of the average of the items, ranging from 1 to 5, with higher scores indicating greater appropriateness of the intervention.
System Usability Scale (SUS)	4 weeks post-trial	The System Usability Scale (SUS) measures perceptions of usability of a given system, in this case, the GUIDE App. The scale consists of 10 items, each rated on a 5-point Likert Scale from 1 ("Strongly disagree") to 5 ("Strongly agree"). Responses are transformed to get a total range of possible values from 0-100, with higher scores indicating higher perceptions of usability. Typically, a score above 68 is regarded as a good score.

Trial Locations

Locations (1): University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States