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

Mental Health Wellness Clinical Trial

Official title:

A Randomized Controlled Trial of a Wellness App for First Responders, Military Personnel and Veterans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336967
• Other study ID #: 855282
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: University of Pennsylvania
• Contact: Morgan K Dunphy
• Phone: 9086743611
• Email: morgan.dunphy[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2026
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Wellness

Intervention

Behavioral:
• GUIDE
The GUIDE App is a wellbeing app designed for first responders and veterans that uses small group support, a learning management system, drivers of behavior change, and an anonymous member experience safeguarded by a leader in identity and login privacy, Okta (okta.com). It includes three main features: 1) Community, 2) Wisdom, and 3) Daily Practice. The Community feature connects app users with an online community of like folks, allowing for human support, encouragement, accountability and coaching. Online communities are moderated by GUIDE employees. The Wisdom feature includes tools and interactive media for personal growth. The Daily Practice feature includes simple, daily routines to maintain mental and emotional wellness.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Nlyten Corp

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility of Intervention Measure (FIM)	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 sum of the items, ranging from 5 to 20, with higher scores indicating greater feasibility of the intervention.	4 weeks post-trial
Other	Acceptability of Intervention Measure (AIM)	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 sum of the items, ranging from 5 to 20, with higher scores indicating greater acceptability of the intervention.	4 weeks post-trial
Other	Intervention Appropriateness Measure (IAM)	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 sum of the items, ranging from 5 to 20, with higher scores indicating greater appropriateness of the intervention.	4 weeks post-trial
Other	System Usability Scale (SUS)	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.	4 weeks post-trial
Primary	PERMA-Profiler Overall Wellbeing Score	1. 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.	Baseline and post-trial, over 4 weeks
Primary	Patient Health Questionnaire for depression symptoms (PHQ-8)	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).	Baseline and post-trial, over 4 weeks
Primary	Generalized Anxiety Disorder (GAD-7)	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.	Baseline and post-trial, over 4 weeks
Primary	WHO Well-being Index (WHO-5)	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.	Baseline and post-trial, over 4 weeks
Primary	Personal Wellbeing Score (PWS)	The Personal Wellbeing Score (PWS) is based on the Office of National Statistics (ONS) four subjective well-being questions (ONS4) and thresholds. Each PWS item is scored as follows: Disagree=0, Neutral=1, Agree=2 and Strongly Agree=3. A high score is better than a low score.	Baseline and post-trial, over 4 weeks
Primary	Difficulties in Emotion Regulation Scale Short Form (DERS-SF)	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%). Can be scored using sums or averages of items. Higher values reflect greater difficulty with emotion regulation. Awareness scale must be reverse coded.	Baseline and post-trial, over 4 weeks
Secondary	Positive Emotion (Positive emotion subscale of the PERMA-Profiler)	1. 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.	Baseline and post-trial, over 4 weeks
Secondary	Social Connectedness (Engagement and Relationship subscales of PERMA-Profiler)	1. 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.	Baseline and post-trial, over 4 weeks
Secondary	Social Connectedness (Number of posts/comments in the app)	Measure derived from GUIDE App metrics.	Week 1 vs Week 4 of app usage period
Secondary	Personal Growth (Meaning and Accomplishment subscales of the PERMA-Profiler)	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.	Baseline and post-trial, over 4 weeks
Secondary	Personal Growth (Total GUIDE lessons and courses completed)	Measure derived from GUIDE App metrics.	Aggregated over 28 days
Secondary	Utrecht Work Engagement Scale (UWES-17)	1. 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 hypothesized 'opposite' of burnout in both university students and employees. Twenty-four self-constructed items were simultaneously formulated in Spanish and English. 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 averaging item scores. The total score ranges from 0 to 6 points. A higher score indicates greater worker engagement.	Baseline and post-trial, over 4 weeks
Secondary	Maslach Burnout Inventory (MBI)	The Maslach Burnout Inventory (MBI) is a psychological assessment instrument comprising 22 symptom items and is considered the "gold standard" for measuring burnout, encompassing 3 scales: emotional exhaustion, depersonalization, and personal accomplishment. Maslach, Jackson, and Leiter described item scoring from 0 to 6. There are score ranges that define low, moderate and high levels of each scale based on the 0-6 scoring.; The 7-level frequency scale for all MBI scales is as follows: Never (0) A few times a year or less (1) Once a month or less (2) A few times a month (3) Once a week (4) A few times a week (5) Every day (6)	Baseline and post-trial, over 4 weeks
Secondary	Job Retention (Employment status)	Whether the participant still has their job at the end of the 4-week trial period.	Baseline and post-trial, over 4 weeks