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

NCT06336967 | Completed Results

• 1 other identifier: 855282
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Wellness

Keywords

first responders; veterans; soldiers; social connectedness; burnout; wellbeing

Outcome Measures

Primary Outcomes (6)

• PERMA-Profiler Overall Wellbeing Score

  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.

  assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported

• 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).

  assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported

• 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.

  assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported

• 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.

  assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported

• 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. 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.

  assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported

• 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%). 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.

  assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported

Secondary Outcomes (14)

• 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

Study Arms (3)

GUIDE with incentives

EXPERIMENTAL

Immediate access to the GUIDE App smartphone application for 4 weeks with the opportunity to earn additional compensation, up to $100 in total, based on app engagement.

Behavioral: GUIDE

GUIDE without incentives

EXPERIMENTAL

Immediate access to the GUIDE App for 4 weeks without the opportunity to earn additional compensation.

Behavioral: GUIDE

Waitlist

NO INTERVENTION

Waitlisted with delayed access to the GUIDE App without the opportunity to earn additional compensation.

Interventions

GUIDE BEHAVIORAL

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.

GUIDE with incentives; GUIDE without incentives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Nlyten Corp: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (1)

• Dunphy MK, Nuske HJ. Evaluating a Mobile Health Intervention (GUIDE App) for First Responders, Military Personnel, and Veterans: Randomized Controlled Trial. J Med Internet Res. 2025 Oct 17;27:e71155. doi: 10.2196/71155.

  PMID: 41105938 DERIVED

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Limitations and Caveats

1\) we relied exclusively on subjective self-report data in the trial. 2) our sample includes only those motivated enough to voluntarily participate in a clinical trial to test a mental health and wellness app, which may not be representative of this population. 3) participants were higher than average in anxiety and depression symptoms as compared to other studies of first responders and military, indicating that generalizability may be difficult. 4) short follow-up period. 5) not blinded.

Results Point of Contact

• Title: Dr. Heather Nuske, PI
• Organization: University of Pennsylvania

heather.nuske@pennmedicine.upenn.edu

(215) 746-6041

Study Officials

• Heather J Nuske, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 29, 2024
• Study Start: April 22, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)