Mental Health WellnessNCT06336967
Testing a Wellness App for First Responders, Military Personnel and Veterans
A study testing GUIDE in people with Mental Health Wellness, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness
- What is being tested?
- GUIDE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not law enforcement, military personnel, or veteran.
- Not employed.
- Paid by GUIDE App/Nlyten Corp.
- Previous use of GUIDE App.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19146
About this study
Official title: A Randomized Controlled Trial of a Wellness App for First Responders, Military Personnel and Veterans
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.
Read the 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).
- Conditions
- Mental Health Wellness
- Being tested
- GUIDE
- Keywords
- first responders, veterans, soldiers, social connectedness, burnout, wellbeing
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUIDEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: GUIDE |
| GUIDE without incentives | Experimental | Immediate access to the GUIDE App for 4 weeks without the opportunity to earn additional compensation. Receives: Behavioral: GUIDE |
| Waitlist | No intervention | Waitlisted with delayed access to the GUIDE App without the opportunity to earn additional compensation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Social Connectedness (Engagement Subscale of 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 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.
Measured: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Social Connectedness (Relationship Subscale of 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 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.
Measured: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Personal Growth (Meaning Subscale 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.
Measured: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Personal Growth (Accomplishment Subscale 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.
Measured: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Utrecht Work Engagement Scale (UWES-17)
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.
Measured: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Maslach Burnout Inventory (MBI) - Emotional Exhaustion
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.
Measured: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Maslach Burnout Inventory (MBI) - Personal Accomplishment
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.
Measured: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Maslach Burnout Inventory (MBI) - Depersonalization
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.
Measured: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Number of Participants Still Employed
Whether the participant still has their job at the end of the 4-week trial period.
Measured: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
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 average of the items, ranging from 1 to 5, with higher scores indicating greater feasibility of the intervention.
Measured: assessed at post-trial (4 weeks)
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 average of the items, ranging from 1 to 5, with higher scores indicating greater acceptability of the intervention.
Measured: 4 weeks post-trial
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 average of the items, ranging from 1 to 5, with higher scores indicating greater appropriateness of the intervention.
Measured: 4 weeks post-trial
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.
Measured: 4 weeks post-trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start22 Apr 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health WellnessStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Nlyten Corp
- Responsible party
- Sponsor
- Investigators
- Heather J Nuske, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336967
- Sponsor's protocol ID
- 855282
- Status last verified
- Jun 2025
- First submitted
- 21 Mar 2024
- Last updated
- 26 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41105938
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Wellness App for First Responders, Military Personnel and Veterans
- ClinicalTrials.gov ID
- NCT06336967
- Acronym / sponsor ID
- 855282
- Conditions
- Mental Health Wellness
- Keywords
- first responders, veterans, soldiers, social connectedness, burnout, wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Nlyten Corp
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Posted 26 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GUIDE with incentives | Experimental | Behavioral: GUIDEImmediate 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. |
| GUIDE without incentives | Experimental | Behavioral: GUIDEImmediate access to the GUIDE App for 4 weeks without the opportunity to earn additional compensation. |
| Waitlist | No intervention | –Waitlisted with delayed access to the GUIDE App without the opportunity to earn additional compensation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Not law enforcement, military personnel, or veteran.
- Not employed.
- Paid by GUIDE App/Nlyten Corp.
- Previous use of GUIDE App.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GUIDEThe 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. | Behavioural | GUIDE with incentives, GUIDE without incentives |
Primary outcome
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.
14 secondary outcomes
Positive Emotion (Positive Emotion Subscale of the PERMA-Profiler)
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Social Connectedness (Engagement Subscale of PERMA-Profiler)
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Social Connectedness (Relationship Subscale of PERMA-Profiler)
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Personal Growth (Meaning Subscale of the PERMA-Profiler)
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Personal Growth (Accomplishment Subscale of the PERMA-Profiler)
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Utrecht Work Engagement Scale (UWES-17)
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Maslach Burnout Inventory (MBI) - Emotional Exhaustion
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Maslach Burnout Inventory (MBI) - Personal Accomplishment
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Maslach Burnout Inventory (MBI) - Depersonalization
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Number of Participants Still Employed
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Feasibility of Intervention Measure (FIM)
Time frame: assessed at post-trial (4 weeks)
Acceptability of Intervention Measure (AIM)
Time frame: 4 weeks post-trial
Intervention Appropriateness Measure (IAM)
Time frame: 4 weeks post-trial
System Usability Scale (SUS)
Time frame: 4 weeks post-trial
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41105938Dunphy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather J Nuske, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GUIDE in people with Mental Health Wellness, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PERMA-Profiler Overall Wellbeing Score (time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06336967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.