Mental Health Wellness
Conditions
Keywords
first responders, veterans, soldiers, social connectedness, burnout, wellbeing
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).
Interventions
BEHAVIORALGUIDE
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.
Sponsors
Nlyten Corp
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment opened on April 22, 2024 and continued through August 31, 2024. Participants were recruited through email distribution lists, GUIDE partnerships, social media posts and in-person events with the population.
Pre-assignment details
Participants who signed the informed consent, but did not attend an introductory Zoom meeting with the clinical research coordinator, were not assigned a treatment group. Participants received app access and instructions during the introductory meeting at the meeting, which finalized their enrollment in the study.
Participants by arm
| Arm | Count |
|---|---|
| GUIDE With Incentives 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. | 39 |
| GUIDE Without Incentives Immediate access to the GUIDE App for 4 weeks without the opportunity to earn additional compensation. | 37 |
| Waitlist Waitlisted with delayed access to the GUIDE App without the opportunity to earn additional compensation. | 39 |
| Total | 115 |
Baseline characteristics
| Characteristic | GUIDE Without Incentives | GUIDE With Incentives | Total | Waitlist |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 38 Participants | 113 Participants | 39 Participants |
| Anxiety (GAD-7) | 11.00 units on a scale STANDARD_DEVIATION 4.34 | 13.36 units on a scale STANDARD_DEVIATION 5.73 | 12.66 units on a scale STANDARD_DEVIATION 4.95 | 13.54 units on a scale STANDARD_DEVIATION 4.32 |
| Depression (PHQ-8) | 5.14 units on a scale STANDARD_DEVIATION 5.05 | 7.36 units on a scale STANDARD_DEVIATION 5.15 | 6.70 units on a scale STANDARD_DEVIATION 5.2 | 7.51 units on a scale STANDARD_DEVIATION 5.19 |
| DERS-SF | 31.19 units on a scale STANDARD_DEVIATION 10.17 | 36.54 units on a scale STANDARD_DEVIATION 12.59 | 35.65 units on a scale STANDARD_DEVIATION 12.16 | 39.00 units on a scale STANDARD_DEVIATION 12.46 |
| PERMA Accomplishment | 7.6 units on a scale STANDARD_DEVIATION 1.44 | 6.83 units on a scale STANDARD_DEVIATION 1.6 | 7.05 units on a scale STANDARD_DEVIATION 1.59 | 6.74 units on a scale STANDARD_DEVIATION 1.6 |
| PERMA Engagement | 6.39 units on a scale STANDARD_DEVIATION 1.55 | 6.46 units on a scale STANDARD_DEVIATION 1.56 | 6.52 units on a scale STANDARD_DEVIATION 1.5 | 6.72 units on a scale STANDARD_DEVIATION 1.39 |
| PERMA Happiness | 6.89 units on a scale STANDARD_DEVIATION 1.9 | 6.64 units on a scale STANDARD_DEVIATION 1.91 | 6.61 units on a scale STANDARD_DEVIATION 1.87 | 6.31 units on a scale STANDARD_DEVIATION 1.81 |
| PERMA Health | 6.80 units on a scale STANDARD_DEVIATION 1.83 | 6.01 units on a scale STANDARD_DEVIATION 1.69 | 6.10 units on a scale STANDARD_DEVIATION 1.82 | 5.54 units on a scale STANDARD_DEVIATION 1.77 |
| PERMA Loneliness | 3.57 units on a scale STANDARD_DEVIATION 2.77 | 3.69 units on a scale STANDARD_DEVIATION 2.99 | 4.14 units on a scale STANDARD_DEVIATION 3.02 | 5.13 units on a scale STANDARD_DEVIATION 3.1 |
| PERMA Meaning | 7.77 units on a scale STANDARD_DEVIATION 1.95 | 6.91 units on a scale STANDARD_DEVIATION 2.03 | 7.13 units on a scale STANDARD_DEVIATION 1.99 | 6.74 units on a scale STANDARD_DEVIATION 1.88 |
| PERMA Negative emotion | 3.81 units on a scale STANDARD_DEVIATION 1.93 | 4.45 units on a scale STANDARD_DEVIATION 2.18 | 4.17 units on a scale STANDARD_DEVIATION 1.96 | 4.22 units on a scale STANDARD_DEVIATION 1.74 |
| PERMA Overall Score | 7.16 units on a scale STANDARD_DEVIATION 1.65 | 6.57 units on a scale STANDARD_DEVIATION 1.43 | 6.72 units on a scale STANDARD_DEVIATION 1.52 | 6.45 units on a scale STANDARD_DEVIATION 1.43 |
| PERMA Positive emotion | 6.61 units on a scale STANDARD_DEVIATION 2.09 | 6.07 units on a scale STANDARD_DEVIATION 1.81 | 6.18 units on a scale STANDARD_DEVIATION 1.86 | 5.89 units on a scale STANDARD_DEVIATION 1.64 |
| PERMA Relationships | 7.43 units on a scale STANDARD_DEVIATION 2.1 | 6.56 units on a scale STANDARD_DEVIATION 2.07 | 6.70 units on a scale STANDARD_DEVIATION 2.09 | 6.14 units on a scale STANDARD_DEVIATION 1.94 |
| Personal Wellbeing Score (PWS) | 77.25 score on a scale STANDARD_DEVIATION 21.57 | 67.52 score on a scale STANDARD_DEVIATION 22.52 | 68.41 score on a scale STANDARD_DEVIATION 23.53 | 60.90 score on a scale STANDARD_DEVIATION 24.04 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 4 Participants | 8 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 4 Participants | 2 Participants | 6 Participants | 0 Participants |
| Race/Ethnicity, Customized Refused to Answer | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 32 Participants | 34 Participants | 102 Participants | 36 Participants |
| Sex: Female, Male Female | 9 Participants | 12 Participants | 33 Participants | 12 Participants |
| Sex: Female, Male Male | 28 Participants | 27 Participants | 82 Participants | 27 Participants |
| WHO-5 Wellbeing | 57.30 score on a scale STANDARD_DEVIATION 21.87 | 53.03 score on a scale STANDARD_DEVIATION 21.32 | 54.12 score on a scale STANDARD_DEVIATION 21.21 | 52.21 score on a scale STANDARD_DEVIATION 20.66 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 37 | 0 / 39 |
| other Total, other adverse events | 0 / 39 | 0 / 37 | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 37 | 0 / 39 |
Outcome results
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%). 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.
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Analysis includes all participants who completed a post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Difficulties in Emotion Regulation Scale Short Form (DERS-SF) | 32.82 units on a scale | Standard Deviation 9.974 |
| GUIDE Without Incentives | Difficulties in Emotion Regulation Scale Short Form (DERS-SF) | 32.06 units on a scale | Standard Deviation 9.825 |
| Waitlist | Difficulties in Emotion Regulation Scale Short Form (DERS-SF) | 36.89 units on a scale | Standard Deviation 11.795 |
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.
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Analyzed for all participants who completed a post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Generalized Anxiety Disorder (GAD-7) | 12.53 units on a scale | Standard Deviation 5.089 |
| GUIDE Without Incentives | Generalized Anxiety Disorder (GAD-7) | 10.34 units on a scale | Standard Deviation 3.235 |
| Waitlist | Generalized Anxiety Disorder (GAD-7) | 13.42 units on a scale | Standard Deviation 4.665 |
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).
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Analysis includes all participants who completed their post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Patient Health Questionnaire for Depression Symptoms (PHQ-8) | 5.15 units on a scale | Standard Deviation 3.509 |
| GUIDE Without Incentives | Patient Health Questionnaire for Depression Symptoms (PHQ-8) | 3.86 units on a scale | Standard Deviation 3.844 |
| Waitlist | Patient Health Questionnaire for Depression Symptoms (PHQ-8) | 6.29 units on a scale | Standard Deviation 4.667 |
Primary
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.
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Analyzed data for all participants who completed the post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | PERMA-Profiler Overall Wellbeing Score | 6.99 score on a scale | Standard Deviation 1.47 |
| GUIDE Without Incentives | PERMA-Profiler Overall Wellbeing Score | 7.46 score on a scale | Standard Deviation 1.62 |
| Waitlist | PERMA-Profiler Overall Wellbeing Score | 6.49 score on a scale | Standard Deviation 1.58 |
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. 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.
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Analysis includes all participants who completed post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Personal Wellbeing Score (PWS) | 73.04 units on a scale | Standard Deviation 24.11 |
| GUIDE Without Incentives | Personal Wellbeing Score (PWS) | 77.62 units on a scale | Standard Deviation 18.72 |
| Waitlist | Personal Wellbeing Score (PWS) | 62.28 units on a scale | Standard Deviation 22.24 |
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.
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Analysis includes all participants who completed their post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | WHO Well-being Index (WHO-5) | 57.41 units on a scale | Standard Deviation 19.394 |
| GUIDE Without Incentives | WHO Well-being Index (WHO-5) | 65.71 units on a scale | Standard Deviation 19.239 |
| Waitlist | WHO Well-being Index (WHO-5) | 52.95 units on a scale | Standard Deviation 21.838 |
Secondary
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.
Time frame: 4 weeks post-trial
Population: Includes: 1) participants from groups who used GUIDE during the trial, 2) participants who completed their post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Acceptability of Intervention Measure (AIM) | 3.757352941 units on a scale | Standard Deviation 1.00469597 |
| GUIDE Without Incentives | Acceptability of Intervention Measure (AIM) | 3.878571429 units on a scale | Standard Deviation 0.777371676 |
Secondary
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.
Time frame: assessed at post-trial (4 weeks)
Population: Included participants from two groups that used GUIDE during the trial, only if they completed their post-trial assessment survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Feasibility of Intervention Measure (FIM) | 3.941176471 units on a scale | Standard Deviation 0.89200749 |
| GUIDE Without Incentives | Feasibility of Intervention Measure (FIM) | 4.078571429 units on a scale | Standard Deviation 0.638159776 |
Secondary
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.
Time frame: 4 weeks post-trial
Population: Includes participants who: 1) assigned to a group that used GUIDE during the trial, 2) completed post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Intervention Appropriateness Measure (IAM) | 3.933823529 units on a scale | Standard Deviation 0.817212612 |
| GUIDE Without Incentives | Intervention Appropriateness Measure (IAM) | 4.085714286 units on a scale | Standard Deviation 0.69118094 |
Secondary
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.
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Analysis includes all participants who completed post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Maslach Burnout Inventory (MBI) - Depersonalization | 8.79 units on a scale | Standard Deviation 6.285 |
| GUIDE Without Incentives | Maslach Burnout Inventory (MBI) - Depersonalization | 8.86 units on a scale | Standard Deviation 6.335 |
| Waitlist | Maslach Burnout Inventory (MBI) - Depersonalization | 9.13 units on a scale | Standard Deviation 6.156 |
Secondary
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.
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Analysis includes all participants who completed post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Maslach Burnout Inventory (MBI) - Emotional Exhaustion | 21.24 units on a scale | Standard Deviation 12.015 |
| GUIDE Without Incentives | Maslach Burnout Inventory (MBI) - Emotional Exhaustion | 19.06 units on a scale | Standard Deviation 10.287 |
| Waitlist | Maslach Burnout Inventory (MBI) - Emotional Exhaustion | 19.97 units on a scale | Standard Deviation 11.507 |
Secondary
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.
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Analysis includes all participants who completed post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Maslach Burnout Inventory (MBI) - Personal Accomplishment | 31.38 units on a scale | Standard Deviation 8.739 |
| GUIDE Without Incentives | Maslach Burnout Inventory (MBI) - Personal Accomplishment | 32.00 units on a scale | Standard Deviation 6.924 |
| Waitlist | Maslach Burnout Inventory (MBI) - Personal Accomplishment | 30.42 units on a scale | Standard Deviation 7.866 |
Secondary
Number of Participants Still Employed
Whether the participant still has their job at the end of the 4-week trial period.
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Only included participants who completed their post-trial assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GUIDE With Incentives | Number of Participants Still Employed | 34 Participants |
| GUIDE Without Incentives | Number of Participants Still Employed | 35 Participants |
| Waitlist | Number of Participants Still Employed | 38 Participants |
Secondary
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.
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Analysis includes participants who completed their post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Personal Growth (Accomplishment Subscale of the PERMA-Profiler) | 7.29 units on a scale | Standard Deviation 1.46 |
| GUIDE Without Incentives | Personal Growth (Accomplishment Subscale of the PERMA-Profiler) | 7.74 units on a scale | Standard Deviation 1.49 |
| Waitlist | Personal Growth (Accomplishment Subscale of the PERMA-Profiler) | 6.95 units on a scale | Standard Deviation 1.65 |
Secondary
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.
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Analysis includes participants who completed their post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Personal Growth (Meaning Subscale of the PERMA-Profiler) | 7.33 units on a scale | Standard Deviation 1.92 |
| GUIDE Without Incentives | Personal Growth (Meaning Subscale of the PERMA-Profiler) | 7.86 units on a scale | Standard Deviation 1.88 |
| Waitlist | Personal Growth (Meaning Subscale of the PERMA-Profiler) | 6.74 units on a scale | Standard Deviation 2.1 |
Secondary
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.
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Analysis includes all participants who completed post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Positive Emotion (Positive Emotion Subscale of the PERMA-Profiler) | 6.65 units on a scale | Standard Deviation 1.65 |
| GUIDE Without Incentives | Positive Emotion (Positive Emotion Subscale of the PERMA-Profiler) | 7.20 units on a scale | Standard Deviation 1.89 |
| Waitlist | Positive Emotion (Positive Emotion Subscale of the PERMA-Profiler) | 5.96 units on a scale | Standard Deviation 1.87 |
Secondary
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.
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Analysis includes all participants who completed a post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Social Connectedness (Engagement Subscale of PERMA-Profiler) | 6.66 units on a scale | Standard Deviation 1.43 |
| GUIDE Without Incentives | Social Connectedness (Engagement Subscale of PERMA-Profiler) | 6.70 units on a scale | Standard Deviation 1.77 |
| Waitlist | Social Connectedness (Engagement Subscale of PERMA-Profiler) | 6.68 units on a scale | Standard Deviation 1.53 |
Secondary
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.
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Analysis includes all participants who completed a post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Social Connectedness (Relationship Subscale of PERMA-Profiler) | 7.03 units on a scale | Standard Deviation 2.03 |
| GUIDE Without Incentives | Social Connectedness (Relationship Subscale of PERMA-Profiler) | 7.81 units on a scale | Standard Deviation 2.03 |
| Waitlist | Social Connectedness (Relationship Subscale of PERMA-Profiler) | 6.14 units on a scale | Standard Deviation 1.93 |
Secondary
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.
Time frame: 4 weeks post-trial
Population: Analysis includes participants who: 1) used GUIDE for the trial period, 2) completed their post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | System Usability Scale (SUS) | 70.07352941 units on a scale | Standard Deviation 19.0442596 |
| GUIDE Without Incentives | System Usability Scale (SUS) | 71.14285714 units on a scale | Standard Deviation 18.85843992 |
Secondary
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.
Time frame: assessed at Baseline and post-trial (over 4 weeks), post-trial (week 4) reported
Population: Analysis includes all participants who completed post-trial assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GUIDE With Incentives | Utrecht Work Engagement Scale (UWES-17) | 61.74 units on a scale | Standard Deviation 17.647 |
| GUIDE Without Incentives | Utrecht Work Engagement Scale (UWES-17) | 62.49 units on a scale | Standard Deviation 14.496 |
| Waitlist | Utrecht Work Engagement Scale (UWES-17) | 58.61 units on a scale | Standard Deviation 16.668 |