Anxiety, Depression, Emotional Regulation
Conditions
Brief summary
Access to mental health care by essential workers and the unemployed during the COVID19 pandemic has been challenging. Usual access to mental health care is limited by social distancing, and for many now unemployed due to closures of businesses, insurance is insufficient to cover the costs of mental health care. For these individuals who are at risk for suicide (isolation, unemployment, financial crisis plus past suicide attempts, significant mental health challenges), access to care is crucial and many maybe turning to online and accessible interventions, such as mental health apps and other online resources. Indeed, organizations such as the VA have already created free access mobile applications for mental health in anticipation of this need. Using Psyberguide, the investigators will identify the top ten free apps that address mental health issues and conduct a nation-wide evaluation of these apps with participants who are essential workers and unemployed with risk for suicide. Participants will first be surveyed about which strategies they have used to manage mental health issues, what apps and online tools they have used, and what usability challenges they have faced. The investigators will then ask a random sample of participant to engage in a randomized trial of these top-rated apps for 4 weeks. Apps will be rated on usability, acceptability, feasibility and effectiveness. Results from this trial will be quickly disseminated through several avenues: (1) the UWAC website and ALACRITY Centers network; (2) through CREATIV Lab's partnership with Mental Health America; (3) through the UW Center for Suicide Prevention and Recovery (CSPAR) and partnerships with other suicide focused organizations including Forefront, the American Foundation for Suicide Prevention, that American Association of Suicidology, the Rocky Mountain MIRECC, and the Defense Suicide Prevention Office and (4) through local partnership with King County and WA state contact tracers.
Detailed description
Participants will be recruited nationally via Prolific. Investigators will aim to recruit 1,000 participants in the clinical trial who are essential workers and/or unemployed due to COVID-19 and have a past history of mental health issues or experiencing suicide ideation motivational risk factors to be randomized (250 per group) to one of the four apps. They will be asked to download their assigned app and use it for 4 weeks. After 4 weeks of use, participants will be asked to provide an evaluation of acceptability, feasibility and usability of the app, how often they used the app, and if they found the app helpful. Participants will also be asked to complete clinical outcome measures.
Interventions
BEHAVIORALMobile Mental Health App - 1
Free mobile mental health application that focuses on meditation
BEHAVIORALMobile Mental Health App - 2
Free mobile mental health application that assists with coping with COVID-19
BEHAVIORALMobile Mental Health App - 3
Free mobile mental health application that focuses on positive psychology.
BEHAVIORALMobile Mental Health App - 4
Free mobile application that addresses mental health issues through mood tracking
Sponsors
National Institute of Mental Health (NIMH)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase 1 * 19 years old and older * Identify as an essential worker or unemployed due to COVID-19 * English-speaking * Access to a mobile device (e.g. smartphone or tablet) * Based in the United States Phase 2 * 19 years old and older * Scored at or above validated cut off scores in Phase 1 (PHQ-2\>3; GAD-2\>3; SBQ-R\>7) or reported history of past suicide attempt * Identify as an essential worker or unemployed due to COVID-19 * English-speaking * Access to a mobile device (e.g. smartphone or tablet) * Based in the United States
Exclusion criteria
Phase 1 * Under the age of 19 * Neither an essential worker nor unemployed due to COVID-19 * Non-English speaking * No access to a mobile device (e.g. smartphone or tablet) * Not based in the United States Phase 2 * Under the age of 19 * Did not score at or above validated cut off scores in Phase 1 (PHQ-2\>3; GAD-2\>3; SBQ-R\>7) nor reported history of past suicide attempt * Neither an essential worker nor unemployed due to COVID-19 * Non-English speaking * No access to a mobile device (e.g. smartphone or tablet) * Not based in the United States
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | PHQ-9 at RCT baseline and RCT follow-up; duration of 4 weeks. | The Patient Health Questionnaire (PHQ-9) consists of 9 depression items and one disability item. Each item is associated with a DSM symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time, with a total sum score ranging from 0 - 27. Higher scores indicate higher depression symptom severity. |
| Suicidal Behavioral Questionnaire-Revised (SBQ-R) | SBQ-R RCT baseline and RCT follow-up; duration of four weeks. | The suicidal behavioral questionnaire revised (SBQ-R) is a self-report questionnaire designed to identify risk factors for suicide. Total scores range from 3 to 18, with higher scores indicate indicating higher risk of suicidal behavior. |
| Brief Difficulties With Emotional Regulation Scale (DERS) | DERS at RCT baseline and RCT follow-up; duration of four weeks. | The Brief Difficulties with Emotional Regulation Scale (DERS) is a brief, 36-item, self-report questionnaire designed to assess multiple aspects of emotion dysregulation. a 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 (almost never \[0-10%\]) to 5 (almost always \[91-100%\]). Total scores range from 18 - 90 with higher scores indicate more difficulty in emotion regulation. |
| Generalized Anxiety Disorder (7-Item) Scale (GAD-7) | GAD-7 at RCT baseline and RCT follow-up; duration of 4 weeks. | The Generalized Anxiety Disorder Scale (GAD-7) is a 7- item screener for generalized anxiety. It consists of items related to generalized anxiety disorder. Participants rate on a scale of 0-3 how much they have experienced in the last two weeks to crease a total sum score ranging from 0 - 21. The scale is a valid screener for generalized anxiety symptoms. Higher scores indicate higher anxiety symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention Measure (AIM) | Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized. | This is a four item measure of intervention acceptability, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. Total mean scores range from 1 - 5, with higher scores indicating higher acceptability. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized. |
| Intervention Appropriateness Measure (IAM) | Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized. | This is a four item measure of intervention appropriateness, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. A total mean score ranges from 1 - 5, with higher scores indicating higher appropriateness. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized. |
| Intervention Usability Scale (IUS) | Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized. | The Intervention Usability Scale (IUS) is a 10-item measure that assesses intervention usability through its likeability, learnability, difficulty, need for support, system integration, and efficiency. The measure is based on the System Usability Scale (SUS), a standardized, normed measure in industry for digital tools. Total scores can range from 0 - 100 with higher scores indicate higher levels of usability. |
| Feasibility of Intervention Measure (FIM) | Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized. | This is a four item measure of intervention feasibility, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable, with a total mean score ranging from 1 to 5. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized. High scores indicate higher levels of feasibility. No data displayed because outcome measure data was not collected therefore zero total participants analyzed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Defeat Scale | Participants will complete the Defeat Scale at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized. | Gilbert and Allan (1998) designed the items on this scale in order to depict a sense of failed struggle and losing rank. This measure requests participants to respond to 16 items on a 5-point Likert scale (ranging from 0 = 'Never' to 4 = 'Always') asking them how much they had felt defeated in the previous seven days, for example item 1 'I feel that I have not made it in life'. This scale has very high internal consistency with Alpha coefficients of 0.94 for females and 0.93 for males in both groups, furthermore reliability of 0.94 for students and 0.93 for depressed group. Total score can range from 0 to 64. Higher scores indicate higher levels of defeat. |
| Brief Resilience Scale (BRS) | Participants will complete the BRS at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized. | The Brief Resilience Scale (BRS) is a 6-item, self-reported measure of an individual's ability to bounce back, resist illness, adapt to stress, or thrive in the face of adversity. Responses for all 6 items are on a scale of 1-5, with a total mean score ranging from 1 to 5. Higher score indicates higher resilience. |
| CAGE-AID | Participants will complete the CAGE-AID at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized. | Standardized measure of alcohol/drug use with a total score range of 0 - 4. Higher scores indicate higher risk for substance use. |
| Entrapment Scale | Participants will complete the Entrapment Scale at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized. | This 16-item entrapment scale asks participants to indicate on a 5-point scale the degree to which the items represent their thoughts and feelings. The response options are 0 = 'not at all like me', 1 = 'a little bit like me', 2 = 'moderately like me', 3= 'quite a bit like me' and 4 = 'extremely like me'. Gilbert and Allan (1998) reported high levels of internal consistency for both student and depressed groups, with Cronbach's alphas respectively of .93 and .86 in Internal Entrapment, and .88 and .89 in External Entrapment. Total score can range from 0 to 64. Higher scores indicate higher levels of entrapment. |
| Interpersonal Needs Questionnaire | Participants will complete the Interpersonal Needs Questionnaire at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized. | Brief questionnaire that asks respondents to think about themselves and other people, based on the respondent's current beliefs and experiences. Higher scores indicate higher levels of thwarted belongingness (subscale range 9 to 63) and perceived burdensomeness (subscale range 9 to 63). |
| Loneliness and Social Distress Scale | Loneliness and Social Distress Scale at 4 weeks | No data displayed because outcome measure data was not collected therefore zero total participants analyzed. |
| PARS EQ-5D | PARS EQ-5D at RCT baseline and RCT follow-up; duration of 4 weeks. | Standardized measure of health status with a total score range of 0 - 1. Maximum score of one indicates the best health state. |
Countries
United States
Participant flow
Pre-assignment details
Investigators will aim to recruit 1,000 participants in the clinical trial who are essential workers and/or unemployed due to COVID-19 and have a past history of mental health issues or experiencing suicide ideation motivational risk factors to be randomized (250 per group) to one of the four apps.
Participants by arm
| Arm | Count |
|---|---|
| Phase 2: Mobile Mental Health App - 1 - Calm Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation | 204 |
| Phase 2: Mobile Mental Health App - 2 - COVID Coach Mobile Mental Health App - 2: Free mobile mental health application that assists with coping with COVID-19 | 212 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea Mobile Mental Health App - 3: Free mobile mental health application that focuses on positive psychology. | 209 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood Mobile Mental Health App - 4: Free mobile application that addresses mental health issues through mood tracking | 213 |
| Total | 838 |
Baseline characteristics
| Characteristic | Phase 2: Mobile Mental Health App - 1 - Calm | Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Phase 2: Mobile Mental Health App - 2 - COVID Coach | Total |
|---|---|---|---|---|---|
| Age, Continuous | 31.4 years STANDARD_DEVIATION 10 | 31.4 years STANDARD_DEVIATION 9.4 | 31.8 years STANDARD_DEVIATION 10.1 | 29.9 years STANDARD_DEVIATION 8.2 | 31.1 years STANDARD_DEVIATION 9.5 |
| Education Bachelor's Degree | 65 Participants | 67 Participants | 64 Participants | 73 Participants | 269 Participants |
| Education Higher Education | 33 Participants | 36 Participants | 34 Participants | 33 Participants | 136 Participants |
| Education High School GED, or less | 27 Participants | 23 Participants | 22 Participants | 28 Participants | 100 Participants |
| Education Some college | 54 Participants | 51 Participants | 74 Participants | 50 Participants | 229 Participants |
| Education Trade/Technical/Vocational | 25 Participants | 32 Participants | 19 Participants | 27 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 19 Participants | 23 Participants | 17 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 183 Participants | 189 Participants | 188 Participants | 190 Participants | 750 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 2 Participants | 5 Participants | 8 Participants |
| Income $100,000 - $149,999 | 11 Participants | 14 Participants | 14 Participants | 15 Participants | 54 Participants |
| Income $10,000 - $31,199 | 58 Participants | 53 Participants | 60 Participants | 56 Participants | 227 Participants |
| Income $150,000 or above | 10 Participants | 13 Participants | 7 Participants | 5 Participants | 35 Participants |
| Income $31,200 - $33,280 | 5 Participants | 8 Participants | 17 Participants | 17 Participants | 47 Participants |
| Income $33,281 - $49,999 | 31 Participants | 31 Participants | 29 Participants | 31 Participants | 122 Participants |
| Income $50,000 - $59,999 | 23 Participants | 17 Participants | 11 Participants | 16 Participants | 67 Participants |
| Income $60,000 - $69,999 | 14 Participants | 14 Participants | 10 Participants | 10 Participants | 48 Participants |
| Income $70,000 - $99,999 | 20 Participants | 27 Participants | 34 Participants | 19 Participants | 100 Participants |
| Income Below $10K | 31 Participants | 30 Participants | 30 Participants | 37 Participants | 128 Participants |
| Marital Status Divorced | 10 Participants | 17 Participants | 14 Participants | 11 Participants | 52 Participants |
| Marital Status Married (including same sex partnership) | 56 Participants | 61 Participants | 61 Participants | 56 Participants | 234 Participants |
| Marital Status Never marred | 131 Participants | 123 Participants | 134 Participants | 136 Participants | 524 Participants |
| Marital Status Separated | 4 Participants | 3 Participants | 1 Participants | 6 Participants | 14 Participants |
| Marital Status Widowed | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 0 Participants | 3 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 26 Participants | 13 Participants | 22 Participants | 23 Participants | 84 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 12 Participants | 15 Participants | 20 Participants | 58 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 12 Participants | 13 Participants | 18 Participants | 53 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 3 Participants | 4 Participants | 7 Participants | 19 Participants |
| Race (NIH/OMB) White | 149 Participants | 169 Participants | 156 Participants | 142 Participants | 616 Participants |
| Sex/Gender, Customized Gender Gender Diverse | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 4 Participants |
| Sex/Gender, Customized Gender Men | 78 Participants | 83 Participants | 85 Participants | 80 Participants | 326 Participants |
| Sex/Gender, Customized Gender Non-binary | 7 Participants | 7 Participants | 10 Participants | 7 Participants | 31 Participants |
| Sex/Gender, Customized Gender Transgender | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Sex/Gender, Customized Gender Women | 118 Participants | 115 Participants | 116 Participants | 118 Participants | 467 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 204 | 0 / 212 | 0 / 209 | 0 / 213 |
| other Total, other adverse events | 0 / 204 | 0 / 212 | 0 / 209 | 0 / 213 |
| serious Total, serious adverse events | 0 / 204 | 0 / 212 | 0 / 209 | 0 / 213 |
Outcome results
Primary
Brief Difficulties With Emotional Regulation Scale (DERS)
The Brief Difficulties with Emotional Regulation Scale (DERS) is a brief, 36-item, self-report questionnaire designed to assess multiple aspects of emotion dysregulation. a 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 (almost never \[0-10%\]) to 5 (almost always \[91-100%\]). Total scores range from 18 - 90 with higher scores indicate more difficulty in emotion regulation.
Time frame: DERS at RCT baseline and RCT follow-up; duration of four weeks.
Population: Participants providing both RCT baseline and RCT follow-up data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Mobile Mental Health App - 1 - Calm | Brief Difficulties With Emotional Regulation Scale (DERS) | RCT Baseline | 42.8 score on a scale | Standard Deviation 11.7 |
| Phase 2: Mobile Mental Health App - 1 - Calm | Brief Difficulties With Emotional Regulation Scale (DERS) | RCT Follow-Up | 42.2 score on a scale | Standard Deviation 13.1 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Brief Difficulties With Emotional Regulation Scale (DERS) | RCT Follow-Up | 44.6 score on a scale | Standard Deviation 14 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Brief Difficulties With Emotional Regulation Scale (DERS) | RCT Baseline | 44.6 score on a scale | Standard Deviation 12.5 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Brief Difficulties With Emotional Regulation Scale (DERS) | RCT Baseline | 44.6 score on a scale | Standard Deviation 12.8 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Brief Difficulties With Emotional Regulation Scale (DERS) | RCT Follow-Up | 44.9 score on a scale | Standard Deviation 13 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Brief Difficulties With Emotional Regulation Scale (DERS) | RCT Baseline | 44.5 score on a scale | Standard Deviation 13 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Brief Difficulties With Emotional Regulation Scale (DERS) | RCT Follow-Up | 44.6 score on a scale | Standard Deviation 14.2 |
p-value: 0.73Mixed Models Analysis
Primary
Generalized Anxiety Disorder (7-Item) Scale (GAD-7)
The Generalized Anxiety Disorder Scale (GAD-7) is a 7- item screener for generalized anxiety. It consists of items related to generalized anxiety disorder. Participants rate on a scale of 0-3 how much they have experienced in the last two weeks to crease a total sum score ranging from 0 - 21. The scale is a valid screener for generalized anxiety symptoms. Higher scores indicate higher anxiety symptom severity.
Time frame: GAD-7 at RCT baseline and RCT follow-up; duration of 4 weeks.
Population: Participants providing both RCT baseline and RCT follow-up data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Mobile Mental Health App - 1 - Calm | Generalized Anxiety Disorder (7-Item) Scale (GAD-7) | RCT Baseline | 7.9 score on a scale | Standard Deviation 4.8 |
| Phase 2: Mobile Mental Health App - 1 - Calm | Generalized Anxiety Disorder (7-Item) Scale (GAD-7) | RCT Follow-Up | 6.7 score on a scale | Standard Deviation 5.1 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Generalized Anxiety Disorder (7-Item) Scale (GAD-7) | RCT Follow-Up | 7.8 score on a scale | Standard Deviation 5.6 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Generalized Anxiety Disorder (7-Item) Scale (GAD-7) | RCT Baseline | 9.2 score on a scale | Standard Deviation 5.6 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Generalized Anxiety Disorder (7-Item) Scale (GAD-7) | RCT Baseline | 8.9 score on a scale | Standard Deviation 5.6 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Generalized Anxiety Disorder (7-Item) Scale (GAD-7) | RCT Follow-Up | 7.3 score on a scale | Standard Deviation 5.8 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Generalized Anxiety Disorder (7-Item) Scale (GAD-7) | RCT Baseline | 8.8 score on a scale | Standard Deviation 5.7 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Generalized Anxiety Disorder (7-Item) Scale (GAD-7) | RCT Follow-Up | 7.8 score on a scale | Standard Deviation 5.6 |
p-value: <0.00195% CI: [-1.6, -1]Mixed Models Analysis
Primary
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) consists of 9 depression items and one disability item. Each item is associated with a DSM symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time, with a total sum score ranging from 0 - 27. Higher scores indicate higher depression symptom severity.
Time frame: PHQ-9 at RCT baseline and RCT follow-up; duration of 4 weeks.
Population: Participants providing both RCT baseline and RCT follow-up data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Mobile Mental Health App - 1 - Calm | Patient Health Questionnaire (PHQ-9) | RCT Baseline | 10.1 score on a scale | Standard Deviation 5.7 |
| Phase 2: Mobile Mental Health App - 1 - Calm | Patient Health Questionnaire (PHQ-9) | RCT Follow-Up | 8.5 score on a scale | Standard Deviation 5.9 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Patient Health Questionnaire (PHQ-9) | RCT Follow-Up | 9.8 score on a scale | Standard Deviation 6.7 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Patient Health Questionnaire (PHQ-9) | RCT Baseline | 11.2 score on a scale | Standard Deviation 6.3 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Patient Health Questionnaire (PHQ-9) | RCT Baseline | 11.0 score on a scale | Standard Deviation 6.5 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Patient Health Questionnaire (PHQ-9) | RCT Follow-Up | 9.7 score on a scale | Standard Deviation 6.6 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Patient Health Questionnaire (PHQ-9) | RCT Baseline | 10.6 score on a scale | Standard Deviation 6.6 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Patient Health Questionnaire (PHQ-9) | RCT Follow-Up | 9.1 score on a scale | Standard Deviation 6.5 |
p-value: <0.00195% CI: [-1.8, -1.1]Mixed Models Analysis
Primary
Suicidal Behavioral Questionnaire-Revised (SBQ-R)
The suicidal behavioral questionnaire revised (SBQ-R) is a self-report questionnaire designed to identify risk factors for suicide. Total scores range from 3 to 18, with higher scores indicate indicating higher risk of suicidal behavior.
Time frame: SBQ-R RCT baseline and RCT follow-up; duration of four weeks.
Population: Participants providing both RCT baseline and RCT follow-up data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Mobile Mental Health App - 1 - Calm | Suicidal Behavioral Questionnaire-Revised (SBQ-R) | RCT Follow-Up | 6.4 score on a scale | Standard Deviation 3.3 |
| Phase 2: Mobile Mental Health App - 1 - Calm | Suicidal Behavioral Questionnaire-Revised (SBQ-R) | RCT Baseline | 6.6 score on a scale | Standard Deviation 3.3 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Suicidal Behavioral Questionnaire-Revised (SBQ-R) | RCT Baseline | 6.9 score on a scale | Standard Deviation 3.8 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Suicidal Behavioral Questionnaire-Revised (SBQ-R) | RCT Follow-Up | 6.7 score on a scale | Standard Deviation 3.7 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Suicidal Behavioral Questionnaire-Revised (SBQ-R) | RCT Baseline | 7.1 score on a scale | Standard Deviation 3.9 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Suicidal Behavioral Questionnaire-Revised (SBQ-R) | RCT Follow-Up | 7.1 score on a scale | Standard Deviation 3.9 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Suicidal Behavioral Questionnaire-Revised (SBQ-R) | RCT Follow-Up | 7.0 score on a scale | Standard Deviation 3.8 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Suicidal Behavioral Questionnaire-Revised (SBQ-R) | RCT Baseline | 7.1 score on a scale | Standard Deviation 3.6 |
p-value: 0.25Mixed Models Analysis
Secondary
Acceptability of Intervention Measure (AIM)
This is a four item measure of intervention acceptability, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. Total mean scores range from 1 - 5, with higher scores indicating higher acceptability. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized.
Time frame: Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.
Population: Participants providing AIM usability data at RCT Follow-Up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Mobile Mental Health App - 1 - Calm | Acceptability of Intervention Measure (AIM) | 3.4 score on a scale | Standard Deviation 1 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Acceptability of Intervention Measure (AIM) | 3.6 score on a scale | Standard Deviation 0.9 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Acceptability of Intervention Measure (AIM) | 3.4 score on a scale | Standard Deviation 1 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Acceptability of Intervention Measure (AIM) | 3.5 score on a scale | Standard Deviation 1 |
p-value: 0.22ANOVA
Secondary
Feasibility of Intervention Measure (FIM)
This is a four item measure of intervention feasibility, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable, with a total mean score ranging from 1 to 5. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized. High scores indicate higher levels of feasibility. No data displayed because outcome measure data was not collected therefore zero total participants analyzed.
Time frame: Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.
Population: No data displayed because outcome measure has zero total participants analyzed.
Secondary
Intervention Appropriateness Measure (IAM)
This is a four item measure of intervention appropriateness, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. A total mean score ranges from 1 - 5, with higher scores indicating higher appropriateness. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized.
Time frame: Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.
Population: Participants providing IAM usability data at RCT Follow-Up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Mobile Mental Health App - 1 - Calm | Intervention Appropriateness Measure (IAM) | 3.6 score on a scale | Standard Deviation 0.9 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Intervention Appropriateness Measure (IAM) | 3.7 score on a scale | Standard Deviation 0.9 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Intervention Appropriateness Measure (IAM) | 3.6 score on a scale | Standard Deviation 0.9 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Intervention Appropriateness Measure (IAM) | 3.7 score on a scale | Standard Deviation 0.8 |
p-value: 0.48ANOVA
Secondary
Intervention Usability Scale (IUS)
The Intervention Usability Scale (IUS) is a 10-item measure that assesses intervention usability through its likeability, learnability, difficulty, need for support, system integration, and efficiency. The measure is based on the System Usability Scale (SUS), a standardized, normed measure in industry for digital tools. Total scores can range from 0 - 100 with higher scores indicate higher levels of usability.
Time frame: Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.
Population: Participants contributing IUS data at RCT Follow-Up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Mobile Mental Health App - 1 - Calm | Intervention Usability Scale (IUS) | 66.8 score on a scale | Standard Deviation 17.3 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Intervention Usability Scale (IUS) | 71.2 score on a scale | Standard Deviation 15.4 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Intervention Usability Scale (IUS) | 65.2 score on a scale | Standard Deviation 17.7 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Intervention Usability Scale (IUS) | 72.9 score on a scale | Standard Deviation 16.7 |
p-value: <0.0001ANOVA
Other Pre-specified
Brief Resilience Scale (BRS)
The Brief Resilience Scale (BRS) is a 6-item, self-reported measure of an individual's ability to bounce back, resist illness, adapt to stress, or thrive in the face of adversity. Responses for all 6 items are on a scale of 1-5, with a total mean score ranging from 1 to 5. Higher score indicates higher resilience.
Time frame: Participants will complete the BRS at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized.
Population: Participants contributing BRS data at RCT follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Mobile Mental Health App - 1 - Calm | Brief Resilience Scale (BRS) | 2.9 score on a scale | Standard Deviation 0.9 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Brief Resilience Scale (BRS) | 3.0 score on a scale | Standard Deviation 0.9 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Brief Resilience Scale (BRS) | 3.0 score on a scale | Standard Deviation 0.9 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Brief Resilience Scale (BRS) | 3.0 score on a scale | Standard Deviation 1 |
Other Pre-specified
CAGE-AID
Standardized measure of alcohol/drug use with a total score range of 0 - 4. Higher scores indicate higher risk for substance use.
Time frame: Participants will complete the CAGE-AID at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized.
Population: Participants contributing to CAGE-AID data at RCT follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Mobile Mental Health App - 1 - Calm | CAGE-AID | 0.9 score on a scale | Standard Deviation 1.4 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | CAGE-AID | 1.0 score on a scale | Standard Deviation 1.4 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | CAGE-AID | 1.3 score on a scale | Standard Deviation 1.5 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | CAGE-AID | 1.2 score on a scale | Standard Deviation 1.5 |
Other Pre-specified
Defeat Scale
Gilbert and Allan (1998) designed the items on this scale in order to depict a sense of failed struggle and losing rank. This measure requests participants to respond to 16 items on a 5-point Likert scale (ranging from 0 = 'Never' to 4 = 'Always') asking them how much they had felt defeated in the previous seven days, for example item 1 'I feel that I have not made it in life'. This scale has very high internal consistency with Alpha coefficients of 0.94 for females and 0.93 for males in both groups, furthermore reliability of 0.94 for students and 0.93 for depressed group. Total score can range from 0 to 64. Higher scores indicate higher levels of defeat.
Time frame: Participants will complete the Defeat Scale at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized.
Population: Participants contributing Defeat Scale data at RCT follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Mobile Mental Health App - 1 - Calm | Defeat Scale | 28.6 score on a scale | Standard Deviation 15.4 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Defeat Scale | 29.5 score on a scale | Standard Deviation 15.2 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Defeat Scale | 28.8 score on a scale | Standard Deviation 15.2 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Defeat Scale | 27.4 score on a scale | Standard Deviation 16.3 |
Other Pre-specified
Entrapment Scale
This 16-item entrapment scale asks participants to indicate on a 5-point scale the degree to which the items represent their thoughts and feelings. The response options are 0 = 'not at all like me', 1 = 'a little bit like me', 2 = 'moderately like me', 3= 'quite a bit like me' and 4 = 'extremely like me'. Gilbert and Allan (1998) reported high levels of internal consistency for both student and depressed groups, with Cronbach's alphas respectively of .93 and .86 in Internal Entrapment, and .88 and .89 in External Entrapment. Total score can range from 0 to 64. Higher scores indicate higher levels of entrapment.
Time frame: Participants will complete the Entrapment Scale at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized.
Population: Participants contributing entrapment data at RCT follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Mobile Mental Health App - 1 - Calm | Entrapment Scale | 20.6 score on a scale | Standard Deviation 15.1 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Entrapment Scale | 23.2 score on a scale | Standard Deviation 16.7 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Entrapment Scale | 22.8 score on a scale | Standard Deviation 16.7 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Entrapment Scale | 21.7 score on a scale | Standard Deviation 16.7 |
Other Pre-specified
Interpersonal Needs Questionnaire
Brief questionnaire that asks respondents to think about themselves and other people, based on the respondent's current beliefs and experiences. Higher scores indicate higher levels of thwarted belongingness (subscale range 9 to 63) and perceived burdensomeness (subscale range 9 to 63).
Time frame: Participants will complete the Interpersonal Needs Questionnaire at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized.
Population: Participants contributing to interpersonal needs data at RCT follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Mobile Mental Health App - 1 - Calm | Interpersonal Needs Questionnaire | Thwarted Belongingness | 30.8 score on a scale | Standard Deviation 13.5 |
| Phase 2: Mobile Mental Health App - 1 - Calm | Interpersonal Needs Questionnaire | Perceived Burdensomeness | 22.8 score on a scale | Standard Deviation 12.9 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Interpersonal Needs Questionnaire | Perceived Burdensomeness | 25.7 score on a scale | Standard Deviation 13.8 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | Interpersonal Needs Questionnaire | Thwarted Belongingness | 32.3 score on a scale | Standard Deviation 12.4 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Interpersonal Needs Questionnaire | Thwarted Belongingness | 32.8 score on a scale | Standard Deviation 13.3 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | Interpersonal Needs Questionnaire | Perceived Burdensomeness | 25.1 score on a scale | Standard Deviation 13.7 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Interpersonal Needs Questionnaire | Thwarted Belongingness | 30.3 score on a scale | Standard Deviation 13.1 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | Interpersonal Needs Questionnaire | Perceived Burdensomeness | 23.4 score on a scale | Standard Deviation 13.6 |
Other Pre-specified
Loneliness and Social Distress Scale
No data displayed because outcome measure data was not collected therefore zero total participants analyzed.
Time frame: Loneliness and Social Distress Scale at 4 weeks
Population: No data displayed because outcome measure has zero total participants analyzed.
Other Pre-specified
PARS EQ-5D
Standardized measure of health status with a total score range of 0 - 1. Maximum score of one indicates the best health state.
Time frame: PARS EQ-5D at RCT baseline and RCT follow-up; duration of 4 weeks.
Population: Participants providing both RCT baseline and RCT follow-up data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Mobile Mental Health App - 1 - Calm | PARS EQ-5D | RCT Baseline | 0.8 score on a scale | Standard Deviation 0.1 |
| Phase 2: Mobile Mental Health App - 1 - Calm | PARS EQ-5D | RCT Follow-Up | 0.8 score on a scale | Standard Deviation 0.1 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | PARS EQ-5D | RCT Follow-Up | 0.8 score on a scale | Standard Deviation 0.2 |
| Phase 2: Mobile Mental Health App - 2 - Covid Coach | PARS EQ-5D | RCT Baseline | 0.7 score on a scale | Standard Deviation 0.2 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | PARS EQ-5D | RCT Baseline | 0.8 score on a scale | Standard Deviation 0.2 |
| Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea | PARS EQ-5D | RCT Follow-Up | 0.8 score on a scale | Standard Deviation 0.2 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | PARS EQ-5D | RCT Baseline | 0.8 score on a scale | Standard Deviation 0.1 |
| Phase 2: Mobile Mental Health App - 4 - Beautiful Mood | PARS EQ-5D | RCT Follow-Up | 0.8 score on a scale | Standard Deviation 0.1 |