Trial Outcomes & Findings for Mobile Mental Health Apps for Suicide Prevention (NCT NCT04536935)
NCT ID: NCT04536935
Last Updated: 2022-10-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
838 participants
Primary outcome timeframe
PHQ-9 at RCT baseline and RCT follow-up; duration of 4 weeks.
Results posted on
2022-10-20
Participant Flow
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.
Participant milestones
| Measure |
Phase 2: Mobile Mental Health App - 1 - Calm
Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation
|
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
|
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.
|
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
|
|---|---|---|---|---|
|
RCT Baseline
STARTED
|
204
|
212
|
209
|
213
|
|
RCT Baseline
COMPLETED
|
204
|
212
|
209
|
213
|
|
RCT Baseline
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
RCT Follow-Up
STARTED
|
204
|
212
|
209
|
213
|
|
RCT Follow-Up
COMPLETED
|
155
|
168
|
152
|
168
|
|
RCT Follow-Up
NOT COMPLETED
|
49
|
44
|
57
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant did not provide age information.
Baseline characteristics by cohort
| Measure |
Phase 2: Mobile Mental Health App - 1 - Calm
n=204 Participants
Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation
|
Phase 2: Mobile Mental Health App - 2 - COVID Coach
n=212 Participants
Mobile Mental Health App - 2: Free mobile mental health application that assists with coping with COVID-19
|
Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea
n=209 Participants
Mobile Mental Health App - 3: Free mobile mental health application that focuses on positive psychology.
|
Phase 2: Mobile Mental Health App - 4 - Beautiful Mood
n=213 Participants
Mobile Mental Health App - 4: Free mobile application that addresses mental health issues through mood tracking
|
Total
n=838 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 10.0 • n=204 Participants • One participant did not provide age information.
|
29.9 years
STANDARD_DEVIATION 8.2 • n=212 Participants • One participant did not provide age information.
|
31.4 years
STANDARD_DEVIATION 9.4 • n=208 Participants • One participant did not provide age information.
|
31.8 years
STANDARD_DEVIATION 10.1 • n=213 Participants • One participant did not provide age information.
|
31.1 years
STANDARD_DEVIATION 9.5 • n=837 Participants • One participant did not provide age information.
|
|
Sex/Gender, Customized
Gender · Women
|
118 Participants
n=204 Participants • A total of five participants did not provide gender data.
|
118 Participants
n=209 Participants • A total of five participants did not provide gender data.
|
115 Participants
n=208 Participants • A total of five participants did not provide gender data.
|
116 Participants
n=212 Participants • A total of five participants did not provide gender data.
|
467 Participants
n=833 Participants • A total of five participants did not provide gender data.
|
|
Sex/Gender, Customized
Gender · Gender Diverse
|
1 Participants
n=204 Participants • A total of five participants did not provide gender data.
|
1 Participants
n=209 Participants • A total of five participants did not provide gender data.
|
2 Participants
n=208 Participants • A total of five participants did not provide gender data.
|
0 Participants
n=212 Participants • A total of five participants did not provide gender data.
|
4 Participants
n=833 Participants • A total of five participants did not provide gender data.
|
|
Sex/Gender, Customized
Gender · Men
|
78 Participants
n=204 Participants • A total of five participants did not provide gender data.
|
80 Participants
n=209 Participants • A total of five participants did not provide gender data.
|
83 Participants
n=208 Participants • A total of five participants did not provide gender data.
|
85 Participants
n=212 Participants • A total of five participants did not provide gender data.
|
326 Participants
n=833 Participants • A total of five participants did not provide gender data.
|
|
Sex/Gender, Customized
Gender · Non-binary
|
7 Participants
n=204 Participants • A total of five participants did not provide gender data.
|
7 Participants
n=209 Participants • A total of five participants did not provide gender data.
|
7 Participants
n=208 Participants • A total of five participants did not provide gender data.
|
10 Participants
n=212 Participants • A total of five participants did not provide gender data.
|
31 Participants
n=833 Participants • A total of five participants did not provide gender data.
|
|
Sex/Gender, Customized
Gender · Transgender
|
0 Participants
n=204 Participants • A total of five participants did not provide gender data.
|
3 Participants
n=209 Participants • A total of five participants did not provide gender data.
|
1 Participants
n=208 Participants • A total of five participants did not provide gender data.
|
1 Participants
n=212 Participants • A total of five participants did not provide gender data.
|
5 Participants
n=833 Participants • A total of five participants did not provide gender data.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=204 Participants
|
17 Participants
n=212 Participants
|
19 Participants
n=209 Participants
|
23 Participants
n=213 Participants
|
80 Participants
n=838 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
183 Participants
n=204 Participants
|
190 Participants
n=212 Participants
|
189 Participants
n=209 Participants
|
188 Participants
n=213 Participants
|
750 Participants
n=838 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=204 Participants
|
5 Participants
n=212 Participants
|
1 Participants
n=209 Participants
|
2 Participants
n=213 Participants
|
8 Participants
n=838 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=204 Participants
|
2 Participants
n=212 Participants
|
0 Participants
n=209 Participants
|
3 Participants
n=213 Participants
|
8 Participants
n=838 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=204 Participants
|
23 Participants
n=212 Participants
|
13 Participants
n=209 Participants
|
22 Participants
n=213 Participants
|
84 Participants
n=838 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=204 Participants
|
0 Participants
n=212 Participants
|
0 Participants
n=209 Participants
|
0 Participants
n=213 Participants
|
0 Participants
n=838 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=204 Participants
|
20 Participants
n=212 Participants
|
12 Participants
n=209 Participants
|
15 Participants
n=213 Participants
|
58 Participants
n=838 Participants
|
|
Race (NIH/OMB)
White
|
149 Participants
n=204 Participants
|
142 Participants
n=212 Participants
|
169 Participants
n=209 Participants
|
156 Participants
n=213 Participants
|
616 Participants
n=838 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=204 Participants
|
18 Participants
n=212 Participants
|
12 Participants
n=209 Participants
|
13 Participants
n=213 Participants
|
53 Participants
n=838 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=204 Participants
|
7 Participants
n=212 Participants
|
3 Participants
n=209 Participants
|
4 Participants
n=213 Participants
|
19 Participants
n=838 Participants
|
|
Marital Status
Divorced
|
10 Participants
n=203 Participants • Nine participants did not provide marital status data.
|
11 Participants
n=209 Participants • Nine participants did not provide marital status data.
|
17 Participants
n=207 Participants • Nine participants did not provide marital status data.
|
14 Participants
n=210 Participants • Nine participants did not provide marital status data.
|
52 Participants
n=829 Participants • Nine participants did not provide marital status data.
|
|
Marital Status
Married (including same sex partnership)
|
56 Participants
n=203 Participants • Nine participants did not provide marital status data.
|
56 Participants
n=209 Participants • Nine participants did not provide marital status data.
|
61 Participants
n=207 Participants • Nine participants did not provide marital status data.
|
61 Participants
n=210 Participants • Nine participants did not provide marital status data.
|
234 Participants
n=829 Participants • Nine participants did not provide marital status data.
|
|
Marital Status
Never marred
|
131 Participants
n=203 Participants • Nine participants did not provide marital status data.
|
136 Participants
n=209 Participants • Nine participants did not provide marital status data.
|
123 Participants
n=207 Participants • Nine participants did not provide marital status data.
|
134 Participants
n=210 Participants • Nine participants did not provide marital status data.
|
524 Participants
n=829 Participants • Nine participants did not provide marital status data.
|
|
Marital Status
Separated
|
4 Participants
n=203 Participants • Nine participants did not provide marital status data.
|
6 Participants
n=209 Participants • Nine participants did not provide marital status data.
|
3 Participants
n=207 Participants • Nine participants did not provide marital status data.
|
1 Participants
n=210 Participants • Nine participants did not provide marital status data.
|
14 Participants
n=829 Participants • Nine participants did not provide marital status data.
|
|
Marital Status
Widowed
|
2 Participants
n=203 Participants • Nine participants did not provide marital status data.
|
0 Participants
n=209 Participants • Nine participants did not provide marital status data.
|
3 Participants
n=207 Participants • Nine participants did not provide marital status data.
|
0 Participants
n=210 Participants • Nine participants did not provide marital status data.
|
5 Participants
n=829 Participants • Nine participants did not provide marital status data.
|
|
Education
High School GED, or less
|
27 Participants
n=204 Participants • One participant did not provide education data.
|
28 Participants
n=211 Participants • One participant did not provide education data.
|
23 Participants
n=209 Participants • One participant did not provide education data.
|
22 Participants
n=213 Participants • One participant did not provide education data.
|
100 Participants
n=837 Participants • One participant did not provide education data.
|
|
Education
Some college
|
54 Participants
n=204 Participants • One participant did not provide education data.
|
50 Participants
n=211 Participants • One participant did not provide education data.
|
51 Participants
n=209 Participants • One participant did not provide education data.
|
74 Participants
n=213 Participants • One participant did not provide education data.
|
229 Participants
n=837 Participants • One participant did not provide education data.
|
|
Education
Trade/Technical/Vocational
|
25 Participants
n=204 Participants • One participant did not provide education data.
|
27 Participants
n=211 Participants • One participant did not provide education data.
|
32 Participants
n=209 Participants • One participant did not provide education data.
|
19 Participants
n=213 Participants • One participant did not provide education data.
|
103 Participants
n=837 Participants • One participant did not provide education data.
|
|
Education
Bachelor's Degree
|
65 Participants
n=204 Participants • One participant did not provide education data.
|
73 Participants
n=211 Participants • One participant did not provide education data.
|
67 Participants
n=209 Participants • One participant did not provide education data.
|
64 Participants
n=213 Participants • One participant did not provide education data.
|
269 Participants
n=837 Participants • One participant did not provide education data.
|
|
Education
Higher Education
|
33 Participants
n=204 Participants • One participant did not provide education data.
|
33 Participants
n=211 Participants • One participant did not provide education data.
|
36 Participants
n=209 Participants • One participant did not provide education data.
|
34 Participants
n=213 Participants • One participant did not provide education data.
|
136 Participants
n=837 Participants • One participant did not provide education data.
|
|
Income
Below $10K
|
31 Participants
n=203 Participants • A total of ten participants did not provide income data.
|
37 Participants
n=206 Participants • A total of ten participants did not provide income data.
|
30 Participants
n=207 Participants • A total of ten participants did not provide income data.
|
30 Participants
n=212 Participants • A total of ten participants did not provide income data.
|
128 Participants
n=828 Participants • A total of ten participants did not provide income data.
|
|
Income
$10,000 - $31,199
|
58 Participants
n=203 Participants • A total of ten participants did not provide income data.
|
56 Participants
n=206 Participants • A total of ten participants did not provide income data.
|
53 Participants
n=207 Participants • A total of ten participants did not provide income data.
|
60 Participants
n=212 Participants • A total of ten participants did not provide income data.
|
227 Participants
n=828 Participants • A total of ten participants did not provide income data.
|
|
Income
$31,200 - $33,280
|
5 Participants
n=203 Participants • A total of ten participants did not provide income data.
|
17 Participants
n=206 Participants • A total of ten participants did not provide income data.
|
8 Participants
n=207 Participants • A total of ten participants did not provide income data.
|
17 Participants
n=212 Participants • A total of ten participants did not provide income data.
|
47 Participants
n=828 Participants • A total of ten participants did not provide income data.
|
|
Income
$33,281 - $49,999
|
31 Participants
n=203 Participants • A total of ten participants did not provide income data.
|
31 Participants
n=206 Participants • A total of ten participants did not provide income data.
|
31 Participants
n=207 Participants • A total of ten participants did not provide income data.
|
29 Participants
n=212 Participants • A total of ten participants did not provide income data.
|
122 Participants
n=828 Participants • A total of ten participants did not provide income data.
|
|
Income
$50,000 - $59,999
|
23 Participants
n=203 Participants • A total of ten participants did not provide income data.
|
16 Participants
n=206 Participants • A total of ten participants did not provide income data.
|
17 Participants
n=207 Participants • A total of ten participants did not provide income data.
|
11 Participants
n=212 Participants • A total of ten participants did not provide income data.
|
67 Participants
n=828 Participants • A total of ten participants did not provide income data.
|
|
Income
$60,000 - $69,999
|
14 Participants
n=203 Participants • A total of ten participants did not provide income data.
|
10 Participants
n=206 Participants • A total of ten participants did not provide income data.
|
14 Participants
n=207 Participants • A total of ten participants did not provide income data.
|
10 Participants
n=212 Participants • A total of ten participants did not provide income data.
|
48 Participants
n=828 Participants • A total of ten participants did not provide income data.
|
|
Income
$70,000 - $99,999
|
20 Participants
n=203 Participants • A total of ten participants did not provide income data.
|
19 Participants
n=206 Participants • A total of ten participants did not provide income data.
|
27 Participants
n=207 Participants • A total of ten participants did not provide income data.
|
34 Participants
n=212 Participants • A total of ten participants did not provide income data.
|
100 Participants
n=828 Participants • A total of ten participants did not provide income data.
|
|
Income
$100,000 - $149,999
|
11 Participants
n=203 Participants • A total of ten participants did not provide income data.
|
15 Participants
n=206 Participants • A total of ten participants did not provide income data.
|
14 Participants
n=207 Participants • A total of ten participants did not provide income data.
|
14 Participants
n=212 Participants • A total of ten participants did not provide income data.
|
54 Participants
n=828 Participants • A total of ten participants did not provide income data.
|
|
Income
$150,000 or above
|
10 Participants
n=203 Participants • A total of ten participants did not provide income data.
|
5 Participants
n=206 Participants • A total of ten participants did not provide income data.
|
13 Participants
n=207 Participants • A total of ten participants did not provide income data.
|
7 Participants
n=212 Participants • A total of ten participants did not provide income data.
|
35 Participants
n=828 Participants • A total of ten participants did not provide income data.
|
PRIMARY outcome
Timeframe: PHQ-9 at RCT baseline and RCT follow-up; duration of 4 weeks.Population: Participants providing both RCT baseline and RCT follow-up data.
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.
Outcome measures
| Measure |
Phase 2: Mobile Mental Health App - 1 - Calm
n=155 Participants
Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation
|
Phase 2: Mobile Mental Health App - 2 - Covid Coach
n=166 Participants
Mobile Mental Health App - 2: Free mobile mental health application that assists with coping with COVID-19
|
Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea
n=151 Participants
Mobile Mental Health App - 3: Free mobile mental health application that focuses on positive psychology.
|
Phase 2: Mobile Mental Health App - 4 - Beautiful Mood
n=165 Participants
Mobile Mental Health App - 4: Free mobile application that addresses mental health issues through mood tracking
|
|---|---|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
RCT Baseline
|
10.1 score on a scale
Standard Deviation 5.7
|
11.2 score on a scale
Standard Deviation 6.3
|
11.0 score on a scale
Standard Deviation 6.5
|
10.6 score on a scale
Standard Deviation 6.6
|
|
Patient Health Questionnaire (PHQ-9)
RCT Follow-Up
|
8.5 score on a scale
Standard Deviation 5.9
|
9.8 score on a scale
Standard Deviation 6.7
|
9.7 score on a scale
Standard Deviation 6.6
|
9.1 score on a scale
Standard Deviation 6.5
|
PRIMARY outcome
Timeframe: GAD-7 at RCT baseline and RCT follow-up; duration of 4 weeks.Population: Participants providing both RCT baseline and RCT follow-up data.
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.
Outcome measures
| Measure |
Phase 2: Mobile Mental Health App - 1 - Calm
n=153 Participants
Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation
|
Phase 2: Mobile Mental Health App - 2 - Covid Coach
n=168 Participants
Mobile Mental Health App - 2: Free mobile mental health application that assists with coping with COVID-19
|
Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea
n=151 Participants
Mobile Mental Health App - 3: Free mobile mental health application that focuses on positive psychology.
|
Phase 2: Mobile Mental Health App - 4 - Beautiful Mood
n=167 Participants
Mobile Mental Health App - 4: Free mobile application that addresses mental health issues through mood tracking
|
|---|---|---|---|---|
|
Generalized Anxiety Disorder (7-Item) Scale (GAD-7)
RCT Baseline
|
7.9 score on a scale
Standard Deviation 4.8
|
9.2 score on a scale
Standard Deviation 5.6
|
8.9 score on a scale
Standard Deviation 5.6
|
8.8 score on a scale
Standard Deviation 5.7
|
|
Generalized Anxiety Disorder (7-Item) Scale (GAD-7)
RCT Follow-Up
|
6.7 score on a scale
Standard Deviation 5.1
|
7.8 score on a scale
Standard Deviation 5.6
|
7.3 score on a scale
Standard Deviation 5.8
|
7.8 score on a scale
Standard Deviation 5.6
|
PRIMARY outcome
Timeframe: DERS at RCT baseline and RCT follow-up; duration of four weeks.Population: Participants providing both RCT baseline and RCT follow-up data.
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.
Outcome measures
| Measure |
Phase 2: Mobile Mental Health App - 1 - Calm
n=153 Participants
Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation
|
Phase 2: Mobile Mental Health App - 2 - Covid Coach
n=163 Participants
Mobile Mental Health App - 2: Free mobile mental health application that assists with coping with COVID-19
|
Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea
n=148 Participants
Mobile Mental Health App - 3: Free mobile mental health application that focuses on positive psychology.
|
Phase 2: Mobile Mental Health App - 4 - Beautiful Mood
n=165 Participants
Mobile Mental Health App - 4: Free mobile application that addresses mental health issues through mood tracking
|
|---|---|---|---|---|
|
Brief Difficulties With Emotional Regulation Scale (DERS)
RCT Baseline
|
42.8 score on a scale
Standard Deviation 11.7
|
44.6 score on a scale
Standard Deviation 12.5
|
44.6 score on a scale
Standard Deviation 12.8
|
44.5 score on a scale
Standard Deviation 13.0
|
|
Brief Difficulties With Emotional Regulation Scale (DERS)
RCT Follow-Up
|
42.2 score on a scale
Standard Deviation 13.1
|
44.6 score on a scale
Standard Deviation 14.0
|
44.9 score on a scale
Standard Deviation 13.0
|
44.6 score on a scale
Standard Deviation 14.2
|
PRIMARY outcome
Timeframe: SBQ-R RCT baseline and RCT follow-up; duration of four weeks.Population: Participants providing both RCT baseline and RCT follow-up data.
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.
Outcome measures
| Measure |
Phase 2: Mobile Mental Health App - 1 - Calm
n=144 Participants
Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation
|
Phase 2: Mobile Mental Health App - 2 - Covid Coach
n=159 Participants
Mobile Mental Health App - 2: Free mobile mental health application that assists with coping with COVID-19
|
Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea
n=139 Participants
Mobile Mental Health App - 3: Free mobile mental health application that focuses on positive psychology.
|
Phase 2: Mobile Mental Health App - 4 - Beautiful Mood
n=154 Participants
Mobile Mental Health App - 4: Free mobile application that addresses mental health issues through mood tracking
|
|---|---|---|---|---|
|
Suicidal Behavioral Questionnaire-Revised (SBQ-R)
RCT Baseline
|
6.6 score on a scale
Standard Deviation 3.3
|
6.9 score on a scale
Standard Deviation 3.8
|
7.1 score on a scale
Standard Deviation 3.9
|
7.1 score on a scale
Standard Deviation 3.6
|
|
Suicidal Behavioral Questionnaire-Revised (SBQ-R)
RCT Follow-Up
|
6.4 score on a scale
Standard Deviation 3.3
|
6.7 score on a scale
Standard Deviation 3.7
|
7.1 score on a scale
Standard Deviation 3.9
|
7.0 score on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Phase 2: Mobile Mental Health App - 1 - Calm
n=152 Participants
Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation
|
Phase 2: Mobile Mental Health App - 2 - Covid Coach
n=164 Participants
Mobile Mental Health App - 2: Free mobile mental health application that assists with coping with COVID-19
|
Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea
n=150 Participants
Mobile Mental Health App - 3: Free mobile mental health application that focuses on positive psychology.
|
Phase 2: Mobile Mental Health App - 4 - Beautiful Mood
n=165 Participants
Mobile Mental Health App - 4: Free mobile application that addresses mental health issues through mood tracking
|
|---|---|---|---|---|
|
Acceptability of Intervention Measure (AIM)
|
3.4 score on a scale
Standard Deviation 1.0
|
3.6 score on a scale
Standard Deviation 0.9
|
3.4 score on a scale
Standard Deviation 1.0
|
3.5 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Phase 2: Mobile Mental Health App - 1 - Calm
n=152 Participants
Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation
|
Phase 2: Mobile Mental Health App - 2 - Covid Coach
n=166 Participants
Mobile Mental Health App - 2: Free mobile mental health application that assists with coping with COVID-19
|
Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea
n=152 Participants
Mobile Mental Health App - 3: Free mobile mental health application that focuses on positive psychology.
|
Phase 2: Mobile Mental Health App - 4 - Beautiful Mood
n=162 Participants
Mobile Mental Health App - 4: Free mobile application that addresses mental health issues through mood tracking
|
|---|---|---|---|---|
|
Intervention Appropriateness Measure (IAM)
|
3.6 score on a scale
Standard Deviation 0.9
|
3.7 score on a scale
Standard Deviation 0.9
|
3.6 score on a scale
Standard Deviation 0.9
|
3.7 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Phase 2: Mobile Mental Health App - 1 - Calm
n=155 Participants
Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation
|
Phase 2: Mobile Mental Health App - 2 - Covid Coach
n=167 Participants
Mobile Mental Health App - 2: Free mobile mental health application that assists with coping with COVID-19
|
Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea
n=152 Participants
Mobile Mental Health App - 3: Free mobile mental health application that focuses on positive psychology.
|
Phase 2: Mobile Mental Health App - 4 - Beautiful Mood
n=166 Participants
Mobile Mental Health App - 4: Free mobile application that addresses mental health issues through mood tracking
|
|---|---|---|---|---|
|
Intervention Usability Scale (IUS)
|
66.8 score on a scale
Standard Deviation 17.3
|
71.2 score on a scale
Standard Deviation 15.4
|
65.2 score on a scale
Standard Deviation 17.7
|
72.9 score on a scale
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Standardized measure of health status with a total score range of 0 - 1. Maximum score of one indicates the best health state.
Outcome measures
| Measure |
Phase 2: Mobile Mental Health App - 1 - Calm
n=153 Participants
Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation
|
Phase 2: Mobile Mental Health App - 2 - Covid Coach
n=167 Participants
Mobile Mental Health App - 2: Free mobile mental health application that assists with coping with COVID-19
|
Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea
n=150 Participants
Mobile Mental Health App - 3: Free mobile mental health application that focuses on positive psychology.
|
Phase 2: Mobile Mental Health App - 4 - Beautiful Mood
n=165 Participants
Mobile Mental Health App - 4: Free mobile application that addresses mental health issues through mood tracking
|
|---|---|---|---|---|
|
PARS EQ-5D
RCT Baseline
|
0.8 score on a scale
Standard Deviation 0.1
|
0.7 score on a scale
Standard Deviation 0.2
|
0.8 score on a scale
Standard Deviation 0.2
|
0.8 score on a scale
Standard Deviation 0.1
|
|
PARS EQ-5D
RCT Follow-Up
|
0.8 score on a scale
Standard Deviation 0.1
|
0.8 score on a scale
Standard Deviation 0.2
|
0.8 score on a scale
Standard Deviation 0.2
|
0.8 score on a scale
Standard Deviation 0.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Standardized measure of alcohol/drug use with a total score range of 0 - 4. Higher scores indicate higher risk for substance use.
Outcome measures
| Measure |
Phase 2: Mobile Mental Health App - 1 - Calm
n=152 Participants
Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation
|
Phase 2: Mobile Mental Health App - 2 - Covid Coach
n=162 Participants
Mobile Mental Health App - 2: Free mobile mental health application that assists with coping with COVID-19
|
Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea
n=146 Participants
Mobile Mental Health App - 3: Free mobile mental health application that focuses on positive psychology.
|
Phase 2: Mobile Mental Health App - 4 - Beautiful Mood
n=160 Participants
Mobile Mental Health App - 4: Free mobile application that addresses mental health issues through mood tracking
|
|---|---|---|---|---|
|
CAGE-AID
|
0.9 score on a scale
Standard Deviation 1.4
|
1.0 score on a scale
Standard Deviation 1.4
|
1.3 score on a scale
Standard Deviation 1.5
|
1.2 score on a scale
Standard Deviation 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Phase 2: Mobile Mental Health App - 1 - Calm
n=155 Participants
Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation
|
Phase 2: Mobile Mental Health App - 2 - Covid Coach
n=168 Participants
Mobile Mental Health App - 2: Free mobile mental health application that assists with coping with COVID-19
|
Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea
n=151 Participants
Mobile Mental Health App - 3: Free mobile mental health application that focuses on positive psychology.
|
Phase 2: Mobile Mental Health App - 4 - Beautiful Mood
n=166 Participants
Mobile Mental Health App - 4: Free mobile application that addresses mental health issues through mood tracking
|
|---|---|---|---|---|
|
Brief Resilience Scale (BRS)
|
2.9 score on a scale
Standard Deviation 0.9
|
3.0 score on a scale
Standard Deviation 0.9
|
3.0 score on a scale
Standard Deviation 0.9
|
3.0 score on a scale
Standard Deviation 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Phase 2: Mobile Mental Health App - 1 - Calm
n=155 Participants
Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation
|
Phase 2: Mobile Mental Health App - 2 - Covid Coach
n=167 Participants
Mobile Mental Health App - 2: Free mobile mental health application that assists with coping with COVID-19
|
Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea
n=152 Participants
Mobile Mental Health App - 3: Free mobile mental health application that focuses on positive psychology.
|
Phase 2: Mobile Mental Health App - 4 - Beautiful Mood
n=167 Participants
Mobile Mental Health App - 4: Free mobile application that addresses mental health issues through mood tracking
|
|---|---|---|---|---|
|
Defeat Scale
|
28.6 score on a scale
Standard Deviation 15.4
|
29.5 score on a scale
Standard Deviation 15.2
|
28.8 score on a scale
Standard Deviation 15.2
|
27.4 score on a scale
Standard Deviation 16.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Phase 2: Mobile Mental Health App - 1 - Calm
n=154 Participants
Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation
|
Phase 2: Mobile Mental Health App - 2 - Covid Coach
n=168 Participants
Mobile Mental Health App - 2: Free mobile mental health application that assists with coping with COVID-19
|
Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea
n=152 Participants
Mobile Mental Health App - 3: Free mobile mental health application that focuses on positive psychology.
|
Phase 2: Mobile Mental Health App - 4 - Beautiful Mood
n=167 Participants
Mobile Mental Health App - 4: Free mobile application that addresses mental health issues through mood tracking
|
|---|---|---|---|---|
|
Entrapment Scale
|
20.6 score on a scale
Standard Deviation 15.1
|
23.2 score on a scale
Standard Deviation 16.7
|
22.8 score on a scale
Standard Deviation 16.7
|
21.7 score on a scale
Standard Deviation 16.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Phase 2: Mobile Mental Health App - 1 - Calm
n=155 Participants
Mobile Mental Health App - 1: Free mobile mental health application that focuses on meditation
|
Phase 2: Mobile Mental Health App - 2 - Covid Coach
n=168 Participants
Mobile Mental Health App - 2: Free mobile mental health application that assists with coping with COVID-19
|
Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea
n=152 Participants
Mobile Mental Health App - 3: Free mobile mental health application that focuses on positive psychology.
|
Phase 2: Mobile Mental Health App - 4 - Beautiful Mood
n=168 Participants
Mobile Mental Health App - 4: Free mobile application that addresses mental health issues through mood tracking
|
|---|---|---|---|---|
|
Interpersonal Needs Questionnaire
Thwarted Belongingness
|
30.8 score on a scale
Standard Deviation 13.5
|
32.3 score on a scale
Standard Deviation 12.4
|
32.8 score on a scale
Standard Deviation 13.3
|
30.3 score on a scale
Standard Deviation 13.1
|
|
Interpersonal Needs Questionnaire
Perceived Burdensomeness
|
22.8 score on a scale
Standard Deviation 12.9
|
25.7 score on a scale
Standard Deviation 13.8
|
25.1 score on a scale
Standard Deviation 13.7
|
23.4 score on a scale
Standard Deviation 13.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Loneliness and Social Distress Scale at 4 weeksPopulation: No data displayed because outcome measure has zero total participants analyzed.
No data displayed because outcome measure data was not collected therefore zero total participants analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Phase 2: Mobile Mental Health App - 1 - Calm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2: Mobile Mental Health App - 2 - COVID Coach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2: Mobile Mental Health App - 3 - 7 Cups of Tea
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2: Mobile Mental Health App - 4 - Beautiful Mood
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place