Trial Outcomes & Findings for App-based Mental Health Promotion in Young European Adults (NCT NCT04148508)
NCT ID: NCT04148508
Last Updated: 2024-12-09
Results Overview
WEMWBS Well-being questionnaire (Tennant et al., 2007; Stewart-Brown et al., 2009) Uni-dimensional scale. Higher scores indicate greater well-being. Scale range 0 to 70 where 70 represents high well-being.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3794 participants
Primary outcome timeframe
Primary outcome endpoint at 3 months
Results posted on
2024-12-09
Participant Flow
Participant milestones
| Measure |
PROMOTE Trial Tailored Emotional Competence
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Plus Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample: A normal sample not showing symptoms of poor mental wellbeing
|
PROMOTE Trial Cognitive-behavioural Approach
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Plus Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample: A normal sample not showing symptoms of poor mental wellbeing
|
PROMOTE Trial Self-monitoring
PROMOTE Trial Self-help: self-monitoring delivered via mobile app
Only Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample: A normal sample not showing symptoms of poor mental wellbeing
|
PREVENT Trial Tailored Emotional Competence
PREVENT Trial: Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Plus Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample: A sub-clinical sample reporting some symptoms poor mental health
|
PREVENT Trial Cognitive Behavioural Approach
PREVENT Trial: Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Plus Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample: A sub-clinical sample reporting some symptoms poor mental health
|
PREVENT Trial Self-Monitoring
PREVENT Trial Self-help: self-monitoring delivered via mobile app
Only Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample: A sub-clinical sample reporting some symptoms poor mental health
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
847
|
841
|
844
|
417
|
423
|
422
|
|
Overall Study
1 Month Follow up
|
449
|
457
|
475
|
208
|
212
|
209
|
|
Overall Study
3 Month Follow up
|
425
|
443
|
447
|
178
|
191
|
199
|
|
Overall Study
12 Month Follow up
|
410
|
426
|
424
|
176
|
174
|
186
|
|
Overall Study
COMPLETED
|
410
|
426
|
424
|
176
|
174
|
186
|
|
Overall Study
NOT COMPLETED
|
437
|
415
|
420
|
241
|
249
|
236
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There was a small proportion of participants for whom no exact age data was recorded. These participants did confirm that they were in the 16 to 22 age group in their consent form, however their specific age was not recorded due to a technical fault with our system. We have exact age for PROMOTE EC 843, CBT 837, SM 837, PREVENT EC 412, CBT 422, EC 419, however all participants were used in the analysis as all confirmed they were in the 16-22 age group.
Baseline characteristics by cohort
| Measure |
PROMOTE Trial Tailored Emotional Competence
n=847 Participants
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did not show symptoms of poor mental health at baseline
|
PROMOTE Trial Cognitive-behavioural Approach
n=841 Participants
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample did not show symptoms of poor mental health at baseline
|
PROMOTE Trial Self-monitoring
n=844 Participants
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did not show symptoms of poor mental health at baseline
|
PREVENT Trial Tailored
n=417 Participants
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did show symptoms of poor mental health at baseline
|
PREVENT Trial Cognitive-
n=423 Participants
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample did show symptoms of poor mental health at baseline
|
PREVENT Trial Self-monitoring
n=422 Participants
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did show symptoms of poor mental health at baseline
|
Total
n=3794 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Age
|
19.2 years
STANDARD_DEVIATION 1.9 • n=843 Participants • There was a small proportion of participants for whom no exact age data was recorded. These participants did confirm that they were in the 16 to 22 age group in their consent form, however their specific age was not recorded due to a technical fault with our system. We have exact age for PROMOTE EC 843, CBT 837, SM 837, PREVENT EC 412, CBT 422, EC 419, however all participants were used in the analysis as all confirmed they were in the 16-22 age group.
|
19.2 years
STANDARD_DEVIATION 1.9 • n=837 Participants • There was a small proportion of participants for whom no exact age data was recorded. These participants did confirm that they were in the 16 to 22 age group in their consent form, however their specific age was not recorded due to a technical fault with our system. We have exact age for PROMOTE EC 843, CBT 837, SM 837, PREVENT EC 412, CBT 422, EC 419, however all participants were used in the analysis as all confirmed they were in the 16-22 age group.
|
19 years
STANDARD_DEVIATION 1.8 • n=837 Participants • There was a small proportion of participants for whom no exact age data was recorded. These participants did confirm that they were in the 16 to 22 age group in their consent form, however their specific age was not recorded due to a technical fault with our system. We have exact age for PROMOTE EC 843, CBT 837, SM 837, PREVENT EC 412, CBT 422, EC 419, however all participants were used in the analysis as all confirmed they were in the 16-22 age group.
|
18.8 years
STANDARD_DEVIATION 2.0 • n=412 Participants • There was a small proportion of participants for whom no exact age data was recorded. These participants did confirm that they were in the 16 to 22 age group in their consent form, however their specific age was not recorded due to a technical fault with our system. We have exact age for PROMOTE EC 843, CBT 837, SM 837, PREVENT EC 412, CBT 422, EC 419, however all participants were used in the analysis as all confirmed they were in the 16-22 age group.
|
18.8 years
STANDARD_DEVIATION 2.0 • n=422 Participants • There was a small proportion of participants for whom no exact age data was recorded. These participants did confirm that they were in the 16 to 22 age group in their consent form, however their specific age was not recorded due to a technical fault with our system. We have exact age for PROMOTE EC 843, CBT 837, SM 837, PREVENT EC 412, CBT 422, EC 419, however all participants were used in the analysis as all confirmed they were in the 16-22 age group.
|
18.8 years
STANDARD_DEVIATION 1.9 • n=419 Participants • There was a small proportion of participants for whom no exact age data was recorded. These participants did confirm that they were in the 16 to 22 age group in their consent form, however their specific age was not recorded due to a technical fault with our system. We have exact age for PROMOTE EC 843, CBT 837, SM 837, PREVENT EC 412, CBT 422, EC 419, however all participants were used in the analysis as all confirmed they were in the 16-22 age group.
|
19 years
STANDARD_DEVIATION 1.9 • n=3770 Participants • There was a small proportion of participants for whom no exact age data was recorded. These participants did confirm that they were in the 16 to 22 age group in their consent form, however their specific age was not recorded due to a technical fault with our system. We have exact age for PROMOTE EC 843, CBT 837, SM 837, PREVENT EC 412, CBT 422, EC 419, however all participants were used in the analysis as all confirmed they were in the 16-22 age group.
|
|
Sex/Gender, Customized
Male
|
220 Participants
n=847 Participants
|
191 Participants
n=841 Participants
|
202 Participants
n=844 Participants
|
86 Participants
n=417 Participants
|
74 Participants
n=423 Participants
|
93 Participants
n=422 Participants
|
866 Participants
n=3794 Participants
|
|
Sex/Gender, Customized
Female
|
621 Participants
n=847 Participants
|
642 Participants
n=841 Participants
|
633 Participants
n=844 Participants
|
323 Participants
n=417 Participants
|
339 Participants
n=423 Participants
|
322 Participants
n=422 Participants
|
2880 Participants
n=3794 Participants
|
|
Sex/Gender, Customized
Neither
|
3 Participants
n=847 Participants
|
7 Participants
n=841 Participants
|
6 Participants
n=844 Participants
|
4 Participants
n=417 Participants
|
8 Participants
n=423 Participants
|
3 Participants
n=422 Participants
|
31 Participants
n=3794 Participants
|
|
Sex/Gender, Customized
Both
|
3 Participants
n=847 Participants
|
1 Participants
n=841 Participants
|
3 Participants
n=844 Participants
|
4 Participants
n=417 Participants
|
2 Participants
n=423 Participants
|
4 Participants
n=422 Participants
|
17 Participants
n=3794 Participants
|
|
Race/Ethnicity, Customized
White
|
752 Participants
n=847 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
726 Participants
n=841 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
725 Participants
n=844 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
349 Participants
n=417 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
355 Participants
n=423 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
356 Participants
n=422 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
3263 Participants
n=3794 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
|
Race/Ethnicity, Customized
Mixed
|
39 Participants
n=847 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
44 Participants
n=841 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
52 Participants
n=844 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
22 Participants
n=417 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
31 Participants
n=423 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
26 Participants
n=422 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
214 Participants
n=3794 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
|
Race/Ethnicity, Customized
Asian
|
23 Participants
n=847 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
37 Participants
n=841 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
39 Participants
n=844 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
23 Participants
n=417 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
19 Participants
n=423 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
21 Participants
n=422 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
162 Participants
n=3794 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=847 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
12 Participants
n=841 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
7 Participants
n=844 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
7 Participants
n=417 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
8 Participants
n=423 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
7 Participants
n=422 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
47 Participants
n=3794 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
|
Race/Ethnicity, Customized
Arab
|
9 Participants
n=847 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
8 Participants
n=841 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
5 Participants
n=844 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
5 Participants
n=417 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
2 Participants
n=423 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
4 Participants
n=422 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
33 Participants
n=3794 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
|
Race/Ethnicity, Customized
Other
|
13 Participants
n=847 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
8 Participants
n=841 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
11 Participants
n=844 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
5 Participants
n=417 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
4 Participants
n=423 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
4 Participants
n=422 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
45 Participants
n=3794 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
|
Race/Ethnicity, Customized
Unknown
|
5 Participants
n=847 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
6 Participants
n=841 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
5 Participants
n=844 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
6 Participants
n=417 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
4 Participants
n=423 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
4 Participants
n=422 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
30 Participants
n=3794 Participants • A row including ethnicity unknown has been added for each group so that the figures add up to 100%
|
|
Region of Enrollment
Belgium
|
166 Participants
n=847 Participants
|
161 Participants
n=841 Participants
|
155 Participants
n=844 Participants
|
60 Participants
n=417 Participants
|
59 Participants
n=423 Participants
|
59 Participants
n=422 Participants
|
660 Participants
n=3794 Participants
|
|
Region of Enrollment
United Kingdom
|
254 Participants
n=847 Participants
|
256 Participants
n=841 Participants
|
256 Participants
n=844 Participants
|
138 Participants
n=417 Participants
|
139 Participants
n=423 Participants
|
141 Participants
n=422 Participants
|
1184 Participants
n=3794 Participants
|
|
Region of Enrollment
Germany
|
288 Participants
n=847 Participants
|
287 Participants
n=841 Participants
|
293 Participants
n=844 Participants
|
77 Participants
n=417 Participants
|
77 Participants
n=423 Participants
|
75 Participants
n=422 Participants
|
1097 Participants
n=3794 Participants
|
|
Region of Enrollment
Spain
|
139 Participants
n=847 Participants
|
137 Participants
n=841 Participants
|
140 Participants
n=844 Participants
|
142 Participants
n=417 Participants
|
148 Participants
n=423 Participants
|
147 Participants
n=422 Participants
|
853 Participants
n=3794 Participants
|
|
Baseline Measures for each trial
PROMOTE Trial WEMWBS
|
52.8 units on a scale
STANDARD_DEVIATION 6.5 • n=847 Participants • PROMOTE trial 2532 participants has wellness as the primary variable of interest so baseline WEMWBS is reported here. PREVENT trial 1262 participants PHQ9 has symptoms of depression as the primary variable of interest, so baseline PHQ9 is reported here. These two variable will be the primary outcomes at 3 months, but the figures here are baseline data
|
53.1 units on a scale
STANDARD_DEVIATION 6.6 • n=841 Participants • PROMOTE trial 2532 participants has wellness as the primary variable of interest so baseline WEMWBS is reported here. PREVENT trial 1262 participants PHQ9 has symptoms of depression as the primary variable of interest, so baseline PHQ9 is reported here. These two variable will be the primary outcomes at 3 months, but the figures here are baseline data
|
52.6 units on a scale
STANDARD_DEVIATION 6.6 • n=844 Participants • PROMOTE trial 2532 participants has wellness as the primary variable of interest so baseline WEMWBS is reported here. PREVENT trial 1262 participants PHQ9 has symptoms of depression as the primary variable of interest, so baseline PHQ9 is reported here. These two variable will be the primary outcomes at 3 months, but the figures here are baseline data
|
—
|
—
|
—
|
52.9 units on a scale
STANDARD_DEVIATION 6.6 • n=2532 Participants • PROMOTE trial 2532 participants has wellness as the primary variable of interest so baseline WEMWBS is reported here. PREVENT trial 1262 participants PHQ9 has symptoms of depression as the primary variable of interest, so baseline PHQ9 is reported here. These two variable will be the primary outcomes at 3 months, but the figures here are baseline data
|
|
Baseline Measures for each trial
PREVENT Trial PHQ9
|
—
|
—
|
—
|
7.4 units on a scale
STANDARD_DEVIATION 4.3 • n=417 Participants • PROMOTE trial 2532 participants has wellness as the primary variable of interest so baseline WEMWBS is reported here. PREVENT trial 1262 participants PHQ9 has symptoms of depression as the primary variable of interest, so baseline PHQ9 is reported here. These two variable will be the primary outcomes at 3 months, but the figures here are baseline data
|
7.7 units on a scale
STANDARD_DEVIATION 4.3 • n=423 Participants • PROMOTE trial 2532 participants has wellness as the primary variable of interest so baseline WEMWBS is reported here. PREVENT trial 1262 participants PHQ9 has symptoms of depression as the primary variable of interest, so baseline PHQ9 is reported here. These two variable will be the primary outcomes at 3 months, but the figures here are baseline data
|
7.6 units on a scale
STANDARD_DEVIATION 4.5 • n=422 Participants • PROMOTE trial 2532 participants has wellness as the primary variable of interest so baseline WEMWBS is reported here. PREVENT trial 1262 participants PHQ9 has symptoms of depression as the primary variable of interest, so baseline PHQ9 is reported here. These two variable will be the primary outcomes at 3 months, but the figures here are baseline data
|
7.6 units on a scale
STANDARD_DEVIATION 4.4 • n=1262 Participants • PROMOTE trial 2532 participants has wellness as the primary variable of interest so baseline WEMWBS is reported here. PREVENT trial 1262 participants PHQ9 has symptoms of depression as the primary variable of interest, so baseline PHQ9 is reported here. These two variable will be the primary outcomes at 3 months, but the figures here are baseline data
|
PRIMARY outcome
Timeframe: Primary outcome endpoint at 3 monthsWEMWBS Well-being questionnaire (Tennant et al., 2007; Stewart-Brown et al., 2009) Uni-dimensional scale. Higher scores indicate greater well-being. Scale range 0 to 70 where 70 represents high well-being.
Outcome measures
| Measure |
Tailored Emotional Competence
n=425 Participants
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
Cognitive-behavioural Approach
n=443 Participants
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
Self-monitoring
n=447 Participants
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
PREVENT Trial Tailored Emotional Competence
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did show symptoms of poor mental health at baseline
|
PREVENT Trial Cognitive-Behavioural Approach
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample did show symptoms of poor mental health at baseline
|
PREVENT Trial Self-monitoring
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did show symptoms of poor mental health at baseline
|
|---|---|---|---|---|---|---|
|
Primary Outcome Measure PROMOTE Trial: Warwick-Edinburgh Mental Well Being Scale (WEMWBS)
|
50.8 score on a scale
Standard Deviation 7.9
|
51.3 score on a scale
Standard Deviation 7.4
|
50.3 score on a scale
Standard Deviation 7.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Primary outcome endpoint at 3 monthsPHQ9 Depression questionnaire (Kroenke et al., 2001). Answered are summed to calculate total score. Scale range 0 to 27 where 27 represents severe depression.
Outcome measures
| Measure |
Tailored Emotional Competence
n=178 Participants
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
Cognitive-behavioural Approach
n=191 Participants
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
Self-monitoring
n=199 Participants
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
PREVENT Trial Tailored Emotional Competence
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did show symptoms of poor mental health at baseline
|
PREVENT Trial Cognitive-Behavioural Approach
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample did show symptoms of poor mental health at baseline
|
PREVENT Trial Self-monitoring
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did show symptoms of poor mental health at baseline
|
|---|---|---|---|---|---|---|
|
Primary Outcome Measure PREVENT Trial (PHQ9)
|
8.4 score on a scale
Standard Deviation 4.8
|
7.7 score on a scale
Standard Deviation 4.6
|
8.8 score on a scale
Standard Deviation 4.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Primary end-point at 3 monthsGAD7 Anxiety questionnaire (Spitzer et al., 2006) Answered are summed to calculate total score. Scale range 0 to 21 where 21 represents high anxiety.
Outcome measures
| Measure |
Tailored Emotional Competence
n=423 Participants
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
Cognitive-behavioural Approach
n=442 Participants
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
Self-monitoring
n=447 Participants
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
PREVENT Trial Tailored Emotional Competence
n=182 Participants
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did show symptoms of poor mental health at baseline
|
PREVENT Trial Cognitive-Behavioural Approach
n=192 Participants
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample did show symptoms of poor mental health at baseline
|
PREVENT Trial Self-monitoring
n=201 Participants
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did show symptoms of poor mental health at baseline
|
|---|---|---|---|---|---|---|
|
Generalized Anxiety Disorder-7 (GAD-7)
|
5.4 score on a scale
Standard Deviation 4
|
5.3 score on a scale
Standard Deviation 3.9
|
5.2 score on a scale
Standard Deviation 3.8
|
7.3 score on a scale
Standard Deviation 4.5
|
7.1 score on a scale
Standard Deviation 4.5
|
7.5 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Primary outcome endpoint at 3 monthsWSAS Social functioning questionnaire (Mundt et al., 2002). Answered are summed to calculate total score. Scale range 0 to 40 where 40 represents low functionality.
Outcome measures
| Measure |
Tailored Emotional Competence
n=415 Participants
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
Cognitive-behavioural Approach
n=432 Participants
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
Self-monitoring
n=438 Participants
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
PREVENT Trial Tailored Emotional Competence
n=165 Participants
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did show symptoms of poor mental health at baseline
|
PREVENT Trial Cognitive-Behavioural Approach
n=184 Participants
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample did show symptoms of poor mental health at baseline
|
PREVENT Trial Self-monitoring
n=194 Participants
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did show symptoms of poor mental health at baseline
|
|---|---|---|---|---|---|---|
|
Work and Social Adjustment Scale (WSAS)
|
10 score on a scale
Standard Deviation 6.6
|
9.3 score on a scale
Standard Deviation 6.1
|
9.7 score on a scale
Standard Deviation 6.4
|
13.6 score on a scale
Standard Deviation 7.1
|
12.2 score on a scale
Standard Deviation 7.4
|
14.3 score on a scale
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Primary outcome endpoint at 3 monthsQuality of life questionnaire (Herdman et al., 2011). Descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. EQ-5D-3L: Unabbreviated name: EuroQol-5 Dimensions - 3 Levels Construct measured: Health status, health related quality of life Unit of measure: scores on a scale (no units) Score range for overall scale: minimum: -0.594; maximum: 1 Method of calculation: the overall score is calculated using a standard algorithm with established value sets specific to each country Subscales: none Higher scores indicate a better health state.
Outcome measures
| Measure |
Tailored Emotional Competence
n=414 Participants
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
Cognitive-behavioural Approach
n=432 Participants
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
Self-monitoring
n=438 Participants
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
PREVENT Trial Tailored Emotional Competence
n=165 Participants
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did show symptoms of poor mental health at baseline
|
PREVENT Trial Cognitive-Behavioural Approach
n=184 Participants
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample did show symptoms of poor mental health at baseline
|
PREVENT Trial Self-monitoring
n=194 Participants
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did show symptoms of poor mental health at baseline
|
|---|---|---|---|---|---|---|
|
Quality of Life (EuroQuol 5D-3L)
|
0.91 score on a scale
Standard Deviation 0.17
|
0.91 score on a scale
Standard Deviation 0.17
|
0.91 score on a scale
Standard Deviation 0.15
|
0.86 score on a scale
Standard Deviation 0.19
|
0.89 score on a scale
Standard Deviation 0.16
|
0.83 score on a scale
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Primary outcome endpoint at 3 monthsPopulation: Population is the number of those completing the 3 month follow up and answering the ADSUS questionnaire. Outcome is the mean number of contacts such as GP/hospital appointments and A and E attendances
ADSUS Service Use Questionnaire. 5 with two parts, A) first rating of yes/no presence of service use then B) details around times/nights of service use. Version used: ADSUS - Adapted Unabbreviated name: Adult Service Use Schedule - Adapted Construct measured: use of health care services over previous 3 months Unit of measure: total number of health care contacts in previous 3 months Method of calculation: number of contacts with each of a range of 10 different health care contact types (GP contacts; nurse contacts; psychiatrist contacts; mental health therapist contacts; mental health hospital admissions; physical health/other hospital admissions; mental health hospital appointments; physical health/other hospital appointments; A\&E attendances; ambulance conveyances) in previous 3 months were recorded; these were summed to produce the total number of contacts across all contact types.
Outcome measures
| Measure |
Tailored Emotional Competence
n=414 Participants
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
Cognitive-behavioural Approach
n=432 Participants
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
Self-monitoring
n=438 Participants
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
|
PREVENT Trial Tailored Emotional Competence
n=163 Participants
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did show symptoms of poor mental health at baseline
|
PREVENT Trial Cognitive-Behavioural Approach
n=184 Participants
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample did show symptoms of poor mental health at baseline
|
PREVENT Trial Self-monitoring
n=194 Participants
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sample did show symptoms of poor mental health at baseline
|
|---|---|---|---|---|---|---|
|
Adult Service Use Schedule (ADSUS-adapted)
|
2.5 contacts
Standard Deviation 8.5
|
2 contacts
Standard Deviation 4.9
|
2 contacts
Standard Deviation 3.9
|
3.9 contacts
Standard Deviation 6.6
|
4.3 contacts
Standard Deviation 12.5
|
3.7 contacts
Standard Deviation 10.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Primary outcome endpoint at 3 monthsAEQ (Carver, 1998) Questionnaire to measure stressful events. 5 point scale with a score of 1-5 for each item. This questionnaire was collected in the research project, but not used in the primary analysis (eg. the PROMOTE and PREVENT trials), so is not reported here.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Primary outcome endpoint at 3 monthsLIDAS Depression assessment questionnaire (Bot et al, 2017). Higher scores indicate more depressive symptoms. This measure was used in screening to assess whether participants had previously suffered from an episode of clinical depression.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Primary outcome endpoint at 3 monthsGeneral and Achievement Appraisal: Measures of appraisal will be derived from existing well-validated instruments that use participant ratings in response to multiple scenarios to indirectly assess major appraisal dimensions (e.g., the Emotion-Index; the Coping-Index (Scherer, 2007, p. 109-110) and newly developed instruments (e.g., the Appraisal Bias Questionnaire and the Emotion Disposition Index), shortened into one brief instrument. Associated achievement-related emotions and perceived control will be measured using abbreviated and brief domain-general variants of Achievement Emotions Questionnaire subscales, which have excellent reliability, internal test validity and external test validity (Pekrun et al., 2011, 2017) and of the perceived academic control and perceived academic value scales (Marsh et al., 2016; Pekrun et al., 2007, 2017). Final items will depend on reliability and redundancy between measures in validation studies.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Primary outcome endpoint at 3 monthsSocial Appraisal: the Rejection Sensitivity Questionnaire (ARSQ) ARSQ (Berenson et al., 2009) will assess rejection sensitivity as an index of social appraisal needs. 9 scenarios with question A and B, score range 1-6.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Primary outcome endpoint at 3 monthsWorry and Rumination: rumination will be assessed using well-validated and established questionnaire measure- the 8-item Penn State Worry Questionnaire-Abbreviated (Kertz et al., 2014). Score range 8 to 40 where higher score is more worry.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Primary outcome endpoint at 3 monthsEmotional Knowledge and Perception: Adapted, shortened and abbreviated versions of the Geneva Emotion Recognition Test Short, GERT-S 20- Performance-based emotion recognition test (Schlegel, K., \& Scherer, K. R., 2016), in which users detect and interpret emotions from the face, voice, and body from 20 short video clips.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Primary outcome endpoint at 3 monthsThe Components of Emotion Understanding Test (CEUT-S), CEUT-S (Sekwena \& Fontaine, 2017)- Questionnaire measure based on the Componential Emotion Approach) will assess emotional understanding and perception.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Primary outcome endpoint at 3 monthsRumination will be assessed using well-validated and established questionnaire measure, the 5-item Brooding subscale of the Response Style Questionnaire (RSQ) (Treynor et al., 2003). Score 5-20 where higher score indicates more rummination.
Outcome measures
Outcome data not reported
Adverse Events
PROMOTE Trial Tailored Emotional Competence
Serious events: 5 serious events
Other events: 37 other events
Deaths: 0 deaths
PROMOTE Trial Cognitive-Behavioural Approach
Serious events: 8 serious events
Other events: 46 other events
Deaths: 0 deaths
PROMOTE Trial Self-monitoring
Serious events: 1 serious events
Other events: 66 other events
Deaths: 0 deaths
PREVENT Trial Tailored Emotional Competence
Serious events: 8 serious events
Other events: 42 other events
Deaths: 0 deaths
PREVENT Trial Cognitive-Behavioural Approach
Serious events: 15 serious events
Other events: 56 other events
Deaths: 0 deaths
PREVENT Trial Self-monitoring
Serious events: 8 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PROMOTE Trial Tailored Emotional Competence
n=847 participants at risk
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample not reporting symptoms of poor mental health at baseline.
|
PROMOTE Trial Cognitive-Behavioural Approach
n=841 participants at risk
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample not reporting symptoms of poor mental health at baseline.
|
PROMOTE Trial Self-monitoring
n=844 participants at risk
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample not reporting symptoms of poor mental health at baseline.
|
PREVENT Trial Tailored Emotional Competence
n=417 participants at risk
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample reporting symptoms of poor mental health at baseline.
|
PREVENT Trial Cognitive-Behavioural Approach
n=423 participants at risk
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample reporting symptoms of poor mental health at baseline.
|
PREVENT Trial Self-monitoring
n=422 participants at risk
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample reporting symptoms of poor mental health at baseline.
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Hospitalisation for overnight stay
|
0.59%
5/847 • Number of events 5 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
0.95%
8/841 • Number of events 8 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
0.12%
1/844 • Number of events 1 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
1.9%
8/417 • Number of events 8 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
3.5%
15/423 • Number of events 15 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
1.9%
8/422 • Number of events 8 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
Other adverse events
| Measure |
PROMOTE Trial Tailored Emotional Competence
n=847 participants at risk
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample not reporting symptoms of poor mental health at baseline.
|
PROMOTE Trial Cognitive-Behavioural Approach
n=841 participants at risk
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample not reporting symptoms of poor mental health at baseline.
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PROMOTE Trial Self-monitoring
n=844 participants at risk
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample not reporting symptoms of poor mental health at baseline.
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PREVENT Trial Tailored Emotional Competence
n=417 participants at risk
Self-help Tailored Emotional Competence delivered via mobile app
Tailored Emotional Competence Self-help: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample reporting symptoms of poor mental health at baseline.
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PREVENT Trial Cognitive-Behavioural Approach
n=423 participants at risk
Self-help cognitive-behavioural approach delivered via mobile app
Cognitive-behavioural Approach: The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample reporting symptoms of poor mental health at baseline.
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PREVENT Trial Self-monitoring
n=422 participants at risk
Self-help self-monitoring delivered via mobile app
Self-monitoring: Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time.
Sample reporting symptoms of poor mental health at baseline.
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Psychiatric disorders
Participant reported suicide risk at follow up
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0.94%
8/847 • Number of events 8 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
0.48%
4/841 • Number of events 4 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
1.2%
10/844 • Number of events 10 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
1.7%
7/417 • Number of events 7 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
2.4%
10/423 • Number of events 10 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
1.9%
8/422 • Number of events 8 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
|
Psychiatric disorders
Participant reported suicide risk at follow-up
|
2.6%
22/847 • Number of events 22 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
3.8%
32/841 • Number of events 32 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
4.4%
37/844 • Number of events 37 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
5.3%
22/417 • Number of events 22 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
7.1%
30/423 • Number of events 30 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
|
5.7%
24/422 • Number of events 24 • The adverse event data was collected over a 21 month time period. This was made up of 9 month recruitment window, and a 12 month follow up period.
Participants were followed up by 1, 3 and 12 month online survey where they were asked about any medical treatment including hospitalisations. A serious adverse event was categorised as when a participant reported one of the 2 situations: an overnight hospitalisation for a mental health reason and/or transport to hospital by ambulance or an overnight stay caused by self harm/injury or misuse of drugs or alcohol.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place