Periodic Reporting for period 4 - ECoWeB (Assessing and Enhancing Emotional Competence for Well-Being (ECoWeB) in the Young: A principled, evidence-based, mobile-health approach to prevent mental disorders and promote mental well-being)
Berichtszeitraum: 2021-12-01 bis 2022-09-30
ECoWeB aims to develop & evaluate a self-help mobile app to promote mental well-being & prevent poor mental health in young people (aged 16-22) across Europe. ECoWeB occurs in the context of growing concerns about the worsening mental health of young people & the need for highly scalable mental health promotion & prevention. Despite a huge growth in apps, the vast majority are not based on scientific principles nor proven in large-scale trials. ECoWeB addresses these major gaps with a large-scale randomised cohort trial, with two novel elements. First, the intervention builds Emotional Competence (EC) skills in young people: the abilities to (i) helpfully appraise emotional situations & ability to cope; (ii) understand & recognise emotions; (iii) regulate emotions. Second, the app is personalised to match the presenting abilities of the individual. We will compare a personalized self-help EC app, a cognitive-behavioural (CBT) app & a self-monitoring app.
Across the project, the main tasks were to:
1) adapt existing & prepare new content for the EC interventions within the app (WP3-5)
2) adapt & validate existing EC measurement instruments (WP3-5)
3) design & build the app (WP2)
4) complete governance & planning necessary for trials (WP7)
5) build the necessary IT systems for trial delivery (WP7)
6) design & build the control interventions (WP7)
7) incorporate young person input into 1-6 to ensure that the intervention will be relevant & engaging (WP8).
8) launch the longitudinal cohort & recruit young people into the trials & follow-up participants at 1,3 & 12-months (WP6)
9) analyze the results (WP7) and write up and disseminate the results
All tasks are now completed. Because of delays in starting the trial & a fire at the external cloud company providing the servers supporting the app, the European Commission approved a 9-month extension to allow all 12-month follow-ups to be completed.
WP1 managed the project, set up structures & processes for communication & decision-making, coordinated project meetings, liaised with the funding body (EC) & monitored progress.
WP2 completed the design of the app in liaison with WP3-7, built an interactive mock-up & further refined it from user feedback. Core features included a Library where users read or watch psychoeducation, Challenges that are learning tasks for users, Tools that are useful in-the-moment strategies, MoodTracker, Emotion Monitor & Emotion Diary.
WP3 (Appraisals) created interventions related to the ability to make accurate & helpful appraisals in achievement & social settings. A cognitive bias modification task was developed to train individuals to make positive interpretations of ambiguous social situations.
WP4 (Emotion Regulation) adapted a proven internet-based intervention related to the ability to regulate emotion processes by focusing on reducing maladaptive repetitive negative thought (RNT: worry, rumination). WP4 developed & trialled an innovative ecological momentary assessment approach to assess RNT, which was found to reliably assess RNT in daily life & outperform trait RNT measures in predicting psychopathology after 3 months.
WP5 (Emotion Knowledge & Perception) adapted, abbreviated & validated performance tests that assess emotional competence as an ability on realistic tasks. WP5 designed & refined a training task to teach young people about different facets of the emotional experience through scenarios, images, & videos.
WP6 & 7 put in place the necessary governance for the trial. WP7 completed a trial protocol outlining all design & procedures for the trial, obtained confirmation from the UK Medicines & Healthcare Regulatory Authority that the app is not a medical device, obtained ethical approval at each site (UK, Spain, Belgium, Germany), prepared trial registration documents & finalised data management & statistical analysis plans. WP7 designed & finalised the content for the control CBT intervention & finalised the personalization algorithm. WP7 built the integrated IT system to assess and screen all participants online at baseline & follow-ups: a bespoke website & assessment portal, independent randomisation & personalisation algorithms & database & reporting system.
WP6 coordinated recruitment into cohort & trials. Recruitment started in October 2020 & closed in July 2021 with 3800 participants. Sample size was increased to compensate for the app outage due to the external fire. Follow-up data was collected at 1, 3 & 12 months.
WP8 worked to ensure that the App will be used by young people during the trial & implementation post-trial. Youth Advisory Boards (YABs) were set up in the UK, Spain, Belgium & Germany, which reviewed key components & provided valuable feedback on the intervention content, the design, name, “look” & functionalities of the app & recruitment strategies. WP8 conducted qualitative interviews with participants in the trials at 3 months follow-up to understand their views & feedback on the app & separately explored attitudes to the app in vulnerable & harder-to-reach groups, including young men not in education, employment or training, young male refugees & migrants.
WP9 set up the dissemination tools & the communication & dissemination plan of ECoWeB, including the ECoWeB website and social media.
The project involved two trials: the ECoWeB-PREVENT trial for young people with elevated vulnerability as assessed on their baseline EC skills to test whether the apps could prevent increase in depression and the ECoWeB-PROMOTE trial for those without such elevated vulnerability to test whether the apps could promote wellbeing.
In the PROMOTE trial, there was no significant difference on any outcome between the different app trial arms: no app had no particular benefit in relatively well-functioning young people.
In the PREVENT trial, the CBT self-help app resulted in lower depression & improved quality-of-life and functioning relative to the self-monitoring control at 3-month follow-up, showing a protective effect. Against predictions, the personalised EC self-help app did not show specific benefit relative to the CBT self-help app or self-monitoring app. These results have been disseminated at leading conferences (EABCT; NIHR Mindtech), via social media & are being submitted to leading journals.
1) adapt existing & prepare new content for the EC interventions within the app (WP3-5)
2) adapt & validate existing EC measurement instruments (WP3-5)
3) design & build the app (WP2)
4) complete governance & planning necessary for trials (WP7)
5) build the necessary IT systems for trial delivery (WP7)
6) design & build the control interventions (WP7)
7) incorporate young person input into 1-6 to ensure that the intervention will be relevant & engaging (WP8).
8) launch the longitudinal cohort & recruit young people into the trials & follow-up participants at 1,3 & 12-months (WP6)
9) analyze the results (WP7) and write up and disseminate the results
All tasks are now completed. Because of delays in starting the trial & a fire at the external cloud company providing the servers supporting the app, the European Commission approved a 9-month extension to allow all 12-month follow-ups to be completed.
WP1 managed the project, set up structures & processes for communication & decision-making, coordinated project meetings, liaised with the funding body (EC) & monitored progress.
WP2 completed the design of the app in liaison with WP3-7, built an interactive mock-up & further refined it from user feedback. Core features included a Library where users read or watch psychoeducation, Challenges that are learning tasks for users, Tools that are useful in-the-moment strategies, MoodTracker, Emotion Monitor & Emotion Diary.
WP3 (Appraisals) created interventions related to the ability to make accurate & helpful appraisals in achievement & social settings. A cognitive bias modification task was developed to train individuals to make positive interpretations of ambiguous social situations.
WP4 (Emotion Regulation) adapted a proven internet-based intervention related to the ability to regulate emotion processes by focusing on reducing maladaptive repetitive negative thought (RNT: worry, rumination). WP4 developed & trialled an innovative ecological momentary assessment approach to assess RNT, which was found to reliably assess RNT in daily life & outperform trait RNT measures in predicting psychopathology after 3 months.
WP5 (Emotion Knowledge & Perception) adapted, abbreviated & validated performance tests that assess emotional competence as an ability on realistic tasks. WP5 designed & refined a training task to teach young people about different facets of the emotional experience through scenarios, images, & videos.
WP6 & 7 put in place the necessary governance for the trial. WP7 completed a trial protocol outlining all design & procedures for the trial, obtained confirmation from the UK Medicines & Healthcare Regulatory Authority that the app is not a medical device, obtained ethical approval at each site (UK, Spain, Belgium, Germany), prepared trial registration documents & finalised data management & statistical analysis plans. WP7 designed & finalised the content for the control CBT intervention & finalised the personalization algorithm. WP7 built the integrated IT system to assess and screen all participants online at baseline & follow-ups: a bespoke website & assessment portal, independent randomisation & personalisation algorithms & database & reporting system.
WP6 coordinated recruitment into cohort & trials. Recruitment started in October 2020 & closed in July 2021 with 3800 participants. Sample size was increased to compensate for the app outage due to the external fire. Follow-up data was collected at 1, 3 & 12 months.
WP8 worked to ensure that the App will be used by young people during the trial & implementation post-trial. Youth Advisory Boards (YABs) were set up in the UK, Spain, Belgium & Germany, which reviewed key components & provided valuable feedback on the intervention content, the design, name, “look” & functionalities of the app & recruitment strategies. WP8 conducted qualitative interviews with participants in the trials at 3 months follow-up to understand their views & feedback on the app & separately explored attitudes to the app in vulnerable & harder-to-reach groups, including young men not in education, employment or training, young male refugees & migrants.
WP9 set up the dissemination tools & the communication & dissemination plan of ECoWeB, including the ECoWeB website and social media.
The project involved two trials: the ECoWeB-PREVENT trial for young people with elevated vulnerability as assessed on their baseline EC skills to test whether the apps could prevent increase in depression and the ECoWeB-PROMOTE trial for those without such elevated vulnerability to test whether the apps could promote wellbeing.
In the PROMOTE trial, there was no significant difference on any outcome between the different app trial arms: no app had no particular benefit in relatively well-functioning young people.
In the PREVENT trial, the CBT self-help app resulted in lower depression & improved quality-of-life and functioning relative to the self-monitoring control at 3-month follow-up, showing a protective effect. Against predictions, the personalised EC self-help app did not show specific benefit relative to the CBT self-help app or self-monitoring app. These results have been disseminated at leading conferences (EABCT; NIHR Mindtech), via social media & are being submitted to leading journals.
ECoWeB progresses beyond the state-of-the-art as the first multinational trial of a mental health promotion/prevention app in young people & by developing & testing an innovative approach to personalisation. Technological advancements include building multiple configurations of the same app for personalisation & the development of new voice analysis technology to identify emotions. We recruited one of the largest datasets & generated evidence on the efficacy of the app in mental health promotion. Our results suggest a self-help app with evidence-based CBT content may be beneficial for selected young people at increased risk, that personalisation of interventions is not straightforward, and that consistent with the literature, it is difficult to further promote wellbeing in relatively high-functioning people. An app focused on proven CBT techniques may be an effective scalable public mental health intervention for young people at elevated risk, with benefit for young people’s wellbeing & associated long-term socio-economic impact.