Emotional competence self-help mobile phone app versus cognitive behavioural self-help app versus self-monitoring app to promote mental wellbeing in healthy young adults (ECoWeB PROMOTE): an international, multicentre, parallel, open-label, randomised controlled trial

Background: Based on evidence that mental health is more than an absence of mental disorders, there have been calls to find ways to promote flourishing at a population level, especially in young people, which requires effective and scalable interventions. Despite their potential for scalability, few mental wellbeing apps have been rigorously tested in high-powered trials, derived from models of healthy emotional functioning, or tailored to individual profiles. We aimed to test a personalised emotional competence self-help app versus a cognitive behavioural therapy (CBT) self-help app versus a self-monitoring app to promote mental wellbeing in healthy young people. Methods: This international, multicentre, parallel, open-label, randomised controlled trial within a cohort multiple randomised trial (including a parallel trial of depression prevention) was done at four university trial sites in four countries (the UK, Germany, Spain, and Belgium). Participants were recruited from schools and universities and via social media from the four respective countries. Eligible participants were aged 16–22 years with well adjusted emotional competence profiles and no current or past diagnosis of major depression. Participants were randomised (1:1:1) to usual practice plus either the emotional competence app, the CBT app or the self-monitoring app, by an independent computerised system, minimised by country, age, and self-reported gender, and followed up for 12 months post-randomisation. The primary outcome was mental wellbeing (indexed by the Warwick–Edinburgh Mental Well Being Scale [WEMWBS]) at 3-month follow-up, analysed in participants who completed the 3-month follow-up assessment. Outcome assessors were masked to group allocation. The study is registered with ClinicalTrials.gov, NCT04148508, and is closed. Findings: Between Oct 15, 2020, and Aug 3, 2021, 2532 participants were enrolled, and 847 were randomly assigned to the emotional competence app, 841 to the CBT app, and 844 to the self-monitoring app. Mean age was 19·2 years (SD 1·8). Of 2532 participants self-reporting gender, 1896 (74·9%) were female, 613 (24·2%) were male, 16 (0·6%) were neither, and seven (0·3%) were both. 425 participants in the emotional competence app group, 443 in the CT app group, and 447 in the self-monitoring app group completed the follow-up assessment at 3 months. There was no difference in mental wellbeing between the groups at 3 months (global p=0·47). The emotional competence app did not differ from the CBT app (mean difference in WEMWBS –0·21 [95% CI –1·08 to 0·66]) or the self-monitoring app (0·32 [–0·54 to 1·19]) and the CBT app did not differ from the self-monitoring app (0·53 [–0·33 to 1·39]). 14 of 1315 participants were admitted to or treated in hospital (or both) for mental health-related reasons, which were considered unrelated to the interventions (five participants in the emotional competence app group, eight in the CBT app group, and one in the self-monitoring app group). No deaths occurred. Interpretation: The emotional competence app and the CBT app provided limited benefit in promoting mental wellbeing in healthy young people. This finding might reflect the low intensity of these interventions and the difficulty improving mental wellbeing via universal digital interventions implemented in low-risk populations

Emotional competence self-help app versus cognitive behavioural self-help app versus self-monitoring app to prevent depression in young adults with elevated risk (ECoWeB PREVENT): an international, multicentre, parallel, open-label, randomised controlled trial

Background: Effective, scalable interventions are needed to prevent poor mental health in young people. Although mental health apps can provide scalable prevention, few have been rigorously tested in high-powered trials built on models of healthy emotional functioning or tailored to individual profiles. We aimed to test a personalised emotional competence app versus a cognitive behavioural therapy (CBT) self-help app versus a self-monitoring app to prevent an increase in depression symptoms in young people. Methods: This multicentre, parallel, open-label, randomised controlled trial, within a cohort multiple randomised trial (including a parallel trial of wellbeing promotion) was done at four university trial sites in the UK, Germany, Spain, and Belgium. Participants were recruited from schools, universities, and social media from the four respective countries. Eligible participants were aged 16–22 years with increased vulnerability indexed by baseline emotional competence profile, without current or past diagnosis of major depression. Participants were randomly assigned (1:1:1) to usual practice plus either the personalised emotional competence self-help app, the generic CBT self-help app, or the self-monitoring app by an independent computerised system, minimised by country, age, and self-reported gender, and followed up for 12 months post-randomisation. Outcome assessors were masked to group allocation. The primary outcome was depression symptoms (according to Patient Health Questionnaire-9 [PHQ-9]) at 3-month follow-up, analysed in participants who completed the 3-month follow-up assessment. The study is registered with ClinicalTrials.gov, NCT04148508, and is closed. Findings: Between Oct 15, 2020, and Aug 3, 2021, 1262 participants were enrolled, including 417 to the emotional competence app, 423 to the CBT app, and 422 to the self-monitoring app. Mean age was 18·8 years (SD 2·0). Of 1262 participants self-reporting gender, 984 (78·0%) were female, 253 (20·0%) were male, 15 (1·2%) were neither, and ten (0·8%) were both. 178 participants in the emotional competence app group, 191 in the CBT app group, and 199 in the self-monitoring app group completed the follow-up assessment at 3 months. At 3 months, depression symptoms were lower with the CBT app than the self-monitoring app (mean difference in PHQ-9 –1·18 [95% CI –2·01 to –0·34]; p=0·006), but depression symptoms did not differ between the emotional competence app and the CBT app (0·63 [–0·22 to 1·49]; p=0·15) or the self-monitoring app and emotional competence app (–0·54 [–1·39 to 0·31]; p=0·21). 31 of the 541 participants who completed any of the follow-up assessments received treatment in hospital or were admitted to hospital for mental health-related reasons considered unrelated to interventions (eight in the emotional competence app group, 15 in the CBT app group, and eight in the self-monitoring app group). No deaths occurred. Interpretation: The CBT app delayed increases in depression symptoms in at-risk young people relative to the self-monitoring app, although this benefit faded by 12 months. Against hypotheses, the emotional competence app was not more effective at reducing depression symptoms than the self-monitoring app. CBT self-help apps might be valuable public mental health interventions for young people given their scalability, non-consumable nature, and affordability

Development of a theoretically and empirically grounded emotion knowledge training for the young.

Background: Digital mental health trainings can be an impactful and efficient way to promote well-being and prevent psychopathology during the sensitive developmental periods of adolescence and young adulthood. However, many online and app-based trainings are often not grounded in science or have low engagement rates due to poor usability. The aim of the current project was to tackle both of these issues in the development of an emotional competence skills training for youth (target age: 16-22). Given that deficits in emotional competence constitute a risk factor for poor mental health, we built a training that aims to increase knowledge and understanding of emotions and the processes that underlie them. Methods: As a theoretical base, we used the Component Process Model to teach youth to understand their emotional experiences as a dynamic process that involves the activation of appraisals, bodily reactions, expressions, action tendencies and subjective feelings. To avoid issues related to low engagement, we included youth across various stages throughout the development of the training program, which allowed us to make changes incrementally at each stage. Feedback from several focus groups, Youth Advisory Board meetings, and a pilot study resulted in the development of a gamified emotional knowledge skills training that teaches young people how to understand, recognize, and reflect on their emotions. Results: Results showed that when it came to digital mental health trainings, youth valued personalization, relatability, fast and colorful graphics, professional audiovisual elements, interactivity, ease-of-use, privacy protection and scientific legitimacy. Conclusions: In this paper, we describe and reflect on the process of developing the training and offer suggestions to help guide future researchers in building mental health trainings that are both supported by science and appealing to young users. This paper describes how a new e-health training was developed, of which the aim is to teach young people about emotions using scientific theory. Topics in the training include: ‘What is an emotion?’, and ‘How can we recognize emotions?’. Learning about emotions can help youth understand their emotional lives, which can promote well-being and prevent psychological issues. The training was developed to be a scientifically grounded training that is engaging for users. We built this training for a non-clinical young audience (16-22), as this is a critical developmental life stage where having access to mental health knowledge is important. The training was built using a theory of emotion that conceptualizes emotions as reactions to a goal-relevant event and consisting of different components: thoughts, bodily sensations, gestures (expressions), actions one wants to take and subjective feelings. Feedback from youth was collected through focus groups, sessions of the Youth Advisory Board, and an anonymous survey. From their input we learned that young people find the following important in digital mental health trainings: personalization, relatability, fast and colorful graphics, professional audiovisual elements, interactivity, ease-of-use, privacy protection and scientific legitimacy. The resulting training consists of psychoeducation videos and content related questions, stimuli from which emotions are identified (i.e., photo and video expressions, and emotion vignettes) and reflection exercises. The content was organized in 10 ‘sessions’ and these were categorized into four ‘challenges’: introduction, parts of an emotion, regulating emotions, recognizing emotions and a summary session. The sessions increase in difficulty and unlock as the user progresses. To conclude, we developed a new e-health training about emotions that is both scientifically grounded and takes the end-user into account