Clinical trial NCT04148508: App-based Mental Health Promotion in Young European Adults
Official title: Assessing and Enhancing Emotional Competence for Well-Being in Young Adults: A Principled, Evidence-based, Mobile-health Approach to Prevent Mental Disorders and Promote Mental Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wellbeing
Mental Disorder
Keywords: Promotion
Prevention
Mobile App
Emotional Competence
Emotional Resiliance
Wellbeing
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: University Ghent
name: Ludwig-Maximilians - University of Munich
name: Universitat Jaume I
name: Audeering GMBH
name: Institute of Communications and Computer Systems, Athens, Greece
name: Monsenso
name: University of Oxford
name: Brno University of Technology
name: The Fraunhofer-Gesellschaft
name: University of Geneva, Switzerland
name: Københavns Universitet
name: Deutsches Jugendinstitut e.V.
First posted: 2019-11-01
Enrollment: 3794
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase III superiority parallel 3-arm randomised multi-centre, multinational cohort randomized controlled trials (cmRCT)
Primary purpose: PREVENTION

Brief summary: The ECoWeB Project aims to develop and disseminate a mobile application (App) to provide engaging and personalized tools and psychological skills to promote emotional wellbeing and prevent mental health problems in adolescents and young adults.

The project team involves 8 European nations (the United Kingdom, Germany, Belgium, Spain, Greece, the Czech Republic, Denmark, and Switzerland) working together in order to improve mental health care and access for adolescents and young adults:

* To use technology as a tool to assess and promote emotional well-being.
* To deliver empirically supported psychological interventions through a smart phone application to address the needs of adolescents and young adults.
* To improve mental well-being and prevent mental health problems in European adolescents and young adults.

The ECoWeb project will consist of 2 RCT's within a longitudinal prospective cohort called ECoWeB-PROMOTE (indicating PROMOTION of well-being and good mental health) and ECoWeB-PREVENT (indicating PREVENTION of general distress, poor mental health and emotional disorders) respectively.

These trials share the same recruitment procedure, interventions, outcomes (including self-report measures of well-being, anxiety, and depression) and design. Both are interested in the promotion of well-being and the prevention of general poor mental health in young people. The key difference is whether the participants are deemed to be at higher or lower risk criteria for poor mental health based on their general emotional competence skills, i.e., for those at low risk, do the interventions further enhance well-being, for those at higher risk, do the interventions prevent the worsening of poor mental health, general stress and distress, as well as enhancing well-being. In all cases the recruitment procedure will be the same, but the inclusion and exclusion criteria are different and the primary outcome measures are different hence they are 2 trials, rather than one, all running within the same cohort.

Detailed description: The effect of the personalised self-help on EC, well-being, risk trajectories, general mental health difficulties, and social, educational, and occupational outcomes, will be evaluated using cohort multiple randomized controlled trials (cmRCTs; Relton et al., 2010). Eligible (healthy) individuals within the prospective cohort meeting relevant criteria will consent to be monitored for a year using a self-help app and web-site assessments. Some of the cohort will be selected at random to be offered additional self-help elements within the app.

It is important to recognise that all participants in the cohort consent at the outset to provide data to be used to assess the benefit of the self-help apps for the outcomes of interest. In a cmRCT, a large observational cohort of participants meeting eligibility criteria is recruited (N) and their outcomes regularly measured. For each RCT, information from the cohort is used to identify all eligible participants (NA). Some eligible participants (nA) are randomly selected and offered the app with self-help components. The outcomes of these randomly selected participants (nA) are then compared with the outcomes of eligible participants not randomly selected; that is, for ECoWeB, those receiving usual practice plus the ECoWeB monitoring through the app (NA-nA).

The cmRCT design has multiple advantages:

(i) it effectively combines a prospective long-term longitudinal cohort with a randomised trial(s): random selection of some participants is equivalent to random allocation of all with respect to generating 2+ groups whose selection and treatment have not been influenced by anyone or anything other than chance and where all known or unknown prognostic factors are distributed evenly at baseline, enabling strong inference about the causal effects of each intervention, whilst retaining key comparison groups that provide information as to the natural history of the condition and to usual care, essential for assessing primary prevention; (ii) consent to "try" a particular intervention is sought only from those offered that intervention, thus replicating the information and consent procedures that exist in routine health care; (iii) because individuals consent in advance to the option of having an intervention offered if eligible, the investigators avoid individuals being knowingly allocated to a "lesser" usual care condition, enhancing recruitment and retention; (iii) there is the facility for multiple RCTs within one cohort; (iv) increased efficiency and representativeness of the sample as longitudinal observational studies typically recruit a greater quantity and more representative sample of participants than RCTs; (v) because the investigators are recruiting from the general population of interested young people and not specifically recruiting individuals with elevated vulnerability or identified problems (and not seeking a clinical population - those with current or past history of psychiatric disorders are excluded), this approach minimises issues of stigmatization by making participation not limited to those with mental health issues but open for all - indeed one goal is that this approach to explore EC will spark interest and dialogue about EC and mental health in young people generally, and communicate how EC is relevant to everyone on a continuum (i.e., an explicitly destigmatizing approach), designed as a public health approach for the general population; (vi) there is no re-use of data and permissions as the cmRCT approach requires that the original consent is for both participation in the cohort and potentially being offered an intervention.

The cmRCT design enables us to:

(i) examine the course of mental well-being and general mental health symptoms over time in higher-risk and lower-risk young people determined on their EC profiles, who are left to their own devices, providing a natural course "baseline" group to assess the trajectory of well-being and symptoms over time and its relationship to EC, and to (ii) test if mobile app based self-help designed to improve EC can change this trajectory. The investigators thus simultaneously test: (a) a central assumption of the EC model that deficits in EC at baseline will predict greater symptoms of poor mental health and reduced mental well-being at 3 and 12 months, controlling for baseline symptoms and well-being; (b) evaluate whether manipulating EC enhances outcomes, enabling strong causal inference.

The ECoWeb project will consist of 2 RCT's called ECoWeB-PROMOTE (indicating PROMOTION of well-being and good mental health) and ECoWeB-PREVENT (indicating PREVENTION of general distress, poor mental health and emotional disorders).

These trials share the same recruitment procedure, interventions, outcomes (including self-report measures of well-being, anxiety, and depression) and design. Both are interested in the promotion of well-being and the prevention of general poor mental health in young people. The key difference is whether the participants are deemed to be at higher or lower risk criteria for poor mental health based on their general emotional competence skills, i.e., for those at low risk, do the interventions further enhance well-being, for those at higher risk, do the interventions prevent the worsening of poor mental health, general stress and distress, as well as enhancing well-being. In all cases the recruitment procedure will be the same, but the inclusion and exclusion criteria are different and the primary outcome measures are different hence they are 2 trials, rather than one, all running within the same cohort.

The ECoWeB-PROMOTE trial will recruit participants not showing elevated risk on their EC profile. The ECoWeB-PROMOTE trial primarily aims to improve and maintain wellbeing in those that are relatively well. A range of indices of poor mental health and wellbeing will be used as outcome measures including wellbeing, depression, anxiety and functioning: Because one index Is needed for the primary outcome, wellbeing on the WEMWBS is the primary outcome measure as potentially most relevant and sensitive for a population that is relatively well.

The ECoWeB-PREVENT trial will recruit participants who have a hypothesized elevated risk of poor mental health based on their EC profile (although they are still well as the investigators are excluding participants with current or past psychiatric disorders) with the primary aim of reducing that risk through the self-help app and promoting well-being (but not selected on clinical diagnoses or symptoms). A range of indices of poor mental health and wellbeing will be used as outcome measures including wellbeing, depression, anxiety and functioning: Because one index Is needed for the primary outcome, depression symptoms (on the Patient health Questionnaire 9) have been selected as the primary outcome, as potentially the most sensitive and important index of poor mental health and distress, and as a strong predictor of future mental illness.

Elevated risk will be determined by an assessment of emotional competence (EC). Participants EC will be assessed by their scores on the emotional competence questionnaires that participants complete at their baseline assessment.

An algorithm is being developed to decide what combination of scores on the EC measures represent high and low risk, based on scoring in the least optimal quartile/tertile against normative data for this age group.

The remit for the Horizon2020 grant scheme is to work towards improving promotion of mental wellbeing and primary prevention of mental disorders, hence the ECoWeB-PREVENT and ECoWeB-PROMOTE trials exclude those with a history of past depression and current depression or a diagnosis of bipolar disorder or psychosis. The sample recruited will therefore be as inclusive as possible across the wider population of 16-22year olds and by definition are not a clinical population.

Eligibility criteria: ECoWeB-PROMOTE Trial

Inclusion criteria

1. Aged 16-22, in the UK, Spain, Belgium and Germany.
2. not indicating elevated vulnerability based on the EC profile within the baseline assessment (as described above);
3. basic literacy in English, Spanish, German, or Dutch, as indicated by ability to complete consent and online questionnaires (12year old reading age or better).
4. Ability to provide informed consent
5. Available for the full duration of the study (12 months)
6. Regular access to a relevant smart phone (using android or IOS systems)

Exclusion criteria

1. Meeting criteria on self-report electronic screening questionnaires for any of the following

   1. current episode or past episode of major depressive disorder reported on the LIDAS and PHQ9
   2. any diagnosis of depression
   3. active suicidality; or
   4. any history of severe mental health problem (i.e., bipolar/psychosis);
2. Currently receiving psychological therapy or counselling or antidepressants or other psychiatric medication.
3. Elevated vulnerability on their emotional competence as assessed within the baseline assessment

ECoWeB-PREVENT Trial

Inclusion criteria

1. Aged 16-22, in the UK, Spain, Belgium and Germany
2. screened for elevated vulnerability criteria on their Emotional Competence profile as assessed within the baseline assessment (as described above);
3. basic literacy in English, Spanish, German, or Dutch as indicated by ability to complete consent and online questionnaires (12year old reading age or better).
4. Ability to provide informed consent
5. Available for the full duration of the study (12 months)
6. Regular access to a relevant smart phone (using android or IOS systems)

Exclusion criteria

1. Meeting criteria on self-report electronic screening questionnaires for any of the following

   1. current episode or past episode of major depressive disorder reported on the LIDAS and PHQ9
   2. any diagnosis of depression
   3. active suicidality; or
   4. any history of severe mental health problem (i.e., bipolar/psychosis);
2. Currently receiving psychological therapy or counselling or antidepressants or other psychiatric medication.

Primary outcomes:
measure: Primary Outcome Measure PROMOTE Trial: Warwick-Edinburgh Mental Well Being Scale (WEMWBS)
timeFrame: Primary outcome endpoint at 3 months
measure: Primary Outcome Measure PREVENT Trial (PHQ9)
timeFrame: Primary outcome endpoint at 3 months
Secondary outcomes:
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Primary end-point at 3 months
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Primary outcome endpoint at 3 months
measure: Quality of Life (EuroQuol 5D-3L)
timeFrame: Primary outcome endpoint at 3 months
measure: Adult Service Use Schedule (ADSUS-adapted)
timeFrame: Primary outcome endpoint at 3 months
Other outcomes:
measure: Adverse Events Questionnaire (AEQ)
timeFrame: Primary outcome endpoint at 3 months
measure: Lifetime Depression Assessment Self-Report Questionnaire (LIDAS)
timeFrame: Primary outcome endpoint at 3 months
measure: Process (Mediator)- Impact of Social Appraisal on Emotional Competence
timeFrame: Primary outcome endpoint at 3 months
measure: Process (Mediator)- Impact of Rejection Sensitivity on Emotional Competence
timeFrame: Primary outcome endpoint at 3 months
measure: Process (Mediator)- Impact of Worry on Emotional Competence
timeFrame: Primary outcome endpoint at 3 months
measure: Process (Mediator)- Impact of Emotional Recognition on Emotional Competence
timeFrame: Primary outcome endpoint at 3 months
measure: Process (Mediator)- Impact of Emotional Understanding on Emotional Competence - Emotional Knowledge and Perception
timeFrame: Primary outcome endpoint at 3 months
measure: Process (Mediator)- Impact of Rumination on Emotional Competence
timeFrame: Primary outcome endpoint at 3 months
Locations:
city: Ghent
country: Belgium
facility: Ghent University
city: Munich
country: Germany
facility: Ludwig-Maximilians-University (LMU)
state: Muenchen
city: Valencia
country: Spain
facility: Universitat Jaume I
state: Castellón
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: Ed Watkins, PhD
role: PRINCIPAL_INVESTIGATOR
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