N/A
N=3,794
App-based Mental Health Promotion in Young European Adults
Wellbeing · Mental Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04148508 ↗Enrolled (actual)
3,794
Serious AEs
1.2%
Results posted
Dec 2024
Primary outcome: Primary: Primary Outcome Measure PROMOTE Trial: Warwick-Edinburgh Mental Well Being Scale (WEMWBS) — 50.8; 51.3; 50.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tailored Emotional Competence Self-help (Behavioral); Cognitive-behavioural Approach (Behavioral); Self-monitoring (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- University of Exeter
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome Measure PROMOTE Trial: Warwick-Edinburgh Mental Well Being Scale (WEMWBS) |
50.8; 51.3; 50.3 | — |
| PRIMARY Primary Outcome Measure PREVENT Trial (PHQ9) |
8.4; 7.7; 8.8 | — |
| SECONDARY Generalized Anxiety Disorder-7 (GAD-7) |
5.4; 5.3; 5.2; 7.3; 7.1; 7.5 | — |
| SECONDARY Work and Social Adjustment Scale (WSAS) |
10; 9.3; 9.7; 13.6; 12.2; 14.3 | — |
| SECONDARY Quality of Life (EuroQuol 5D-3L) |
0.91; 0.91; 0.91; 0.86; 0.89; 0.83 | — |
| SECONDARY Adult Service Use Schedule (ADSUS-adapted) |
2.5; 2; 2; 3.9; 4.3; 3.7 | — |
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.
Eligibility Criteria
ECoWeB-PROMOTE Trial
Inclusion criteria
- Aged 16-22, in the UK, Spain, Belgium and Germany.
- not indicating elevated vulnerability based on the EC profile within the baseline assessment (as described above);
- basic literacy in English, Spanish, German, or Dutch, as indicated by ability to complete consent and online questionnaires (12year old reading age or better).
- Ability to provide informed consent
- Available for the full duration of the study (12 months)
- Regular access to a relevant smart phone (using android or IOS systems)
Exclusion criteria
- Meeting criteria on self-report electronic screening questionnaires for any of the following
- current episode or past episode of major depressive disorder reported on the LIDAS and PHQ9
- any diagnosis of depression
- active suicidality; or
- any history of severe mental health problem (i.e., bipolar/psychosis);
- Currently receiving psychological therapy or counselling or antidepressants or other psychiatric medication.
- Elevated vulnerability on their emotional competence as assessed within the baseline assessment
ECoWeB-PREVENT Trial
Inclusion criteria
- Aged 16-22, in the UK, Spain, Belgium and Germany
- screened for elevated vulnerability criteria on their Emotional Competence profile as assessed within the baseline assessment (as described above);
- basic literacy in English, Spanish, German, or Dutch as indicated by ability to complete consent and online questionnaires (12year old reading age or better).
- Ability to provide informed consent
- Available for the full duration of the study (12 months)
- Regular access to a relevant smart phone (using android or IOS systems)
Exclusion criteria
- Meeting criteria on self-report electronic screening questionnaires for any of the following
- current episode or past episode of major depressive disorder reported on the LIDAS and PHQ9
- any diagnosis of depression
- active suicidality; or
- any history of severe mental health problem (i.e., bipolar/psychosis);
- Currently receiving psychological therapy or counselling or antidepressants or other psychiatric medication.
Data sourced from ClinicalTrials.gov (NCT04148508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.