App-based Mental Health Promotion in Young European Adults

NCT04148508 | Completed Results DMC

• 1 other identifier: 1819/32
• Study Type: interventional
• Target: 3,794
• Locations: 4 countries
• Sites: 4

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.

Conditions

Wellbeing; Mental Disorder

Keywords

Promotion; Prevention; Mobile App; Emotional Competence; Emotional Resiliance; Wellbeing

Outcome Measures

Primary Outcomes (2)

• Primary Outcome Measure PROMOTE Trial: Warwick-Edinburgh Mental Well Being Scale (WEMWBS)

  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.

  Primary outcome endpoint at 3 months

• Primary Outcome Measure PREVENT Trial (PHQ9)

  PHQ9 Depression questionnaire (Kroenke et al., 2001). Answered are summed to calculate total score. Scale range 0 to 27 where 27 represents severe depression.

  Primary outcome endpoint at 3 months

Secondary Outcomes (4)

• Generalized Anxiety Disorder-7 (GAD-7)

  Primary end-point at 3 months

• Work and Social Adjustment Scale (WSAS)

  Primary outcome endpoint at 3 months

• Quality of Life (EuroQuol 5D-3L)

  Primary outcome endpoint at 3 months

• Adult Service Use Schedule (ADSUS-adapted)

  Primary outcome endpoint at 3 months

Other Outcomes (8)

• Adverse Events Questionnaire (AEQ)

  Primary outcome endpoint at 3 months

• Lifetime Depression Assessment Self-Report Questionnaire (LIDAS)

  Primary outcome endpoint at 3 months

• Process (Mediator)- Impact of Social Appraisal on Emotional Competence

  Primary outcome endpoint at 3 months

Study Arms (3)

Tailored Emotional Competence

EXPERIMENTAL

Self-help Tailored Emotional Competence delivered via mobile app

Behavioral: Tailored Emotional Competence Self-help; Behavioral: Self-monitoring

Cognitive-behavioural Approach

ACTIVE COMPARATOR

Self-help cognitive-behavioural approach delivered via mobile app

Behavioral: Cognitive-behavioural Approach; Behavioral: Self-monitoring

Self-monitoring

PLACEBO COMPARATOR

Self-help self-monitoring delivered via mobile app

Behavioral: Self-monitoring

Interventions

Tailored Emotional Competence Self-help BEHAVIORAL

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

Tailored Emotional Competence

Cognitive-behavioural Approach BEHAVIORAL

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.

Cognitive-behavioural Approach

Self-monitoring BEHAVIORAL

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; Self-monitoring; Tailored Emotional Competence

Eligibility Criteria

• Age: 16 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)
• Meeting criteria on self-report electronic screening questionnaires for any of the following

Sponsors & Collaborators

• University of Exeter: lead
• University Ghent: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• Universitat Jaume I: collaborator
• Audeering GMBH: collaborator
• Institute of Communications and Computer Systems, Athens, Greece: collaborator
• Monsenso: collaborator
• University of Oxford: collaborator
• Brno University of Technology: collaborator
• The Fraunhofer-Gesellschaft: collaborator
• University of Geneva, Switzerland: collaborator
• Københavns Universitet: collaborator
• Deutsches Jugendinstitut e.V.: collaborator

Study Sites (4)

Ghent University

Ghent, 9000, Belgium

Location

Ludwig-Maximilians-University (LMU)

Munich, Muenchen, 80539, Germany

Location

Universitat Jaume I

Valencia, Castellón, CP 12071, Spain

Location

University of Exeter

Exeter, Devon, EX4 4QG, United Kingdom

Location

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MeSH Terms

Conditions

Mental Disorders

Interventions

Blood Glucose Self-Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Limitations and Caveats

This trial was a cohort randomised cohort trial with two cohorts (Promote: for lower vulnerability participants, primary outcome, WEMWBS; Prevent: for higher vulnerability participants, PHQ9 primary outcome), all other methodology, intervention, measures the same, with each trial to be analysed separately. There was an outage of the treatment app for 1 month because of a fire at server firm, necessitating replenishment of sample.

Results Point of Contact

• Title: Professor Ed Watkins
• Organization: University of Exeter

e.r.watkins@exeter.ac.uk

01392 724692

Study Officials

• Ed Watkins, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Researchers will be blinded to condition. Participants join a cohort and all receive an App, but are not explicitly told which condition they are in.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase III superiority parallel 3-arm randomised multi-centre, multinational cohort randomized controlled trials (cmRCT)

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: November 1, 2019
• Study Start: October 9, 2020
• Primary Completion: July 31, 2022
• Study Completion: September 30, 2022
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study protocol, statistical analysis plan and informed consent form will be uploaded with this registration. Data Access: Post-analysis, the final anonymised dataset will preferentially be stored in Open Research Exeter (ORE), the University of Exeter's open access repository. The data will be available from 24 months after trial completion (end of December 2021).
• Access Criteria: Access to these data is permitted but controlled through requests made via the repository to a review panel from the trial team, led by the chief investigator, which will assess requests on scientific merit and commercial sensitivity. Although use is permitted, this will be on the basis that the source of the data is acknowledged (including the funder) and it includes reference to the data set 'handle', and a data access agreement is signed, subject to approval by funder.

Locations

GB (1); DE (1); BE (1); ES (1)