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App-based Mental Health Promotion in Young European Adults (ECoWeB)

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ClinicalTrials.gov Identifier: NCT04148508
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : November 9, 2020
Sponsor:
Collaborators:
University Ghent
Ludwig-Maximilians - University of Munich
Universitat Jaume I
AUDEERING GMBH
Institute of Communications and Computer Systems, Athens, Greece
MONSENSO APS
University of Oxford
VYSOKE UCENI TECHNICKE V BRNE
FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG
University of Geneva, Switzerland
OBENHAVNS UNIVERSITET
DEUTSCHES JUGENDINSTITUT EV
Information provided by (Responsible Party):
University of Exeter

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.


Condition or disease Intervention/treatment Phase
Wellbeing Mental Disorder Behavioral: Tailored Emotional Competence Self-help Behavioral: Cognitive-behavioural Approach Behavioral: Self-monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase III superiority parallel 3-arm randomised multi-centre, multinational cohort randomized controlled trials (cmRCT)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
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
Actual Study Start Date : October 9, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tailored Emotional Competence
Self-help Tailored Emotional Competence delivered via mobile app
Behavioral: Tailored Emotional Competence Self-help
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

Behavioral: Self-monitoring
Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time

Active Comparator: Cognitive-behavioural Approach
Self-help cognitive-behavioural approach delivered via mobile app
Behavioral: Cognitive-behavioural Approach
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.

Behavioral: Self-monitoring
Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time

Placebo Comparator: Self-monitoring
Self-help self-monitoring delivered via mobile app
Behavioral: Self-monitoring
Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time




Primary Outcome Measures :
  1. Primary Outcome Measure PROMOTE Trial: Warwick-Edinburgh Mental Well Being Scale (WEMWBS) [ Time Frame: Primary outcome endpoint at 3 months ]
    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.

  2. Primary Outcome Measure PREVENT Trial (PHQ9) [ Time Frame: Primary outcome endpoint at 3 months ]
    PHQ9 Depression questionnaire (Kroenke et al., 2001). Answered are summed to calculate total score. Scale range 0 to 27 where 27 represents severe depression.


Secondary Outcome Measures :
  1. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Primary end-point at 3 months ]
    GAD7 Anxiety questionnaire (Spitzer et al., 2006) Answered are summed to calculate total score. Scale range 0 to 21 where 21 represents high anxiety.

  2. Work and Social Adjustment Scale (WSAS) [ Time Frame: Primary outcome endpoint at 3 months ]
    WSAS Social functioning questionnaire (Mundt et al., 2002). Answered are summed to calculate total score. Scale range 0 to 40 where 40 represents low functionality.

  3. Quality of Life (EuroQuol 5D-3L) [ Time Frame: Primary outcome endpoint at 3 months ]
    Quality of life questionnaire (Herdman et al., 2011). Descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.

  4. Adult Service Use Schedule (ADSUS-adapted) [ Time Frame: Primary outcome endpoint at 3 months ]
    ADSUS Service Use Questionnaire. 5 with two parts, A) first rate yes/no presence of service use then B) details around times/nights of service use.

  5. Lifetime Depression Assessment Self-Report Questionnaire (LIDAS) [ Time Frame: Primary outcome endpoint at 3 months ]
    LIDAS Depression assessment questionnaire (Bot et al, 2017). Higher scores indicate more depressive symptoms.

  6. Adverse Events Questionnaire (AEQ) [ Time Frame: Primary outcome endpoint at 3 months ]
    AEQ (Carver, 1998) Questionnaire to measure stressful events. 5 point scale with a score of 1-5 for each item.


Other Outcome Measures:
  1. Process (mediator)- impact of social appraisal on emotional competence [ Time Frame: Primary outcome endpoint at 3 months ]
    General and Achievement Appraisal: Measures of appraisal will be derived from existing well-validated instruments that use participant ratings in response to multiple scenarios to indirectly assess major appraisal dimensions (e.g., the Emotion-Index; the Coping-Index (Scherer, 2007, p. 109-110) and newly developed instruments (e.g., the Appraisal Bias Questionnaire and the Emotion Disposition Index), shortened into one brief instrument. Associated achievement-related emotions and perceived control will be measured using abbreviated and brief domain-general variants of Achievement Emotions Questionnaire subscales, which have excellent reliability, internal test validity and external test validity (Pekrun et al., 2011, 2017) and of the perceived academic control and perceived academic value scales (Marsh et al., 2016; Pekrun et al., 2007, 2017). Final items will depend on reliability and redundancy between measures in validation studies.

  2. Process (mediator)- impact of rejection sensitivity on emotional competence [ Time Frame: Primary outcome endpoint at 3 months ]
    Social Appraisal: the Rejection Sensitivity Questionnaire (ARSQ) ARSQ (Berenson et al., 2009) will assess rejection sensitivity as an index of social appraisal needs. 9 scenarios with question A and B, score range 1-6.

  3. Process (mediator)- impact of worry on emotional competence [ Time Frame: Primary outcome endpoint at 3 months ]
    Worry and Rumination: rumination will be assessed using well-validated and established questionnaire measure- the 8-item Penn State Worry Questionnaire-Abbreviated (Kertz et al., 2014). Score range 8 to 40 where higher score is more worry.

  4. Process (mediator)- impact of emotional recognition on emotional competence [ Time Frame: Primary outcome endpoint at 3 months ]
    Emotional Knowledge and Perception: Adapted, shortened and abbreviated versions of the Geneva Emotion Recognition Test Short, GERT-S 20- Performance-based emotion recognition test (Schlegel, K., & Scherer, K. R., 2016), in which users detect and interpret emotions from the face, voice, and body from 20 short video clips.

  5. Process (mediator)- impact of emotional understanding on emotional competence - emotional knowledge and perception [ Time Frame: Primary outcome endpoint at 3 months ]
    The Components of Emotion Understanding Test (CEUT-S), CEUT-S (Sekwena & Fontaine, 2017)- Questionnaire measure based on the Componential Emotion Approach) will assess emotional understanding and perception.

  6. Process (mediator)- impact of rumination on emotional competence [ Time Frame: Primary outcome endpoint at 3 months ]
    Rumination will be assessed using well-validated and established questionnaire measure, the 5-item Brooding subscale of the Response Style Questionnaire (RSQ) (Treynor et al., 2003). Score 5-20 where higher score indicates more rummination.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04148508


Contacts
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Contact: Lexy Newbold, PhD 07890384247 ecoweb@exeter.ac.uk
Contact: Ed Watkins, PhD 01392724692 ext 4692 e.r.watkins@exeter.ac.uk

Locations
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Belgium
Ghent University Recruiting
Ghent, Belgium, 9000
Contact: Johnny Fontaine, PhD    +32 9 264 64 56    johnny.fontaine@ugent.be   
Contact: Arpine Hovasapian, PhD       arpine.hovasapian@ugent.be   
Germany
Ludwig-Maximilians-University (LMU) Not yet recruiting
Munich, Muenchen, Germany, 80539
Contact: Johanna Löchner, PhD    0176 80694969    johanna.loechner@psy.lmu.de   
Contact: Thomas Ehring, Prof PhD    +49 89 - 2180 5172    Thomas.Ehring@psy.lmu.de   
Spain
Universitat Jaume I Not yet recruiting
Valencia, Castellón, Spain, CP 12071
Contact: Azucena Garcia Palacios, PhD, Prof    964387640    azucena@uji.es   
Contact: Guadalupe Molinari, PhD    964387645    molinari@uji.es   
United Kingdom
University of Exeter Recruiting
Exeter, Devon, United Kingdom, EX4 4QG
Contact: Lexy Newbold, PhD    07890384247    ecoweb@exeter.ac.uk   
Contact: Ed Watkins, PhD       ecoweb@exeter.ac.uk   
Sponsors and Collaborators
University of Exeter
University Ghent
Ludwig-Maximilians - University of Munich
Universitat Jaume I
AUDEERING GMBH
Institute of Communications and Computer Systems, Athens, Greece
MONSENSO APS
University of Oxford
VYSOKE UCENI TECHNICKE V BRNE
FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG
University of Geneva, Switzerland
OBENHAVNS UNIVERSITET
DEUTSCHES JUGENDINSTITUT EV
Investigators
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Principal Investigator: Ed Watkins, PhD University of Exeter
  Study Documents (Full-Text)

Documents provided by University of Exeter:
Statistical Analysis Plan  [PDF] June 28, 2019
Informed Consent Form  [PDF] October 23, 2019
Study Protocol  [PDF] October 23, 2019

Publications:
Goldberg, L. R., (1999) A broad-bandwith, public-domain, personality inventory measuring the lower-level facets of several Five-Factor models I. Mervielde, I.J. Deary, F. de Fruyt, F. Ostendorf (Eds.), Personality psychology in Europe, Vol. 7, Tilburg University Press, Tilburg (1999), pp. 7-28
Scherer, K.R., Hosoya, G., & Ryser, A. (2019). Modelling the effects of dispositional determinants on the frequency of experiencing depressive mood in the Swiss Household Panel. In preparation.
Pekrun, R., Goetz, T., Frenzel, A.C., Barchfield, P., & Perry, R.P. (2011). Measuring emotions in students' learning and performance: The Achievement Emotions Questionnaire (AEQ). Contemp Educ Psychol, 36, 36-48
Sekwena, E.K. & Fontaine, J.R.J. (2018). Redefining and assessing emotional understanding based on the componential emotion approach. South African J of Psychol, 48(2), 243-254.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Exeter
ClinicalTrials.gov Identifier: NCT04148508    
Other Study ID Numbers: 1819/32
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant and clinical and economic data reported in publications will be made available through the University of Exeter's Institutional Repository - Open Research Exeter (see https://ore.exeter.ac.uk).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Exeter:
Promotion
Prevention
Mobile App
Emotional Competence
Emotional Resiliance
Wellbeing
Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders