App-based Mental Health Promotion in Young European Adults

Mental Disorder Clinical Trial

— ECoWeB  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04148508
• Other study ID #: 1819/32
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 9, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: July 2022
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3840
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorder
• Mental Disorders
• Psychotic Disorders
• Wellbeing

Intervention

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
• 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.
• 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

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent
Germany	Ludwig-Maximilians-University (LMU)	Munich	Muenchen
Spain	Universitat Jaume I	Valencia	Castellón
United Kingdom	University of Exeter	Exeter	Devon

Sponsors (13)

Lead Sponsor	Collaborator
University of Exeter	AUDEERING GMBH, DEUTSCHES JUGENDINSTITUT EV, FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG, Institute of Communications and Computer Systems, Athens, Greece, Ludwig-Maximilians - University of Munich, MONSENSO APS, OBENHAVNS UNIVERSITET, Universitat Jaume I, University Ghent, University of Geneva, Switzerland, University of Oxford, VYSOKE UCENI TECHNICKE V BRNE

Countries where clinical trial is conducted

Belgium,  Germany,  Spain,  United Kingdom, 

References & Publications (21)

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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

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9. — View Citation

Hopko DR, Stanley MA, Reas DL, Wetherell JL, Beck JG, Novy DM, Averill PM. Assessing worry in older adults: confirmatory factor analysis of the Penn State Worry Questionnaire and psychometric properties of an abbreviated model. Psychol Assess. 2003 Jun;15(2):173-83. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. — View Citation

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Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. — View Citation

Nolen-Hoeksema S, Morrow J. A prospective study of depression and posttraumatic stress symptoms after a natural disaster: the 1989 Loma Prieta Earthquake. J Pers Soc Psychol. 1991 Jul;61(1):115-21. — View Citation

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

Relton C, Torgerson D, O'Cathain A, Nicholl J. Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design. BMJ. 2010 Mar 19;340:c1066. doi: 10.1136/bmj.c1066. — View Citation

Scherer KR. Evidence for the existence of emotion dispositions and the effects of appraisal bias. Emotion. 2021 Sep;21(6):1224-1238. doi: 10.1037/emo0000861. Epub 2020 Jul 27. — View Citation

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.

Schlegel K, Scherer KR. Introducing a short version of the Geneva Emotion Recognition Test (GERT-S): Psychometric properties and construct validation. Behav Res Methods. 2016 Dec;48(4):1383-1392. — View Citation

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.

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

Stewart-Brown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal construct validity of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS): a Rasch analysis using data from the Scottish Health Education Population Survey. Health Qual Life Outcomes. 2009 Feb 19;7:15. doi: 10.1186/1477-7525-7-15. — View Citation

Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process (mediator)- impact of social appraisal on emotional competence	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.	Primary outcome endpoint at 3 months
Other	Process (mediator)- impact of rejection sensitivity on emotional competence	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.	Primary outcome endpoint at 3 months
Other	Process (mediator)- impact of worry on emotional competence	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.	Primary outcome endpoint at 3 months
Other	Process (mediator)- impact of emotional recognition on emotional competence	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.	Primary outcome endpoint at 3 months
Other	Process (mediator)- impact of emotional understanding on emotional competence - emotional knowledge and perception	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.	Primary outcome endpoint at 3 months
Other	Process (mediator)- impact of rumination on emotional competence	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.	Primary outcome endpoint at 3 months
Primary	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	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	Generalized Anxiety Disorder-7 (GAD-7)	GAD7 Anxiety questionnaire (Spitzer et al., 2006) Answered are summed to calculate total score. Scale range 0 to 21 where 21 represents high anxiety.	Primary end-point at 3 months
Secondary	Work and Social Adjustment Scale (WSAS)	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.	Primary outcome endpoint at 3 months
Secondary	Quality of Life (EuroQuol 5D-3L)	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.	Primary outcome endpoint at 3 months
Secondary	Adult Service Use Schedule (ADSUS-adapted)	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.	Primary outcome endpoint at 3 months
Secondary	Lifetime Depression Assessment Self-Report Questionnaire (LIDAS)	LIDAS Depression assessment questionnaire (Bot et al, 2017). Higher scores indicate more depressive symptoms.	Primary outcome endpoint at 3 months
Secondary	Adverse Events Questionnaire (AEQ)	AEQ (Carver, 1998) Questionnaire to measure stressful events. 5 point scale with a score of 1-5 for each item.	Primary outcome endpoint at 3 months