Mental Disorder, Wellbeing
Conditions
Keywords
Promotion, Prevention, Mobile App, Emotional Competence, Emotional Resiliance, Wellbeing
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.
Interventions
BEHAVIORALTailored 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
BEHAVIORALCognitive-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.
BEHAVIORALSelf-monitoring
Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
Sponsors
University Ghent
Ludwig-Maximilians - University of Munich
Universitat Jaume I
Audeering GMBH
Institute of Communications and Computer Systems, Athens, Greece
Monsenso
University of Oxford
Brno University of Technology
The Fraunhofer-Gesellschaft
University of Geneva, Switzerland
Københavns Universitet
Deutsches Jugendinstitut e.V.
University of Exeter
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, 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.
Intervention model description
Phase III superiority parallel 3-arm randomised multi-centre, multinational cohort randomized controlled trials (cmRCT)
Eligibility
Sex/Gender
ALL
Age
16 Years to 22 Years
Healthy volunteers
Yes
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure PROMOTE Trial: Warwick-Edinburgh Mental Well Being Scale (WEMWBS) | 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. |
| Primary Outcome Measure PREVENT Trial (PHQ9) | 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
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder-7 (GAD-7) | 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. |
| Work and Social Adjustment Scale (WSAS) | 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. |
| Quality of Life (EuroQuol 5D-3L) | 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. EQ-5D-3L: Unabbreviated name: EuroQol-5 Dimensions - 3 Levels Construct measured: Health status, health related quality of life Unit of measure: scores on a scale (no units) Score range for overall scale: minimum: -0.594; maximum: 1 Method of calculation: the overall score is calculated using a standard algorithm with established value sets specific to each country Subscales: none Higher scores indicate a better health state. |
| Adult Service Use Schedule (ADSUS-adapted) | Primary outcome endpoint at 3 months | ADSUS Service Use Questionnaire. 5 with two parts, A) first rating of yes/no presence of service use then B) details around times/nights of service use. Version used: ADSUS - Adapted Unabbreviated name: Adult Service Use Schedule - Adapted Construct measured: use of health care services over previous 3 months Unit of measure: total number of health care contacts in previous 3 months Method of calculation: number of contacts with each of a range of 10 different health care contact types (GP contacts; nurse contacts; psychiatrist contacts; mental health therapist contacts; mental health hospital admissions; physical health/other hospital admissions; mental health hospital appointments; physical health/other hospital appointments; A&E attendances; ambulance conveyances) in previous 3 months were recorded; these were summed to produce the total number of contacts across all contact types. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Process (Mediator)- Impact of Emotional Understanding on Emotional Competence - Emotional Knowledge and Perception | 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. |
| Adverse Events Questionnaire (AEQ) | 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. This questionnaire was collected in the research project, but not used in the primary analysis (eg. the PROMOTE and PREVENT trials), so is not reported here. |
| Process (Mediator)- Impact of Rumination on Emotional Competence | 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. |
| Lifetime Depression Assessment Self-Report Questionnaire (LIDAS) | Primary outcome endpoint at 3 months | LIDAS Depression assessment questionnaire (Bot et al, 2017). Higher scores indicate more depressive symptoms. This measure was used in screening to assess whether participants had previously suffered from an episode of clinical depression. |
| Process (Mediator)- Impact of Social Appraisal on Emotional Competence | 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. |
| Process (Mediator)- Impact of Rejection Sensitivity on Emotional Competence | 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. |
| Process (Mediator)- Impact of Worry on Emotional Competence | 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. |
| Process (Mediator)- Impact of Emotional Recognition on Emotional Competence | 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. |
Countries
Belgium, Germany, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PROMOTE Trial Tailored Emotional Competence Self-help Tailored Emotional Competence delivered via mobile app
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
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
Sample did not show symptoms of poor mental health at baseline | 847 |
| PROMOTE Trial Cognitive-behavioural Approach Self-help cognitive-behavioural approach delivered via mobile app
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.
Sample did not show symptoms of poor mental health at baseline | 841 |
| PROMOTE Trial Self-monitoring Self-help self-monitoring delivered via mobile 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
Sample did not show symptoms of poor mental health at baseline | 844 |
| PREVENT Trial Tailored Self-help Tailored Emotional Competence delivered via mobile app
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
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
Sample did show symptoms of poor mental health at baseline | 417 |
| PREVENT Trial Cognitive- Self-help cognitive-behavioural approach delivered via mobile app
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.
Sample did show symptoms of poor mental health at baseline | 423 |
| PREVENT Trial Self-monitoring Self-help self-monitoring delivered via mobile 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
Sample did show symptoms of poor mental health at baseline | 422 |
| Total | 3,794 |
Baseline characteristics
| Characteristic | Total | PROMOTE Trial Tailored Emotional Competence | PROMOTE Trial Cognitive-behavioural Approach | PROMOTE Trial Self-monitoring | PREVENT Trial Tailored | PREVENT Trial Cognitive- | PREVENT Trial Self-monitoring |
|---|---|---|---|---|---|---|---|
| Age, Continuous Age | 19 years STANDARD_DEVIATION 1.9 | 19.2 years STANDARD_DEVIATION 1.9 | 19.2 years STANDARD_DEVIATION 1.9 | 19 years STANDARD_DEVIATION 1.8 | 18.8 years STANDARD_DEVIATION 2 | 18.8 years STANDARD_DEVIATION 2 | 18.8 years STANDARD_DEVIATION 1.9 |
| Baseline Measures for each trial PREVENT Trial PHQ9 | 7.6 units on a scale STANDARD_DEVIATION 4.4 | — | — | — | 7.4 units on a scale STANDARD_DEVIATION 4.3 | 7.7 units on a scale STANDARD_DEVIATION 4.3 | 7.6 units on a scale STANDARD_DEVIATION 4.5 |
| Baseline Measures for each trial PROMOTE Trial WEMWBS | 52.9 units on a scale STANDARD_DEVIATION 6.6 | 52.8 units on a scale STANDARD_DEVIATION 6.5 | 53.1 units on a scale STANDARD_DEVIATION 6.6 | 52.6 units on a scale STANDARD_DEVIATION 6.6 | — | — | — |
| Race/Ethnicity, Customized Arab | 33 Participants | 9 Participants | 8 Participants | 5 Participants | 5 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 162 Participants | 23 Participants | 37 Participants | 39 Participants | 23 Participants | 19 Participants | 21 Participants |
| Race/Ethnicity, Customized Black | 47 Participants | 6 Participants | 12 Participants | 7 Participants | 7 Participants | 8 Participants | 7 Participants |
| Race/Ethnicity, Customized Mixed | 214 Participants | 39 Participants | 44 Participants | 52 Participants | 22 Participants | 31 Participants | 26 Participants |
| Race/Ethnicity, Customized Other | 45 Participants | 13 Participants | 8 Participants | 11 Participants | 5 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Unknown | 30 Participants | 5 Participants | 6 Participants | 5 Participants | 6 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 3263 Participants | 752 Participants | 726 Participants | 725 Participants | 349 Participants | 355 Participants | 356 Participants |
| Region of Enrollment Belgium | 660 Participants | 166 Participants | 161 Participants | 155 Participants | 60 Participants | 59 Participants | 59 Participants |
| Region of Enrollment Germany | 1097 Participants | 288 Participants | 287 Participants | 293 Participants | 77 Participants | 77 Participants | 75 Participants |
| Region of Enrollment Spain | 853 Participants | 139 Participants | 137 Participants | 140 Participants | 142 Participants | 148 Participants | 147 Participants |
| Region of Enrollment United Kingdom | 1184 Participants | 254 Participants | 256 Participants | 256 Participants | 138 Participants | 139 Participants | 141 Participants |
| Sex/Gender, Customized Both | 17 Participants | 3 Participants | 1 Participants | 3 Participants | 4 Participants | 2 Participants | 4 Participants |
| Sex/Gender, Customized Female | 2880 Participants | 621 Participants | 642 Participants | 633 Participants | 323 Participants | 339 Participants | 322 Participants |
| Sex/Gender, Customized Male | 866 Participants | 220 Participants | 191 Participants | 202 Participants | 86 Participants | 74 Participants | 93 Participants |
| Sex/Gender, Customized Neither | 31 Participants | 3 Participants | 7 Participants | 6 Participants | 4 Participants | 8 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 847 | 0 / 841 | 0 / 844 | 0 / 417 | 0 / 423 | 0 / 422 |
| other Total, other adverse events | 37 / 847 | 46 / 841 | 66 / 844 | 42 / 417 | 56 / 423 | 49 / 422 |
| serious Total, serious adverse events | 5 / 847 | 8 / 841 | 1 / 844 | 8 / 417 | 15 / 423 | 8 / 422 |
Outcome results
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.
Time frame: Primary outcome endpoint at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Emotional Competence | Primary Outcome Measure PREVENT Trial (PHQ9) | 8.4 score on a scale | Standard Deviation 4.8 |
| Cognitive-behavioural Approach | Primary Outcome Measure PREVENT Trial (PHQ9) | 7.7 score on a scale | Standard Deviation 4.6 |
| Self-monitoring | Primary Outcome Measure PREVENT Trial (PHQ9) | 8.8 score on a scale | Standard Deviation 4.9 |
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.
Time frame: Primary outcome endpoint at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Emotional Competence | Primary Outcome Measure PROMOTE Trial: Warwick-Edinburgh Mental Well Being Scale (WEMWBS) | 50.8 score on a scale | Standard Deviation 7.9 |
| Cognitive-behavioural Approach | Primary Outcome Measure PROMOTE Trial: Warwick-Edinburgh Mental Well Being Scale (WEMWBS) | 51.3 score on a scale | Standard Deviation 7.4 |
| Self-monitoring | Primary Outcome Measure PROMOTE Trial: Warwick-Edinburgh Mental Well Being Scale (WEMWBS) | 50.3 score on a scale | Standard Deviation 7.6 |
Secondary
Adult Service Use Schedule (ADSUS-adapted)
ADSUS Service Use Questionnaire. 5 with two parts, A) first rating of yes/no presence of service use then B) details around times/nights of service use. Version used: ADSUS - Adapted Unabbreviated name: Adult Service Use Schedule - Adapted Construct measured: use of health care services over previous 3 months Unit of measure: total number of health care contacts in previous 3 months Method of calculation: number of contacts with each of a range of 10 different health care contact types (GP contacts; nurse contacts; psychiatrist contacts; mental health therapist contacts; mental health hospital admissions; physical health/other hospital admissions; mental health hospital appointments; physical health/other hospital appointments; A&E attendances; ambulance conveyances) in previous 3 months were recorded; these were summed to produce the total number of contacts across all contact types.
Time frame: Primary outcome endpoint at 3 months
Population: Population is the number of those completing the 3 month follow up and answering the ADSUS questionnaire. Outcome is the mean number of contacts such as GP/hospital appointments and A and E attendances
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Emotional Competence | Adult Service Use Schedule (ADSUS-adapted) | 2.5 contacts | Standard Deviation 8.5 |
| Cognitive-behavioural Approach | Adult Service Use Schedule (ADSUS-adapted) | 2 contacts | Standard Deviation 4.9 |
| Self-monitoring | Adult Service Use Schedule (ADSUS-adapted) | 2 contacts | Standard Deviation 3.9 |
| PREVENT Trial Tailored Emotional Competence | Adult Service Use Schedule (ADSUS-adapted) | 3.9 contacts | Standard Deviation 6.6 |
| PREVENT Trial Cognitive-Behavioural Approach | Adult Service Use Schedule (ADSUS-adapted) | 4.3 contacts | Standard Deviation 12.5 |
| PREVENT Trial Self-monitoring | Adult Service Use Schedule (ADSUS-adapted) | 3.7 contacts | Standard Deviation 10.8 |
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.
Time frame: Primary end-point at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Emotional Competence | Generalized Anxiety Disorder-7 (GAD-7) | 5.4 score on a scale | Standard Deviation 4 |
| Cognitive-behavioural Approach | Generalized Anxiety Disorder-7 (GAD-7) | 5.3 score on a scale | Standard Deviation 3.9 |
| Self-monitoring | Generalized Anxiety Disorder-7 (GAD-7) | 5.2 score on a scale | Standard Deviation 3.8 |
| PREVENT Trial Tailored Emotional Competence | Generalized Anxiety Disorder-7 (GAD-7) | 7.3 score on a scale | Standard Deviation 4.5 |
| PREVENT Trial Cognitive-Behavioural Approach | Generalized Anxiety Disorder-7 (GAD-7) | 7.1 score on a scale | Standard Deviation 4.5 |
| PREVENT Trial Self-monitoring | Generalized Anxiety Disorder-7 (GAD-7) | 7.5 score on a scale | Standard Deviation 4.4 |
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. EQ-5D-3L: Unabbreviated name: EuroQol-5 Dimensions - 3 Levels Construct measured: Health status, health related quality of life Unit of measure: scores on a scale (no units) Score range for overall scale: minimum: -0.594; maximum: 1 Method of calculation: the overall score is calculated using a standard algorithm with established value sets specific to each country Subscales: none Higher scores indicate a better health state.
Time frame: Primary outcome endpoint at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Emotional Competence | Quality of Life (EuroQuol 5D-3L) | 0.91 score on a scale | Standard Deviation 0.17 |
| Cognitive-behavioural Approach | Quality of Life (EuroQuol 5D-3L) | 0.91 score on a scale | Standard Deviation 0.17 |
| Self-monitoring | Quality of Life (EuroQuol 5D-3L) | 0.91 score on a scale | Standard Deviation 0.15 |
| PREVENT Trial Tailored Emotional Competence | Quality of Life (EuroQuol 5D-3L) | 0.86 score on a scale | Standard Deviation 0.19 |
| PREVENT Trial Cognitive-Behavioural Approach | Quality of Life (EuroQuol 5D-3L) | 0.89 score on a scale | Standard Deviation 0.16 |
| PREVENT Trial Self-monitoring | Quality of Life (EuroQuol 5D-3L) | 0.83 score on a scale | Standard Deviation 0.23 |
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.
Time frame: Primary outcome endpoint at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Emotional Competence | Work and Social Adjustment Scale (WSAS) | 10 score on a scale | Standard Deviation 6.6 |
| Cognitive-behavioural Approach | Work and Social Adjustment Scale (WSAS) | 9.3 score on a scale | Standard Deviation 6.1 |
| Self-monitoring | Work and Social Adjustment Scale (WSAS) | 9.7 score on a scale | Standard Deviation 6.4 |
| PREVENT Trial Tailored Emotional Competence | Work and Social Adjustment Scale (WSAS) | 13.6 score on a scale | Standard Deviation 7.1 |
| PREVENT Trial Cognitive-Behavioural Approach | Work and Social Adjustment Scale (WSAS) | 12.2 score on a scale | Standard Deviation 7.4 |
| PREVENT Trial Self-monitoring | Work and Social Adjustment Scale (WSAS) | 14.3 score on a scale | Standard Deviation 7.4 |
Other Pre-specified
Adverse Events Questionnaire (AEQ)
AEQ (Carver, 1998) Questionnaire to measure stressful events. 5 point scale with a score of 1-5 for each item. This questionnaire was collected in the research project, but not used in the primary analysis (eg. the PROMOTE and PREVENT trials), so is not reported here.
Time frame: Primary outcome endpoint at 3 months
Other Pre-specified
Lifetime Depression Assessment Self-Report Questionnaire (LIDAS)
LIDAS Depression assessment questionnaire (Bot et al, 2017). Higher scores indicate more depressive symptoms. This measure was used in screening to assess whether participants had previously suffered from an episode of clinical depression.
Time frame: Primary outcome endpoint at 3 months
Other Pre-specified
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.
Time frame: Primary outcome endpoint at 3 months
Other Pre-specified
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.
Time frame: Primary outcome endpoint at 3 months
Other Pre-specified
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.
Time frame: Primary outcome endpoint at 3 months
Other Pre-specified
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.
Time frame: Primary outcome endpoint at 3 months
Other Pre-specified
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.
Time frame: Primary outcome endpoint at 3 months
Other Pre-specified
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.
Time frame: Primary outcome endpoint at 3 months