Assessing and Enhancing Emotional Competence for Well-Being (ECoWeB) in Young Adults: A principled, evidence-based, mobile- health approach to prevent mental disorders and promote mental well-being Trial Protocol Version 1.1 dated 23/10/2019 This protocol has regard for the HRA guidance and order of content Funded by: Horizon 2020-EU.3.1.2. - Preventing disease Record Number: 664247 Table 1 Protocol Version Number and Date Version Date Changes from previous version 0.1 29/11/2018 Based on HRA template as advised by sponsor 0.2 11/12/2108 Further work by LN 0.3 14/01/2019 LN adding in measures, materials and procedures 0.4 21/01/2019 Queries answered by EW, adding in latest materials 0.5 01/02/2019 Addressing comments by EW 0.6 12/02/2019 Editing by EW and LN and Appendices 0.7 18/02/2019 Consortium protocol 0.8 19/02/2019 MHRA review protocol draft 0.9 06/03/2019 MHRA submission protocol 1.0 23/04/2019 Post MHRA, separate info sheets 1.1 23/10/2019 Post UK ethics with addition of insurance wording in section 13.9, also reduction in measures in section 33, and addition of pre-screening help pages in Appendix 16.1. Increase of participant payment from £30 to a maximum of £60 page 7.1.3. Change to assessment collection by the majority of the assessment data at baseline and follow ups being collected using Qualtrics (see section 5 and 7). Table 2 Protocol Amendments Amendment Date Changes from previous version Date Authorised 1 23.10.2019 As per version 1.1 above 23.10.2019 2 Assessing and Enhancing Emotional Competence for Well-Being (ECoWeB) in Young Adults: A principled, evidence-based, mobile-health approach to prevent mental disorders and promote mental well-being ECoWeb: The Emotional Competence for Well-Being in Young Adults Study RESEARCH REFERENCE NUMBERS University of Exeter CLES Ethics Committee reference: eCLESPsy000048 v3.0 ISRCTN: Clinical trials Number: 3 SIGNATURE PAGE The undersigned confirm that the following protocol has been agreed and accepted and that the Chief Investigator agrees to conduct the trial in compliance with the approved protocol and will adhere to the principles outlined including clinical trial regulations, GCP guidelines, the Sponsor’s SOPs, and other regulatory requirements. I agree to ensure that the confidential information contained in this document will not be used for any other purpose other than the evaluation or conduct of the clinical investigation without the prior written consent of the Sponsor. I also confirm that I will make the findings of the trial publicly available through publication or other dissemination tools without any unnecessary delay and that an honest accurate and transparent account of the trial will be given; and that any discrepancies and serious breaches of GCP from the trial as planned in this protocol will be explained. For and on behalf of the Trial Sponsor: Date: . 01/05/2019 Signature: Name (please print): Ms Pam Baxter ...................................................................................................... Position: Senior Research Governance Officer ................................................................................ Chief Investigator: Signature: Date: . 30/04/2019 Name (please print): Edward Watkins...................................................................... 4 KEY TRIAL CONTACTS Table 3 Key contacts Chief Investigator Professor Ed Watkins, Sir Henry Wellcome Building for Mood Disorders Research, School of Psychology, College of Life and Environmental Sciences, University of Exeter, EX4 4QG. 01392 724692, [email protected] Project Manager Gavin Huggett, Sir Henry Wellcome Building for Mood Disorders Research, School of Psychology, College of Life and Environmental Sciences, University of Exeter, EX4 4QG. 01392 Trial Co-ordinator Dr Lexy Newbold, Sir Henry Wellcome Building for Mood Disorders Research, School of Psychology, College of Life and Environmental Sciences, University of Exeter, EX4 4QG. 01392 724692, [email protected] Sponsor University of Exeter Sponsor’s Representative Ms Pam Baxter Senior Research Governance Officer University of Exeter, Research Ethics and Governance Office, Lafrowda House St Germans Road, Exeter, Devon EX4 6TL Email: [email protected] Tel: 01392 723588 Mobile: 07485042117 Funder(s) European Commission, email: [email protected], phone: +352 2929 42210 Clinical Trials Unit Professor Rod Taylor, Exeter Clinical Trials Unit, College of Medicine and Health, University of Exeter, College House, St Luke's Campus, Magdalen Road, Exeter, Devon, EX1 2LU, 01392 726 037 https://ctu.exeter.ac.uk Key Protocol Contributors Professor Ed Watkins, Dr Lexy Newbold, Professor Rod Taylor, Dr Fiona Warren Statistician Dr Fiona Warren, Institute of Health Research, University of Exeter, Devon, 01392722749, [email protected] Site Team (UK) University of Exeter (Trial Coordinator, project manager and chief investigator (contacts above) Site 2 Team Belgium UNIVERSITEIT GENT, SINT PIETERSNIEUWSTRAAT 25 9000 GENT, Belgium 5 Site 3 Team (Germany LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN, GESCHWISTER SCHOLL PLATZ 1, 80539 MUENCHEN, Germany Site 4 Team (Spain) UNIVERSITAT JAUME I DE CASTELLON, AVENIDA VICENT SOS BAYNAT S/N 12006 CASTELLON DE LA PLANA, Spain, Table 4 Collaborators AUDEERING GMBH LANDSBERGER STRASSE 46 D, 82205 GILCHING, Germany INSTITUTE OF Patission Str. 42, 10682 ATHINA, Greece, COMMUNICATION AND COMPUTER SYSTEMS MONSENSO APS LANGELINIE ALLÉ 47, DK-2100 COPENHAGEN O, DENMARK THE UNIVERSITY OF THE CHANCELLOR, MASTERS AND SCHOLARS WELLINGTON SQUARE, Oxford OF UNIVERSITY OFFICES, OX1 2JD OXFORD, United Kingdom VYSOKE UCENI TECHNICKE V ANTONINSKA 548/1, 601 90 BRNO STRED BRNE Czech Republic FRAUNHOFER GESELLSCHAFT HANSASTRASSE 27C, 80686 MUNCHEN, ZUR FOERDERUNG DER E.V.Germany ANGEWANDTEN FORSCHUNG UNIVERSITE DE GENEVE RUE DU GENERAL DUFOUR 24, 1211 GENEVE, Switzerland OBENHAVNS UNIVERSITET NORREGADE 10, 1165 KOBENHAVN, Denmark DEUTSCHES JUGENDINSTITUT NOCKHERSTRASSE 2, 81541 MUNCHEN EV Germany 6 i. LIST of CONTENTS Table 5 List of contents GENERAL INFORMATION Page No. TITLE PAGE 1 RESEARCH REFERENCE NUMBERS 3 SIGNATURE PAGE 4 KEY TRIAL CONTACTS 5 i. LIST of CONTENTS 7 ii. LIST OF ABBREVIATIONS 8 iii. TRIAL SUMMARY 11 iv. FUNDING 13 v. ROLE OF SPONSOR AND FUNDER 14 vi. ROLES & RESPONSIBILITIES OF TRIAL MANAGEMENT COMMITTEES, GROUPS 15 AND INDIVIDUALS vii, PROTOCOL CONTRIBUTERS 19 viii. KEYWORDS 19 ix. TRIAL FLOW CHART 19 SECTION 1. BACKGROUND 23 2. RATIONALE 24 3. OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS 31 4. TRIAL DESIGN 52 5. TRIAL SETTING 52 6. PARTICIPANT ELIGIBILITY CRITERIA 53 7. TRIAL PROCEDURES 55 8. TRIAL TREATMENTS 68 9. ADVERSE EVENTS 74 10. STATISTICS AND DATA ANALYSIS 79 11. DATA MANAGEMENT 83 12. MONITORING, AUDIT & INSPECTION 84 13 ETHICAL AND REGULATORY CONSIDERATIONS 84 14. DISSEMINATION POLICY 96 15. REFERENCES 98 16. APPENDICIES 106 7 ii. LIST OF ABBREVIATIONS Define all unusual or ‘technical’ terms related to the trial. Add or delete as appropriate to your trial. Maintain alphabetical order for ease of reference. AE Adverse Event AR Adverse Reaction CA Competent Authority CI Chief Investigator CRF Case Report Form CRO Contract Research Organisation CTA Clinical Trial Authorisation CTU Clinical Trials Unit DMC Data Monitoring Committee DMEC Data Management and Ethics Committee DMP Data Management Plan DoW Description of Work (Annex 1 of the Grant Agreement) DSUR Development Safety Update Report EAB External Advisory Board EC Emotional Competence ECom European Commission ECRF Electronic Case Report Form EU European Union Eudra CT European Clinical Trials Database GA General Assembly GCP Good Clinical Practice GMP Good Manufacturing Practice ICF Informed Consent Form IMB Innovation Management Board IP(R) Intellectual Property (Rights) ISF Investigator Site File (This forms part of the TMF) ISRCTN International Standard Randomised Controlled Trials Number 8 MA Marketing Authorisation MS Member State PI Principal Investigator PIC Participant Identification Centre PIS Participant Information Sheet PMT Project Management Team QA Quality Assurance QC Quality Control QP Qualified Person RCT Randomised Control Trial REC Research Ethics Committee SAE Serious Adverse Event SAP Statistical Analysis Plan SAR Serious Adverse Reaction SDV Source Data Verification SOP Standard Operating Procedure SSI Site Specific Information SUSAR Suspected Unexpected Serious Adverse Reaction TMF Trial Master File TMG Trial Management Group TP Trial Protocol TSC Trial Steering Committee WP(L) Work Package (Lead) YAB Youth Advisory Board 9 Location/Collaborator Abbreviations EXCTU Exeter University Clinical Trials Unit UNEXE The University Of Exeter LMU Ludwig-Maximilians Uplattplniversitaet Muenchen UGENT Universiteit Gent AUD Audeering GMBH UJI Universitat Jaume I De Castellon ICCS Institute Of Communication And Computer Systems MSS Monsenso Aps UOXF The University Of Oxford BUT Vysoke Uceni Technicke V Brne FRAU Fraunhofer Gesellschaft Zur Foerderung Der Angewandten Forschung E.V. UNIGE Universite De Geneve UCPH Kobenhavns Universitet DJI Deutsches Jugendinstitut Ev 10 iii ECoWEB Project Summary The European Commission funded ECoWeB project consists of consortium of academic researchers and technical collaborators who are conducting two major tasks: A new self-help app will be designed to improve wellbeing and prevent mental ill health in young adults This new app will be tested in the cohort randomised controlled ECoWeB study. Two randomised controlled trials called