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This is a repository copy of Clinical effectiveness, cost-effectiveness and acceptability of low-intensity interventions in the management of obsessive compulsive disorder : the Obsessive Compulsive Treatment Efficacy randomised controlled Trial (OCTET). White Rose Research Online URL for this paper: https://eprints.whiterose.ac.uk/118695/ Version: Published Version Article: Lovell, Karina, Bower, Peter, Gellatly, Judith et al. (21 more authors) (2017) Clinical effectiveness, cost-effectiveness and acceptability of low-intensity interventions in the management of obsessive compulsive disorder : the Obsessive Compulsive Treatment Efficacy randomised controlled Trial (OCTET). Health technology assessment. pp. 1-164. ISSN 2046-4924 https://doi.org/10.3310/hta21370 Reuse Items deposited in White Rose Research Online are protected by copyright, with all rights reserved unless indicated otherwise. 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[email protected] https://eprints.whiterose.ac.uk/ HEALTH TECHNOLOGY ASSESSMENT VOLUME 21 ISSUE 37 JUNE 2017 ISSN 1366-5278 Clinical effectiveness, cost-effectiveness and acceptability of low-intensity interventions in the management of obsessive–compulsive disorder: the Obsessive–Compulsive Treatment Efficacy randomised controlled Trial (OCTET) Karina Lovell, Peter Bower, Judith Gellatly, Sarah Byford, Penny Bee, Dean McMillan, Catherine Arundel, Simon Gilbody, Lina Gega, Gillian Hardy, Shirley Reynolds, Michael Barkham, Patricia Mottram, Nicola Lidbetter, Rebecca Pedley, Jo Molle, Emily Peckham, Jasmin Knopp-Hoffer, Owen Price, Janice Connell, Margaret Heslin, Christopher Foley, Faye Plummer and Christopher Roberts DOI 10.3310/hta21370 Clinical effectiveness, cost-effectiveness and acceptability of low-intensity interventions in the management of – obsessive compulsive disorder: the – Obsessive Compulsive Treatment Efficacy randomised controlled Trial (OCTET) Karina Lovell,1* Peter Bower,2 Judith Gellatly,1 Sarah Byford,3 Penny Bee,1 Dean McMillan,4 Catherine Arundel,5 Simon Gilbody,4 Lina Gega,6 Gillian Hardy,7 Shirley Reynolds,8 Michael Barkham,7 Patricia Mottram,9 Nicola Lidbetter,10 Rebecca Pedley,1 Jo Molle,11 Emily Peckham,5 Jasmin Knopp-Hoffer,2 Owen Price,1 Janice Connell,12 Margaret Heslin,3 Christopher Foley,13 Faye Plummer5 and Christopher Roberts13 1Division of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK 2Centre for Primary Care, University of Manchester, Manchester, UK 3King’s Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK 4Hull York Medical School and Department of Health Sciences, University of York, York, UK 5Department of Health Sciences, University of York, York, UK 6Social Work and Communities, Northumbria University, Newcastle, UK 7Department of Psychology, University of Sheffield, Sheffield, UK 8School of Psychology, University of Reading, Reading, UK 9Cheshire & Wirral Partnership, NHS Foundation Trust, Wallasey, UK 10Anxiety UK, Manchester, UK 11Norwich Medical School, University of East Anglia, Norwich, UK 12School of Health and Related Research, University of Sheffield, Sheffield, UK 13Centre for Biostatistics in the Institute of Population Health, University of Manchester, Manchester, UK *Corresponding author Declared competing interests of authors: Karina Lovell,Sarah Byford and Shirley Reynolds reportgrants from theNational Institute for Health Researchduring the conductof thestudy. Michael Barkhamreports that hewas the leadinvestigator in the development oftheClinical Outcomes in Routine Evaluation – Outcome Measure, whichis used inthe trial. Simon Gilbody reportsprevious membership oftheHealth Technology Assessment Clinical Trials Board. Disclaimer: This report contains transcripts of interviews conducted in thecourse ofthe research and contains language thatmay offend somereaders. Published June 2017 DOI: 10.3310/hta21370 This reportshould be referenced as follows: Lovell K,Bower P, Gellatly J,Byford S, Bee P, McMillan D, et al.Clinical effectiveness, cost-effectiveness and acceptability of low-intensity interventions inthe management of obsessive–compulsive disorder: the Obsessive–Compulsive Treatment Efficacy randomised controlled Trial(OCTET). Health TechnolAssess 2017;21(37). HealthTechnology Assessment isindexed and abstracted in IndexMedicus/MEDLINE, Excerpta Medica/EMBASE, ScienceCitation Index Expanded (SciSearch®) andCurrent Contents®/ Clinical Medicine. Health Technology Assessment HTA/HTATAR ISSN1366-5278(Print) ISSN2046-4924(Online) Impactfactor:4.236 HealthTechnologyAssessmentisindexedinMEDLINE,CINAHL,EMBASE,TheCochraneLibraryandtheClarivateAnalyticsScience CitationIndex. ThisjournalisamemberofandsubscribestotheprinciplesoftheCommitteeonPublicationEthics(COPE)(www.publicationethics.org/). Editorialcontact:[email protected] ThefullHTAarchiveisfreelyavailabletoviewonlineatwww.journalslibrary.nihr.ac.uk/hta.Print-on-demandcopiescanbepurchasedfromthe reportpagesoftheNIHRJournalsLibrarywebsite:www.journalslibrary.nihr.ac.uk CriteriaforinclusionintheHealthTechnologyAssessmentjournal ReportsarepublishedinHealthTechnologyAssessment(HTA)if(1)theyhaveresultedfromworkfortheHTAprogramme,and(2)they areofasufficientlyhighscientificqualityasassessedbythereviewersandeditors. ReviewsinHealthTechnologyAssessmentaretermed‘systematic’whentheaccountofthesearchappraisalandsynthesismethods(to minimisebiasesandrandomerrors)would,intheory,permitthereplicationofthereviewbyothers. HTAprogramme TheHTAprogramme,partoftheNationalInstituteforHealthResearch(NIHR),wassetupin1993.Itproduceshigh-qualityresearch informationontheeffectiveness,costsandbroaderimpactofhealthtechnologiesforthosewhouse,manageandprovidecareintheNHS. ‘Healthtechnologies’arebroadlydefinedasallinterventionsusedtopromotehealth,preventandtreatdisease,andimproverehabilitation andlong-termcare. ThejournalisindexedinNHSEvidenceviaitsabstractsincludedinMEDLINEanditsTechnologyAssessmentReportsinformNationalInstitute forHealthandCareExcellence(NICE)guidance.HTAresearchisalsoanimportantsourceofevidenceforNationalScreeningCommittee(NSC) policydecisions. FormoreinformationabouttheHTAprogrammepleasevisitthewebsite:http://www.nets.nihr.ac.uk/programmes/hta Thisreport TheresearchreportedinthisissueofthejournalwasfundedbytheHTAprogrammeasprojectnumber09/81/01.Thecontractualstartdate wasinSeptember2011.ThedraftreportbeganeditorialreviewinOctober2015andwasacceptedforpublicationinApril2016.Theauthors havebeenwhollyresponsibleforalldatacollection,analysisandinterpretation,andforwritinguptheirwork.TheHTAeditorsandpublisher havetriedtoensuretheaccuracyoftheauthors’reportandwouldliketothankthereviewersfortheirconstructivecommentsonthedraft document.However,theydonotacceptliabilityfordamagesorlossesarisingfrommaterialpublishedinthisreport. ThisreportpresentsindependentresearchfundedbytheNationalInstituteforHealthResearch(NIHR).Theviewsandopinionsexpressedby authorsinthispublicationarethoseoftheauthorsanddonotnecessarilyreflectthoseoftheNHS,theNIHR,NETSCC,theHTAprogramme ortheDepartmentofHealth.Ifthereareverbatimquotationsincludedinthispublicationtheviewsandopinionsexpressedbythe intervieweesarethoseoftheintervieweesanddonotnecessarilyreflectthoseoftheauthors,thoseoftheNHS,theNIHR,NETSCC,theHTA programmeortheDepartmentofHealth. ©Queen’sPrinterandControllerofHMSO2017.ThisworkwasproducedbyLovelletal.underthetermsofacommissioning contractissuedbytheSecretaryofStateforHealth.Thisissuemaybefreelyreproducedforthepurposesofprivateresearchand studyandextracts(orindeed,thefullreport)maybeincludedinprofessionaljournalsprovidedthatsuitableacknowledgement ismadeandthereproductionisnotassociatedwithanyformofadvertising.Applicationsforcommercialreproductionshouldbe addressedto:NIHRJournalsLibrary,NationalInstituteforHealthResearch,Evaluation,TrialsandStudiesCoordinatingCentre, AlphaHouse,UniversityofSouthamptonSciencePark,SouthamptonSO167NS,UK. PublishedbytheNIHRJournalsLibrary(www.journalslibrary.nihr.ac.uk),producedbyPrepressProjectsLtd,Perth,Scotland (www.prepress-projects.co.uk). Health Technology Assessment Editor-in-Chief Professor Hywel Williams Director, HTA Programme, UK and Foundation Professor and Co-Director of the Centre of Evidence-Based Dermatology, University of Nottingham, UK NIHR Journals Library Editor-in-Chief Professor Tom Walley Director, NIHR Evaluation, Trials and Studies and Director of the EME Programme, UK NIHR Journals Library Editors Professor Ken Stein Chair of HTA and EME Editorial Board and Professor of Public Health, University of Exeter Medical School, UK Professor Andree Le May Chair of NIHR Journals Library Editorial Group (HS&DR, PGfAR, PHR journals) Dr Martin Ashton-Key Consultant in Public Health Medicine/Consultant Advisor, NETSCC, UK Professor Matthias Beck Chair in Public Sector Management and Subject Leader (Management Group), Queen’s University Management School, Queen’s University Belfast, UK Dr Tessa Crilly Director, Crystal Blue Consulting Ltd, UK Dr Eugenia Cronin Senior Scientific Advisor, Wessex Institute, UK Ms Tara Lamont Scientific Advisor, NETSCC, UK Dr Catriona McDaid Senior Research Fellow, York Trials Unit, Department of Health Sciences, University of York, UK Professor William McGuire Professor of Child Health, Hull York Medical School, University of York, UK Professor Geoffrey Meads Professor of Health Sciences Research, Health and Wellbeing Research Group, University of Winchester, UK Professor John Norrie Chair in Medical Statistics, University of Edinburgh, UK Professor John Powell Consultant Clinical Adviser, National Institute for Health and Care Excellence (NICE), UK Professor James Raftery Professor of Health Technology Assessment, Wessex Institute, Faculty of Medicine, University of Southampton, UK Dr Rob Riemsma Reviews Manager, Kleijnen Systematic Reviews Ltd, UK Professor Helen Roberts Professor of Child Health Research, UCL Institute of Child Health, UK Professor Jonathan Ross Professor of Sexual Health and HIV, University Hospital Birmingham, UK Professor Helen Snooks Professor of Health Services Research, Institute of Life Science, College of Medicine, Swansea University, UK Professor Jim Thornton Professor of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, University of Nottingham, UK Professor Martin Underwood Director, Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, UK Please visit the website for a list of members of the NIHR Journals Library Board: www.journalslibrary.nihr.ac.uk/about/editors Editorial contact: [email protected] NIHRJournalsLibrary www.journalslibrary.nihr.ac.uk DOI:10.3310/hta21370 HEALTHTECHNOLOGYASSESSMENT2017 VOL.21 NO.37 Abstract Clinical effectiveness, cost-effectiveness and acceptability of low-intensity interventions in the management of – – obsessive compulsive disorder: the Obsessive Compulsive Treatment Efficacy randomised controlled Trial (OCTET) Karina Lovell,1* Peter Bower,2 Judith Gellatly,1 Sarah Byford,3 Penny Bee,1 Dean McMillan,4 Catherine Arundel,5 Simon Gilbody,4 Lina Gega,6 Gillian Hardy,7 Shirley Reynolds,8 Michael Barkham,7 Patricia Mottram,9 Nicola Lidbetter,10 Rebecca Pedley,1 Jo Molle,11 Emily Peckham,5 Jasmin Knopp-Hoffer,2 Owen Price,1 Janice Connell,12 Margaret Heslin,3 Christopher Foley,13 Faye Plummer5 and Christopher Roberts13 1Division of Nursing,Midwifery andSocial Work, University of Manchester, Manchester, UK 2Centre forPrimary Care, University of Manchester, Manchester, UK 3King’s Health Economics, Institute ofPsychiatry, Psychology and Neuroscience, King’s College London,London, UK 4Hull YorkMedical School and Department ofHealth Sciences, University ofYork, York, UK 5Department ofHealth Sciences, University ofYork, York, UK 6Social WorkandCommunities, Northumbria University, Newcastle, UK 7Department ofPsychology, University ofSheffield, Sheffield, UK 8School ofPsychology, University of Reading,Reading, UK 9Cheshire & Wirral Partnership, NHS FoundationTrust, Wallasey, UK 10Anxiety UK, Manchester, UK 11Norwich Medical School, University ofEast Anglia, Norwich, UK 12School ofHealth and Related Research, University of Sheffield, Sheffield, UK 13Centre forBiostatistics in theInstitute of Population Health,University ofManchester, Manchester, UK *Corresponding author [email protected] Background: The Obsessive–Compulsive Treatment Efficacy randomised controlledTrial emergedfrom a research recommendation inNational Institute for Health and Care Excellence obsessive–compulsive disorder (OCD) guidelines, whichspecified the needtoevaluate cognitive–behavioural therapy (CBT) treatment intensity formats. Objectives: To determine theclinical effectiveness and cost-effectiveness of two low-intensity CBT interventions [supported computerised cognitive–behavioural therapy (cCBT) and guidedself-help]: (1) compared with waiting list for high-intensity CBTin adultswith OCD at3months; and (2) plus high-intensity CBTcompared with waiting list plushigh-intensity CBTin adultswith OCD at 12months. To determine patientand professional acceptability of low-intensity CBTinterventions. Design: A three-arm, multicentre, randomised controlled trial. ©Queen’sPrinterandControllerofHMSO2017.ThisworkwasproducedbyLovelletal.underthetermsofacommissioningcontractissuedbytheSecretaryofStateforHealth. Thisissuemaybefreelyreproducedforthepurposesofprivateresearchandstudyandextracts(orindeed,thefullreport)maybeincludedinprofessionaljournalsprovidedthat vii suitableacknowledgementismadeandthereproductionisnotassociatedwithanyformofadvertising.Applicationsforcommercialreproductionshouldbeaddressedto:NIHR JournalsLibrary,NationalInstituteforHealthResearch,Evaluation,TrialsandStudiesCoordinatingCentre,AlphaHouse,UniversityofSouthamptonSciencePark,Southampton SO167NS,UK.

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Dean McMillan, Catherine Arundel, Simon Gilbody, Lina Gega, . HTA Programme, UK and Foundation Professor and Co-Director of the University of Winchester, UK .. PhD doctor of philosophy. PHQ-9. Patient Health Questionnaire-9. PWP . Participants were randomised to one of three arms: 1.
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