{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T15:27:26Z","timestamp":1784906846960,"version":"3.55.0"},"reference-count":38,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,2,11]],"date-time":"2020-02-11T00:00:00Z","timestamp":1581379200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,2,11]],"date-time":"2020-02-11T00:00:00Z","timestamp":1581379200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100013986","name":"UK Government","doi-asserted-by":"crossref","award":["PHE IPS study"],"award-info":[{"award-number":["PHE IPS study"]}],"id":[{"id":"10.13039\/100013986","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Unemployment is highly prevalent in populations with alcohol and drug dependence and the employment support offered in addiction-treatment programmes is ineffective. Individual Placement and Support (IPS) is an evidence-based intervention for competitive employment. IPS has been extensively studied in severe mental illness and physical disabilities, but there have been no formal randomised controlled trials (RCTs) in alcohol and drug dependence. The Individual Placement and Support for Alcohol and Drug Dependence (IPS-AD) study should determine whether IPS for patients with alcohol use disorder (AUD), opioid use disorder (OUD) and other drug use disorder is effective.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design\/methods<\/jats:title>\n                    <jats:p>The IPS-AD study is a seven-site, pragmatic, two-arm, parallel-group, superiority RCT. IPS-AD includes a realist process evaluation. Eligible patients (adult, unemployed or economically inactive for at least 6\u2009months and wishing to obtain open job market employment and enrolled in ongoing community treatment-as-usual (TAU; the control condition) in England for AUD, OUD and other drug use disorders) will be randomised (1:1) to receive TAU and any standard employment support, or TAU plus IPS (the experimental condition) for 9 months with up to 4 months of in-work support. The primary outcome measure will be competitive employment status (at least 1 day (7\u2009h)) during an 18-month follow-up, determined by patient-level, trial-data-linkage with national tax and state benefit databases. From meta-analysis, an 18% target difference on this measure of vocational effectiveness (for the experimental intervention) and a two-sided 5% level of statistical significance, will require a minimum target sample of 832 participants to achieve 90% power for a pre-registered, mixed-effects, multi-variable logistic regression model. A maximum-likelihood multiple-imputation approach will manage missing outcome data. IPS-AD has six vocational secondary outcome measures during the 18-month follow-up: (1) total time in competitive employment (and corresponding National Insurance contributions and tax paid); (2) time from randomisation to first competitive employment; (3) number of competitive job appointments; (4) job tenure (length of longest held competitive employment); (5) sustained employment (tenure in a single appointment for at least 13\u2009weeks); and (6) job search self-efficacy. A primary cost-benefit analysis and a secondary cost-effectiveness analysis will be done using the primary outcome and secondary vocational outcomes, respectively and will include addiction treatment and social and health outcomes and their associated reference costs. The process evaluation will address IPS implementation and delivery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The IPS-AD study is the first large-scale, multi-site, definitive, superiority RCT of IPS for people with alcohol and drug dependence. Findings from the study will have substantial implications for service delivery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ISRCTN Registry, ID:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.isrctn.com\/ISRCTN24159790?q=&amp;filters=conditionCategory:Mental%20and%20Behavioural%20Disorders%2CrecruitmentCountry:United%20Kingdom&amp;sort=&amp;offset=3&amp;totalResults=1095&amp;page=1&amp;pageSize=10&amp;searchType=basic-search\">ISRCTN24159790<\/jats:ext-link>\n                      . Registered on 1 February 2018.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-020-4099-4","type":"journal-article","created":{"date-parts":[[2020,2,11]],"date-time":"2020-02-11T11:02:50Z","timestamp":1581418970000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Protocol for a multi-centre, definitive randomised controlled trial of the effectiveness of Individual Placement and Support for employment support among people with alcohol and drug dependence"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1307-2498","authenticated-orcid":false,"given":"John","family":"Marsden","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Anders","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"Clark","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyriacos","family":"Colocassis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Eastwood","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Knight","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Melaugh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Quinn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginia","family":"Wright","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jez","family":"Stannard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,2,11]]},"reference":[{"key":"4099_CR1","volume-title":"Is work good for your health and well-being?","author":"G Waddell","year":"2006","unstructured":"Waddell G, Burton AK. 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The protocol, PIS, PCF and research questionnaires were approved by the East of England-Cambridge East Research Ethics Committee (reference: 17\/EE\/0454) and the Health Research Authority (Integrated Research Application System (IRAS) project number: 233276). The protocol was first approved by the Ethics Committee on 21 December 2017 and amended on 23 May 2018 to incorporate the independent process evaluation (version 1.0).","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Consent Forms for the trial include consent for publication of results in peer-reviewed journals.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"All authors have completed the uniform disclosure form of the International Committee of Medical Journal Editors (\n                      \n                      ).In the past 3 years, JM declares research grants from the National Institute for Health Research (National Institute for Health Research (NIHR); randomised controlled trial of depot naltrexone for OUD, and a randomised controlled trial of acamprosate for AUD), and the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Mental Health Foundation Trust (SLaM; randomised controlled trial of novel cognitive therapy for cocaine use disorder). He has part-time employment as Senior Academic Advisor for the Alcohol, Drugs, Tobacco and Justice Division, Health Improvement Directorate, PHE and is a clinical academic consultant for the US National Institute on Drug Abuse, Centre for Clinical Trials Network. JM declares an unrestricted research grant at IoPPN and SLaM from Indivior via Action on Addiction for a randomised controlled trial of personalised psychosocial intervention in opioid-agonist medication for OUD (published in 2019) and from 2019 an unrestricted research grant funding at IoPPN and SLaM from Indivior for a 3-year, multi-centre, randomised controlled trial of injectable depot buprenorphine for OUD. He has received honoraria and travel support from Reckitt-Benckiser (2016; treatment of OUD) and PCM Scientific and Martindale for the Improving Outcomes in Treatment of Opioid Dependence Conference (2018).All other authors have no competing interests to declare.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"167"}}