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Persons with psychiatric disabilities may reduce their engagement in meaningful activities to various degrees with possible fluctuations over time. We hypothesized that activity engagement can be altered when opportunities and support are offered at an individual and a group peer-based level. Evidence is lacking regarding mental health interventions that enable engagement in meaningful activities, and powered effect studies are warranted.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>We propose an 8-month combined individual and group peer-based intervention, Meaningful Activities and Recovery (MA&amp;R), and a study protocol for a multicentre two-armed parallel randomized controlled trial (RCT). The trial investigates the effects of MA&amp;R in community mental health centres in Copenhagen and municipality services in Denmark. The trial will comprise 128 participants with psychiatric disabilities who will be randomized to one of two groups: (1) MA&amp;R in addition to standard mental healthcare or (2) standard mental healthcare alone. The primary outcome is self-reported activity engagement, measured by Profiles of Engagement in People with Severe Mental Illness. Secondary outcomes are recovery, functioning and quality of life. Data will be collected at baseline and at follow-up at the end of the intervention.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Discussion<\/jats:title>\n<jats:p>This study adds new knowledge to a field with limited evidence, i.e. the clinical effectiveness of rehabilitation interventions among people with psychiatric disabilities, directly targeting activity engagement. The pragmatic design, regarding in- and exclusion criteria and settings, may allow assessment of the intervention\u2019s effect under real-life conditions. The randomization, adequate power and fidelity monitoring allow testing of the intervention\u2019s efficacy. The multicentre study design increases the potential for implementation in various mental health settings if the findings are positive. As the nature of the intervention does not permit blinding of the participants or staff, it may increase the risk of expectancy and performance bias. This must be considered when interpreting the findings.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p>ClinicalTrials.gov <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03963245\">NCT03963245<\/jats:ext-link>. Registered on 29 May 2019<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s13063-020-04722-3","type":"journal-article","created":{"date-parts":[[2020,9,14]],"date-time":"2020-09-14T12:02:53Z","timestamp":1600084973000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Meaningful Activities and Recovery (MA&amp;R): the effect of a novel rehabilitation intervention among persons with psychiatric disabilities on activity engagement\u2014study protocol for a randomized controlled trial"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8252-389X","authenticated-orcid":false,"given":"Siv Therese Bogevik","family":"Bj\u00f8rkedal","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrika","family":"Bejerholm","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lene Falgaard","family":"Eplov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"M\u00f8ller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,9,14]]},"reference":[{"issue":"2","key":"4722_CR1","doi-asserted-by":"crossref","first-page":"105","DOI":"10.1007\/s10728-012-0235-y","volume":"22","author":"A Rudnick","year":"2014","unstructured":"Rudnick A. 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Curr Psychiatry Rep. 2019;21(2):10.","journal-title":"Curr Psychiatry Rep"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-04722-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-020-04722-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-04722-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,9,14]],"date-time":"2021-09-14T00:02:40Z","timestamp":1631577760000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-020-04722-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,9,14]]},"references-count":53,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["4722"],"URL":"https:\/\/doi.org\/10.1186\/s13063-020-04722-3","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,9,14]]},"assertion":[{"value":"12 May 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 September 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 September 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The trial is approved by the regional committee of ethics (H-18017307) and the Danish Data Protection Agency (VD-2018-299, I-Suite nr: 6543). The protocol is registered at  (Protocol Record NCT 03963245). Protocol amendments that may affect the conduct of the study will be submitted to Clinical Trials. Participants\u2019 data are collected, stored and processed following GPDR. The project is carried out following the Helsinki Declaration. Written, informed consent is obtained before the participants are included in the research project and data are collected. The researcher emphasizes that participation is voluntary and that at any time, the participants may withdraw from participating in the trial without any consequences for them or the mental health services they receive or may need in the future.Because the MA&R trial is not assumed to be associated with any risk of harm, according to the investigators of similar interventions, a data monitoring committee will not be appointed, nor will any interim analysis be performed.Regarding ancillary and post-trial care, there is free access to treatment in Denmark; accordingly, participants in this study have free access to the necessary treatment.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interest.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"789"}}