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Some literature suggests only short-term positive effects of consultation liaison on patient-related outcomes, whereas collaborative care demonstrates both short-term and long-term positive effects. To our knowledge, only one randomized trial has compared the effects of these models. Collaborative care was superior to consultation liaison in reducing symptoms of depression for up to 3\u2009months, but the authors found no difference at 9-months' follow-up. The Collabri Flex Trial for Depression and the Collabri Flex Trial for Anxiety aim to compare the effects of collaborative care with those of a form of consultation liaison that contains potential contaminating elements from collaborative care. The trials build on knowledge from the previous cluster-randomized Collabri trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Two randomized, investigator-initiated, parallel-group, superiority trials have been established: one investigating the effects of collaborative care vs consultation liaison for depression and one investigating the effects of collaborative care vs consultation liaison for generalized anxiety, panic disorder and social anxiety disorder at 6-months' follow-up. Participants are recruited from general practices in the Capital Region of Denmark: 240 in the depression trial and 284 in the anxiety trial. The primary outcome is self-reported depression symptoms (Beck Depression Inventory (BDI-II)) in the depression trial and self-reported anxiety symptoms (Beck Anxiety Inventory (BAI)) in the anxiety trial. In both trials, the self-reported secondary outcomes are general psychological problems and symptoms (Symptom Checklist 90-Revised), functional impairment (Sheehan Disability Scale) and general well-being (World Health Organization-Five Well-Being Index). In the depression trial, BAI is an additional secondary outcome, and BDI-II is an additional secondary outcome in the anxiety trial. Explorative outcomes will also be collected.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>The results will supplement those of the cluster-randomized Collabri trials and provide pivotal information about the effects of collaborative care in Denmark.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><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\/NCT03113175\">NCT03113175<\/jats:ext-link>and<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03113201\">NCT03113201<\/jats:ext-link>. Registered on 13 April 2017.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s13063-019-3657-0","type":"journal-article","created":{"date-parts":[[2019,10,25]],"date-time":"2019-10-25T18:24:53Z","timestamp":1572027893000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials)"],"prefix":"10.1186","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1485-300X","authenticated-orcid":false,"given":"Nadja Kehler","family":"Curth","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ursula","family":"Brinck-Claussen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kirstine Bro","family":"J\u00f8rgensen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susanne","family":"Rosendal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carsten","family":"Hjorth\u00f8j","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Merete","family":"Nordentoft","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lene Falgaard","family":"Eplov","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2019,10,25]]},"reference":[{"key":"3657_CR1","doi-asserted-by":"publisher","first-page":"96","DOI":"10.1046\/j.0001-690X.2003.00231.x","volume":"109","author":"LR Olsen","year":"2004","unstructured":"Olsen LR, Mortensen EL, Bech P. 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Any protocol modifications will be described in the reporting of findings. Access to the full protocol can be achieved upon request. All data will be electronically stored and entry restricted. Researchers and project staff members will have access to data. Personally identifiable data will be handled according to the Danish law regarding personal information (\u2018Lov om behandling af personoplysninger\u2019).The GP obtains patients\u2019 consent to participation. This is based on oral and written information. A friend or family member can be present at an information meeting. Participants have at least 24\u2009h to decide whether they wish to participate. Written consent forms must be signed, and participants receive the original; an electronic copy will be stored in the electronic system REDCap. Participants are informed of their rights to leave the study at any time and with no consequences for future treatment. There are no known circumstances that can lead to exclusion after a patient is included. The participant will be notified if such circumstances arise. The authors are not aware of previous reporting of adverse events of collaborative care. The treatment modalities embedded in the collaborative care model are provided according to National guidelines, and symptom severity and suicidality are monitored.The study protocol has been evaluated and approved by the Regional Ethics Committees of the Capital Region (identification number: H-16034303) and the Danish Data Protection Agency (local journal number: RHP-2017-050, 05910), and has been registered with ClinicalTrials.gov (, identification numbers NCT03113175 and NCT03113201). A checklist of Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) is available in Additional\u00a0file\u00a0and a full SPIRIT figure is shown in Fig.\u00a0.Findings from the trials will be communicated as part of a Health Technology Assessment and through one or more scientific papers.","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 interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"607"}}