{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T23:30:24Z","timestamp":1784158224297,"version":"3.55.0"},"reference-count":36,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,7,16]],"date-time":"2021-07-16T00:00:00Z","timestamp":1626393600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,7,16]],"date-time":"2021-07-16T00:00:00Z","timestamp":1626393600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100007437","name":"TrygFonden","doi-asserted-by":"publisher","award":["124341"],"award-info":[{"award-number":["124341"]}],"id":[{"id":"10.13039\/501100007437","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Many patients with coronary artery disease (CAD) and valvular heart disease (VHD) suffer from psychological distress. Such stress is associated with increased morbidity, reduced quality of life and delayed return to work. European guidelines emphasize recognition and intervention, but evidence-based treatment options are limited and perceived as costly. The present study will test the effect of brief, group-based cognitive therapy as an adjunct to usual cardiac rehabilitation in a randomized design.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>A total of 148 patients with CAD and\/or VHD after surgical intervention and concomitant psychological distress (defined as HADS anxiety (A) or depression (D) score \u22658) will be randomized to either usual out-patient cardiac rehabilitation (CR) comprising an 8-week multidisciplinary programme or usual care supplemented by five group-based cognitive therapy sessions performed by trained CR nurses. A structured, standardized treatment manual will be used. Patients will be randomized 1:1 at three different sites. Additionally, a non-randomized sub-group of 40 matched patients without signs of psychological distress will be followed to investigate spontaneous variation in HADS. The primary outcome is Hospital Anxiety and Depression Score (HADS). Secondary outcomes are adherence to cardiac rehabilitation (CR), health-related quality of life measured by HeartQoL, time to return to work, adherence to lifestyle interventions and cardiovascular readmissions. Patients are followed up for 12\u2009months.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>To our knowledge, this is the first randomized controlled trial (RCT) on patients with cardiac disease with an intensive group-based programme of cognitive therapy performed by CR nurses, which makes it affordable and widely implementable. The outcome will elucidate the feasibility and effect of cognitive therapy as an adjunct to CR in patients with post-surgery CAD and\/or VHD and psychological distress and could possibly benefit patients with other heart conditions as well. The clinical trial complies with the Declaration of Helsinki. The trial has been approved by The Regional Research Ethics Committee (file number H-16042832) and The Danish Data Protection Agency. The results will be disseminated as original research in peer-reviewed manuscripts.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\">www.clinicaltrials.gov<\/jats:ext-link><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04254315\">NCT04254315<\/jats:ext-link>. Retrospectively registered on 30 January 2020.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-021-05405-3","type":"journal-article","created":{"date-parts":[[2021,7,16]],"date-time":"2021-07-16T09:03:07Z","timestamp":1626426187000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Intensive group-based cognitive therapy in patients with cardiac disease and psychological distress\u2014a randomized controlled trial protocol"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5114-7761","authenticated-orcid":false,"given":"Annette","family":"Holdgaard","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Eckhardt-Hansen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Lund","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina Funch","family":"Lassen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kirstine L\u00e6rum","family":"Sibiliz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dan Eik","family":"H\u00f8fsten","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Prescott","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanne Kruuse","family":"Rasmusen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,7,16]]},"reference":[{"issue":"9","key":"5405_CR1","doi-asserted-by":"publisher","first-page":"910","DOI":"10.1177\/2047487318770510","volume":"25","author":"F Norlund","year":"2018","unstructured":"Norlund F, Liss\u00e5ker C, Wallert J, Held C, Olsson EM. Factors associated with emotional distress in patients with myocardial infarction: results from the SWEDEHEART registry. Eur J Prev Cardiol. 2018;25(9):910\u201320. https:\/\/doi.org\/10.1177\/2047487318770510.","journal-title":"Eur J Prev Cardiol"},{"issue":"12","key":"5405_CR2","doi-asserted-by":"publisher","first-page":"1350","DOI":"10.1161\/CIR.0000000000000019","volume":"129","author":"JH Lichtman","year":"2014","unstructured":"Lichtman JH, Froelicher ES, Blumenthal JA, Carney RM, Doering LV, Frasure-Smith N, et al. Depression as a risk factor for poor prognosis among patients with acute coronary syndrome: systematic review and recommendations: a scientific statement from the American Heart Association. Circulation. 2014;129(12):1350\u201369.","journal-title":"Circulation"},{"key":"5405_CR3","doi-asserted-by":"crossref","unstructured":"Murphy B, Le Grande M, Alvarenga M, Worcester M, Jackson A. Anxiety and depression after a cardiac event: prevalence and predictors. Front Psychol. 2020;10 Tilg\u00e6ngelig hos: https:\/\/www.frontiersin.org\/articles\/10.3389\/fpsyg.2019.03010\/full. [henvist 23. marts 2020].","DOI":"10.3389\/fpsyg.2019.03010"},{"issue":"5","key":"5405_CR4","doi-asserted-by":"publisher","first-page":"552","DOI":"10.1177\/2047487315571889","volume":"23","author":"MR van Dijk","year":"2016","unstructured":"van Dijk MR, Utens EM, Dulfer K, Al-Qezweny MN, van Geuns R-J, Daemen J, et al. Depression and anxiety symptoms as predictors of mortality in PCI patients at 10 years of follow-up. Eur J Prev Cardiol. 2016;23(5):552\u20138.","journal-title":"Eur J Prev Cardiol"},{"issue":"14","key":"5405_CR5","doi-asserted-by":"publisher","first-page":"1510","DOI":"10.1177\/2047487319841475","volume":"26","author":"CT Liss\u00e5ker","year":"2019","unstructured":"Liss\u00e5ker CT, Norlund F, Wallert J, Held C, Olsson EM. Persistent emotional distress after a first-time myocardial infarction and its association to late cardiovascular and non-cardiovascular mortality. Eur J Prev Cardiol. 2019;26(14):1510\u20138. https:\/\/doi.org\/10.1177\/2047487319841475.","journal-title":"Eur J Prev Cardiol"},{"issue":"3","key":"5405_CR6","doi-asserted-by":"publisher","first-page":"246","DOI":"10.1177\/1474515117731391","volume":"17","author":"B Borregaard","year":"2018","unstructured":"Borregaard B, Ekholm O, Riber L, S\u00f8rensen J, M\u00f8ller JE, Thrysoe L, et al. Patient-reported outcomes after aortic and mitral valve surgery \u2013 results from the DenHeart study. Eur J Cardiovasc Nurs. 2018;17(3):246\u201354.","journal-title":"Eur J Cardiovasc Nurs"},{"key":"5405_CR7","doi-asserted-by":"publisher","first-page":"66","DOI":"10.1016\/j.jpsychores.2018.07.002","volume":"112","author":"SK Berg","year":"2018","unstructured":"Berg SK, Rasmussen TB, Thrysoee L, Thorup CB, Borregaard B, Christensen AV, et al. Mental health is a risk factor for poor outcomes in patients with cardiac disease: findings from the national DenHeart survey. J Psychosom Res. 2018;112:66\u201372. https:\/\/doi.org\/10.1016\/j.jpsychores.2018.07.002.","journal-title":"J Psychosom Res"},{"key":"5405_CR8","doi-asserted-by":"publisher","unstructured":"Rao A, Zecchin R, Newton P, Phillips J, DiGiacomo M, Denniss A, et al. The prevalence and impact of depression and anxiety in cardiac rehabilitation: a longitudinal cohort study. Eur J Prev Cardiol. 2020;27(5):478-89. https:\/\/doi.org\/10.1177\/2047487319871716. Epub 2019 Oct 9.","DOI":"10.1177\/2047487319871716"},{"issue":"17","key":"5405_CR9","doi-asserted-by":"publisher","first-page":"2024","DOI":"10.1161\/hc4201.097834","volume":"104","author":"RM Carney","year":"2001","unstructured":"Carney RM, Blumenthal JA, Stein PK, Watkins L, Catellier D, Berkman LF, et al. Depression, heart rate variability, and acute myocardial infarction. Circulation. 2001;104(17):2024\u20138.","journal-title":"Circulation"},{"issue":"4","key":"5405_CR10","doi-asserted-by":"publisher","first-page":"656","DOI":"10.1016\/j.jacc.2005.05.041","volume":"46","author":"A Sherwood","year":"2005","unstructured":"Sherwood A, Hinderliter AL, Watkins LL, Waugh RA, Blumenthal JA. Impaired endothelial function in coronary heart disease patients with depressive symptomatology. J Am Coll Cardiol. 2005;46(4):656\u20139. https:\/\/doi.org\/10.1016\/j.jacc.2005.05.041.","journal-title":"J Am Coll Cardiol"},{"key":"5405_CR11","doi-asserted-by":"crossref","unstructured":"Smedegaard L, Num\u00e9 A, Charlot M, Kragholm K, Gislason G, Hansen PR. Return to work and risk of subsequent detachment from employment after myocardial infarction: insights from Danish Nationwide Registries. JAHA. 2017;6(10) Tilg\u00e6ngelig hos: https:\/\/www.ahajournals.org\/doi\/10.1161\/JAHA.117.006486. [henvist 31. august 2020].","DOI":"10.1161\/JAHA.117.006486"},{"issue":"12","key":"5405_CR12","doi-asserted-by":"publisher","first-page":"e0208842","DOI":"10.1371\/journal.pone.0208842","volume":"13","author":"M Stendardo","year":"2018","unstructured":"Stendardo M, Bonci M, Casillo V, Miglio R, Giovannini G, Nardini M, et al. Predicting return to work after acute myocardial infarction: socio-occupational factors overcome clinical conditions. Lazzeri C, redakt\u00f8r. PLoS ONE. 2018;13(12):e0208842.","journal-title":"PLoS ONE"},{"issue":"8","key":"5405_CR13","doi-asserted-by":"publisher","first-page":"742","DOI":"10.1097\/PSY.0000000000000626","volume":"80","author":"J Reavell","year":"2018","unstructured":"Reavell J, Hopkinson M, Clarkesmith D, Lane DA. Effectiveness of cognitive behavioral therapy for depression and anxiety in patients with cardiovascular disease: a systematic review and meta-analysis. Psychosom Med. 2018;80(8):742\u201353. https:\/\/doi.org\/10.1097\/PSY.0000000000000626.","journal-title":"Psychosom Med"},{"issue":"14","key":"5405_CR14","doi-asserted-by":"publisher","first-page":"1341","DOI":"10.1161\/CIRCULATIONAHA.115.018926","volume":"133","author":"A Blumenthal James","year":"2016","unstructured":"Blumenthal James A, Andrew S, Smith Patrick J, Lana W, Stephanie M, Kraus William E, et al. Enhancing cardiac rehabilitation with stress management training. Circulation. 2016;133(14):1341\u201350.","journal-title":"Circulation"},{"issue":"2","key":"5405_CR15","doi-asserted-by":"publisher","first-page":"134","DOI":"10.1001\/archinternmed.2010.510","volume":"171","author":"M Gulliksson","year":"2011","unstructured":"Gulliksson M, Burell G, Vessby B, Lundin L, Toss H, Sv\u00e4rdsudd K. Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM). Arch Intern Med. 2011;171(2):134\u201340.","journal-title":"Arch Intern Med"},{"issue":"3","key":"5405_CR16","doi-asserted-by":"publisher","first-page":"200","DOI":"10.7326\/0003-4819-158-3-201302050-00583","volume":"158","author":"A-W Chan","year":"2013","unstructured":"Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, G\u00f8tzsche PC, Krle\u017ea-Jeri\u0107 K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200.","journal-title":"Ann Intern Med"},{"issue":"4","key":"5405_CR17","doi-asserted-by":"publisher","first-page":"295","DOI":"10.7326\/0003-4819-148-4-200802190-00008","volume":"148","author":"I Boutron","year":"2008","unstructured":"Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, for the CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148(4):295.","journal-title":"Ann Intern Med"},{"issue":"4","key":"5405_CR18","doi-asserted-by":"publisher","first-page":"275","DOI":"10.1016\/j.genhosppsych.2005.03.002","volume":"27","author":"KZ Bambauer","year":"2005","unstructured":"Bambauer KZ, Locke SE, Aupont O, Mullan MG, McLaughlin TJ. Using the Hospital Anxiety and Depression Scale to screen for depression in patients with cardiac disease. Gen Hosp Psychiatry. 2005;27(4):275\u201384. https:\/\/doi.org\/10.1016\/j.genhosppsych.2005.03.002.","journal-title":"Gen Hosp Psychiatry"},{"issue":"543","key":"5405_CR19","first-page":"801","volume":"57","author":"M Scherer","year":"2007","unstructured":"Scherer M, Himmel W, Stanske B, Scherer F, Koschack J, Kochen MM, et al. Psychological distress in primary care patients with heart failure: a longitudinal study. Br J Gen Pract. 2007;57(543):801\u20137.","journal-title":"Br J Gen Pract"},{"issue":"10","key":"5405_CR20","doi-asserted-by":"publisher","first-page":"e78493","DOI":"10.1371\/journal.pone.0078493","volume":"8","author":"M Haddad","year":"2013","unstructured":"Haddad M, Walters P, Phillips R, Tsakok J, Williams P, Mann A, et al. Detecting depression in patients with coronary heart disease: a diagnostic evaluation of the PHQ-9 and HADS-D in primary care, findings from the UPBEAT-UK Study. Shimizu E, redakt\u00f8r. PLoS ONE. 2013;8(10):e78493.","journal-title":"PLoS ONE"},{"issue":"4","key":"5405_CR21","doi-asserted-by":"publisher","first-page":"411","DOI":"10.1016\/j.jpsychores.2006.11.010","volume":"62","author":"I Lie","year":"2007","unstructured":"Lie I, Arnesen H, Sandvik L, Hamilton G, Bunch HE. Effects of a home-based intervention program on anxiety and depression 6 months after coronary artery bypass grafting: a randomized controlled trial. J Psychosom Res. 2007;62(4):411\u20138.","journal-title":"J Psychosom Res"},{"issue":"17","key":"5405_CR22","doi-asserted-by":"publisher","first-page":"1768","DOI":"10.1161\/CIRCULATIONAHA.108.190769","volume":"118","author":"JH Lichtman","year":"2008","unstructured":"Lichtman JH, Thomas BJ, Blumenthal James A, Nancy F-S, Kaufmann Peter G, Fran\u00e7ois L, et al. Depression and coronary heart disease. Circulation. 2008;118(17):1768\u201375.","journal-title":"Circulation"},{"issue":"6","key":"5405_CR23","doi-asserted-by":"publisher","first-page":"624","DOI":"10.1177\/2047487318769766","volume":"26","author":"SK Berg","year":"2019","unstructured":"Berg SK, Thorup CB, Borregaard B, Christensen AV, Thrysoee L, Rasmussen TB, et al. Patient-reported outcomes are independent predictors of one-year mortality and cardiac events across cardiac diagnoses: findings from the national DenHeart survey. Eur J Prev Cardiol. 2019;26(6):624\u201337.","journal-title":"Eur J Prev Cardiol"},{"key":"5405_CR24","doi-asserted-by":"publisher","unstructured":"Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale an updated literature review. J Psychosom Res. 2002;52(2):69-77. https:\/\/doi.org\/10.1016\/s0022-3999(01)00296-3.","DOI":"10.1016\/s0022-3999(01)00296-3"},{"key":"5405_CR25","doi-asserted-by":"crossref","unstructured":"Christensen AV, Dixon JK, Juel K, Ekholm O, Rasmussen TB, Borregaard B, et al. Psychometric properties of the Danish Hospital Anxiety and Depression Scale in patients with cardiac disease: results from the DenHeart survey. Health Qual Life Outcomes. 2020;18 Tilg\u00e6ngelig hos: https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6947856\/. [henvist 24. september 2020].","DOI":"10.1186\/s12955-019-1264-0"},{"issue":"1","key":"5405_CR26","doi-asserted-by":"publisher","first-page":"90","DOI":"10.1177\/2047487312450544","volume":"21","author":"N Oldridge","year":"2014","unstructured":"Oldridge N, H\u00f6fer S, McGee H, Conroy R, Doyle F, Saner H. The HeartQoL: Part I. Development of a new core health-related quality of life questionnaire for patients with ischemic heart disease. Eur J Prev Cardiol. 2014;21(1):90\u20137.","journal-title":"Eur J Prev Cardiol"},{"issue":"1","key":"5405_CR27","doi-asserted-by":"publisher","first-page":"98","DOI":"10.1177\/2047487312450545","volume":"21","author":"N Oldridge","year":"2014","unstructured":"Oldridge N, H\u00f6fer S, McGee H, Conroy R, Doyle F, Saner H. The HeartQoL: Part II. Validation of a new core health-related quality of life questionnaire for patients with ischemic heart disease. Eur J Prev Cardiol. 2014;21(1):98\u2013106.","journal-title":"Eur J Prev Cardiol"},{"key":"5405_CR28","first-page":"391\u2009s","volume-title":"Cognitive behavior therapy: basics and beyond","author":"JS Beck","year":"2011","unstructured":"Beck JS, Beck JS. Cognitive behavior therapy: basics and beyond. 2nd ed. New York: Guilford Press; 2011. p. 391\u2009s.","edition":"2"},{"key":"5405_CR29","volume-title":"Cognitive therapy: recent development","author":"M Arendt","year":"2012","unstructured":"Arendt M. Cognitive therapy: recent development; 2012."},{"issue":"3","key":"5405_CR30","doi-asserted-by":"publisher","first-page":"171","DOI":"10.1891\/0889-8391.31.3.171","volume":"31","author":"L Hallis","year":"2017","unstructured":"Hallis L, Cameli L, Bekkouche NS, Kn\u00e4uper B. Combining cognitive therapy with acceptance and commitment therapy for depression: a group therapy feasibility study. J Cogn Psychother. 2017;31(3):171\u201390. https:\/\/doi.org\/10.1891\/0889-8391.31.3.171.","journal-title":"J Cogn Psychother"},{"key":"5405_CR31","first-page":"266\u2009s","volume-title":"The ACT matrix: a new approach to building psychological flexibility across settings & populations","author":"KL Polk","year":"2014","unstructured":"Polk KL, Schoendorff B, redakt\u00f8rer. The ACT matrix: a new approach to building psychological flexibility across settings & populations. Oakland: Context Press, an imprint of New Harbinger Publications, Inc; 2014. p. 266\u2009s."},{"key":"5405_CR32","volume-title":"Cognitive treatment of panic disorder and social phobia: a guide for clients and therapists","author":"E Hougaard","year":"2007","unstructured":"Hougaard E, Hougaard E, Rosenberg NK. Cognitive treatment of panic disorder and social phobia: a guide for clients and therapists. Kbh: Danish psychological publishers; 2007."},{"key":"5405_CR33","volume-title":"Lykkef\u00e6lden: Illustrated guide on how to stop the fight and live life","author":"R Harris","year":"2013","unstructured":"Harris R, Aisbett B. Lykkef\u00e6lden: Illustrated guide on how to stop the fight and live life. Virum: Danish Psychological publishers; 2013."},{"key":"5405_CR34","volume-title":"Cognitive behavioral therapy for depression: manual for group therapy","author":"MJ Due","year":"2008","unstructured":"Due MJ. Cognitive behavioral therapy for depression: manual for group therapy. Virum: Danish psychological publishers; 2008."},{"key":"5405_CR35","volume-title":"A behavioral activation in depression: a clinical guide","author":"CR Martell","year":"2012","unstructured":"Martell CR, Dimidjian S, Herman-Dunn R. A behavioral activation in depression: a clinical guide. Kbh: Danish psychological publishers; 2012."},{"issue":"4","key":"5405_CR36","doi-asserted-by":"publisher","first-page":"810","DOI":"10.1249\/MSS.0000000000002193","volume":"52","author":"T Karlsen","year":"2020","unstructured":"Karlsen T, Videm V, Halle M, Ellingsen \u00d8, St\u00f8ylen A, Dalen H, et al. Baseline and exercise predictors of V\u02d9O2peak in systolic heart failure patients: results from SMARTEX-HF. Med Sci Sports Exerc. 2020;52(4):810\u20139.","journal-title":"Med Sci Sports Exerc"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05405-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-021-05405-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05405-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,7,16]],"date-time":"2021-07-16T09:07:23Z","timestamp":1626426443000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-021-05405-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7,16]]},"references-count":36,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["5405"],"URL":"https:\/\/doi.org\/10.1186\/s13063-021-05405-3","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,7,16]]},"assertion":[{"value":"3 March 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 June 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"16 July 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The Ethics Committee for the Capital Region of Denmark (file number H-16042832) and the Danish Data Protection Agency have approved the trail, and the study is registered at  (NCT04254315)The study is performed in accordance with the Declaration of Helsinki in its latest form. Participants can withdraw from the study at any time without any explanation or consequences. The regional ethics committee will be asked for permission in the case of protocol amendments.A patient from the control group and the intervention group can follow the same group at the usual CR to make sure that the treatment will not be delayed.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"No consent for publication is required.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"455"}}