Improving health-related quality of life in patients with endometriosis-related chronic pain: The COGENS trial

Improving health-related quality of life in patients with endometriosis-related chronic pain: The COGENS trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Improving health-related quality of life in patients with endometriosis-related chronic pain: The COGENS trial Zoë Boersen, Joukje Marije Oosterman, Frederik Paul Hendrik Louis Jacob Dijkhuizen, and 9 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7907021/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 12 Mar, 2026 Read the published version in BMC Women's Health → Version 1 posted 11 You are reading this latest preprint version Abstract Research Question: Endometriosis-related chronic pain leads to impaired health-related quality of life (HRQoL). Endometriosis surgery can improve chronic pain and HRQoL, but not to the same level as healthy women. Cognitive behavioral therapy (CBT) is promising for the treatment of chronic pain. In this study we evaluate the effect of CBT on HRQoL in patients undergoing surgery for endometriosis-related chronic pain. Design: This randomized controlled, single-blind multicenter, clinical trial, 100 Dutch patients undergoing surgery for endometriosis related chronic pain were included. Participants were randomized between endometriosis surgery only or endometriosis surgery plus the intervention: seven sessions of CBT. Questionnaires evaluated HRQoL, pain intensity, catastrophizing, anxiety, fatigue, and perceived stress four weeks prior to surgery (T0), and two (T1) and 16 (T2) weeks after the final CBT session. Hair cortisol concentrations (HCC) were analyzed to measure chronic stress. Group differences were evaluated with linear mixed models. Results Inclusion occurred between November 24, 2020 and December 28, 2023. The intention to treat analysis included 100 patients, 50 in each group. In the CBT group, the Endometriosis Health Profile (EHP)-30 modular part (p = .021) and the Short Form (SF)-36 physical component scale (p = .008) improved more when compared to the surgery-only group. Pain catastrophizing (p = .019) and anxiety (p = .047) were significantly lower in patients who were in the CBT group. The EHP-30 core part, SF-36 mental component scale, pain intensity, fatigue, perceived stress, and HCC. Conclusions CBT can improve HRQoL in patients surgically treated for endometriosis-related chronic pain. The reduction of pain catastrophizing was a major factor in this effect. Trial register ClinicalTrials.gov NCT04448366. Registered on June 3th, 2020. First participant enrollment: 24-11-2020. https://clinicaltrials.gov/study/NCT04448366?cond=NCT04448366&rank=1. The data generated and analyzed during the current study are available at Radboud Data Repository. The data can be accessed via https://doi.org/10.34973/fqsc-wd42. Data will be available for academic and non-commercial purposes upon reasonable request, starting one year after publication date. Endometriosis Chronic Pain Catastrophizing Cognitive Behavioral Therapy Health Related Quality of Life Surgery Full Text Additional Declarations No competing interests reported. Supplementary Files CONSORTchecklist2462025.docx Cite Share Download PDF Status: Published Journal Publication published 12 Mar, 2026 Read the published version in BMC Women's Health → Version 1 posted Editorial decision: Revision requested 05 Dec, 2025 Reviews received at journal 03 Dec, 2025 Reviewers agreed at journal 17 Nov, 2025 Reviewers agreed at journal 12 Nov, 2025 Reviews received at journal 26 Oct, 2025 Reviewers agreed at journal 26 Oct, 2025 Reviewers invited by journal 24 Oct, 2025 Editor assigned by journal 24 Oct, 2025 Editor invited by journal 24 Oct, 2025 Submission checks completed at journal 22 Oct, 2025 First submitted to journal 22 Oct, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7907021","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":539447031,"identity":"79a51cab-90a6-4ab3-ab5d-310abed34c51","order_by":0,"name":"Zoë Boersen","email":"","orcid":"","institution":"Rijnstate Hospital","correspondingAuthor":false,"prefix":"","firstName":"Zoë","middleName":"","lastName":"Boersen","suffix":""},{"id":539447032,"identity":"9f0182d0-89b6-42a0-a30f-4cae0446cd1d","order_by":1,"name":"Joukje Marije Oosterman","email":"","orcid":"","institution":"Radboud University 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trial","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-womens-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmwh","sideBox":"Learn more about [BMC Women's Health](http://bmcwomenshealth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bmwh/default.aspx","title":"BMC Women's Health","twitterHandle":"","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Endometriosis, Chronic Pain, Catastrophizing, Cognitive Behavioral Therapy, Health Related Quality of Life, Surgery","lastPublishedDoi":"10.21203/rs.3.rs-7907021/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7907021/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eResearch Question:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEndometriosis-related chronic pain leads to impaired health-related quality of life (HRQoL). Endometriosis surgery can improve chronic pain and HRQoL, but not to the same level as healthy women. Cognitive behavioral therapy (CBT) is promising for the treatment of chronic pain. In this study we evaluate the effect of CBT on HRQoL in patients undergoing surgery for endometriosis-related chronic pain.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDesign:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis randomized controlled, single-blind multicenter, clinical trial, 100 Dutch patients undergoing surgery for endometriosis related chronic pain were included. Participants were randomized between endometriosis surgery only or endometriosis surgery plus the intervention: seven sessions of CBT. Questionnaires evaluated HRQoL, pain intensity, catastrophizing, anxiety, fatigue, and perceived stress four weeks prior to surgery (T0), and two (T1) and 16 (T2) weeks after the final CBT session. Hair cortisol concentrations (HCC) were analyzed to measure chronic stress. Group differences were evaluated with linear mixed models.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInclusion occurred between November 24, 2020 and December 28, 2023. The intention to treat analysis included 100 patients, 50 in each group. In the CBT group, the Endometriosis Health Profile (EHP)-30 modular part (p = .021) and the Short Form (SF)-36 physical component scale (p = .008) improved more when compared to the surgery-only group. Pain catastrophizing (p = .019) and anxiety (p = .047) were significantly lower in patients who were in the CBT group. The EHP-30 core part, SF-36 mental component scale, pain intensity, fatigue, perceived stress, and HCC.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCBT can improve HRQoL in patients surgically treated for endometriosis-related chronic pain. The reduction of pain catastrophizing was a major factor in this effect.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial register\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eClinicalTrials.gov NCT04448366. Registered on June 3th, 2020. First participant enrollment: 24-11-2020. https://clinicaltrials.gov/study/NCT04448366?cond=NCT04448366\u0026amp;rank=1. The data generated and analyzed during the current study are available at Radboud Data Repository. The data can be accessed via https://doi.org/10.34973/fqsc-wd42. Data will be available for academic and non-commercial purposes upon reasonable request, starting one year after publication date.\u003c/p\u003e","manuscriptTitle":"Improving health-related quality of life in patients with endometriosis-related chronic pain: The COGENS trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-11-05 18:55:22","doi":"10.21203/rs.3.rs-7907021/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-12-05T08:42:22+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-12-03T10:03:48+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"264347683326593456222071919054233396981","date":"2025-11-17T23:44:31+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"186111998412181601009305862602095242469","date":"2025-11-12T12:59:53+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-10-26T20:39:01+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"262510919361325144210289720601361550565","date":"2025-10-26T15:50:01+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-24T22:22:27+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-10-24T15:32:41+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-10-24T13:58:32+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-10-22T16:16:17+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Women's Health","date":"2025-10-22T16:12:11+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-womens-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmwh","sideBox":"Learn more about [BMC Women's Health](http://bmcwomenshealth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bmwh/default.aspx","title":"BMC Women's Health","twitterHandle":"","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"a7cfee11-fb82-4157-9e4c-b347a71a8914","owner":[],"postedDate":"November 5th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-03-16T16:11:12+00:00","versionOfRecord":{"articleIdentity":"rs-7907021","link":"https://doi.org/10.1186/s12905-026-04340-2","journal":{"identity":"bmc-womens-health","isVorOnly":false,"title":"BMC Women's Health"},"publishedOn":"2026-03-12 16:00:32","publishedOnDateReadable":"March 12th, 2026"},"versionCreatedAt":"2025-11-05 18:55:22","video":"","vorDoi":"10.1186/s12905-026-04340-2","vorDoiUrl":"https://doi.org/10.1186/s12905-026-04340-2","workflowStages":[]},"version":"v1","identity":"rs-7907021","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7907021","identity":"rs-7907021","version":["v1"]},"buildId":"WvIrzKhiLBfengagbw6Ux","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}