Cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: protocol for the randomised, single-blinded, parallel-group Sleep-RA trial
BackgroundMore than half of patients with rheumatoid arthritis complain of insomnia, which is predominantly treated with hypnotic drugs. However, cognitive behavioural therapy for insomnia is recommended as the first-line treatment in international guidelines on sleep. Patients with rheumatoid arthr...
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| Veröffentlicht in: | Current controlled trials in cardiovascular medicine 2020-05, Vol.21 (1), p.440-440, Article 440 |
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| creator | Latocha, K. M. Loppenthin, K. B. Ostergaard, M. Jennum, P. J. Christensen, R. Hetland, M. Rogind, H. Lundbak, T. Midtgaard, Julie Esbensen, B. A. |
| description | BackgroundMore than half of patients with rheumatoid arthritis complain of insomnia, which is predominantly treated with hypnotic drugs. However, cognitive behavioural therapy for insomnia is recommended as the first-line treatment in international guidelines on sleep. Patients with rheumatoid arthritis suffer from debilitating symptoms, such as fatigue and pain, which can also be linked to sleep disturbance. It remains to be determined whether cognitive behavioural therapy for insomnia can be effective in patients with rheumatoid arthritis. The aim of the Sleep-RA trial is to investigate the efficacy of cognitive behavioural therapy for insomnia on sleep and disease-related symptoms in patients with rheumatoid arthritis. The primary objective is to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep efficiency from baseline to week 7 in patients with rheumatoid arthritis. The key secondary objectives are to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep onset latency, wake after sleep onset, total sleep time, insomnia, sleep quality, fatigue, impact of rheumatoid arthritis and depressive symptoms from baseline to week 26 in patients with rheumatoid arthritis.MethodsThe Sleep-RA trial is a randomised controlled trial with a two-group parallel design. Sixty patients with rheumatoid arthritis, insomnia and low-to-moderate disease activity will be allocated 1:1 to treatment with cognitive behavioural therapy for insomnia or usual care. Patients in the intervention group will receive nurse-led, group-based cognitive behavioural therapy for insomnia once a week for 6 weeks. Outcome assessments will be carried out at baseline, after treatment (week 7) and at follow-up (week 26).DiscussionData on treatment of insomnia in patients with rheumatoid arthritis are sparse. The Sleep-RA trial is the first randomised controlled trial to investigate the efficacy of cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis. Because symptoms of rheumatoid arthritis and insomnia have many similarities, we also find it relevant to investigate the secondary effects of cognitive behavioural therapy for insomnia on fatigue, impact of rheumatoid arthritis, depressive symptoms, pain, functional status, health-related quality of life and disease activity.If we find cognitive behavioural therapy for insomnia to be effective in patients with rheu |
| doi_str_mv | 10.1186/s13063-020-04282-6 |
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M. ; Loppenthin, K. B. ; Ostergaard, M. ; Jennum, P. J. ; Christensen, R. ; Hetland, M. ; Rogind, H. ; Lundbak, T. ; Midtgaard, Julie ; Esbensen, B. A.</creator><creatorcontrib>Latocha, K. M. ; Loppenthin, K. B. ; Ostergaard, M. ; Jennum, P. J. ; Christensen, R. ; Hetland, M. ; Rogind, H. ; Lundbak, T. ; Midtgaard, Julie ; Esbensen, B. A.</creatorcontrib><description>BackgroundMore than half of patients with rheumatoid arthritis complain of insomnia, which is predominantly treated with hypnotic drugs. However, cognitive behavioural therapy for insomnia is recommended as the first-line treatment in international guidelines on sleep. Patients with rheumatoid arthritis suffer from debilitating symptoms, such as fatigue and pain, which can also be linked to sleep disturbance. It remains to be determined whether cognitive behavioural therapy for insomnia can be effective in patients with rheumatoid arthritis. The aim of the Sleep-RA trial is to investigate the efficacy of cognitive behavioural therapy for insomnia on sleep and disease-related symptoms in patients with rheumatoid arthritis. The primary objective is to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep efficiency from baseline to week 7 in patients with rheumatoid arthritis. The key secondary objectives are to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep onset latency, wake after sleep onset, total sleep time, insomnia, sleep quality, fatigue, impact of rheumatoid arthritis and depressive symptoms from baseline to week 26 in patients with rheumatoid arthritis.MethodsThe Sleep-RA trial is a randomised controlled trial with a two-group parallel design. Sixty patients with rheumatoid arthritis, insomnia and low-to-moderate disease activity will be allocated 1:1 to treatment with cognitive behavioural therapy for insomnia or usual care. Patients in the intervention group will receive nurse-led, group-based cognitive behavioural therapy for insomnia once a week for 6 weeks. Outcome assessments will be carried out at baseline, after treatment (week 7) and at follow-up (week 26).DiscussionData on treatment of insomnia in patients with rheumatoid arthritis are sparse. The Sleep-RA trial is the first randomised controlled trial to investigate the efficacy of cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis. Because symptoms of rheumatoid arthritis and insomnia have many similarities, we also find it relevant to investigate the secondary effects of cognitive behavioural therapy for insomnia on fatigue, impact of rheumatoid arthritis, depressive symptoms, pain, functional status, health-related quality of life and disease activity.If we find cognitive behavioural therapy for insomnia to be effective in patients with rheumatoid arthritis this will add weight to the argument that evidence-based non-pharmacological treatment for insomnia in rheumatological outpatient clinics is eligible in accordance with the existing international guidelines on sleep.Trial registrationClinicalTrials.gov: NCT03766100. Registered on 30 November 2018.</description><identifier>ISSN: 1745-6215</identifier><identifier>EISSN: 1745-6215</identifier><identifier>DOI: 10.1186/s13063-020-04282-6</identifier><identifier>PMID: 32471477</identifier><language>eng</language><publisher>LONDON: Springer Nature</publisher><subject>Antiarthritic agents ; Arthritis ; Arthritis, Rheumatoid - complications ; Behavior modification ; Behavioral medicine ; Care and treatment ; Chronic illnesses ; Clinical trials ; Cognitive Behavioral Therapy - methods ; Cognitive behavioural therapy for insomnia ; Cognitive-behavioral therapy ; Denmark ; Depression - etiology ; Depression - therapy ; Disease ; Drugs ; Evidence-based medicine ; Exercise ; Fatigue ; Fatigue - etiology ; Fitness training programs ; Health risk assessment ; Humans ; Inflammatory arthritis ; Insomnia ; Life Sciences & Biomedicine ; Medicine, Research & Experimental ; Multicenter Studies as Topic ; Non-pharmacological treatment ; Pain ; Patients ; Physical fitness ; Polysomnography ; Psychotherapy, Group - methods ; Quality of Life ; Randomized Controlled Trials as Topic ; Research & Experimental Medicine ; Rheumatoid arthritis ; Rheumatoid factor ; Rheumatology ; Science & Technology ; Single-Blind Method ; Sleep ; Sleep disturbance ; Sleep Initiation and Maintenance Disorders - etiology ; Sleep Initiation and Maintenance Disorders - therapy ; Study Protocol ; Time Factors ; Treatment Outcome</subject><ispartof>Current controlled trials in cardiovascular medicine, 2020-05, Vol.21 (1), p.440-440, Article 440</ispartof><rights>COPYRIGHT 2020 BioMed Central Ltd.</rights><rights>The Author(s) 2020. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s) 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>9</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000537957200002</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-c563t-55a0e4d57caedae2f41c4d3d92dfd4a25b1fb6ae8a13515e9f9a52ef933452163</citedby><cites>FETCH-LOGICAL-c563t-55a0e4d57caedae2f41c4d3d92dfd4a25b1fb6ae8a13515e9f9a52ef933452163</cites><orcidid>0000-0003-2381-2127 ; 0000-0002-3739-7414 ; 0000-0002-6600-0631</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7257190/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7257190/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,729,782,786,866,887,2106,2118,27933,27934,28257,28258,53800,53802</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32471477$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Latocha, K. M.</creatorcontrib><creatorcontrib>Loppenthin, K. B.</creatorcontrib><creatorcontrib>Ostergaard, M.</creatorcontrib><creatorcontrib>Jennum, P. J.</creatorcontrib><creatorcontrib>Christensen, R.</creatorcontrib><creatorcontrib>Hetland, M.</creatorcontrib><creatorcontrib>Rogind, H.</creatorcontrib><creatorcontrib>Lundbak, T.</creatorcontrib><creatorcontrib>Midtgaard, Julie</creatorcontrib><creatorcontrib>Esbensen, B. A.</creatorcontrib><title>Cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: protocol for the randomised, single-blinded, parallel-group Sleep-RA trial</title><title>Current controlled trials in cardiovascular medicine</title><addtitle>TRIALS</addtitle><addtitle>Trials</addtitle><description>BackgroundMore than half of patients with rheumatoid arthritis complain of insomnia, which is predominantly treated with hypnotic drugs. However, cognitive behavioural therapy for insomnia is recommended as the first-line treatment in international guidelines on sleep. Patients with rheumatoid arthritis suffer from debilitating symptoms, such as fatigue and pain, which can also be linked to sleep disturbance. It remains to be determined whether cognitive behavioural therapy for insomnia can be effective in patients with rheumatoid arthritis. The aim of the Sleep-RA trial is to investigate the efficacy of cognitive behavioural therapy for insomnia on sleep and disease-related symptoms in patients with rheumatoid arthritis. The primary objective is to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep efficiency from baseline to week 7 in patients with rheumatoid arthritis. The key secondary objectives are to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep onset latency, wake after sleep onset, total sleep time, insomnia, sleep quality, fatigue, impact of rheumatoid arthritis and depressive symptoms from baseline to week 26 in patients with rheumatoid arthritis.MethodsThe Sleep-RA trial is a randomised controlled trial with a two-group parallel design. Sixty patients with rheumatoid arthritis, insomnia and low-to-moderate disease activity will be allocated 1:1 to treatment with cognitive behavioural therapy for insomnia or usual care. Patients in the intervention group will receive nurse-led, group-based cognitive behavioural therapy for insomnia once a week for 6 weeks. Outcome assessments will be carried out at baseline, after treatment (week 7) and at follow-up (week 26).DiscussionData on treatment of insomnia in patients with rheumatoid arthritis are sparse. The Sleep-RA trial is the first randomised controlled trial to investigate the efficacy of cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis. Because symptoms of rheumatoid arthritis and insomnia have many similarities, we also find it relevant to investigate the secondary effects of cognitive behavioural therapy for insomnia on fatigue, impact of rheumatoid arthritis, depressive symptoms, pain, functional status, health-related quality of life and disease activity.If we find cognitive behavioural therapy for insomnia to be effective in patients with rheumatoid arthritis this will add weight to the argument that evidence-based non-pharmacological treatment for insomnia in rheumatological outpatient clinics is eligible in accordance with the existing international guidelines on sleep.Trial registrationClinicalTrials.gov: NCT03766100. Registered on 30 November 2018.</description><subject>Antiarthritic agents</subject><subject>Arthritis</subject><subject>Arthritis, Rheumatoid - complications</subject><subject>Behavior modification</subject><subject>Behavioral medicine</subject><subject>Care and treatment</subject><subject>Chronic illnesses</subject><subject>Clinical trials</subject><subject>Cognitive Behavioral Therapy - methods</subject><subject>Cognitive behavioural therapy for insomnia</subject><subject>Cognitive-behavioral therapy</subject><subject>Denmark</subject><subject>Depression - etiology</subject><subject>Depression - therapy</subject><subject>Disease</subject><subject>Drugs</subject><subject>Evidence-based medicine</subject><subject>Exercise</subject><subject>Fatigue</subject><subject>Fatigue - etiology</subject><subject>Fitness training programs</subject><subject>Health risk assessment</subject><subject>Humans</subject><subject>Inflammatory arthritis</subject><subject>Insomnia</subject><subject>Life Sciences & Biomedicine</subject><subject>Medicine, Research & Experimental</subject><subject>Multicenter Studies as Topic</subject><subject>Non-pharmacological treatment</subject><subject>Pain</subject><subject>Patients</subject><subject>Physical fitness</subject><subject>Polysomnography</subject><subject>Psychotherapy, Group - methods</subject><subject>Quality of Life</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Research & Experimental Medicine</subject><subject>Rheumatoid arthritis</subject><subject>Rheumatoid factor</subject><subject>Rheumatology</subject><subject>Science & Technology</subject><subject>Single-Blind Method</subject><subject>Sleep</subject><subject>Sleep disturbance</subject><subject>Sleep Initiation and Maintenance Disorders - etiology</subject><subject>Sleep Initiation and Maintenance Disorders - therapy</subject><subject>Study Protocol</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>1745-6215</issn><issn>1745-6215</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>AOWDO</sourceid><sourceid>ARHDP</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>DOA</sourceid><recordid>eNqNUttqFTEUHUSxtfoDPsiAL4JOzT0zPgjl4KVQELw8h0yyc07KnGRMMi39Fz_WnJ5aWvFB8pCdZK212SuraZ5jdIxxL95mTJGgHSKoQ4z0pBMPmkMsGe8EwfzhnfqgeZLzOUKMDpQ9bg4oYRIzKQ-bX6u4Dr74C2hH2OgLH5ekp7ZsIOn5qnUxtT7kuA1e16KddfEQSm4vfdm0aQPLVpfobatT2aSqk9-1c4olmjhdk6tQm3Swcesz2Ddt9mE9QTdOPtjdeda13QRTt05xmdtvE8DcfT1pS_J6eto8cnrK8OxmP2p-fPzwffW5O_vy6XR1ctYZLmjpONcImOXSaLAaiGPYMEvtQKyzTBM-YjcKDb3GlGMOgxs0J-AGShknWNCj5nSva6M-V3PyW52uVNReXV_EtFZ1Pm8mUKPsMQIy9tRwJkcYBsuFFE6MSAhwuGq932vNy7gFa6pbdcJ7ovdfgt-odbxQknCJB1QFXt0IpPhzgVxUtc7ANOkAccmKMNQTRHnfV-jLv6Dn9ftCtUoRSRFlmKM7qLWuA_jgYu1rdqLqRFScEHwgFXX8D1RdFrbexADO1_t7BLInmBRzTuBuZ8RI7fKp9vlUNZ_qOp9q5_SLu-7cUv4EsgL6PeASxuiyqWkzcAtDCHEqBy5JrRBZ-VLzGMMqLqFU6uv_p9LfFxwD5A</recordid><startdate>20200529</startdate><enddate>20200529</enddate><creator>Latocha, K. M.</creator><creator>Loppenthin, K. B.</creator><creator>Ostergaard, M.</creator><creator>Jennum, P. J.</creator><creator>Christensen, R.</creator><creator>Hetland, M.</creator><creator>Rogind, H.</creator><creator>Lundbak, T.</creator><creator>Midtgaard, Julie</creator><creator>Esbensen, B. 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M. ; Loppenthin, K. B. ; Ostergaard, M. ; Jennum, P. J. ; Christensen, R. ; Hetland, M. ; Rogind, H. ; Lundbak, T. ; Midtgaard, Julie ; Esbensen, B. A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c563t-55a0e4d57caedae2f41c4d3d92dfd4a25b1fb6ae8a13515e9f9a52ef933452163</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Antiarthritic agents</topic><topic>Arthritis</topic><topic>Arthritis, Rheumatoid - complications</topic><topic>Behavior modification</topic><topic>Behavioral medicine</topic><topic>Care and treatment</topic><topic>Chronic illnesses</topic><topic>Clinical trials</topic><topic>Cognitive Behavioral Therapy - methods</topic><topic>Cognitive behavioural therapy for insomnia</topic><topic>Cognitive-behavioral therapy</topic><topic>Denmark</topic><topic>Depression - etiology</topic><topic>Depression - therapy</topic><topic>Disease</topic><topic>Drugs</topic><topic>Evidence-based medicine</topic><topic>Exercise</topic><topic>Fatigue</topic><topic>Fatigue - etiology</topic><topic>Fitness training programs</topic><topic>Health risk assessment</topic><topic>Humans</topic><topic>Inflammatory arthritis</topic><topic>Insomnia</topic><topic>Life Sciences & Biomedicine</topic><topic>Medicine, Research & Experimental</topic><topic>Multicenter Studies as Topic</topic><topic>Non-pharmacological treatment</topic><topic>Pain</topic><topic>Patients</topic><topic>Physical fitness</topic><topic>Polysomnography</topic><topic>Psychotherapy, Group - methods</topic><topic>Quality of Life</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Research & Experimental Medicine</topic><topic>Rheumatoid arthritis</topic><topic>Rheumatoid factor</topic><topic>Rheumatology</topic><topic>Science & Technology</topic><topic>Single-Blind Method</topic><topic>Sleep</topic><topic>Sleep disturbance</topic><topic>Sleep Initiation and Maintenance Disorders - etiology</topic><topic>Sleep Initiation and Maintenance Disorders - therapy</topic><topic>Study Protocol</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Latocha, K. M.</creatorcontrib><creatorcontrib>Loppenthin, K. B.</creatorcontrib><creatorcontrib>Ostergaard, M.</creatorcontrib><creatorcontrib>Jennum, P. J.</creatorcontrib><creatorcontrib>Christensen, R.</creatorcontrib><creatorcontrib>Hetland, M.</creatorcontrib><creatorcontrib>Rogind, H.</creatorcontrib><creatorcontrib>Lundbak, T.</creatorcontrib><creatorcontrib>Midtgaard, Julie</creatorcontrib><creatorcontrib>Esbensen, B. A.</creatorcontrib><collection>Web of Knowledge</collection><collection>Web of Science - Science Citation Index Expanded - 2020</collection><collection>Web of Science - Social Sciences Citation Index – 2020</collection><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</collection><collection>Social Sciences Citation Index</collection><collection>Web of Science Primary (SCIE, SSCI & AHCI)</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Current controlled trials in cardiovascular medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Latocha, K. M.</au><au>Loppenthin, K. B.</au><au>Ostergaard, M.</au><au>Jennum, P. J.</au><au>Christensen, R.</au><au>Hetland, M.</au><au>Rogind, H.</au><au>Lundbak, T.</au><au>Midtgaard, Julie</au><au>Esbensen, B. A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: protocol for the randomised, single-blinded, parallel-group Sleep-RA trial</atitle><jtitle>Current controlled trials in cardiovascular medicine</jtitle><stitle>TRIALS</stitle><addtitle>Trials</addtitle><date>2020-05-29</date><risdate>2020</risdate><volume>21</volume><issue>1</issue><spage>440</spage><epage>440</epage><pages>440-440</pages><artnum>440</artnum><issn>1745-6215</issn><eissn>1745-6215</eissn><abstract>BackgroundMore than half of patients with rheumatoid arthritis complain of insomnia, which is predominantly treated with hypnotic drugs. However, cognitive behavioural therapy for insomnia is recommended as the first-line treatment in international guidelines on sleep. Patients with rheumatoid arthritis suffer from debilitating symptoms, such as fatigue and pain, which can also be linked to sleep disturbance. It remains to be determined whether cognitive behavioural therapy for insomnia can be effective in patients with rheumatoid arthritis. The aim of the Sleep-RA trial is to investigate the efficacy of cognitive behavioural therapy for insomnia on sleep and disease-related symptoms in patients with rheumatoid arthritis. The primary objective is to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep efficiency from baseline to week 7 in patients with rheumatoid arthritis. The key secondary objectives are to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep onset latency, wake after sleep onset, total sleep time, insomnia, sleep quality, fatigue, impact of rheumatoid arthritis and depressive symptoms from baseline to week 26 in patients with rheumatoid arthritis.MethodsThe Sleep-RA trial is a randomised controlled trial with a two-group parallel design. Sixty patients with rheumatoid arthritis, insomnia and low-to-moderate disease activity will be allocated 1:1 to treatment with cognitive behavioural therapy for insomnia or usual care. Patients in the intervention group will receive nurse-led, group-based cognitive behavioural therapy for insomnia once a week for 6 weeks. Outcome assessments will be carried out at baseline, after treatment (week 7) and at follow-up (week 26).DiscussionData on treatment of insomnia in patients with rheumatoid arthritis are sparse. The Sleep-RA trial is the first randomised controlled trial to investigate the efficacy of cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis. Because symptoms of rheumatoid arthritis and insomnia have many similarities, we also find it relevant to investigate the secondary effects of cognitive behavioural therapy for insomnia on fatigue, impact of rheumatoid arthritis, depressive symptoms, pain, functional status, health-related quality of life and disease activity.If we find cognitive behavioural therapy for insomnia to be effective in patients with rheumatoid arthritis this will add weight to the argument that evidence-based non-pharmacological treatment for insomnia in rheumatological outpatient clinics is eligible in accordance with the existing international guidelines on sleep.Trial registrationClinicalTrials.gov: NCT03766100. Registered on 30 November 2018.</abstract><cop>LONDON</cop><pub>Springer Nature</pub><pmid>32471477</pmid><doi>10.1186/s13063-020-04282-6</doi><tpages>17</tpages><orcidid>https://orcid.org/0000-0003-2381-2127</orcidid><orcidid>https://orcid.org/0000-0002-3739-7414</orcidid><orcidid>https://orcid.org/0000-0002-6600-0631</orcidid><oa>free_for_read</oa></addata></record> |
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| issn | 1745-6215 1745-6215 |
| language | eng |
| recordid | cdi_proquest_journals_2730341508 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Web of Science - Science Citation Index Expanded - 2020<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" />; SpringerNature Journals; PubMed Central; Web of Science - Social Sciences Citation Index – 2020<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" />; PubMed Central Open Access; Springer Nature OA Free Journals |
| subjects | Antiarthritic agents Arthritis Arthritis, Rheumatoid - complications Behavior modification Behavioral medicine Care and treatment Chronic illnesses Clinical trials Cognitive Behavioral Therapy - methods Cognitive behavioural therapy for insomnia Cognitive-behavioral therapy Denmark Depression - etiology Depression - therapy Disease Drugs Evidence-based medicine Exercise Fatigue Fatigue - etiology Fitness training programs Health risk assessment Humans Inflammatory arthritis Insomnia Life Sciences & Biomedicine Medicine, Research & Experimental Multicenter Studies as Topic Non-pharmacological treatment Pain Patients Physical fitness Polysomnography Psychotherapy, Group - methods Quality of Life Randomized Controlled Trials as Topic Research & Experimental Medicine Rheumatoid arthritis Rheumatoid factor Rheumatology Science & Technology Single-Blind Method Sleep Sleep disturbance Sleep Initiation and Maintenance Disorders - etiology Sleep Initiation and Maintenance Disorders - therapy Study Protocol Time Factors Treatment Outcome |
| title | Cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: protocol for the randomised, single-blinded, parallel-group Sleep-RA trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-11-29T22%3A54%3A18IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_proqu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Cognitive%20behavioural%20therapy%20for%20insomnia%20in%20patients%20with%20rheumatoid%20arthritis:%20protocol%20for%20the%20randomised,%20single-blinded,%20parallel-group%20Sleep-RA%20trial&rft.jtitle=Current%20controlled%20trials%20in%20cardiovascular%20medicine&rft.au=Latocha,%20K.%20M.&rft.date=2020-05-29&rft.volume=21&rft.issue=1&rft.spage=440&rft.epage=440&rft.pages=440-440&rft.artnum=440&rft.issn=1745-6215&rft.eissn=1745-6215&rft_id=info:doi/10.1186/s13063-020-04282-6&rft_dat=%3Cgale_proqu%3EA627366592%3C/gale_proqu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2730341508&rft_id=info:pmid/32471477&rft_galeid=A627366592&rft_doaj_id=oai_doaj_org_article_b7810e2b83c547be99d5676f6b066ef1&rfr_iscdi=true |