{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T04:27:08Z","timestamp":1772166428310,"version":"3.50.1"},"reference-count":64,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,12,1]],"date-time":"2021-12-01T00:00:00Z","timestamp":1638316800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,12,11]],"date-time":"2021-12-11T00:00:00Z","timestamp":1639180800000},"content-version":"vor","delay-in-days":10,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"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>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Insomnia is common in people with long-term medical conditions and is related to increased mortality and morbidity. Cognitive behavioral therapy for insomnia (CBT-I) is first choice treatment and effective for people with insomnia and comorbid long-term medical conditions. However, CBT-I has some limitations as it might not always be available or appeal to patients with medical conditions. Furthermore, a small proportion of patients do not respond to CBT-I. Preliminary evidence and clinical experience suggest that low-dose amitriptyline (AM) might be an effective alternative to treat insomnia in patients with medical comorbidity. In this randomized controlled trial, we will determine whether AM is non-inferior to the first choice treatment for insomnia, CBT-I.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods\/design<\/jats:title>\n                    <jats:p>This study will test if treatment with low-dose amitriptyline for insomnia in patients with medical comorbidity is non-inferior to CBT-I in a multicenter randomized controlled non-inferiority trial. Participants will be 190 adults with a long-term medical condition and insomnia. Participants will be randomly allocated to one of two intervention arms: 12\u2009weeks\u2009AM (starting with 10\u2009mg per day, and if ineffective at 3\u2009weeks, doubling this dose) or 12\u2009weeks of CBT-I consisting of 6 weekly sessions and a follow-up session 6\u2009weeks later. The primary outcome is subjective insomnia severity, measured with the Insomnia Severity Index (ISI). The primary endpoint is at 12\u2009weeks. Secondary outcomes include sleep quality (e.g., sleep efficiency), questionnaires on daytime functioning (physical functioning and impairment of functioning), and symptoms (e.g., fatigue, pain, anxiety) at 12\u2009weeks and 12\u2009months post treatment and relapse of insomnia until 12\u2009months after treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>Irrespective of the outcome, this study will be a much-needed contribution to evidence based clinical guidelines on the treatment of insomnia in patients with medical comorbidity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      Dutch Trial Register\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.trialregister.nl\/trial\/7971\">NTR NL7971<\/jats:ext-link>\n                      . Registered on 18 August 2019\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-021-05868-4","type":"journal-article","created":{"date-parts":[[2021,12,11]],"date-time":"2021-12-11T09:04:33Z","timestamp":1639213473000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["TIMELAPSE study\u2014efficacy of low-dose amitriptyline versus cognitive behavioral therapy for chronic insomnia in patients with medical comorbidity: study protocol of a randomized controlled multicenter non-inferiority trial"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4246-4543","authenticated-orcid":false,"given":"Nynke L.","family":"Rauwerda","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hans","family":"Knoop","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irene","family":"Pot","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annemieke","family":"van Straten","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marian E.","family":"Rikkert","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anouk","family":"Zondervan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thom P. J.","family":"Timmerhuis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annemarie M. J.","family":"Braamse","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H. Myrthe","family":"Boss","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,12,11]]},"reference":[{"issue":"2","key":"5868_CR1","doi-asserted-by":"publisher","first-page":"213","DOI":"10.1093\/sleep\/30.2.213","volume":"30","author":"DJ Taylor","year":"2007","unstructured":"Taylor DJ, Mallory LJ, Lichstein KL, Durrence HH, Riedel BW, Bush AJ. Comorbidity of chronic insomnia with medical problems. Sleep. 2007;30(2):213\u20138. https:\/\/doi.org\/10.1093\/sleep\/30.2.213.","journal-title":"Sleep"},{"issue":"10","key":"5868_CR2","doi-asserted-by":"publisher","first-page":"1099","DOI":"10.1001\/archinte.158.10.1099","volume":"158","author":"DA Katz","year":"1998","unstructured":"Katz DA, McHorney CA. Clinical correlates of insomnia in patients with chronic illness. Arch Intern Med. 1998;158(10):1099\u2013107. https:\/\/doi.org\/10.1001\/archinte.158.10.1099.","journal-title":"Arch Intern Med"},{"issue":"7","key":"5868_CR3","doi-asserted-by":"publisher","first-page":"859","DOI":"10.5665\/SLEEP.1114","volume":"34","author":"R Budhiraja","year":"2011","unstructured":"Budhiraja R, Roth T, Hudgel DW, Budhiraja P, Drake CL. Prevalence and polysomnographic correlates of insomnia comorbid with medical disorders. Sleep. 2011;34(7):859\u201367. https:\/\/doi.org\/10.5665\/SLEEP.1114.","journal-title":"Sleep"},{"key":"5868_CR4","doi-asserted-by":"publisher","first-page":"947","DOI":"10.1176\/appi.books.9780890425596","volume-title":"Diagnostic and statistical manual of mental disorders: DSM-5","author":"A American Psychiatric","year":"2013","unstructured":"American Psychiatric A. American Psychiatric Association DSMTF. In: Diagnostic and statistical manual of mental disorders: DSM-5. 5th ed. Washington, D.C.: American Psychiatric Association; 2013. p. 947.","edition":"5"},{"issue":"11","key":"5868_CR5","doi-asserted-by":"publisher","first-page":"1140","DOI":"10.7150\/jca.12490","volume":"6","author":"HF Fang","year":"2015","unstructured":"Fang HF, Miao NF, Chen CD, Sithole T, Chung MH. Risk of cancer in patients with insomnia, parasomnia, and obstructive sleep apnea: a nationwide nested case-control study. J Cancer. 2015;6(11):1140\u20137. https:\/\/doi.org\/10.7150\/jca.12490.","journal-title":"J Cancer"},{"key":"5868_CR6","doi-asserted-by":"publisher","first-page":"11","DOI":"10.1016\/j.smrv.2015.10.002","volume":"30","author":"T Anothaisintawee","year":"2016","unstructured":"Anothaisintawee T, Reutrakul S, Van Cauter E, Thakkinstian A. Sleep disturbances compared to traditional risk factors for diabetes development: systematic review and meta-analysis. Sleep Med Rev. 2016;30:11\u201324. https:\/\/doi.org\/10.1016\/j.smrv.2015.10.002.","journal-title":"Sleep Med Rev"},{"issue":"1","key":"5868_CR7","doi-asserted-by":"publisher","first-page":"57","DOI":"10.1177\/2047487312460020","volume":"21","author":"F Sofi","year":"2014","unstructured":"Sofi F, Cesari F, Casini A, Macchi C, Abbate R, Gensini GF. Insomnia and risk of cardiovascular disease: a meta-analysis. Eur J Prev Cardiol. 2014;21(1):57\u201364. https:\/\/doi.org\/10.1177\/2047487312460020.","journal-title":"Eur J Prev Cardiol"},{"issue":"3","key":"5868_CR8","doi-asserted-by":"publisher","first-page":"554","DOI":"10.1007\/s11920-015-0554-4","volume":"17","author":"RA Bernert","year":"2015","unstructured":"Bernert RA, Kim JS, Iwata NG, Perlis ML. Sleep disturbances as an evidence-based suicide risk factor. Curr Psychiatry Rep. 2015;17(3):554. https:\/\/doi.org\/10.1007\/s11920-015-0554-4.","journal-title":"Curr Psychiatry Rep"},{"issue":"4","key":"5868_CR9","doi-asserted-by":"publisher","first-page":"227","DOI":"10.1207\/S15402010BSM0104_5","volume":"1","author":"DJ Taylor","year":"2003","unstructured":"Taylor DJ, Lichstein KL, Durrence HH. Insomnia as a health risk factor. Behav Sleep Med. 2003;1(4):227\u201347. https:\/\/doi.org\/10.1207\/S15402010BSM0104_5.","journal-title":"Behav Sleep Med"},{"issue":"5","key":"5868_CR10","doi-asserted-by":"publisher","first-page":"342","DOI":"10.1136\/injuryprev-2015-041844","volume":"22","author":"CL Lin","year":"2016","unstructured":"Lin CL, Chung CH, Tsai YH, Chien WC. Association between sleep disorders and injury: a nationwide population-based retrospective cohort study. Inj Prev. 2016;22(5):342\u20136. https:\/\/doi.org\/10.1136\/injuryprev-2015-041844.","journal-title":"Inj Prev"},{"issue":"4","key":"5868_CR11","doi-asserted-by":"publisher","first-page":"346","DOI":"10.1097\/YCO.0b013e3283473375","volume":"24","author":"D Dikeos","year":"2011","unstructured":"Dikeos D, Georgantopoulos G. Medical comorbidity of sleep disorders. Curr Opin Psychiatr. 2011;24(4):346\u201354. https:\/\/doi.org\/10.1097\/YCO.0b013e3283473375.","journal-title":"Curr Opin Psychiatr"},{"issue":"3","key":"5868_CR12","first-page":"229","volume":"51","author":"DA Katz","year":"2002","unstructured":"Katz DA, McHorney CA. The relationship between insomnia and health-related quality of life in patients with chronic illness. J Fam Pract. 2002;51(3):229\u201335.","journal-title":"J Fam Pract"},{"issue":"4","key":"5868_CR13","doi-asserted-by":"publisher","first-page":"443","DOI":"10.1093\/sleep\/34.4.443","volume":"34","author":"K Sarsour","year":"2011","unstructured":"Sarsour K, Kalsekar A, Swindle R, Foley K, Walsh JK. The association between insomnia severity and healthcare and productivity costs in a health plan sample. Sleep. 2011;34(4):443\u201350. https:\/\/doi.org\/10.1093\/sleep\/34.4.443.","journal-title":"Sleep"},{"issue":"1","key":"5868_CR14","first-page":"55","volume":"32","author":"M Daley","year":"2009","unstructured":"Daley M, Morin CM, LeBlanc M, Gr\u00e9goire JP, Savard J. The economic burden of insomnia: direct and indirect costs for individuals with insomnia syndrome, insomnia symptoms, and good sleepers. Sleep. 2009;32(1):55\u201364.","journal-title":"Sleep"},{"issue":"6","key":"5868_CR15","doi-asserted-by":"publisher","first-page":"675","DOI":"10.1111\/jsr.12594","volume":"26","author":"D Riemann","year":"2017","unstructured":"Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, et al. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017;26(6):675\u2013700. https:\/\/doi.org\/10.1111\/jsr.12594.","journal-title":"J Sleep Res"},{"issue":"19","key":"5868_CR16","doi-asserted-by":"publisher","first-page":"2005","DOI":"10.1001\/jama.2009.682","volume":"301","author":"CM Morin","year":"2009","unstructured":"Morin CM, Valli\u00e8res A, Guay B, Ivers H, Savard J, M\u00e9rette C, et al. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA. 2009;301(19):2005\u201315. https:\/\/doi.org\/10.1001\/jama.2009.682.","journal-title":"JAMA"},{"issue":"11","key":"5868_CR17","doi-asserted-by":"publisher","first-page":"1398","DOI":"10.1093\/sleep\/29.11.1398","volume":"29","author":"CM Morin","year":"2006","unstructured":"Morin CM, Bootzin RR, Buysse DJ, Edinger JD, Espie CA, Lichstein KL. Psychological and behavioral treatment of insomnia:update of the recent evidence (1998-2004). Sleep. 2006;29(11):1398\u2013414. https:\/\/doi.org\/10.1093\/sleep\/29.11.1398.","journal-title":"Sleep"},{"key":"5868_CR18","doi-asserted-by":"publisher","first-page":"6","DOI":"10.1016\/j.smrv.2014.05.001","volume":"19","author":"EA Koffel","year":"2015","unstructured":"Koffel EA, Koffel JB, Gehrman PR. A meta-analysis of group cognitive behavioral therapy for insomnia. Sleep Med Rev. 2015;19:6\u201316. https:\/\/doi.org\/10.1016\/j.smrv.2014.05.001.","journal-title":"Sleep Med Rev"},{"issue":"3","key":"5868_CR19","doi-asserted-by":"publisher","first-page":"237","DOI":"10.1053\/smrv.2002.0266","volume":"7","author":"AG Harvey","year":"2003","unstructured":"Harvey AG, Tang NK. Cognitive behaviour therapy for primary insomnia: can we rest yet? Sleep Med Rev. 2003;7(3):237\u201362. https:\/\/doi.org\/10.1053\/smrv.2002.0266.","journal-title":"Sleep Med Rev"},{"key":"5868_CR20","doi-asserted-by":"publisher","first-page":"101208","DOI":"10.1016\/j.smrv.2019.08.002","volume":"48","author":"T van der Zweerde","year":"2019","unstructured":"van der Zweerde T, Bisdounis L, Kyle SD, Lancee J, van Straten A. Cognitive behavioral therapy for insomnia: a meta-analysis of long-term effects in controlled studies. Sleep Med Rev. 2019;48:101208. https:\/\/doi.org\/10.1016\/j.smrv.2019.08.002.","journal-title":"Sleep Med Rev"},{"key":"5868_CR21","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1016\/j.smrv.2017.02.001","volume":"38","author":"A van Straten","year":"2018","unstructured":"van Straten A, van der Zweerde T, Kleiboer A, Cuijpers P, Morin CM, Lancee J. Cognitive and behavioral therapies in the treatment of insomnia: a meta-analysis. Sleep Med Rev. 2018;38:3\u201316. https:\/\/doi.org\/10.1016\/j.smrv.2017.02.001.","journal-title":"Sleep Med Rev"},{"issue":"3","key":"5868_CR22","doi-asserted-by":"publisher","first-page":"302","DOI":"10.1016\/j.sleep.2009.05.018","volume":"11","author":"CR Jungquist","year":"2010","unstructured":"Jungquist CR, O'Brien C, Matteson-Rusby S, Smith MT, Pigeon WR, Xia Y, et al. The efficacy of cognitive-behavioral therapy for insomnia in patients with chronic pain. Sleep Med. 2010;11(3):302\u20139. https:\/\/doi.org\/10.1016\/j.sleep.2009.05.018.","journal-title":"Sleep Med"},{"issue":"4","key":"5868_CR23","doi-asserted-by":"publisher","first-page":"489","DOI":"10.1093\/sleep\/31.4.489","volume":"31","author":"R Manber","year":"2008","unstructured":"Manber R, Edinger JD, Gress JL, San Pedro-Salcedo MG, Kuo TF, Kalista T. Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia. Sleep. 2008;31(4):489\u201395. https:\/\/doi.org\/10.1093\/sleep\/31.4.489.","journal-title":"Sleep"},{"issue":"3","key":"5868_CR24","doi-asserted-by":"publisher","first-page":"205","DOI":"10.1016\/j.smrv.2008.06.001","volume":"13","author":"D Riemann","year":"2009","unstructured":"Riemann D, Perlis ML. The treatments of chronic insomnia: a review of benzodiazepine receptor agonists and psychological and behavioral therapies. Sleep Med Rev. 2009;13(3):205\u201314. https:\/\/doi.org\/10.1016\/j.smrv.2008.06.001.","journal-title":"Sleep Med Rev"},{"issue":"2","key":"5868_CR25","doi-asserted-by":"publisher","first-page":"293","DOI":"10.1007\/s00127-011-0344-1","volume":"47","author":"CM Sonnenberg","year":"2012","unstructured":"Sonnenberg CM, Bierman EJ, Deeg DJ, Comijs HC, van Tilburg W, Beekman AT. Ten-year trends in benzodiazepine use in the Dutch population. Soc Psychiatr Epidemiol. 2012;47(2):293\u2013301. https:\/\/doi.org\/10.1007\/s00127-011-0344-1.","journal-title":"Soc Psychiatr Epidemiol"},{"issue":"4","key":"5868_CR26","doi-asserted-by":"publisher","first-page":"411","DOI":"10.1093\/sleep\/24.4.411","volume":"24","author":"N Vincent","year":"2001","unstructured":"Vincent N, Lionberg C. Treatment preference and patient satisfaction in chronic insomnia. Sleep. 2001;24(4):411\u20137. https:\/\/doi.org\/10.1093\/sleep\/24.4.411.","journal-title":"Sleep"},{"issue":"4","key":"5868_CR27","doi-asserted-by":"publisher","first-page":"302","DOI":"10.1093\/sleep\/15.4.302","volume":"15","author":"CM Morin","year":"1992","unstructured":"Morin CM, Gaulier B, Barry T, Kowatch RA. Patients\u2019 acceptance of psychological and pharmacological therapies for insomnia. Sleep. 1992;15(4):302\u20135. https:\/\/doi.org\/10.1093\/sleep\/15.4.302.","journal-title":"Sleep"},{"issue":"6","key":"5868_CR28","doi-asserted-by":"publisher","first-page":"955","DOI":"10.1007\/s11606-018-4390-1","volume":"33","author":"E Koffel","year":"2018","unstructured":"Koffel E, Bramoweth AD, Ulmer CS. Increasing access to and utilization of cognitive behavioral therapy for insomnia (CBT-I): a narrative review. J Gen Intern Med. 2018;33(6):955\u201362. https:\/\/doi.org\/10.1007\/s11606-018-4390-1.","journal-title":"J Gen Intern Med"},{"key":"5868_CR29","doi-asserted-by":"publisher","unstructured":"Harvey AG, Soehner A, Lombrozo T, B\u00e9langer L, Rifkin J, Morin CM. \u2018Folk theories\u2019 about the causes of insomnia. Cognit Ther Res. 2013;37(5). https:\/\/doi.org\/10.1007\/s10608-013-9543-2.","DOI":"10.1007\/s10608-013-9543-2"},{"issue":"574","key":"5868_CR30","doi-asserted-by":"publisher","first-page":"e180","DOI":"10.3399\/bjgp10X484183","volume":"60","author":"JV Dyas","year":"2010","unstructured":"Dyas JV, Apekey TA, Tilling M, \u00d8rner R, Middleton H, Siriwardena AN. Patients\u2019 and clinicians\u2019 experiences of consultations in primary care for sleep problems and insomnia: a focus group study. Br J Gen Pract. 2010;60(574):e180\u2013200. https:\/\/doi.org\/10.3399\/bjgp10X484183.","journal-title":"Br J Gen Pract"},{"issue":"2","key":"5868_CR31","doi-asserted-by":"publisher","first-page":"275","DOI":"10.1016\/j.jsmc.2019.01.008","volume":"14","author":"LF Buenaver","year":"2019","unstructured":"Buenaver LF, Townsend D, Ong JC. Delivering cognitive behavioral therapy for insomnia in the real world: considerations and controversies. Sleep Med Clin. 2019;14(2):275\u201381. https:\/\/doi.org\/10.1016\/j.jsmc.2019.01.008.","journal-title":"Sleep Med Clin"},{"issue":"2","key":"5868_CR32","doi-asserted-by":"publisher","first-page":"167","DOI":"10.1016\/j.jsmc.2019.01.001","volume":"14","author":"GB Raglan","year":"2019","unstructured":"Raglan GB, Swanson LM, Arnedt JT. Cognitive Behavioral Therapy for Insomnia in Patients with Medical and Psychiatric Comorbidities. Sleep Med Clin. 2019;14(2):167\u201375. https:\/\/doi.org\/10.1016\/j.jsmc.2019.01.001.","journal-title":"Sleep Med Clin"},{"issue":"5","key":"5868_CR33","doi-asserted-by":"publisher","first-page":"820","DOI":"10.1037\/0022-006X.76.5.820","volume":"76","author":"N Vincent","year":"2008","unstructured":"Vincent N, Lewycky S, Finnegan H. Barriers to engagement in sleep restriction and stimulus control in chronic insomnia. J Consult Clin Psychol. 2008;76(5):820\u20138. https:\/\/doi.org\/10.1037\/0022-006X.76.5.820.","journal-title":"J Consult Clin Psychol"},{"issue":"4","key":"5868_CR34","doi-asserted-by":"publisher","first-page":"468","DOI":"10.1097\/JCP.0000000000000338","volume":"35","author":"J Kamphuis","year":"2015","unstructured":"Kamphuis J, Taxis K, Schuiling-Veninga CC, Bruggeman R, Lancel M. Off-label prescriptions of low-dose quetiapine and mirtazapine for insomnia in the Netherlands. J Clin Psychopharmacol. 2015;35(4):468\u201370. https:\/\/doi.org\/10.1097\/JCP.0000000000000338.","journal-title":"J Clin Psychopharmacol"},{"issue":"11","key":"5868_CR35","doi-asserted-by":"publisher","first-page":"1577","DOI":"10.1177\/0269881110379307","volume":"24","author":"SJ Wilson","year":"2010","unstructured":"Wilson SJ, Nutt DJ, Alford C, Argyropoulos SV, Baldwin DS, Bateson AN, et al. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders. J Psychopharmacol. 2010;24(11):1577\u2013601. https:\/\/doi.org\/10.1177\/0269881110379307.","journal-title":"J Psychopharmacol"},{"key":"5868_CR36","volume":"5","author":"H Everitt","year":"2018","unstructured":"Everitt H, Baldwin DS, Stuart B, Lipinska G, Mayers A, Malizia AL, et al. Antidepressants for insomnia in adults. Cochrane Database Syst Rev. 2018;5:CD010753.","journal-title":"Cochrane Database Syst Rev"},{"issue":"7","key":"5868_CR37","doi-asserted-by":"publisher","first-page":"670","DOI":"10.1016\/j.parkreldis.2013.03.003","volume":"19","author":"S Rios Romenets","year":"2013","unstructured":"Rios Romenets S, Creti L, Fichten C, Bailes S, Libman E, Pelletier A, et al. Doxepin and cognitive behavioural therapy for insomnia in patients with Parkinson\u2019s disease -- a randomized study. Parkinsonism Relat Disord. 2013;19(7):670\u20135. https:\/\/doi.org\/10.1016\/j.parkreldis.2013.03.003.","journal-title":"Parkinsonism Relat Disord"},{"key":"5868_CR38","doi-asserted-by":"publisher","first-page":"j603","DOI":"10.1136\/bmj.j603","volume":"356","author":"J Wong","year":"2017","unstructured":"Wong J, Motulsky A, Abrahamowicz M, Eguale T, Buckeridge DL, Tamblyn R. Off-label indications for antidepressants in primary care: descriptive study of prescriptions from an indication based electronic prescribing system. BMJ. 2017;356:j603. https:\/\/doi.org\/10.1136\/bmj.j603.","journal-title":"BMJ"},{"issue":"7","key":"5868_CR39","doi-asserted-by":"publisher","first-page":"664","DOI":"10.1016\/j.cpr.2012.06.006","volume":"32","author":"DR Schwartz","year":"2012","unstructured":"Schwartz DR, Carney CE. Mediators of cognitive-behavioral therapy for insomnia: a review of randomized controlled trials and secondary analysis studies. Clin Psychol Rev. 2012;32(7):664\u201375. https:\/\/doi.org\/10.1016\/j.cpr.2012.06.006.","journal-title":"Clin Psychol Rev"},{"issue":"2","key":"5868_CR40","doi-asserted-by":"publisher","first-page":"151","DOI":"10.1016\/S2215-0366(18)30464-4","volume":"6","author":"TF Blanken","year":"2019","unstructured":"Blanken TF, Benjamins JS, Borsboom D, Vermunt JK, Paquola C, Ramautar J, et al. Insomnia disorder subtypes derived from life history and traits of affect and personality. Lancet Psychiatr. 2019;6(2):151\u201363. https:\/\/doi.org\/10.1016\/S2215-0366(18)30464-4.","journal-title":"Lancet Psychiatr"},{"issue":"5","key":"5868_CR41","doi-asserted-by":"publisher","first-page":"601","DOI":"10.1093\/sleep\/34.5.601","volume":"34","author":"CM Morin","year":"2011","unstructured":"Morin CM, Belleville G, B\u00e9langer L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011;34(5):601\u20138. https:\/\/doi.org\/10.1093\/sleep\/34.5.601.","journal-title":"Sleep"},{"issue":"11","key":"5868_CR42","doi-asserted-by":"publisher","first-page":"1553","DOI":"10.1093\/sleep\/33.11.1553","volume":"33","author":"AD Krystal","year":"2010","unstructured":"Krystal AD, Durrence HH, Scharf M, Jochelson P, Rogowski R, Ludington E, et al. Efficacy and safety of doxepin 1\u2009mg and 3\u2009mg in a 12-week sleep laboratory and outpatient trial of elderly subjects with chronic primary insomnia. Sleep. 2010;33(11):1553\u201361. https:\/\/doi.org\/10.1093\/sleep\/33.11.1553.","journal-title":"Sleep"},{"key":"5868_CR43","doi-asserted-by":"publisher","DOI":"10.1007\/978-90-368-0754-8","volume-title":"Behandeling van langdurige slapeloosheid","author":"M Verbeek IV","year":"2014","unstructured":"Verbeek M IV. Behandeling van langdurige slapeloosheid. Bohn Stafleu van Loghum: The Netherlands; 2014. https:\/\/doi.org\/10.1007\/978-90-368-0754-8."},{"issue":"9","key":"5868_CR44","doi-asserted-by":"publisher","first-page":"1155","DOI":"10.1093\/sleep\/29.9.1155","volume":"29","author":"DJ Buysse","year":"2006","unstructured":"Buysse DJ, Ancoli-Israel S, Edinger JD, Lichstein KL, Morin CM. Recommendations for a standard research assessment of insomnia. Sleep. 2006;29(9):1155\u201373. https:\/\/doi.org\/10.1093\/sleep\/29.9.1155.","journal-title":"Sleep"},{"issue":"2","key":"5868_CR45","doi-asserted-by":"publisher","first-page":"287","DOI":"10.5665\/sleep.1642","volume":"35","author":"CE Carney","year":"2012","unstructured":"Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, et al. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012;35(2):287\u2013302. https:\/\/doi.org\/10.5665\/sleep.1642.","journal-title":"Sleep"},{"key":"5868_CR46","doi-asserted-by":"publisher","first-page":"40","DOI":"10.1016\/j.jpsychores.2017.05.007","volume":"98","author":"M Worm-Smeitink","year":"2017","unstructured":"Worm-Smeitink M, Gielissen M, Bloot L, van Laarhoven HWM, van Engelen BGM, van Riel P, et al. The assessment of fatigue: psychometric qualities and norms for the Checklist individual strength. J Psychosom Res. 2017;98:40\u20136. https:\/\/doi.org\/10.1016\/j.jpsychores.2017.05.007.","journal-title":"J Psychosom Res"},{"issue":"2","key":"5868_CR47","doi-asserted-by":"publisher","first-page":"69","DOI":"10.1016\/S0022-3999(01)00296-3","volume":"52","author":"I Bjelland","year":"2002","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\u201377. https:\/\/doi.org\/10.1016\/S0022-3999(01)00296-3.","journal-title":"J Psychosom Res"},{"issue":"6","key":"5868_CR48","doi-asserted-by":"publisher","first-page":"361","DOI":"10.1111\/j.1600-0447.1983.tb09716.x","volume":"67","author":"AS Zigmond","year":"1983","unstructured":"Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361\u201370. https:\/\/doi.org\/10.1111\/j.1600-0447.1983.tb09716.x.","journal-title":"Acta Psychiatr Scand"},{"issue":"11","key":"5868_CR49","doi-asserted-by":"publisher","first-page":"1055","DOI":"10.1016\/S0895-4356(98)00097-3","volume":"51","author":"NK Aaronson","year":"1998","unstructured":"Aaronson NK, Muller M, Cohen PD, Essink-Bot ML, Fekkes M, Sanderman R, et al. Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol. 1998;51(11):1055\u201368. https:\/\/doi.org\/10.1016\/S0895-4356(98)00097-3.","journal-title":"J Clin Epidemiol"},{"issue":"3","key":"5868_CR50","doi-asserted-by":"publisher","first-page":"241","DOI":"10.1016\/S0920-9964(99)00130-9","volume":"42","author":"K Thompson","year":"2000","unstructured":"Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophr Res. 2000;42(3):241\u20137. https:\/\/doi.org\/10.1016\/S0920-9964(99)00130-9.","journal-title":"Schizophr Res"},{"issue":"5","key":"5868_CR51","doi-asserted-by":"publisher","first-page":"461","DOI":"10.1192\/bjp.180.5.461","volume":"180","author":"JC Mundt","year":"2002","unstructured":"Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatr. 2002;180(5):461\u20134. https:\/\/doi.org\/10.1192\/bjp.180.5.461.","journal-title":"Br J Psychiatr"},{"issue":"3","key":"5868_CR52","doi-asserted-by":"publisher","first-page":"202","DOI":"10.1192\/bjp.bp.108.061960","volume":"195","author":"R Uher","year":"2009","unstructured":"Uher R, Farmer A, Henigsberg N, Rietschel M, Mors O, Maier W, et al. Adverse reactions to antidepressants. Br J Psychiatr. 2009;195(3):202\u201310. https:\/\/doi.org\/10.1192\/bjp.bp.108.061960.","journal-title":"Br J Psychiatr"},{"issue":"6","key":"5868_CR53","doi-asserted-by":"publisher","first-page":"540","DOI":"10.1093\/sleep\/14.6.540","volume":"14","author":"MW Johns","year":"1991","unstructured":"Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991;14(6):540\u20135. https:\/\/doi.org\/10.1093\/sleep\/14.6.540.","journal-title":"Sleep"},{"issue":"2","key":"5868_CR54","doi-asserted-by":"publisher","first-page":"77","DOI":"10.1016\/S0006-3223(98)00126-7","volume":"44","author":"JF Rosenbaum","year":"1998","unstructured":"Rosenbaum JF, Fava M, Hoog SL, Ascroft RC, Krebs WB. Selective serotonin reuptake inhibitor discontinuation syndrome: a randomized clinical trial. Biol Psychiatr. 1998;44(2):77\u201387. https:\/\/doi.org\/10.1016\/S0006-3223(98)00126-7.","journal-title":"Biol Psychiatr"},{"issue":"6","key":"5868_CR55","doi-asserted-by":"publisher","first-page":"743","DOI":"10.1177\/1054773816654137","volume":"27","author":"S Sidani","year":"2018","unstructured":"Sidani S, Epstein DR, Fox M, Miranda J. Psychometric properties of the treatment perception and preferences measure. Clin Nurs Res. 2018;27(6):743\u201361. https:\/\/doi.org\/10.1177\/1054773816654137.","journal-title":"Clin Nurs Res"},{"key":"5868_CR56","first-page":"137","volume-title":"Lepper HS, editor","author":"S Lyubomirsky","year":"1997","unstructured":"Lyubomirsky S. A measure of subjective happiness: preliminary reliability and construct validation. In: Lepper HS, editor. The Netherlands: Social Indicators Research; 1997. p. 137\u201355."},{"issue":"6","key":"5868_CR57","doi-asserted-by":"publisher","first-page":"1063","DOI":"10.1037\/0022-3514.54.6.1063","volume":"54","author":"D Watson","year":"1988","unstructured":"Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988;54(6):1063\u201370. https:\/\/doi.org\/10.1037\/0022-3514.54.6.1063.","journal-title":"J Pers Soc Psychol"},{"issue":"8","key":"5868_CR58","doi-asserted-by":"publisher","first-page":"869","DOI":"10.1016\/S0005-7967(01)00061-4","volume":"40","author":"AG Harvey","year":"2002","unstructured":"Harvey AG. A cognitive model of insomnia. Behav Res Ther. 2002;40(8):869\u201393. https:\/\/doi.org\/10.1016\/S0005-7967(01)00061-4.","journal-title":"Behav Res Ther"},{"issue":"11","key":"5868_CR59","doi-asserted-by":"publisher","first-page":"1547","DOI":"10.1093\/sleep\/30.11.1547","volume":"30","author":"CM Morin","year":"2007","unstructured":"Morin CM, Valli\u00e8res A, Ivers H. Dysfunctional beliefs and attitudes about sleep (DBAS): validation of a brief version (DBAS-16). Sleep. 2007;30(11):1547\u201354. https:\/\/doi.org\/10.1093\/sleep\/30.11.1547.","journal-title":"Sleep"},{"issue":"3","key":"5868_CR60","doi-asserted-by":"publisher","first-page":"263","DOI":"10.1016\/0005-7967(85)90004-X","volume":"23","author":"PM Nicassio","year":"1985","unstructured":"Nicassio PM, Mendlowitz DR, Fussell JJ, Petras L. The phenomenology of the pre-sleep state: the development of the pre-sleep arousal scale. Behav Res Ther. 1985;23(3):263\u201371. https:\/\/doi.org\/10.1016\/0005-7967(85)90004-X.","journal-title":"Behav Res Ther"},{"issue":"8","key":"5868_CR61","doi-asserted-by":"publisher","first-page":"1305","DOI":"10.5665\/sleep.3918","volume":"37","author":"J Savard","year":"2014","unstructured":"Savard J, Ivers H, Savard MH, Morin CM. Is a video-based cognitive behavioral therapy for insomnia as efficacious as a professionally administered treatment in breast cancer? Results of a randomized controlled trial. Sleep. 2014;37(8):1305\u201314. https:\/\/doi.org\/10.5665\/sleep.3918.","journal-title":"Sleep"},{"issue":"6","key":"5868_CR62","doi-asserted-by":"publisher","first-page":"536","DOI":"10.1197\/j.aem.2005.01.010","volume":"12","author":"JH Tamayo-Sarver","year":"2005","unstructured":"Tamayo-Sarver JH, Albert JM, Tamayo-Sarver M, Cydulka RK. Advanced statistics: how to determine whether your intervention is different, at least as effective as, or equivalent: a basic introduction. Acad Emerg Med. 2005;12(6):536\u201342. https:\/\/doi.org\/10.1197\/j.aem.2005.01.010.","journal-title":"Acad Emerg Med"},{"key":"5868_CR63","volume-title":"Multiple imputation for nonresponse in surveys","author":"DB Rubin","year":"2004","unstructured":"Rubin DB. Multiple imputation for nonresponse in surveys. New York: Wiley; 2004."},{"issue":"3","key":"5868_CR64","doi-asserted-by":"publisher","first-page":"200","DOI":"10.7326\/0003-4819-158-3-201302050-00583","volume":"158","author":"AW Chan","year":"2013","unstructured":"Chan AW, 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\u20137. https:\/\/doi.org\/10.7326\/0003-4819-158-3-201302050-00583.","journal-title":"Ann Intern Med"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05868-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-021-05868-4\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05868-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,12,11]],"date-time":"2021-12-11T09:09:03Z","timestamp":1639213743000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-021-05868-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,12]]},"references-count":64,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["5868"],"URL":"https:\/\/doi.org\/10.1186\/s13063-021-05868-4","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-795884\/v1","asserted-by":"object"}]},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,12]]},"assertion":[{"value":"28 June 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 November 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 December 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 study has been approved by the Amsterdam University Medical Centre Research Ethics Committee and the competent authority. All substantial amendments will be notified to the medical ethical committee and to the competent authority.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"All authors gave the corresponding author written consent to submit the manuscript for publication.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they do not have competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"904"}}