{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T11:07:31Z","timestamp":1790420851356,"version":"4.1.0"},"reference-count":73,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2021,6,7]],"date-time":"2021-06-07T00:00:00Z","timestamp":1623024000000},"content-version":"unspecified","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000027","name":"National Institute on Alcohol Abuse and Alcoholism","doi-asserted-by":"publisher","award":["R21AA025175"],"award-info":[{"award-number":["R21AA025175"]}],"id":[{"id":"10.13039\/100000027","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,5,26]]},"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>As many as 74% of veterans with alcohol use disorders (AUDS) report symptoms of insomnia. Insomnia represents a barrier to alcohol treatment because insomnia symptoms (1) may lead to relapse among those who use alcohol to help them sleep and may negatively impact (2) executive functions and (3) emotion regulation skills. Cognitive\u2013behavioural therapy for insomnia (CBT-I) is an efficacious first-line treatment for insomnia; however, no research has examined the impact of CBT-I on individuals\u2019 response to alcohol treatment. In the Sleep and Alcohol for Veterans (Project SAVE) randomised controlled trial, we hypothesise that CBT-I will enhance the efficacy of alcohol treatment among Veterans with insomnia by enhancing their abilities to attend to treatment, regulate emotions and initiate sleep without alcohol.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>Eighty Veterans enrolled in alcohol treatment at the Veterans Administration (VA) hospital will be randomly assigned to receive either CBT-I or single-session sleep hygiene (SH) education. Individuals will be eligible to participate if they meet <jats:italic>Diagnostic and Statistical Manual of Mental Disorders<\/jats:italic>, Fifth Edition (DSM-5) criteria for moderate to severe AUD and Insomnia Disorder of at least 1-month duration. Participants will complete assessments at baseline, post-treatment and 6-week follow-up. Preliminary process outcomes include retention\/recruitment rates and treatment satisfaction (feasibility and acceptability, respectively). Primary outcomes are insomnia severity, percentage of heavy-drinking days and alcohol-related problems. We will assess a variety of secondary clinical and mechanistic outcomes (eg, post-traumatic stress disorder (PTSD) symptoms, attention and working memory).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>Ethics approval was obtained in October 2018. Data collection began in July 2019 and is planned for completion by July 2021. Trial results will be disseminated at local and national conferences, in peer-reviewed publications and through media outlets, as available. Results will also be shared with interested participants and clinical collaborators at the end of the trial.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>clinicaltrials.gov identifier <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT03806491\">NCT03806491<\/jats:ext-link> (pre-results).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-045667","type":"journal-article","created":{"date-parts":[[2021,6,8]],"date-time":"2021-06-08T12:51:32Z","timestamp":1623156692000},"page":"e045667","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Protocol for the Project SAVE randomised controlled trial examining CBT for insomnia among veterans in treatment for alcohol use disorder"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct03806491","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0624-1414","authenticated-orcid":false,"given":"Mary Beth","family":"Miller","sequence":"first","affiliation":[{"name":"Department of Psychiatry, University of Missouri, Columbia, MO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane","family":"Metrik","sequence":"additional","affiliation":[{"name":"Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island, USA"},{"name":"Mental Health & Behavioral Sciences Service, Providence VA Medical Center, Providence, RI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John E","family":"McGeary","sequence":"additional","affiliation":[{"name":"Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island, USA"},{"name":"Mental Health & Behavioral Sciences Service, Providence VA Medical Center, Providence, RI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Borsari","sequence":"additional","affiliation":[{"name":"Mental Health Service, San Francisco VA Health Care System, San Francisco, CA, USA"},{"name":"Department of Psychiatry and Behavioral Services, University of California San Francisco, San Francisco, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina S","family":"McCrae","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, University of Missouri, Columbia, MO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Maddoux","sequence":"additional","affiliation":[{"name":"Harry S Truman Memorial Veterans\" Hospital, Columbia, Missouri, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J Todd","family":"Arnedt","sequence":"additional","affiliation":[{"name":"Psychiatry, University of Michigan, Ann Arbor, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer E","family":"Merrill","sequence":"additional","affiliation":[{"name":"Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kate B","family":"Carey","sequence":"additional","affiliation":[{"name":"Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,6,8]]},"reference":[{"key":"2025101813173786000_11.6.e045667.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.addbeh.2015.06.021"},{"key":"2025101813173786000_11.6.e045667.2","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.158.3.399"},{"key":"2025101813173786000_11.6.e045667.3","doi-asserted-by":"crossref","first-page":"362","DOI":"10.1111\/ajad.12199","article-title":"The association between sleep disturbances and alcohol relapse: a 12-month observational cohort study","volume":"24","author":"Kolla","year":"2015","journal-title":"Am J Addict"},{"key":"2025101813173786000_11.6.e045667.4","doi-asserted-by":"crossref","first-page":"362","DOI":"10.1016\/j.addbeh.2010.12.014","article-title":"Characterizing binge drinking among U.S. military veterans receiving a brief alcohol intervention","volume":"36","author":"Cucciare","year":"2011","journal-title":"Addict Behav"},{"key":"2025101813173786000_11.6.e045667.5","doi-asserted-by":"publisher","DOI":"10.5665\/sleep.4172"},{"key":"2025101813173786000_11.6.e045667.6","doi-asserted-by":"publisher","DOI":"10.5665\/sleep.2116"},{"key":"2025101813173786000_11.6.e045667.7","first-page":"249","article-title":"The relationship between emotion regulation, dysfunctional beliefs about sleep, and sleep quality - An exploratory study","volume":"14","author":"Sandru","year":"2014","journal-title":"Journal of Evidence-Based Psychotherapies"},{"key":"2025101813173786000_11.6.e045667.8","doi-asserted-by":"publisher","DOI":"10.1111\/jcpp.12125"},{"key":"2025101813173786000_11.6.e045667.9","doi-asserted-by":"publisher","DOI":"10.1016\/j.brat.2013.05.014"},{"key":"2025101813173786000_11.6.e045667.10","doi-asserted-by":"crossref","first-page":"25-33","DOI":"10.1037\/tra0000064","article-title":"The relationship between subjective sleep disturbance, sleep quality, and emotion regulation difficulties in a sample of college students reporting trauma exposure","volume":"8","author":"Pickett","year":"2016","journal-title":"Psychol Trauma"},{"key":"2025101813173786000_11.6.e045667.11","doi-asserted-by":"crossref","first-page":"168","DOI":"10.1080\/08897077.2019.1674238","article-title":"Dissemination of cognitive behavioral therapy for substance use disorders in the Department of Veterans Affairs health care system: description and evaluation of veteran outcomes","volume":"42","author":"DeMarce","year":"2021","journal-title":"Subst Abus"},{"key":"2025101813173786000_11.6.e045667.12","doi-asserted-by":"crossref","first-page":"417","DOI":"10.1016\/j.alcohol.2014.12.003","article-title":"Assessment and treatment of insomnia in adult patients with alcohol use disorders","volume":"49","author":"Brower","year":"2015","journal-title":"Alcohol"},{"key":"2025101813173786000_11.6.e045667.13","doi-asserted-by":"publisher","DOI":"10.1001\/jama.295.17.2003"},{"key":"2025101813173786000_11.6.e045667.14","doi-asserted-by":"publisher","DOI":"10.15288\/jsa.2001.62.211"},{"key":"2025101813173786000_11.6.e045667.15","doi-asserted-by":"publisher","DOI":"10.1016\/j.mehy.2009.10.020"},{"key":"2025101813173786000_11.6.e045667.16","doi-asserted-by":"crossref","first-page":"593","DOI":"10.1017\/S1352465813000465","article-title":"Sleep related beliefs and their association with alcohol relapse following residential alcohol detoxification treatment","volume":"42","author":"Smith","year":"2014","journal-title":"Behav Cogn Psychother"},{"key":"2025101813173786000_11.6.e045667.17","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1111\/j.1521-0391.2013.12056.x","article-title":"The course of sleep disturbances in early alcohol recovery: an observational cohort study","volume":"23","author":"Kolla","year":"2014","journal-title":"Am J Addict"},{"key":"2025101813173786000_11.6.e045667.18","doi-asserted-by":"publisher","DOI":"10.1111\/acer.13217"},{"key":"2025101813173786000_11.6.e045667.19","doi-asserted-by":"publisher","DOI":"10.1038\/npp.2015.143"},{"key":"2025101813173786000_11.6.e045667.20","doi-asserted-by":"publisher","DOI":"10.1111\/j.1530-0277.2008.00706.x"},{"key":"2025101813173786000_11.6.e045667.21","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2011.10101436"},{"key":"2025101813173786000_11.6.e045667.22","doi-asserted-by":"crossref","first-page":"21","DOI":"10.2147\/PRBM.S10041","article-title":"New developments in cognitive behavioral therapy as the first-line treatment of insomnia","volume":"4","author":"Siebern","year":"2011","journal-title":"Psychol Res Behav Manag"},{"key":"2025101813173786000_11.6.e045667.23","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.159.1.5"},{"key":"2025101813173786000_11.6.e045667.24","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpsychores.2011.11.010"},{"key":"2025101813173786000_11.6.e045667.25","doi-asserted-by":"publisher","DOI":"10.5665\/sleep.3408"},{"key":"2025101813173786000_11.6.e045667.26","doi-asserted-by":"crossref","first-page":"499","DOI":"10.1093\/sleep\/32.4.499","article-title":"Cognitive behavioral therapy for patients with primary insomnia or insomnia associated predominantly with mixed psychiatric disorders: a randomized clinical trial","volume":"32","author":"Edinger","year":"2009","journal-title":"Sleep"},{"key":"2025101813173786000_11.6.e045667.27","doi-asserted-by":"publisher","DOI":"10.1016\/j.brat.2014.07.016"},{"key":"2025101813173786000_11.6.e045667.28","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/26.2.177"},{"key":"2025101813173786000_11.6.e045667.29","doi-asserted-by":"crossref","first-page":"308","DOI":"10.1002\/gps.4143","article-title":"National evaluation of the effectiveness of cognitive behavioral therapy for insomnia among older versus younger veterans","volume":"30","author":"Karlin","year":"2015","journal-title":"Int J Geriatr Psychiatry"},{"key":"2025101813173786000_11.6.e045667.30","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsmc.2014.02.007"},{"key":"2025101813173786000_11.6.e045667.31","doi-asserted-by":"publisher","DOI":"10.1016\/j.cpr.2005.04.004"},{"key":"2025101813173786000_11.6.e045667.32","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2006.06.007"},{"key":"2025101813173786000_11.6.e045667.33","doi-asserted-by":"publisher","DOI":"10.1016\/j.brat.2011.02.003"},{"key":"2025101813173786000_11.6.e045667.34","doi-asserted-by":"publisher","DOI":"10.1111\/j.1360-0443.2004.00835.x"},{"key":"2025101813173786000_11.6.e045667.35","doi-asserted-by":"crossref","first-page":"259","DOI":"10.5665\/sleep.4410","article-title":"Effects of cognitive behavioral therapy for insomnia on suicidal ideation in veterans","volume":"38","author":"Trockel","year":"2015","journal-title":"Sleep"},{"key":"2025101813173786000_11.6.e045667.36","doi-asserted-by":"crossref","first-page":"1244","DOI":"10.1111\/acer.14030","article-title":"Cognitive behavioral therapy for insomnia in Alcohol\u2010Dependent veterans: a randomized, controlled pilot study","volume":"28","author":"Chakravorty","year":"2019","journal-title":"Alcoholism: Clinical and Experimental Research"},{"key":"2025101813173786000_11.6.e045667.37","doi-asserted-by":"crossref","first-page":"200","DOI":"10.1016\/j.drugalcdep.2017.09.029","article-title":"Insomnia treatment in the context of alcohol use disorder: a systematic review and meta-analysis","volume":"181","author":"Miller","year":"2017","journal-title":"Drug Alcohol Depend"},{"key":"2025101813173786000_11.6.e045667.38","doi-asserted-by":"publisher","DOI":"10.1016\/j.neuropharm.2017.03.006"},{"key":"2025101813173786000_11.6.e045667.39","doi-asserted-by":"publisher","DOI":"10.1038\/s41386-019-0446-0"},{"key":"2025101813173786000_11.6.e045667.40","doi-asserted-by":"publisher","DOI":"10.1177\/1359105310390544"},{"key":"2025101813173786000_11.6.e045667.41","doi-asserted-by":"crossref","first-page":"104","DOI":"10.1037\/apl0000154","article-title":"Helping employees sleep well: effects of cognitive behavioral therapy for insomnia on work outcomes","volume":"102","author":"Barnes","year":"2017","journal-title":"Journal of Applied Psychology"},{"key":"2025101813173786000_11.6.e045667.42","doi-asserted-by":"crossref","first-page":"1567","DOI":"10.1093\/sleep\/27.8.1567","article-title":"Derivation of research diagnostic criteria for insomnia: report of an American Academy of sleep medicine work group","volume":"27","author":"Edinger","year":"2004","journal-title":"Sleep"},{"key":"2025101813173786000_11.6.e045667.43","unstructured":"Manber R , Friedman L , Siebern AT . Cognitive behavioral therapy for insomnia in veterans: therapist manual. Washington, DC: U.S. Department of Veterans Affairs, 2014."},{"key":"2025101813173786000_11.6.e045667.44","unstructured":"Sobell LC , Sobell MB . Timeline follow-back users guide. Toronto: ARF, 1996."},{"key":"2025101813173786000_11.6.e045667.45","doi-asserted-by":"publisher","DOI":"10.1016\/j.smrv.2011.02.005"},{"key":"2025101813173786000_11.6.e045667.46","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/0146-6402(94)90001-9","article-title":"Fair tests of clinical trials: a treatment implementation model","volume":"16","author":"Lichstein","year":"1994","journal-title":"Advan Behav Research and Therapy"},{"key":"2025101813173786000_11.6.e045667.47","doi-asserted-by":"publisher","DOI":"10.1016\/0005-7916(72)90045-6"},{"key":"2025101813173786000_11.6.e045667.48","doi-asserted-by":"publisher","DOI":"10.1016\/0149-7189(79)90094-6"},{"key":"2025101813173786000_11.6.e045667.49","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1111\/dar.12522","article-title":"The client satisfaction Questionnaire-8: psychometric properties in a cross-sectional survey of people attending residential substance abuse treatment","volume":"37","author":"Kelly","year":"2018","journal-title":"Drug Alcohol Rev"},{"key":"2025101813173786000_11.6.e045667.50","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/34.5.601"},{"key":"2025101813173786000_11.6.e045667.51","doi-asserted-by":"publisher","DOI":"10.5664\/jcsm.27286"},{"key":"2025101813173786000_11.6.e045667.52","doi-asserted-by":"crossref","unstructured":"Miller WR , Tonigan JS , Longabaugh R . The Drinker Inventory of Consequences (DrInC): An instrument for assessing adverse consequences of alcohol abuse (Project MATCH Monograph Series). In: Us department of health and human services pHs. Rockville, MD: National Institute on Alcohol Abuse and Alcoholism, 1995.","DOI":"10.1037\/e563232012-001"},{"key":"2025101813173786000_11.6.e045667.53","doi-asserted-by":"publisher","DOI":"10.15288\/jsad.2009.70.304"},{"key":"2025101813173786000_11.6.e045667.54","doi-asserted-by":"crossref","first-page":"744","DOI":"10.1176\/appi.ajp.2018.18030357","article-title":"Neurofunctional domains derived from deep behavioral phenotyping in alcohol use disorder","volume":"176","author":"Kwako","year":"2019","journal-title":"American Journal of Psychiatry"},{"key":"2025101813173786000_11.6.e045667.55","doi-asserted-by":"publisher","DOI":"10.1007\/s11121-007-0070-9"},{"key":"2025101813173786000_11.6.e045667.56","doi-asserted-by":"publisher","DOI":"10.1111\/acer.12205"},{"key":"2025101813173786000_11.6.e045667.57","doi-asserted-by":"publisher","DOI":"10.1207\/s15327906mbr3901_4"},{"key":"2025101813173786000_11.6.e045667.58","unstructured":"Hayes AF . Introduction to mediation, moderation, and conditional process analysis: a regression-based approach. New York, NY: Guilford Press, 2013."},{"key":"2025101813173786000_11.6.e045667.59","doi-asserted-by":"publisher","DOI":"10.1080\/00273171.2012.640596"},{"key":"2025101813173786000_11.6.e045667.60","doi-asserted-by":"publisher","DOI":"10.1037\/a0033888"},{"key":"2025101813173786000_11.6.e045667.61","doi-asserted-by":"publisher","DOI":"10.5665\/sleep.1642"},{"key":"2025101813173786000_11.6.e045667.62","doi-asserted-by":"publisher","DOI":"10.1037\/pas0000254"},{"key":"2025101813173786000_11.6.e045667.63","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2011.06.017"},{"key":"2025101813173786000_11.6.e045667.64","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.166.10.1092"},{"key":"2025101813173786000_11.6.e045667.65","doi-asserted-by":"publisher","DOI":"10.1111\/j.1530-0277.1999.tb04349.x"},{"key":"2025101813173786000_11.6.e045667.66","doi-asserted-by":"publisher","DOI":"10.1037\/0022-3514.54.6.1063"},{"key":"2025101813173786000_11.6.e045667.67","doi-asserted-by":"publisher","DOI":"10.1007\/s10862-015-9514-x"},{"key":"2025101813173786000_11.6.e045667.68","doi-asserted-by":"publisher","DOI":"10.1016\/j.actaastro.2011.07.015"},{"key":"2025101813173786000_11.6.e045667.69","doi-asserted-by":"publisher","DOI":"10.3758\/BF03200977"},{"key":"2025101813173786000_11.6.e045667.70","doi-asserted-by":"crossref","unstructured":"Schmiedek F , L\u00c3\u00b6vd\u00c3\u00a9n M , Lindenberger U . A task is a task is a task: putting complex span, n-back, and other working memory indicators in psychometric context. Front Psychol 2014;5.doi:10.3389\/fpsyg.2014.01475","DOI":"10.3389\/fpsyg.2014.01475"},{"key":"2025101813173786000_11.6.e045667.71","doi-asserted-by":"publisher","DOI":"10.1037\/0096-3445.128.1.78"},{"key":"2025101813173786000_11.6.e045667.72","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1002\/jeab.221","article-title":"Syntax for calculation of discounting indices from the monetary choice questionnaire and probability discounting questionnaire","volume":"106","author":"Gray","year":"2016","journal-title":"J Exp Anal Behav"},{"key":"2025101813173786000_11.6.e045667.73","doi-asserted-by":"publisher","DOI":"10.1016\/j.addbeh.2014.02.013"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2020-045667","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T20:17:47Z","timestamp":1760818667000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2020-045667"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,6]]},"references-count":73,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2021,6,8]]},"published-print":{"date-parts":[[2021,6]]}},"alternative-id":["10.1136\/bmjopen-2020-045667"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2020-045667","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,6]]}}}