xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05965609</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-2021-1200</org_study_id>
      <nct_id>NCT05965609</nct_id>
    </id_info>
    <brief_title>Optimizing Sleep Health in Nurses</brief_title>
    <acronym>OSHIN</acronym>
    <official_title>Piloting an Adaption of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Oregon State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Academy of Sleep Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Monash University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Oregon State University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the proposed study is to pilot test two behavioral sleep intervention strategies&#xD;
        for improving insomnia among night shift working nurses.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Night shift nurses with insomnia who meet all study criteria will receive one of two insomnia&#xD;
        therapies. The specific therapy for insomnia will be determine by chance (like a flip of a&#xD;
        coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or&#xD;
        multicomponent relaxation therapy for insomnia, both modified for shift workers. Both&#xD;
        therapies will be conducted over telehealth by interventionists trained in behavioral sleep&#xD;
        medicine.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">August 11, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 14, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors. Participants are asked not to share details of their treatment with other individuals at their workplace.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Insomnia Severity Index</measure>
      <time_frame>At baseline and at the post-treatment assessment (occurring at approximately 21 weeks)</time_frame>
      <description>Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Retention Rate</measure>
      <time_frame>At the post-treatment assessment (occurring at approximately 21 weeks)</time_frame>
      <description>Defined as [number of participants who complete minimal therapeutic dose (at least 4 sessions)] / [number of randomized participants in treatment arm]</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Session Attendance</measure>
      <time_frame>At the post-treatment assessment (occurring at approximately 21 weeks)</time_frame>
      <description>For enrolled participants, attendance rates will be calculated as [number of visits attended] / [number of total visits]</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Implementation Assessment Measure</measure>
      <time_frame>At the post-treatment assessment (occurring at approximately 21 weeks)</time_frame>
      <description>Validated questionnaire; total score range between 12 and 60, with higher numbers representing greater feasibility, acceptability, and appropriateness.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Fatigue Severity Scale</measure>
      <time_frame>At baseline and at the post-treatment assessment (occurring at approximately 21 weeks)</time_frame>
      <description>Validated questionnaire; total score range between 9 and 63, with higher numbers representing greater fatigue.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Epworth Sleepiness Scale</measure>
      <time_frame>At baseline and at the post-treatment assessment (occurring at approximately 21 weeks)</time_frame>
      <description>Validated questionnaire; total score range between 0 and 24, with higher numbers representing greater sleepiness propensity</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Circadian Rhythm Sleep-Wake Disorders, Shift Work Type</condition>
    <condition>Sleep Initiation and Maintenance Disorders</condition>
    <arm_group>
      <arm_group_label>CBTI</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Cognitive Behavioral Therapy for Insomnia</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MRTI</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Multicomponent Relaxation Therapy for Insomnia</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>CBTI</intervention_name>
      <description>Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep</description>
      <arm_group_label>CBTI</arm_group_label>
      <other_name>Cognitive Behavioral Therapy for Insomnia</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MRTI</intervention_name>
      <description>Intervention includes education about sleep and behavioral and relaxation strategies to improve sleep</description>
      <arm_group_label>MRTI</arm_group_label>
      <other_name>Multicomponent Relaxation Therapy for Insomnia</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Current shift working nurse in Oregon&#xD;
  &#xD;
            -  Expect to continue on shift work schedule during the study&#xD;
  &#xD;
            -  Meets criteria for an insomnia disorder&#xD;
  &#xD;
            -  Elevated insomnia symptoms&#xD;
  &#xD;
            -  Have daily access to internet on a smartphone, tablet, or computer; and&#xD;
  &#xD;
            -  Can read and write in English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People with uncontrolled medical conditions&#xD;
  &#xD;
            -  Presence of safety risk or condition in which study participation may be ineffective&#xD;
               or result in increased risk to safety&#xD;
  &#xD;
            -  Some current treatments for insomnia&#xD;
  &#xD;
            -  Permanent day, evening, or rotating shift schedule&#xD;
  &#xD;
            -  History of seizures or manic episode; or&#xD;
  &#xD;
            -  Current/expected pregnancy during the study period&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jessica Dietch, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Oregon State University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jessica R Dietch, PhD</last_name>
      <phone>541-737-1358</phone>
      <email>jessee.dietch@oregonstate.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lucy Kozii, MD, MPH</last_name>
      <email>koziil@oregonstate.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Oregon State University</name>
        <address>
          <city>Corvallis</city>
          <state>Oregon</state>
          <zip>97331</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jessee Dietch, PhD</last_name>
        <phone>541-737-1358</phone>
        <email>jessee.dietch@oregonstate.edu</email>
      </contact>
      <investigator>
        <last_name>Jessee Dietch, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>McMenamin TM. A time to work: recent trends in shift work and flexible schedules. Monthly Lab Rev. 2007;130:3.</citation>
    </reference>
    <reference>
      <citation>Torquati L, Mielke GI, Brown WJ, Kolbe-Alexander T. Shift work and the risk of cardiovascular disease. A systematic review and meta-analysis including dose-response relationship. Scand J Work Environ Health. 2018 May 1;44(3):229-238. doi: 10.5271/sjweh.3700. Epub 2017 Dec 16.</citation>
      <PMID>29247501</PMID>
    </reference>
    <reference>
      <citation>Frost P, Kolstad HA, Bonde JP. Shift work and the risk of ischemic heart disease - a systematic review of the epidemiologic evidence. Scand J Work Environ Health. 2009 May;35(3):163-79. doi: 10.5271/sjweh.1319. Epub 2009 Apr 22.</citation>
      <PMID>19387517</PMID>
    </reference>
    <reference>
      <citation>Brown DL, Feskanich D, Sanchez BN, Rexrode KM, Schernhammer ES, Lisabeth LD. Rotating night shift work and the risk of ischemic stroke. Am J Epidemiol. 2009 Jun 1;169(11):1370-7. doi: 10.1093/aje/kwp056. Epub 2009 Apr 8.</citation>
      <PMID>19357324</PMID>
    </reference>
    <reference>
      <citation>Hansen J, Lassen CF. Nested case-control study of night shift work and breast cancer risk among women in the Danish military. Occup Environ Med. 2012 Aug;69(8):551-6. doi: 10.1136/oemed-2011-100240. Epub 2012 May 29.</citation>
      <PMID>22645325</PMID>
    </reference>
    <reference>
      <citation>Jia Y, Lu Y, Wu K, Lin Q, Shen W, Zhu M, Huang S, Chen J. Does night work increase the risk of breast cancer? A systematic review and meta-analysis of epidemiological studies. Cancer Epidemiol. 2013 Jun;37(3):197-206. doi: 10.1016/j.canep.2013.01.005. Epub 2013 Feb 9.</citation>
      <PMID>23403128</PMID>
    </reference>
    <reference>
      <citation>Rao D, Yu H, Bai Y, Zheng X, Xie L. Does night-shift work increase the risk of prostate cancer? a systematic review and meta-analysis. Onco Targets Ther. 2015 Oct 5;8:2817-26. doi: 10.2147/OTT.S89769. eCollection 2015.</citation>
      <PMID>26491356</PMID>
    </reference>
    <reference>
      <citation>Lin X, Chen W, Wei F, Ying M, Wei W, Xie X. Night-shift work increases morbidity of breast cancer and all-cause mortality: a meta-analysis of 16 prospective cohort studies. Sleep Med. 2015 Nov;16(11):1381-1387. doi: 10.1016/j.sleep.2015.02.543. Epub 2015 May 11.</citation>
      <PMID>26498240</PMID>
    </reference>
    <reference>
      <citation>Karlsson B, Knutsson A, Lindahl B. Is there an association between shift work and having a metabolic syndrome? Results from a population based study of 27,485 people. Occup Environ Med. 2001 Nov;58(11):747-52. doi: 10.1136/oem.58.11.747.</citation>
      <PMID>11600731</PMID>
    </reference>
    <reference>
      <citation>Gan Y, Yang C, Tong X, Sun H, Cong Y, Yin X, Li L, Cao S, Dong X, Gong Y, Shi O, Deng J, Bi H, Lu Z. Shift work and diabetes mellitus: a meta-analysis of observational studies. Occup Environ Med. 2015 Jan;72(1):72-8. doi: 10.1136/oemed-2014-102150. Epub 2014 Jul 16.</citation>
      <PMID>25030030</PMID>
    </reference>
    <reference>
      <citation>Barger LK, Lockley SW, Rajaratnam SM, Landrigan CP. Neurobehavioral, health, and safety consequences associated with shift work in safety-sensitive professions. Curr Neurol Neurosci Rep. 2009 Mar;9(2):155-64. doi: 10.1007/s11910-009-0024-7.</citation>
      <PMID>19268039</PMID>
    </reference>
    <reference>
      <citation>Johnson AL, Jung L, Song Y, Brown KC, Weaver MT, Richards KC. Sleep deprivation and error in nurses who work the night shift. J Nurs Adm. 2014 Jan;44(1):17-22. doi: 10.1097/NNA.0000000000000016. Erratum In: J Nurs Adm. 2014 Mar;44(3):186. Song, Yeonsu [added].</citation>
      <PMID>24316614</PMID>
    </reference>
    <reference>
      <citation>Lee A, Myung SK, Cho JJ, Jung YJ, Yoon JL, Kim MY. Night Shift Work and Risk of Depression: Meta-analysis of Observational Studies. J Korean Med Sci. 2017 Jul;32(7):1091-1096. doi: 10.3346/jkms.2017.32.7.1091.</citation>
      <PMID>28581264</PMID>
    </reference>
    <reference>
      <citation>Angerer P, Schmook R, Elfantel I, Li J. Night Work and the Risk of Depression. Dtsch Arztebl Int. 2017 Jul 16;114(24):404-411. doi: 10.3238/arztebl.2017.0404.</citation>
      <PMID>28669378</PMID>
    </reference>
    <reference>
      <citation>Gu F, Han J, Laden F, Pan A, Caporaso NE, Stampfer MJ, Kawachi I, Rexrode KM, Willett WC, Hankinson SE, Speizer FE, Schernhammer ES. Total and cause-specific mortality of U.S. nurses working rotating night shifts. Am J Prev Med. 2015 Mar;48(3):241-52. doi: 10.1016/j.amepre.2014.10.018. Epub 2015 Jan 6.</citation>
      <PMID>25576495</PMID>
    </reference>
    <reference>
      <citation>Bureau of Labor Statistics. Standard occupational classification groups. 2018. Retrieved from bls.gov/soc/</citation>
    </reference>
    <reference>
      <citation>Lee KA. Self-reported sleep disturbances in employed women. Sleep. 1992 Dec;15(6):493-8. doi: 10.1093/sleep/15.6.493.</citation>
      <PMID>1475563</PMID>
    </reference>
    <reference>
      <citation>Oyane NM, Pallesen S, Moen BE, Akerstedt T, Bjorvatn B. Associations between night work and anxiety, depression, insomnia, sleepiness and fatigue in a sample of Norwegian nurses. PLoS One. 2013 Aug 7;8(8):e70228. doi: 10.1371/journal.pone.0070228. eCollection 2013.</citation>
      <PMID>23950914</PMID>
    </reference>
    <reference>
      <citation>Lajoie P, Aronson KJ, Day A, Tranmer J. A cross-sectional study of shift work, sleep quality and cardiometabolic risk in female hospital employees. BMJ Open. 2015 Mar 10;5(3):e007327. doi: 10.1136/bmjopen-2014-007327.</citation>
      <PMID>25757950</PMID>
    </reference>
    <reference>
      <citation>Karhula K, Hakola T, Koskinen A, Ojajarvi A, Kivimaki M, Harma M. Permanent night workers sleep and psychosocial factors in hospital work. A comparison to day and shift work. Chronobiol Int. 2018 Jun;35(6):785-794. doi: 10.1080/07420528.2018.1466792. Epub 2018 May 15.</citation>
      <PMID>29764221</PMID>
    </reference>
    <reference>
      <citation>Givens ML, Malecki KC, Peppard PE, Palta M, Said A, Engelman CD, Walsh MC, Nieto FJ. Shiftwork, Sleep Habits, and Metabolic Disparities: Results from the Survey of the Health of Wisconsin. Sleep Health. 2015 Jun;1(2):115-120. doi: 10.1016/j.sleh.2015.04.014.</citation>
      <PMID>26894229</PMID>
    </reference>
    <reference>
      <citation>Harma M, Tenkanen L, Sjoblom T, Alikoski T, Heinsalmi P. Combined effects of shift work and life-style on the prevalence of insomnia, sleep deprivation and daytime sleepiness. Scand J Work Environ Health. 1998 Aug;24(4):300-7. doi: 10.5271/sjweh.324.</citation>
      <PMID>9754862</PMID>
    </reference>
    <reference>
      <citation>Drake CL, Roehrs T, Richardson G, Walsh JK, Roth T. Shift work sleep disorder: prevalence and consequences beyond that of symptomatic day workers. Sleep. 2004 Dec 15;27(8):1453-62. doi: 10.1093/sleep/27.8.1453.</citation>
      <PMID>15683134</PMID>
    </reference>
    <reference>
      <citation>Stepanski EJ, Perlis ML. Behavioral sleep medicine. An emerging subspecialty in health psychology and sleep medicine. J Psychosom Res. 2000 Nov;49(5):343-7. doi: 10.1016/s0022-3999(00)00171-9.</citation>
      <PMID>11164058</PMID>
    </reference>
    <reference>
      <citation>Okajima I, Komada Y, Inoue Y. A meta-analysis on the treatment effectiveness of cognitive behavioral therapy for primary insomnia. Sleep Biol Rhythms. 2011;9(1):24-34.</citation>
    </reference>
    <reference>
      <citation>Murtagh DR, Greenwood KM. Identifying effective psychological treatments for insomnia: a meta-analysis. J Consult Clin Psychol. 1995 Feb;63(1):79-89. doi: 10.1037//0022-006x.63.1.79.</citation>
      <PMID>7896994</PMID>
    </reference>
    <reference>
      <citation>Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80. doi: 10.1176/ajp.151.8.1172.</citation>
      <PMID>8037252</PMID>
    </reference>
    <reference>
      <citation>Geiger-Brown JM, Rogers VE, Liu W, Ludeman EM, Downton KD, Diaz-Abad M. Cognitive behavioral therapy in persons with comorbid insomnia: A meta-analysis. Sleep Med Rev. 2015 Oct;23:54-67. doi: 10.1016/j.smrv.2014.11.007. Epub 2014 Nov 29.</citation>
      <PMID>25645130</PMID>
    </reference>
    <reference>
      <citation>Taylor DJ, Pruiksma KE. Cognitive and behavioural therapy for insomnia (CBT-I) in psychiatric populations: a systematic review. Int Rev Psychiatry. 2014 Apr;26(2):205-13. doi: 10.3109/09540261.2014.902808.</citation>
      <PMID>24892895</PMID>
    </reference>
    <reference>
      <citation>Smith MT, Huang MI, Manber R. Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. Clin Psychol Rev. 2005 Jul;25(5):559-92. doi: 10.1016/j.cpr.2005.04.004.</citation>
      <PMID>15970367</PMID>
    </reference>
    <reference>
      <citation>Dietch J, Wu J, Slavish D, et al. Characteristics of participants in trials of cognitive-behavioral therapy for insomnia: a systematic review and data synthesis. Pre-registered at PROSPERO (ID: CRD42020159476). In preparation.</citation>
    </reference>
    <reference>
      <citation>Jarnefelt H, Lagerstedt R, Kajaste S, Sallinen M, Savolainen A, Hublin C. Cognitive behavioral therapy for shift workers with chronic insomnia. Sleep Med. 2012 Dec;13(10):1238-46. doi: 10.1016/j.sleep.2012.10.003. Epub 2012 Nov 16.</citation>
      <PMID>23168269</PMID>
    </reference>
    <reference>
      <citation>Jarnefelt H, Harma M, Sallinen M, Virkkala J, Paajanen T, Martimo KP, Hublin C. Cognitive behavioural therapy interventions for insomnia among shift workers: RCT in an occupational health setting. Int Arch Occup Environ Health. 2020 Jul;93(5):535-550. doi: 10.1007/s00420-019-01504-6. Epub 2019 Dec 18. Erratum In: Int Arch Occup Environ Health. 2020 Mar 3;:</citation>
      <PMID>31853633</PMID>
    </reference>
    <reference>
      <citation>Peter L, Reindl R, Zauter S, Hillemacher T, Richter K. Effectiveness of an Online CBT-I Intervention and a Face-to-Face Treatment for Shift Work Sleep Disorder: A Comparison of Sleep Diary Data. Int J Environ Res Public Health. 2019 Aug 24;16(17):3081. doi: 10.3390/ijerph16173081.</citation>
      <PMID>31450619</PMID>
    </reference>
    <reference>
      <citation>Vallières A, Roy M, Bastille-Denis E, Claveau S, Simon T. Exploring a behavioural therapy for insomnia in shift workers. J Sleep Disord Ther. 2015;4(202);2167-0277.</citation>
    </reference>
    <reference>
      <citation>Koffel EA, Koffel JB, Gehrman PR. A meta-analysis of group cognitive behavioral therapy for insomnia. Sleep Med Rev. 2015 Feb;19:6-16. doi: 10.1016/j.smrv.2014.05.001. Epub 2014 May 14.</citation>
      <PMID>24931811</PMID>
    </reference>
    <reference>
      <citation>American Psychiatric Association. Diagnostic and Statistical Manual Of Mental Disorders (DSM-5®). American Psychiatric Pub; 2013.</citation>
    </reference>
    <reference>
      <citation>Morgenthaler TI, Lee-Chiong T, Alessi C, Friedman L, Aurora RN, Boehlecke B, Brown T, Chesson AL Jr, Kapur V, Maganti R, Owens J, Pancer J, Swick TJ, Zak R; Standards of Practice Committee of the American Academy of Sleep Medicine. Practice parameters for the clinical evaluation and treatment of circadian rhythm sleep disorders. An American Academy of Sleep Medicine report. Sleep. 2007 Nov;30(11):1445-59. doi: 10.1093/sleep/30.11.1445. Erratum In: Sleep. 2008 Jul 1;31(7):table of contents.</citation>
      <PMID>18041479</PMID>
    </reference>
    <reference>
      <citation>Arendt J. Shift work: coping with the biological clock. Occup Med (Lond). 2010 Jan;60(1):10-20. doi: 10.1093/occmed/kqp162.</citation>
      <PMID>20051441</PMID>
    </reference>
    <reference>
      <citation>Spielman AJ, Saskin P, Thorpy MJ. Treatment of chronic insomnia by restriction of time in bed. Sleep. 1987 Feb;10(1):45-56.</citation>
      <PMID>3563247</PMID>
    </reference>
    <reference>
      <citation>Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.</citation>
      <PMID>28851459</PMID>
    </reference>
    <reference>
      <citation>Bei B, Wiley JF, Trinder J, Manber R. Beyond the mean: A systematic review on the correlates of daily intraindividual variability of sleep/wake patterns. Sleep Med Rev. 2016 Aug;28:108-24. doi: 10.1016/j.smrv.2015.06.003. Epub 2015 Jul 2.</citation>
      <PMID>26588182</PMID>
    </reference>
    <reference>
      <citation>Ganesan S, Magee M, Stone JE, Mulhall MD, Collins A, Howard ME, Lockley SW, Rajaratnam SMW, Sletten TL. The Impact of Shift Work on Sleep, Alertness and Performance in Healthcare Workers. Sci Rep. 2019 Mar 15;9(1):4635. doi: 10.1038/s41598-019-40914-x.</citation>
      <PMID>30874565</PMID>
    </reference>
    <reference>
      <citation>Taylor DJ, Wilkerson AK, Pruiksma KE, Dietch JR, Wardle-Pinkston S. Structured Clinical interview for Sleep Disorders-Revised (SCISD-R). 2019. Retrieved from insomnia.arizona.edu/scisd</citation>
    </reference>
    <reference>
      <citation>Taylor DJ, Wilkerson AK, Pruiksma KE, Williams JM, Ruggero CJ, Hale W, Mintz J, Organek KM, Nicholson KL, Litz BT, Young-McCaughan S, Dondanville KA, Borah EV, Brundige A, Peterson AL; STRONG STAR Consortium. Reliability of the Structured Clinical Interview for DSM-5 Sleep Disorders Module. J Clin Sleep Med. 2018 Mar 15;14(3):459-464. doi: 10.5664/jcsm.7000.</citation>
      <PMID>29458705</PMID>
    </reference>
    <reference>
      <citation>Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.</citation>
      <PMID>11438246</PMID>
    </reference>
    <reference>
      <citation>Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.</citation>
      <PMID>18431116</PMID>
    </reference>
    <reference>
      <citation>Manber R, Carney CE. Treatment plans and interventions for insomnia: a case formulation approach. Guilford Publications; 2015.</citation>
    </reference>
    <reference>
      <citation>Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.</citation>
      <PMID>15367063</PMID>
    </reference>
    <reference>
      <citation>Carney CE, Edinger JD, Kuchibhatla M, Lachowski AM, Bogouslavsky O, Krystal AD, Shapiro CM. Cognitive Behavioral Insomnia Therapy for Those With Insomnia and Depression: A Randomized Controlled Clinical Trial. Sleep. 2017 Apr 1;40(4):zsx019. doi: 10.1093/sleep/zsx019.</citation>
      <PMID>28199710</PMID>
    </reference>
    <reference>
      <citation>Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.</citation>
      <PMID>21532953</PMID>
    </reference>
    <reference>
      <citation>Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.</citation>
      <PMID>9881538</PMID>
    </reference>
    <reference>
      <citation>Chung F, Abdullah HR, Liao P. STOP-Bang Questionnaire: A Practical Approach to Screen for Obstructive Sleep Apnea. Chest. 2016 Mar;149(3):631-8. doi: 10.1378/chest.15-0903. Epub 2016 Jan 12.</citation>
      <PMID>26378880</PMID>
    </reference>
    <reference>
      <citation>Manber R, Bernert RA, Suh S, Nowakowski S, Siebern AT, Ong JC. CBT for insomnia in patients with high and low depressive symptom severity: adherence and clinical outcomes. J Clin Sleep Med. 2011 Dec 15;7(6):645-52. doi: 10.5664/jcsm.1472.</citation>
      <PMID>22171204</PMID>
    </reference>
    <reference>
      <citation>Seligman ME. The effectiveness of psychotherapy. The Consumer Reports study. Am Psychol. 1995 Dec;50(12):965-74. doi: 10.1037//0003-066x.50.12.965.</citation>
      <PMID>8561380</PMID>
    </reference>
    <reference>
      <citation>Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.</citation>
      <PMID>2803071</PMID>
    </reference>
    <reference>
      <citation>Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.</citation>
      <PMID>1798888</PMID>
    </reference>
    <reference>
      <citation>Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.</citation>
      <PMID>22294820</PMID>
    </reference>
    <reference>
      <citation>Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011 Oct;4(5):332-7. doi: 10.1111/j.1752-8062.2011.00347.x.</citation>
      <PMID>22029804</PMID>
    </reference>
    <reference>
      <citation>Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.</citation>
      <PMID>21035130</PMID>
    </reference>
    <reference>
      <citation>Carter PA, Dyer KA, Mikan SQ. Sleep disturbance, chronic stress, and depression in hospice nurses: testing the feasibility of an intervention. Oncol Nurs Forum. 2013 Sep;40(5):E368-73. doi: 10.1188/13.ONF.E368-E373.</citation>
      <PMID>23989029</PMID>
    </reference>
    <reference>
      <citation>Fiorentino L, McQuaid JR, Liu L, Natarajan L, He F, Cornejo M, Lawton S, Parker BA, Sadler GR, Ancoli-Israel S. Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study. Nat Sci Sleep. 2010 Dec 16;2:1-8. doi: 10.2147/nss.s8004. Print 2010.</citation>
      <PMID>23616695</PMID>
    </reference>
    <reference>
      <citation>Pruiksma KE, Taylor DJ, Mintz J, Nicholson KL, Rodgers M, Young-McCaughan S, Hall-Clark BN, Fina BA, Dondanville KA, Cobos B, Wardle-Pinkston S, Litz BT, Roache JD, Peterson AL; STRONG STAR Consortium. A pilot randomized controlled trial of cognitive behavioral treatment for trauma-related nightmares in active duty military personnel. J Clin Sleep Med. 2020 Jan 15;16(1):29-40. doi: 10.5664/jcsm.8116. Epub 2019 Nov 26.</citation>
      <PMID>31957648</PMID>
    </reference>
    <reference>
      <citation>Taylor DJ, Zimmerman MR, Gardner CE, Williams JM, Grieser EA, Tatum JI, Bramoweth AD, Francetich JM, Ruggero C. A pilot randomized controlled trial of the effects of cognitive-behavioral therapy for insomnia on sleep and daytime functioning in college students. Behav Ther. 2014 May;45(3):376-89. doi: 10.1016/j.beth.2013.12.010. Epub 2014 Jan 3.</citation>
      <PMID>24680232</PMID>
    </reference>
    <reference>
      <citation>Harvey AG, Soehner AM, Kaplan KA, Hein K, Lee J, Kanady J, Li D, Rabe-Hesketh S, Ketter TA, Neylan TC, Buysse DJ. Treating insomnia improves mood state, sleep, and functioning in bipolar disorder: a pilot randomized controlled trial. J Consult Clin Psychol. 2015 Jun;83(3):564-77. doi: 10.1037/a0038655. Epub 2015 Jan 26.</citation>
      <PMID>25622197</PMID>
    </reference>
    <reference>
      <citation>Tang NK, Goodchild CE, Salkovskis PM. Hybrid cognitive-behaviour therapy for individuals with insomnia and chronic pain: a pilot randomised controlled trial. Behav Res Ther. 2012 Dec;50(12):814-21. doi: 10.1016/j.brat.2012.08.006. Epub 2012 Sep 10.</citation>
      <PMID>23123531</PMID>
    </reference>
    <reference>
      <citation>Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.</citation>
      <PMID>22169081</PMID>
    </reference>
    <reference>
      <citation>Bureau of Labor Statistics UDoL. Occupational Outlook Handbook, Registered Nurses. 2020.</citation>
    </reference>
    <reference>
      <citation>Horowitz TS, Cade BE, Wolfe JM, Czeisler CA. Efficacy of bright light and sleep/darkness scheduling in alleviating circadian maladaptation to night work. Am J Physiol Endocrinol Metab. 2001 Aug;281(2):E384-91. doi: 10.1152/ajpendo.2001.281.2.E384.</citation>
      <PMID>11440916</PMID>
    </reference>
    <reference>
      <citation>Boivin DB, James FO. Circadian adaptation to night-shift work by judicious light and darkness exposure. J Biol Rhythms. 2002 Dec;17(6):556-67. doi: 10.1177/0748730402238238.</citation>
      <PMID>12465889</PMID>
    </reference>
    <reference>
      <citation>Smith MR, Fogg LF, Eastman CI. A compromise circadian phase position for permanent night work improves mood, fatigue, and performance. Sleep. 2009 Nov;32(11):1481-9. doi: 10.1093/sleep/32.11.1481.</citation>
      <PMID>19928387</PMID>
    </reference>
    <reference>
      <citation>Minors DS, Waterhouse JM. Does 'anchor sleep' entrain circadian rhythms? Evidence from constant routine studies. J Physiol. 1983 Dec;345:451-67. doi: 10.1113/jphysiol.1983.sp014988.</citation>
      <PMID>6663508</PMID>
    </reference>
    <reference>
      <citation>Jackson ML, Banks S, Belenky G. Investigation of the effectiveness of a split sleep schedule in sustaining sleep and maintaining performance. Chronobiol Int. 2014 Dec;31(10):1218-30. doi: 10.3109/07420528.2014.957305. Epub 2014 Sep 15.</citation>
      <PMID>25222346</PMID>
    </reference>
    <reference>
      <citation>Vallières A, Bastille-Denis E, Morin C, Espie C. Circadian rhythm disorders II-shift work. The Oxford Handbook of Sleep and Sleep Disorders. 2012;1:626-643.</citation>
    </reference>
    <reference>
      <citation>Zee PC, Goldstein CA. Treatment of shift work disorder and jet lag. Curr Treat Options Neurol. 2010 Sep;12(5):396-411. doi: 10.1007/s11940-010-0090-9.</citation>
      <PMID>20842597</PMID>
    </reference>
    <reference>
      <citation>Huang LB, Tsai MC, Chen CY, Hsu SC. The effectiveness of light/dark exposure to treat insomnia in female nurses undertaking shift work during the evening/night shift. J Clin Sleep Med. 2013 Jul 15;9(7):641-6. doi: 10.5664/jcsm.2824.</citation>
      <PMID>23853555</PMID>
    </reference>
    <reference>
      <citation>Crowley SJ, Lee C, Tseng CY, Fogg LF, Eastman CI. Combinations of bright light, scheduled dark, sunglasses, and melatonin to facilitate circadian entrainment to night shift work. J Biol Rhythms. 2003 Dec;18(6):513-23. doi: 10.1177/0748730403258422.</citation>
      <PMID>14667152</PMID>
    </reference>
    <reference>
      <citation>Crowley SJ, Lee C, Tseng CY, Fogg LF, Eastman CI. Complete or partial circadian re-entrainment improves performance, alertness, and mood during night-shift work. Sleep. 2004 Sep 15;27(6):1077-87. doi: 10.1093/sleep/27.6.1077.</citation>
      <PMID>15532201</PMID>
    </reference>
    <reference>
      <citation>Hallbeck MS, Lowndes BR, Bingener J, Abdelrahman AM, Yu D, Bartley A, Park AE. The impact of intraoperative microbreaks with exercises on surgeons: A multi-center cohort study. Appl Ergon. 2017 Apr;60:334-341. doi: 10.1016/j.apergo.2016.12.006. Epub 2016 Dec 29.</citation>
      <PMID>28166893</PMID>
    </reference>
    <reference>
      <citation>Ker K, Edwards PJ, Felix LM, Blackhall K, Roberts I. Caffeine for the prevention of injuries and errors in shift workers. Cochrane Database Syst Rev. 2010 May 12;2010(5):CD008508. doi: 10.1002/14651858.CD008508.</citation>
      <PMID>20464765</PMID>
    </reference>
    <reference>
      <citation>Schweitzer PK, Randazzo AC, Stone K, Erman M, Walsh JK. Laboratory and field studies of naps and caffeine as practical countermeasures for sleep-wake problems associated with night work. Sleep. 2006 Jan;29(1):39-50. doi: 10.1093/sleep/29.1.39.</citation>
      <PMID>16453980</PMID>
    </reference>
    <reference>
      <citation>Van Dongen HP, Price NJ, Mullington JM, Szuba MP, Kapoor SC, Dinges DF. Caffeine eliminates psychomotor vigilance deficits from sleep inertia. Sleep. 2001 Nov 1;24(7):813-9. doi: 10.1093/sleep/24.7.813.</citation>
      <PMID>11683484</PMID>
    </reference>
    <reference>
      <citation>Garbarino S, Mascialino B, Penco MA, Squarcia S, De Carli F, Nobili L, Beelke M, Cuomo G, Ferrillo F. Professional shift-work drivers who adopt prophylactic naps can reduce the risk of car accidents during night work. Sleep. 2004 Nov 1;27(7):1295-302. doi: 10.1093/sleep/27.7.1295.</citation>
      <PMID>15586782</PMID>
    </reference>
    <reference>
      <citation>Tremaine R, Dorrian J, Lack L, Lovato N, Ferguson S, Zhou X, Roach G. The relationship between subjective and objective sleepiness and performance during a simulated night-shift with a nap countermeasure. Appl Ergon. 2010 Dec;42(1):52-61. doi: 10.1016/j.apergo.2010.04.005. Epub 2010 May 14.</citation>
      <PMID>20471003</PMID>
    </reference>
    <reference>
      <citation>Bonnefond A, Muzet A, Winter-Dill AS, Bailloeuil C, Bitouze F, Bonneau A. Innovative working schedule: introducing one short nap during the night shift. Ergonomics. 2001 Aug 15;44(10):937-45. doi: 10.1080/00140130110061138.</citation>
      <PMID>11681794</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Oregon State University</investigator_affiliation>
      <investigator_full_name>Jessee Dietch</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>insomnia</keyword>
    <keyword>shift work</keyword>
    <keyword>circadian rhythm</keyword>
    <keyword>sleep psychology</keyword>
    <keyword>behavioral sleep medicine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
      <mesh_term>Sleep Wake Disorders</mesh_term>
      <mesh_term>Sleep Disorders, Circadian Rhythm</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified data may be uploaded to a data repository to make it accessible for publication.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Data will become available within 2 years after the publication of the results pertaining to the primary aims and will be available for at least 2 years.</ipd_time_frame>
      <ipd_access_criteria>Data will be shared only with investigators who have a clear and rigorous analytic plan and who sign a data use agreement with the principal investigator.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05965609
  org study id: IRB-2021-1200
  nct id: NCT05965609
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the proposed study is to pilot test two behavioral sleep intervention strategies
        for improving insomnia among night shift working nurses.
  Night shift nurses with insomnia who meet all study criteria will receive one of two insomnia
        therapies. The specific therapy for insomnia will be determine by chance (like a flip of a
        coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or
        multicomponent relaxation therapy for insomnia, both modified for shift workers. Both
        therapies will be conducted over telehealth by interventionists trained in behavioral sleep
        medicine.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors. Participants are asked not to share details of their treatment with other individuals at their workplace.
  measure: Change in Insomnia Severity Index
  time frame: At baseline and at the post-treatment assessment (occurring at approximately 21 weeks)
  description: Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity
  measure: Retention Rate
  time frame: At the post-treatment assessment (occurring at approximately 21 weeks)
  description: Defined as [number of participants who complete minimal therapeutic dose (at least 4 sessions)] / [number of randomized participants in treatment arm]
  measure: Session Attendance
  time frame: At the post-treatment assessment (occurring at approximately 21 weeks)
  description: For enrolled participants, attendance rates will be calculated as [number of visits attended] / [number of total visits]
  measure: Implementation Assessment Measure
  time frame: At the post-treatment assessment (occurring at approximately 21 weeks)
  description: Validated questionnaire; total score range between 12 and 60, with higher numbers representing greater feasibility, acceptability, and appropriateness.
  measure: Change in Fatigue Severity Scale
  time frame: At baseline and at the post-treatment assessment (occurring at approximately 21 weeks)
  description: Validated questionnaire; total score range between 9 and 63, with higher numbers representing greater fatigue.
  measure: Change in Epworth Sleepiness Scale
  time frame: At baseline and at the post-treatment assessment (occurring at approximately 21 weeks)
  description: Validated questionnaire; total score range between 0 and 24, with higher numbers representing greater sleepiness propensity
  arm group label: CBTI
  arm group type: Other
  description: Cognitive Behavioral Therapy for Insomnia
  arm group label: MRTI
  arm group type: Other
  description: Multicomponent Relaxation Therapy for Insomnia
  intervention type: Behavioral
  intervention name: CBTI
  description: Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep
  arm group label: CBTI
  other name: Cognitive Behavioral Therapy for Insomnia
  intervention type: Behavioral
  intervention name: MRTI
  description: Intervention includes education about sleep and behavioral and relaxation strategies to improve sleep
  arm group label: MRTI
  other name: Multicomponent Relaxation Therapy for Insomnia
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jessica Dietch, PhD
  role: Principal Investigator
  affiliation: Oregon State University
  last name: Jessica R Dietch, PhD
  phone: 541-737-1358
  email: jessee.dietch@oregonstate.edu
  last name: Lucy Kozii, MD, MPH
  email: koziil@oregonstate.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  citation: McMenamin TM. A time to work: recent trends in shift work and flexible schedules. Monthly Lab Rev. 2007;130:3.
  citation: Torquati L, Mielke GI, Brown WJ, Kolbe-Alexander T. Shift work and the risk of cardiovascular disease. A systematic review and meta-analysis including dose-response relationship. Scand J Work Environ Health. 2018 May 1;44(3):229-238. doi: 10.5271/sjweh.3700. Epub 2017 Dec 16.
  PMID: 29247501
  citation: Frost P, Kolstad HA, Bonde JP. Shift work and the risk of ischemic heart disease - a systematic review of the epidemiologic evidence. Scand J Work Environ Health. 2009 May;35(3):163-79. doi: 10.5271/sjweh.1319. Epub 2009 Apr 22.
  PMID: 19387517
  citation: Brown DL, Feskanich D, Sanchez BN, Rexrode KM, Schernhammer ES, Lisabeth LD. Rotating night shift work and the risk of ischemic stroke. Am J Epidemiol. 2009 Jun 1;169(11):1370-7. doi: 10.1093/aje/kwp056. Epub 2009 Apr 8.
  PMID: 19357324
  citation: Hansen J, Lassen CF. Nested case-control study of night shift work and breast cancer risk among women in the Danish military. Occup Environ Med. 2012 Aug;69(8):551-6. doi: 10.1136/oemed-2011-100240. Epub 2012 May 29.
  PMID: 22645325
  citation: Jia Y, Lu Y, Wu K, Lin Q, Shen W, Zhu M, Huang S, Chen J. Does night work increase the risk of breast cancer? A systematic review and meta-analysis of epidemiological studies. Cancer Epidemiol. 2013 Jun;37(3):197-206. doi: 10.1016/j.canep.2013.01.005. Epub 2013 Feb 9.
  PMID: 23403128
  citation: Rao D, Yu H, Bai Y, Zheng X, Xie L. Does night-shift work increase the risk of prostate cancer? a systematic review and meta-analysis. Onco Targets Ther. 2015 Oct 5;8:2817-26. doi: 10.2147/OTT.S89769. eCollection 2015.
  PMID: 26491356
  citation: Lin X, Chen W, Wei F, Ying M, Wei W, Xie X. Night-shift work increases morbidity of breast cancer and all-cause mortality: a meta-analysis of 16 prospective cohort studies. Sleep Med. 2015 Nov;16(11):1381-1387. doi: 10.1016/j.sleep.2015.02.543. Epub 2015 May 11.
  PMID: 26498240
  citation: Karlsson B, Knutsson A, Lindahl B. Is there an association between shift work and having a metabolic syndrome? Results from a population based study of 27,485 people. Occup Environ Med. 2001 Nov;58(11):747-52. doi: 10.1136/oem.58.11.747.
  PMID: 11600731
  citation: Gan Y, Yang C, Tong X, Sun H, Cong Y, Yin X, Li L, Cao S, Dong X, Gong Y, Shi O, Deng J, Bi H, Lu Z. Shift work and diabetes mellitus: a meta-analysis of observational studies. Occup Environ Med. 2015 Jan;72(1):72-8. doi: 10.1136/oemed-2014-102150. Epub 2014 Jul 16.
  PMID: 25030030
  citation: Barger LK, Lockley SW, Rajaratnam SM, Landrigan CP. Neurobehavioral, health, and safety consequences associated with shift work in safety-sensitive professions. Curr Neurol Neurosci Rep. 2009 Mar;9(2):155-64. doi: 10.1007/s11910-009-0024-7.
  PMID: 19268039
  citation: Johnson AL, Jung L, Song Y, Brown KC, Weaver MT, Richards KC. Sleep deprivation and error in nurses who work the night shift. J Nurs Adm. 2014 Jan;44(1):17-22. doi: 10.1097/NNA.0000000000000016. Erratum In: J Nurs Adm. 2014 Mar;44(3):186. Song, Yeonsu [added].
  PMID: 24316614
  citation: Lee A, Myung SK, Cho JJ, Jung YJ, Yoon JL, Kim MY. Night Shift Work and Risk of Depression: Meta-analysis of Observational Studies. J Korean Med Sci. 2017 Jul;32(7):1091-1096. doi: 10.3346/jkms.2017.32.7.1091.
  PMID: 28581264
  citation: Angerer P, Schmook R, Elfantel I, Li J. Night Work and the Risk of Depression. Dtsch Arztebl Int. 2017 Jul 16;114(24):404-411. doi: 10.3238/arztebl.2017.0404.
  PMID: 28669378
  citation: Gu F, Han J, Laden F, Pan A, Caporaso NE, Stampfer MJ, Kawachi I, Rexrode KM, Willett WC, Hankinson SE, Speizer FE, Schernhammer ES. Total and cause-specific mortality of U.S. nurses working rotating night shifts. Am J Prev Med. 2015 Mar;48(3):241-52. doi: 10.1016/j.amepre.2014.10.018. Epub 2015 Jan 6.
  PMID: 25576495
  citation: Bureau of Labor Statistics. Standard occupational classification groups. 2018. Retrieved from bls.gov/soc/
  citation: Lee KA. Self-reported sleep disturbances in employed women. Sleep. 1992 Dec;15(6):493-8. doi: 10.1093/sleep/15.6.493.
  PMID: 1475563
  citation: Oyane NM, Pallesen S, Moen BE, Akerstedt T, Bjorvatn B. Associations between night work and anxiety, depression, insomnia, sleepiness and fatigue in a sample of Norwegian nurses. PLoS One. 2013 Aug 7;8(8):e70228. doi: 10.1371/journal.pone.0070228. eCollection 2013.
  PMID: 23950914
  citation: Lajoie P, Aronson KJ, Day A, Tranmer J. A cross-sectional study of shift work, sleep quality and cardiometabolic risk in female hospital employees. BMJ Open. 2015 Mar 10;5(3):e007327. doi: 10.1136/bmjopen-2014-007327.
  PMID: 25757950
  citation: Karhula K, Hakola T, Koskinen A, Ojajarvi A, Kivimaki M, Harma M. Permanent night workers sleep and psychosocial factors in hospital work. A comparison to day and shift work. Chronobiol Int. 2018 Jun;35(6):785-794. doi: 10.1080/07420528.2018.1466792. Epub 2018 May 15.
  PMID: 29764221
  citation: Givens ML, Malecki KC, Peppard PE, Palta M, Said A, Engelman CD, Walsh MC, Nieto FJ. Shiftwork, Sleep Habits, and Metabolic Disparities: Results from the Survey of the Health of Wisconsin. Sleep Health. 2015 Jun;1(2):115-120. doi: 10.1016/j.sleh.2015.04.014.
  PMID: 26894229
  citation: Harma M, Tenkanen L, Sjoblom T, Alikoski T, Heinsalmi P. Combined effects of shift work and life-style on the prevalence of insomnia, sleep deprivation and daytime sleepiness. Scand J Work Environ Health. 1998 Aug;24(4):300-7. doi: 10.5271/sjweh.324.
  PMID: 9754862
  citation: Drake CL, Roehrs T, Richardson G, Walsh JK, Roth T. Shift work sleep disorder: prevalence and consequences beyond that of symptomatic day workers. Sleep. 2004 Dec 15;27(8):1453-62. doi: 10.1093/sleep/27.8.1453.
  PMID: 15683134
  citation: Stepanski EJ, Perlis ML. Behavioral sleep medicine. An emerging subspecialty in health psychology and sleep medicine. J Psychosom Res. 2000 Nov;49(5):343-7. doi: 10.1016/s0022-3999(00)00171-9.
  PMID: 11164058
  citation: Okajima I, Komada Y, Inoue Y. A meta-analysis on the treatment effectiveness of cognitive behavioral therapy for primary insomnia. Sleep Biol Rhythms. 2011;9(1):24-34.
  citation: Murtagh DR, Greenwood KM. Identifying effective psychological treatments for insomnia: a meta-analysis. J Consult Clin Psychol. 1995 Feb;63(1):79-89. doi: 10.1037//0022-006x.63.1.79.
  PMID: 7896994
  citation: Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80. doi: 10.1176/ajp.151.8.1172.
  PMID: 8037252
  citation: Geiger-Brown JM, Rogers VE, Liu W, Ludeman EM, Downton KD, Diaz-Abad M. Cognitive behavioral therapy in persons with comorbid insomnia: A meta-analysis. Sleep Med Rev. 2015 Oct;23:54-67. doi: 10.1016/j.smrv.2014.11.007. Epub 2014 Nov 29.
  PMID: 25645130
  citation: Taylor DJ, Pruiksma KE. Cognitive and behavioural therapy for insomnia (CBT-I) in psychiatric populations: a systematic review. Int Rev Psychiatry. 2014 Apr;26(2):205-13. doi: 10.3109/09540261.2014.902808.
  PMID: 24892895
  citation: Smith MT, Huang MI, Manber R. Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. Clin Psychol Rev. 2005 Jul;25(5):559-92. doi: 10.1016/j.cpr.2005.04.004.
  PMID: 15970367
  citation: Dietch J, Wu J, Slavish D, et al. Characteristics of participants in trials of cognitive-behavioral therapy for insomnia: a systematic review and data synthesis. Pre-registered at PROSPERO (ID: CRD42020159476). In preparation.
  citation: Jarnefelt H, Lagerstedt R, Kajaste S, Sallinen M, Savolainen A, Hublin C. Cognitive behavioral therapy for shift workers with chronic insomnia. Sleep Med. 2012 Dec;13(10):1238-46. doi: 10.1016/j.sleep.2012.10.003. Epub 2012 Nov 16.
  PMID: 23168269
  citation: Jarnefelt H, Harma M, Sallinen M, Virkkala J, Paajanen T, Martimo KP, Hublin C. Cognitive behavioural therapy interventions for insomnia among shift workers: RCT in an occupational health setting. Int Arch Occup Environ Health. 2020 Jul;93(5):535-550. doi: 10.1007/s00420-019-01504-6. Epub 2019 Dec 18. Erratum In: Int Arch Occup Environ Health. 2020 Mar 3;:
  PMID: 31853633
  citation: Peter L, Reindl R, Zauter S, Hillemacher T, Richter K. Effectiveness of an Online CBT-I Intervention and a Face-to-Face Treatment for Shift Work Sleep Disorder: A Comparison of Sleep Diary Data. Int J Environ Res Public Health. 2019 Aug 24;16(17):3081. doi: 10.3390/ijerph16173081.
  PMID: 31450619
  citation: Vallières A, Roy M, Bastille-Denis E, Claveau S, Simon T. Exploring a behavioural therapy for insomnia in shift workers. J Sleep Disord Ther. 2015;4(202);2167-0277.
  citation: Koffel EA, Koffel JB, Gehrman PR. A meta-analysis of group cognitive behavioral therapy for insomnia. Sleep Med Rev. 2015 Feb;19:6-16. doi: 10.1016/j.smrv.2014.05.001. Epub 2014 May 14.
  PMID: 24931811
  citation: American Psychiatric Association. Diagnostic and Statistical Manual Of Mental Disorders (DSM-5®). American Psychiatric Pub; 2013.
  citation: Morgenthaler TI, Lee-Chiong T, Alessi C, Friedman L, Aurora RN, Boehlecke B, Brown T, Chesson AL Jr, Kapur V, Maganti R, Owens J, Pancer J, Swick TJ, Zak R; Standards of Practice Committee of the American Academy of Sleep Medicine. Practice parameters for the clinical evaluation and treatment of circadian rhythm sleep disorders. An American Academy of Sleep Medicine report. Sleep. 2007 Nov;30(11):1445-59. doi: 10.1093/sleep/30.11.1445. Erratum In: Sleep. 2008 Jul 1;31(7):table of contents.
  PMID: 18041479
  citation: Arendt J. Shift work: coping with the biological clock. Occup Med (Lond). 2010 Jan;60(1):10-20. doi: 10.1093/occmed/kqp162.
  PMID: 20051441
  citation: Spielman AJ, Saskin P, Thorpy MJ. Treatment of chronic insomnia by restriction of time in bed. Sleep. 1987 Feb;10(1):45-56.
  PMID: 3563247
  citation: Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
  PMID: 28851459
  citation: Bei B, Wiley JF, Trinder J, Manber R. Beyond the mean: A systematic review on the correlates of daily intraindividual variability of sleep/wake patterns. Sleep Med Rev. 2016 Aug;28:108-24. doi: 10.1016/j.smrv.2015.06.003. Epub 2015 Jul 2.
  PMID: 26588182
  citation: Ganesan S, Magee M, Stone JE, Mulhall MD, Collins A, Howard ME, Lockley SW, Rajaratnam SMW, Sletten TL. The Impact of Shift Work on Sleep, Alertness and Performance in Healthcare Workers. Sci Rep. 2019 Mar 15;9(1):4635. doi: 10.1038/s41598-019-40914-x.
  PMID: 30874565
  citation: Taylor DJ, Wilkerson AK, Pruiksma KE, Dietch JR, Wardle-Pinkston S. Structured Clinical interview for Sleep Disorders-Revised (SCISD-R). 2019. Retrieved from insomnia.arizona.edu/scisd
  citation: Taylor DJ, Wilkerson AK, Pruiksma KE, Williams JM, Ruggero CJ, Hale W, Mintz J, Organek KM, Nicholson KL, Litz BT, Young-McCaughan S, Dondanville KA, Borah EV, Brundige A, Peterson AL; STRONG STAR Consortium. Reliability of the Structured Clinical Interview for DSM-5 Sleep Disorders Module. J Clin Sleep Med. 2018 Mar 15;14(3):459-464. doi: 10.5664/jcsm.7000.
  PMID: 29458705
  citation: Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
  PMID: 11438246
  citation: Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.
  PMID: 18431116
  citation: Manber R, Carney CE. Treatment plans and interventions for insomnia: a case formulation approach. Guilford Publications; 2015.
  citation: Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.
  PMID: 15367063
  citation: Carney CE, Edinger JD, Kuchibhatla M, Lachowski AM, Bogouslavsky O, Krystal AD, Shapiro CM. Cognitive Behavioral Insomnia Therapy for Those With Insomnia and Depression: A Randomized Controlled Clinical Trial. Sleep. 2017 Apr 1;40(4):zsx019. doi: 10.1093/sleep/zsx019.
  PMID: 28199710
  citation: Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
  PMID: 21532953
  citation: Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
  PMID: 9881538
  citation: Chung F, Abdullah HR, Liao P. STOP-Bang Questionnaire: A Practical Approach to Screen for Obstructive Sleep Apnea. Chest. 2016 Mar;149(3):631-8. doi: 10.1378/chest.15-0903. Epub 2016 Jan 12.
  PMID: 26378880
  citation: Manber R, Bernert RA, Suh S, Nowakowski S, Siebern AT, Ong JC. CBT for insomnia in patients with high and low depressive symptom severity: adherence and clinical outcomes. J Clin Sleep Med. 2011 Dec 15;7(6):645-52. doi: 10.5664/jcsm.1472.
  PMID: 22171204
  citation: Seligman ME. The effectiveness of psychotherapy. The Consumer Reports study. Am Psychol. 1995 Dec;50(12):965-74. doi: 10.1037//0003-066x.50.12.965.
  PMID: 8561380
  citation: Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
  PMID: 2803071
  citation: Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
  PMID: 1798888
  citation: Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
  PMID: 22294820
  citation: Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011 Oct;4(5):332-7. doi: 10.1111/j.1752-8062.2011.00347.x.
  PMID: 22029804
  citation: Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.
  PMID: 21035130
  citation: Carter PA, Dyer KA, Mikan SQ. Sleep disturbance, chronic stress, and depression in hospice nurses: testing the feasibility of an intervention. Oncol Nurs Forum. 2013 Sep;40(5):E368-73. doi: 10.1188/13.ONF.E368-E373.
  PMID: 23989029
  citation: Fiorentino L, McQuaid JR, Liu L, Natarajan L, He F, Cornejo M, Lawton S, Parker BA, Sadler GR, Ancoli-Israel S. Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study. Nat Sci Sleep. 2010 Dec 16;2:1-8. doi: 10.2147/nss.s8004. Print 2010.
  PMID: 23616695
  citation: Pruiksma KE, Taylor DJ, Mintz J, Nicholson KL, Rodgers M, Young-McCaughan S, Hall-Clark BN, Fina BA, Dondanville KA, Cobos B, Wardle-Pinkston S, Litz BT, Roache JD, Peterson AL; STRONG STAR Consortium. A pilot randomized controlled trial of cognitive behavioral treatment for trauma-related nightmares in active duty military personnel. J Clin Sleep Med. 2020 Jan 15;16(1):29-40. doi: 10.5664/jcsm.8116. Epub 2019 Nov 26.
  PMID: 31957648
  citation: Taylor DJ, Zimmerman MR, Gardner CE, Williams JM, Grieser EA, Tatum JI, Bramoweth AD, Francetich JM, Ruggero C. A pilot randomized controlled trial of the effects of cognitive-behavioral therapy for insomnia on sleep and daytime functioning in college students. Behav Ther. 2014 May;45(3):376-89. doi: 10.1016/j.beth.2013.12.010. Epub 2014 Jan 3.
  PMID: 24680232
  citation: Harvey AG, Soehner AM, Kaplan KA, Hein K, Lee J, Kanady J, Li D, Rabe-Hesketh S, Ketter TA, Neylan TC, Buysse DJ. Treating insomnia improves mood state, sleep, and functioning in bipolar disorder: a pilot randomized controlled trial. J Consult Clin Psychol. 2015 Jun;83(3):564-77. doi: 10.1037/a0038655. Epub 2015 Jan 26.
  PMID: 25622197
  citation: Tang NK, Goodchild CE, Salkovskis PM. Hybrid cognitive-behaviour therapy for individuals with insomnia and chronic pain: a pilot randomised controlled trial. Behav Res Ther. 2012 Dec;50(12):814-21. doi: 10.1016/j.brat.2012.08.006. Epub 2012 Sep 10.
  PMID: 23123531
  citation: Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.
  PMID: 22169081
  citation: Bureau of Labor Statistics UDoL. Occupational Outlook Handbook, Registered Nurses. 2020.
  citation: Horowitz TS, Cade BE, Wolfe JM, Czeisler CA. Efficacy of bright light and sleep/darkness scheduling in alleviating circadian maladaptation to night work. Am J Physiol Endocrinol Metab. 2001 Aug;281(2):E384-91. doi: 10.1152/ajpendo.2001.281.2.E384.
  PMID: 11440916
  citation: Boivin DB, James FO. Circadian adaptation to night-shift work by judicious light and darkness exposure. J Biol Rhythms. 2002 Dec;17(6):556-67. doi: 10.1177/0748730402238238.
  PMID: 12465889
  citation: Smith MR, Fogg LF, Eastman CI. A compromise circadian phase position for permanent night work improves mood, fatigue, and performance. Sleep. 2009 Nov;32(11):1481-9. doi: 10.1093/sleep/32.11.1481.
  PMID: 19928387
  citation: Minors DS, Waterhouse JM. Does 'anchor sleep' entrain circadian rhythms? Evidence from constant routine studies. J Physiol. 1983 Dec;345:451-67. doi: 10.1113/jphysiol.1983.sp014988.
  PMID: 6663508
  citation: Jackson ML, Banks S, Belenky G. Investigation of the effectiveness of a split sleep schedule in sustaining sleep and maintaining performance. Chronobiol Int. 2014 Dec;31(10):1218-30. doi: 10.3109/07420528.2014.957305. Epub 2014 Sep 15.
  PMID: 25222346
  citation: Vallières A, Bastille-Denis E, Morin C, Espie C. Circadian rhythm disorders II-shift work. The Oxford Handbook of Sleep and Sleep Disorders. 2012;1:626-643.
  citation: Zee PC, Goldstein CA. Treatment of shift work disorder and jet lag. Curr Treat Options Neurol. 2010 Sep;12(5):396-411. doi: 10.1007/s11940-010-0090-9.
  PMID: 20842597
  citation: Huang LB, Tsai MC, Chen CY, Hsu SC. The effectiveness of light/dark exposure to treat insomnia in female nurses undertaking shift work during the evening/night shift. J Clin Sleep Med. 2013 Jul 15;9(7):641-6. doi: 10.5664/jcsm.2824.
  PMID: 23853555
  citation: Crowley SJ, Lee C, Tseng CY, Fogg LF, Eastman CI. Combinations of bright light, scheduled dark, sunglasses, and melatonin to facilitate circadian entrainment to night shift work. J Biol Rhythms. 2003 Dec;18(6):513-23. doi: 10.1177/0748730403258422.
  PMID: 14667152
  citation: Crowley SJ, Lee C, Tseng CY, Fogg LF, Eastman CI. Complete or partial circadian re-entrainment improves performance, alertness, and mood during night-shift work. Sleep. 2004 Sep 15;27(6):1077-87. doi: 10.1093/sleep/27.6.1077.
  PMID: 15532201
  citation: Hallbeck MS, Lowndes BR, Bingener J, Abdelrahman AM, Yu D, Bartley A, Park AE. The impact of intraoperative microbreaks with exercises on surgeons: A multi-center cohort study. Appl Ergon. 2017 Apr;60:334-341. doi: 10.1016/j.apergo.2016.12.006. Epub 2016 Dec 29.
  PMID: 28166893
  citation: Ker K, Edwards PJ, Felix LM, Blackhall K, Roberts I. Caffeine for the prevention of injuries and errors in shift workers. Cochrane Database Syst Rev. 2010 May 12;2010(5):CD008508. doi: 10.1002/14651858.CD008508.
  PMID: 20464765
  citation: Schweitzer PK, Randazzo AC, Stone K, Erman M, Walsh JK. Laboratory and field studies of naps and caffeine as practical countermeasures for sleep-wake problems associated with night work. Sleep. 2006 Jan;29(1):39-50. doi: 10.1093/sleep/29.1.39.
  PMID: 16453980
  citation: Van Dongen HP, Price NJ, Mullington JM, Szuba MP, Kapoor SC, Dinges DF. Caffeine eliminates psychomotor vigilance deficits from sleep inertia. Sleep. 2001 Nov 1;24(7):813-9. doi: 10.1093/sleep/24.7.813.
  PMID: 11683484
  citation: Garbarino S, Mascialino B, Penco MA, Squarcia S, De Carli F, Nobili L, Beelke M, Cuomo G, Ferrillo F. Professional shift-work drivers who adopt prophylactic naps can reduce the risk of car accidents during night work. Sleep. 2004 Nov 1;27(7):1295-302. doi: 10.1093/sleep/27.7.1295.
  PMID: 15586782
  citation: Tremaine R, Dorrian J, Lack L, Lovato N, Ferguson S, Zhou X, Roach G. The relationship between subjective and objective sleepiness and performance during a simulated night-shift with a nap countermeasure. Appl Ergon. 2010 Dec;42(1):52-61. doi: 10.1016/j.apergo.2010.04.005. Epub 2010 May 14.
  PMID: 20471003
  citation: Bonnefond A, Muzet A, Winter-Dill AS, Bailloeuil C, Bitouze F, Bonneau A. Innovative working schedule: introducing one short nap during the night shift. Ergonomics. 2001 Aug 15;44(10):937-45. doi: 10.1080/00140130110061138.
  PMID: 11681794
  responsible party type: Principal Investigator
  investigator affiliation: Oregon State University
  investigator full name: Jessee Dietch
  investigator title: Principal Investigator
  mesh term: Sleep Initiation and Maintenance Disorders
  mesh term: Sleep Wake Disorders
  mesh term: Sleep Disorders, Circadian Rhythm
  sharing ipd: Yes
  ipd description: De-identified data may be uploaded to a data repository to make it accessible for publication.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Data will become available within 2 years after the publication of the results pertaining to the primary aims and will be available for at least 2 years.
  ipd access criteria: Data will be shared only with investigators who have a clear and rigorous analytic plan and who sign a data use agreement with the principal investigator.