Efficacy study comparing a CBT-I developed for shift workers (CBT-I-S) to standard CBT-I (cognitive behavioural therapy for insomnia) on sleep onset latency, total sleep time, subjective sleep quality, and daytime sleepiness: study protocol for a parallel group randomised controlled trial with online therapy groups of seven sessions each.
Humans
Cognitive Behavioral Therapy
/ methods
Sleep Initiation and Maintenance Disorders
/ therapy
Randomized Controlled Trials as Topic
Sleep Quality
Treatment Outcome
Adult
Time Factors
Sleep Latency
Sleep
Male
Shift Work Schedule
/ adverse effects
Female
Middle Aged
Sleep Disorders, Circadian Rhythm
/ therapy
Young Adult
Sleep Duration
CBT-I vs. a newly developed manual
Efficacy study
Insomnia
Online group therapy
Shift workers
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
26 Aug 2024
26 Aug 2024
Historique:
received:
15
11
2023
accepted:
14
08
2024
medline:
27
8
2024
pubmed:
27
8
2024
entrez:
26
8
2024
Statut:
epublish
Résumé
Shift workers are at an increased risk of developing sleep disorders. The standard therapy recommended for sleep disorders is cognitive behavioural therapy for insomnia (CBT-I). Many of its interventions are based on a regular sleep and wake rhythm, which is difficult to apply for shift workers. We have therefore developed a new therapy manual specifically for shift workers (CBT-I-S), which should be more applicable to their needs. In particular, all interventions that require regularity have been removed, and instead, interventions that address factors that proved to be relevant to sleep in our preliminary study have been integrated. We now want to test this manual for its effectiveness. A randomised controlled trial with N = 142 will be conducted to compare two conditions: the newly developed therapy manual will be carried out in the experimental group, while cognitive behavioural therapy for insomnia will be employed in the standard group. Both treatments will be conducted online via MS Teams in a group setting with seven sessions each. Data will be collected at three measurement points (pre, post, 6-month follow-up) and analysed using linear mixed models. The study will investigate whether the two treatments have led to significant improvements in total sleep time, sleep onset latency, subjective sleep quality and daytime sleepiness in shift workers. It will also examine whether the new therapy manual is superior to standard therapy in shift workers and whether these effects are stable. We assume that interventions designed to address depressive mood, anxiety, worry, rumination, dysfunctional thought patterns and attitudes towards sleep will also improve sleep. If this is indeed the case, these interventions could replace previous ones that require regularity. This could significantly improve the treatment of insomnia in shift workers. German Clinical Trials Registry DRKS DRKS00032086 . Registered on August 16, 2023.
Sections du résumé
BACKGROUND
BACKGROUND
Shift workers are at an increased risk of developing sleep disorders. The standard therapy recommended for sleep disorders is cognitive behavioural therapy for insomnia (CBT-I). Many of its interventions are based on a regular sleep and wake rhythm, which is difficult to apply for shift workers. We have therefore developed a new therapy manual specifically for shift workers (CBT-I-S), which should be more applicable to their needs. In particular, all interventions that require regularity have been removed, and instead, interventions that address factors that proved to be relevant to sleep in our preliminary study have been integrated. We now want to test this manual for its effectiveness.
METHODS
METHODS
A randomised controlled trial with N = 142 will be conducted to compare two conditions: the newly developed therapy manual will be carried out in the experimental group, while cognitive behavioural therapy for insomnia will be employed in the standard group. Both treatments will be conducted online via MS Teams in a group setting with seven sessions each. Data will be collected at three measurement points (pre, post, 6-month follow-up) and analysed using linear mixed models. The study will investigate whether the two treatments have led to significant improvements in total sleep time, sleep onset latency, subjective sleep quality and daytime sleepiness in shift workers. It will also examine whether the new therapy manual is superior to standard therapy in shift workers and whether these effects are stable.
DISCUSSION
CONCLUSIONS
We assume that interventions designed to address depressive mood, anxiety, worry, rumination, dysfunctional thought patterns and attitudes towards sleep will also improve sleep. If this is indeed the case, these interventions could replace previous ones that require regularity. This could significantly improve the treatment of insomnia in shift workers.
TRIAL REGISTRATION
BACKGROUND
German Clinical Trials Registry DRKS DRKS00032086 . Registered on August 16, 2023.
Identifiants
pubmed: 39187859
doi: 10.1186/s13063-024-08403-3
pii: 10.1186/s13063-024-08403-3
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Comparative Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
562Informations de copyright
© 2024. The Author(s).
Références
Crönlein T, Galetke W, Young P. Schlafmedizin 1x1. Berlin Heidelberg: Springer; 2017.
doi: 10.1007/978-3-662-49789-0
Hermann E, Gassmann D, Munsch S. Schlafstörungen. In: Margraf J, Schneider S, editors. Lehrbuch der Verhaltenstherapie, vol. 2. Heidelberg: Springer Medizin Verlag; 2009 p. 187–224.
doi: 10.1007/978-3-540-79543-8_10
Holzinger B, Klösch G. Schlafcoaching: Wer wach sein will, muss schlafen. Wien: Goldegg Verlag; 2013.
Pollmächer T, Wetter TC, Bassetti CLA, Högl B, Randerath W, Wiater A, editors. Handbuch Schlafmedizin. München: Elsevier; 2020.
Spiegelhalder K, Backhaus J, Riemann D. Schlafstörungen. 2nd ed. Göttingen: Hogrefe; 2011.
Baglioni C, Espie CA, Riemann D, editors. Cognitive-behavioural therapy für insomnia (CBT-I) across the life span. Guidelines and clinical protocols for health professionals. Oxford: John Wiley & Sons Ltd; 2022.
Reynolds AC, Sweetman A, Crowther ME, Paterson JL, Scott H, Lechat B, Wanstall SE, Brown BWJ, Lovato N, Adams RJ, Eastwood PR. Is cognitive behavioral therapy for insomnia (CBTi) efficacious for treating insomnia symptoms in shift workers? A systematic review and meta-analysis. Sleep Med Rev. 2023. https://doi.org/10.1016/j.smrv.2022.101716 .
Nachreiner F, Arlinghaus A, Horn D. Unterschiedliche psychosoziale Effekte unterschiedlicher Schichtsysteme. Z Arb Wiss. 2019. https://doi.org/10.1007/s41449-018-00139-6 .
Costa G. Shift work and health: current problems and preventive actions. SH@W 2010; https://doi.org/10.5491/SHAW.2010.1.2.112 .
Seibt A, Knauth P, Griefahn B. Arbeitsmedizinische Leitlinie der Deutschen Gesellschaft für Arbeitsmedizin und Umweltmedizin e. V. Nacht- und Schichtarbeit. Arbeitsmedizin | Sozialmedizin | Umweltmedizin. 2006;41(8):390–7.
Falkai P, Wittchen HU, editors. American Psychiatric Association: Diagnostisches und Statistisches Manual Psychischer Störungen: DSM-5 (2., korrigierte Auflage). Göttingen: Hogrefe; 2018.
Riemann D, Morin CM, Reynolds CF. Das Kapitel Schlafstörungen im DSM-V – ein Zwischenbericht. Z Psychiatr Psychol Psychother. 2011;59(4):275–80.
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. https://doi.org/10.1093/sleep/27.8.1453 .
Espie CA. Standard CBT-I protocol for the treatment of insomnia disorder. In: Baglioni C, Espie CA, Riemann D, editors. Cognitive-behavioural therapy für insomnia (CBT-I) across the life span. Guidelines and clinical protocols for health professionals. Oxford: John Wiley & Sons Ltd; 2022. p. 19–41.
Jang EH, Hong Y, Kim Y, Lee S, Ahn Y, Jeong KS, Jang T-W, Lim H, Jung E, Shift Work Disorder Study Group, Chung S, Suh S. The development of a sleep intervention for firefighters: the FIT-IN (Firefighter’s Therapy for Insomnia and Nightmares) Study. Int J Environ Res Public Health. 2020; https://doi.org/10.3390/ijerph17238738 .
Järnefelt H, Lagerstedt R, Kajaste S, Sallinen M, Savolainen A, Hublin C. Cognitive behavioral therapy for shift workers with chronic insomnia. Sleep Med. 2012(13); https://doi.org/10.1016/j.sleep.2012.10.003 .
Booker LA, Sletten TL, Barnes M, Alvaro P, Collins A, Chai-Coetzer CL, et al. The effectiveness of an individualized sleep and shift work education and coaching program to manage shift work disorder in nurses: a randomized controlled trial. J Clin Sleep Med. 2022. https://doi.org/10.5664/jcsm.9782 .
Atlantis E, Chow C-M, Kirby A, Singh MF. An effective exercise-based intervention for improving mental health and quality of life measures: a randomized controlled trial. Prev Med. 2004. https://doi.org/10.1016/j.ypmed.2004.02.007 .
Lee KA, Gay CL, Alsten CR. Home-based behavioral sleep training for shift workers: a pilot study. Behav Sleep Med. 2014;12(6):455–68.
doi: 10.1080/15402002.2013.825840
pubmed: 24229383
Ito-Masui A, Sakamoto R, Matsuo E, Kawamoto E, Motomura E, Tanii H, Yu H, Sano A, Imai H, Shimaoka M. Effect of an internet-delivered cognitive behavioral therapy-based sleep improvement app for shift workers at high risk of sleep disorder: single-arm, nonrandomized trial. JMIR. 2023. https://doi.org/10.2196/45834 .
Ell J, Brückner HA, Johann AF, Steinmetz L, Güth LJ, Feige B, Järnefelt H, Vallières A, Frase L, Domschke K, Riemann D, Lehr D, Spiegelhalder K. Digital cognitive behavioural therapy for insomnia reduces insomnia in nurses suffering from shift work disorder: a randomized-controlled pilot trial. J Sleep Res. 2024. https://doi.org/10.1111/jsr.14193 .
Vallières A, Pappathomas A, de Billy GS, Mérette C, Carrier J, Paquette T, Bastien CH. Behavioural therapy for shift work disorder improves shift workers’ sleep, sleepiness and mental health: a pilot randomized control trial. J Sleep Res. 2024. https://doi.org/10.1111/jsr.14162 .
Espie CA, Broomfield NM, MacMahon KMA, Macphee LM, Taylor LM (2006). The attention-intention-effort pathway in the development of psychophysiologic insomnia: a theoretical review. Sleep Med Rev. 2006; https://doi.org/10.1016/j.smrv.2006.03.002 .
Becker E, Margraf J. Generalisierte Angststörung. Ein Therapieprogramm. Weinheim: Beltz-Verlag; 2002.
Schaub A, Roth E, Goldmann U. Kognitiv-psychoedukative Therapie zur Bewältigung von Depression. Ein Therapiemanual (2. Aufl.). Göttingen: Hogrefe; 2013.
Pitschel-Walz G, Bäuml J, Kissling W. Psychoedukation bei Depressionen. Manual zur Leitung von Patienten- und Angehörigengruppen. München: Urban & Fischer Verlag; 2003.
Teismann T, Hanning S, Brachel R, Willutzki U. Kognitive Verhaltenstherapie depressiven Grübelns. Berlin: Springer; 2012.
doi: 10.1007/978-3-642-25229-7
Feld A, Rudy JM. Coaching der Positiven Psychologie. Manual für Coaches. Salzburg: Paris-Lodron-Universität; 2017.
Scharfenstein A, Basler H-D. Schlafstörungen. Auf dem Weg zu einem besseren Schlaf. Trainerhandbuch. Göttingen: Vandenhoeck & Ruprecht; 2004.
Müller T, Paterok B. Schlaftraining. Ein Therapiemanual zur Behandlung von Schlafstörungen (2., überarbeitete Auflage). Göttingen: Hogrefe; 2010.
Crönlein T. Primäre Insomnie. Ein Gruppentherapieprogramm für den stationären Bereich. Göttingen: Hogrefe; 2013.
Reinberg A, Ashkenazi. Internal desynchronization of circadian rhythms and tolerance to shift work. Chronobiol Int. 2008; https://doi.org/10.1080/07420520802256101 .
Saksvik IB, Bjorvatn B, Hetland H, Sandal GM, Pallesen S. Individual differences in tolerance to shift work – a systematic review. Sleep Med Rev. 2011;15:221–35.
doi: 10.1016/j.smrv.2010.07.002
pubmed: 20851006
Kerkhof GA. Shift work and sleep disorder comorbidity tend to go hand in hand. Chronobiol Int. 2018. https://doi.org/10.1080/07420528.2017.1392552 .
Järnefelt H, Spiegelhalder K. CBT-I Protocols for Shift Workers and Health Operators. In: Baglioni C, Espie C, Riemann D, editors. Cognitive-behavioural therapy for insomnia (CBT-I) across the life span. Guidelines and clinical protocols for health professionals. Chichester: John Wiley & Sons Ltd; 2022.
Binder R, Schöller F, Weeß H-G. Therapie-Tools Schlafstörungen. Weinheim: Beltz; 2020.
Scharfenstein A, Basler H-D. Schlafstörungen. Auf dem Weg zu einem besseren Schlaf. Schlaftagebuch. Göttingen: Vandenhoeck & Ruprecht; 2004.
Faul F, Buchner A, Erdfelder E, Lang A-G, Buchner A. G*Power3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39(2):175–91.
doi: 10.3758/BF03193146
pubmed: 17695343
George D, Mallery P. SPSS for Windows step by step: a simple guide and reference (11.0 update, 4th ed.). Boston: Allyn & Baco; 2003.
Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989. https://doi.org/10.1016/0165-1781(89)90047-4 .
Carpenter JS, Andrykowski MA. Psychometric evaluation of the Pittsburgh Sleep Quality Index. J Psychosom Res. 1998;45(1):5–13.
doi: 10.1016/S0022-3999(97)00298-5
pubmed: 9720850
Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991. https://doi.org/10.1093/sleep/14.6.540 .
Kendzerska TB, Smith PM, Brignardell-Petersen R, Leung RS, Tomlinson GA. Evaluation of the measurement properties of the Epworth sleepiness scale: a systematic review. Sleep Med Rev. 2014. https://doi.org/10.1016/j.smrv.2013.08.002 .
doi: 10.1016/j.smrv.2013.08.002
pubmed: 24135493
Morin CM. Insomnia: Psychological assessment and management. New York: Guilford Press; 1993.
Bastien CH, Vallières A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001. https://doi.org/10.1016/s1389-9457(00)00065-4 .
Herrmann-Lingen C, Buss U, Snaith RP. Hospital Anxiety and Depression Scale, Deutsche Version (HADS-D) (Vol. 3). Huber: Bern; 2011.
Geue K, Strauß B, Brähler E, editors. Diagnostische Verfahren in der Psychotherapie. Göttingen: Hogrefe; 2016.
Weingartz S, Pillmann F. Meinungen-zum-Schlaf-Fragebogen. Deutsche Version der DBAS-16 zur Erfassung dysfunktionaler Überzeugungen und Einstellungen zum Schlaf. Somnologie. 2009; https://doi.org/10.1007/s11818-008-0356-6 .
Gieselmann A, de Jong-Mayer R, Pietrowsky R. Kognitive und körperliche Erregung in der Phase vor dem Einschlafen. Die deutsche Version der Pre-Sleep Arousal Scale (PSAS). Z Klin Psychol Psychother. 2012;41(2):73–80.
doi: 10.1026/1616-3443/a000134
Vochem JK. Wie beeinflussen körperliche und kognitive Erregung sowie nächtliches Auf-die-Uhr-Schauen den Schlaf? Normierung der Fragebögen Pre Sleep Arousal Scale (PSAS) und Time Monitoring Behaviour-10 (TMB-10) anhand von gesunden Schläfern und Anwendung bei Patienten mit primärer Insomnie. Inaugural-Dissertation zur Erlangung des Medizinischen Doktorgrades der Medizinischen Fakultät der Albert- Ludwigs- Universität Freiburg i.Br.; 2017.
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; https://doi.org/10.1016/0005-7967(85)90004-X .
Grünberger T. Study website. http://www.schlaf-und-schicht.com . Accessed 15 Nov 2023.