Determination of Optimal Sleep Treatment Elements - MOST
NCT ID: NCT05561829
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
489 participants
INTERVENTIONAL
2022-09-08
2024-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The main objectives of the DOSE Project are
1. To conduct MOST on a multi-component smartphone or web application targeting insomnia
2. To identify the components and combination of components that demonstrate the best expected obtainable outcome
3. To examine potential moderators of the effect of the individual treatment components on insomnia severity,
4. To determine which application build (i.e., combination of components) is optimal to test in a subsequent RCT.
This study employs a fractional factorial experimental design conducted with individuals experiencing moderate-to-severe insomnia. With random allocation, participants will receive a version of the application in which one or more of the five core CBT-I components (i.e., sleep hygiene education, sleep restriction, stimulus control therapy, deactivation/relaxation training, cognitive therapy) are presented in various combinations. The intervention lasts 10 weeks, including an initial one-week assessment period.
Baseline group differences (concerning socio-demographic, disease-related, and psychosocial data) will be explored to test the success of the randomization. If differences are found, sensitivity analyses will be made to evaluate their possible influence on the results. Main effects will be analysed using Mixed Linear Models (MLMs) based on the intent-to-treat sample, comparing aggregated groups of N = 2 x 320 (e.g., plus/minus sleep restriction or plus/minus sleep hygiene etc.) on all outcome variables. MLMs account for the hierarchical, non-independent nature of the data (i.e., repeated measures nested within patients and treatment conditions), testing the time\*group interaction effect, reflecting the effect of treatment. Moderation analyses will evaluate whether individual differences in various baseline variables (e.g., physical function, expectations, computer proficiency, chronotype, etc.) influence intervention effects.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sleep Hygiene
Administration of sleep hygiene education (single intervention)
Sleep Hygiene Education
Automated digital administration of a sleep hygiene education module via mobile or web application, lasting approximately six weeks. The aim is to identify and modify environmental and lifestyle factors that may interfere with sleep.
Cognitive Therapy
Administration of cognitive therapy only (single intervention)
Cognitive Therapy
Automated digital administration of a cognitive therapy module via mobile or web application, lasting approximately six weeks. The aim is to identify, challenge, and modify dysfunctional beliefs about sleep.
Relaxation Training
Administration of relaxation training only (single intervention)
Relaxation Training
Automated digital administration of a relaxation training module via mobile or web application, lasting approximately six weeks. The aim is to reduce somatic tension and limit intrusive thought processes that interfere with sleep.
Relaxation Training, Cognitive Therapy, Sleep Hygiene
Administration of relaxation training, cognitive therapy, and sleep hygiene education (3 interventions)
Relaxation Training
Automated digital administration of a relaxation training module via mobile or web application, lasting approximately six weeks. The aim is to reduce somatic tension and limit intrusive thought processes that interfere with sleep.
Cognitive Therapy
Automated digital administration of a cognitive therapy module via mobile or web application, lasting approximately six weeks. The aim is to identify, challenge, and modify dysfunctional beliefs about sleep.
Sleep Hygiene Education
Automated digital administration of a sleep hygiene education module via mobile or web application, lasting approximately six weeks. The aim is to identify and modify environmental and lifestyle factors that may interfere with sleep.
Stimulus Control
Administration of stimulus control therapy only (single intervention)
Stimulus Control Therapy
Automated digital administration of a stimulus control therapy module via mobile or web application, lasting approximately six weeks. The aim is to strengthen associations between sleep and the sleep environment and to eliminate conditioning of non-sleep behavior and the sleep environment.
Stimulus Control, Cognitive Therapy, Sleep Hygiene
Administration of stimulus control therapy, cognitive therapy, and sleep hygiene education (3 interventions)
Stimulus Control Therapy
Automated digital administration of a stimulus control therapy module via mobile or web application, lasting approximately six weeks. The aim is to strengthen associations between sleep and the sleep environment and to eliminate conditioning of non-sleep behavior and the sleep environment.
Cognitive Therapy
Automated digital administration of a cognitive therapy module via mobile or web application, lasting approximately six weeks. The aim is to identify, challenge, and modify dysfunctional beliefs about sleep.
Sleep Hygiene Education
Automated digital administration of a sleep hygiene education module via mobile or web application, lasting approximately six weeks. The aim is to identify and modify environmental and lifestyle factors that may interfere with sleep.
Stimulus Control, Relaxation Training, Sleep Hygiene
Administration of stimulus control therapy, relaxation training, and sleep hygiene education (3 interventions)
Stimulus Control Therapy
Automated digital administration of a stimulus control therapy module via mobile or web application, lasting approximately six weeks. The aim is to strengthen associations between sleep and the sleep environment and to eliminate conditioning of non-sleep behavior and the sleep environment.
Relaxation Training
Automated digital administration of a relaxation training module via mobile or web application, lasting approximately six weeks. The aim is to reduce somatic tension and limit intrusive thought processes that interfere with sleep.
Sleep Hygiene Education
Automated digital administration of a sleep hygiene education module via mobile or web application, lasting approximately six weeks. The aim is to identify and modify environmental and lifestyle factors that may interfere with sleep.
Stimulus Control, Relaxation Training, Cognitive Therapy
Administration of stimulus control therapy, relaxation training, and cognitive therapy (3 interventions)
Stimulus Control Therapy
Automated digital administration of a stimulus control therapy module via mobile or web application, lasting approximately six weeks. The aim is to strengthen associations between sleep and the sleep environment and to eliminate conditioning of non-sleep behavior and the sleep environment.
Relaxation Training
Automated digital administration of a relaxation training module via mobile or web application, lasting approximately six weeks. The aim is to reduce somatic tension and limit intrusive thought processes that interfere with sleep.
Cognitive Therapy
Automated digital administration of a cognitive therapy module via mobile or web application, lasting approximately six weeks. The aim is to identify, challenge, and modify dysfunctional beliefs about sleep.
Sleep Optimization
Administration of sleep optimization only (single intervention)
Sleep Optimization
Automated digital administration of a sleep optimization module via mobile or web application, lasting approximately six weeks. Based on the participant's situation and needs, sleep restriction, sleep compression, or circadian-rhythm normalization is advised and conducted. The aim is to optimise the participant's sleep efficiency.
Sleep Optimization, Cognitive Therapy, Sleep Hygiene
Administration of sleep optimization, cognitive therapy, and sleep hygiene education (3 interventions)
Sleep Optimization
Automated digital administration of a sleep optimization module via mobile or web application, lasting approximately six weeks. Based on the participant's situation and needs, sleep restriction, sleep compression, or circadian-rhythm normalization is advised and conducted. The aim is to optimise the participant's sleep efficiency.
Cognitive Therapy
Automated digital administration of a cognitive therapy module via mobile or web application, lasting approximately six weeks. The aim is to identify, challenge, and modify dysfunctional beliefs about sleep.
Sleep Hygiene Education
Automated digital administration of a sleep hygiene education module via mobile or web application, lasting approximately six weeks. The aim is to identify and modify environmental and lifestyle factors that may interfere with sleep.
Sleep Optimization, Relaxation Training, Sleep Hygiene
Administration of sleep optimization, relaxation training, and sleep hygiene education (3 interventions)
Sleep Optimization
Automated digital administration of a sleep optimization module via mobile or web application, lasting approximately six weeks. Based on the participant's situation and needs, sleep restriction, sleep compression, or circadian-rhythm normalization is advised and conducted. The aim is to optimise the participant's sleep efficiency.
Relaxation Training
Automated digital administration of a relaxation training module via mobile or web application, lasting approximately six weeks. The aim is to reduce somatic tension and limit intrusive thought processes that interfere with sleep.
Sleep Hygiene Education
Automated digital administration of a sleep hygiene education module via mobile or web application, lasting approximately six weeks. The aim is to identify and modify environmental and lifestyle factors that may interfere with sleep.
Sleep Optimization, Relaxation Training, Cognitive Therapy
Administration of sleep optimization, relaxation training, and cognitive therapy (3 interventions)
Sleep Optimization
Automated digital administration of a sleep optimization module via mobile or web application, lasting approximately six weeks. Based on the participant's situation and needs, sleep restriction, sleep compression, or circadian-rhythm normalization is advised and conducted. The aim is to optimise the participant's sleep efficiency.
Relaxation Training
Automated digital administration of a relaxation training module via mobile or web application, lasting approximately six weeks. The aim is to reduce somatic tension and limit intrusive thought processes that interfere with sleep.
Cognitive Therapy
Automated digital administration of a cognitive therapy module via mobile or web application, lasting approximately six weeks. The aim is to identify, challenge, and modify dysfunctional beliefs about sleep.
Sleep Optimization, Stimulus Control, Sleep Hygiene
Administration of sleep optimization, stimulus control therapy, and sleep hygiene education (3 interventions)
Sleep Optimization
Automated digital administration of a sleep optimization module via mobile or web application, lasting approximately six weeks. Based on the participant's situation and needs, sleep restriction, sleep compression, or circadian-rhythm normalization is advised and conducted. The aim is to optimise the participant's sleep efficiency.
Stimulus Control Therapy
Automated digital administration of a stimulus control therapy module via mobile or web application, lasting approximately six weeks. The aim is to strengthen associations between sleep and the sleep environment and to eliminate conditioning of non-sleep behavior and the sleep environment.
Sleep Hygiene Education
Automated digital administration of a sleep hygiene education module via mobile or web application, lasting approximately six weeks. The aim is to identify and modify environmental and lifestyle factors that may interfere with sleep.
Sleep Optimization, Stimulus Control, Cognitive Therapy
Administration of sleep optimization, stimulus control therapy, and cognitive therapy (3 interventions)
Sleep Optimization
Automated digital administration of a sleep optimization module via mobile or web application, lasting approximately six weeks. Based on the participant's situation and needs, sleep restriction, sleep compression, or circadian-rhythm normalization is advised and conducted. The aim is to optimise the participant's sleep efficiency.
Stimulus Control Therapy
Automated digital administration of a stimulus control therapy module via mobile or web application, lasting approximately six weeks. The aim is to strengthen associations between sleep and the sleep environment and to eliminate conditioning of non-sleep behavior and the sleep environment.
Cognitive Therapy
Automated digital administration of a cognitive therapy module via mobile or web application, lasting approximately six weeks. The aim is to identify, challenge, and modify dysfunctional beliefs about sleep.
Sleep Optimization, Stimulus Control, Relaxation Training
Administration of sleep optimization, stimulus control therapy, and relaxation training (3 interventions)
Sleep Optimization
Automated digital administration of a sleep optimization module via mobile or web application, lasting approximately six weeks. Based on the participant's situation and needs, sleep restriction, sleep compression, or circadian-rhythm normalization is advised and conducted. The aim is to optimise the participant's sleep efficiency.
Stimulus Control Therapy
Automated digital administration of a stimulus control therapy module via mobile or web application, lasting approximately six weeks. The aim is to strengthen associations between sleep and the sleep environment and to eliminate conditioning of non-sleep behavior and the sleep environment.
Relaxation Training
Automated digital administration of a relaxation training module via mobile or web application, lasting approximately six weeks. The aim is to reduce somatic tension and limit intrusive thought processes that interfere with sleep.
Sleep Optimization, Stimulus Control, Relaxation Training, Cognitive Therapy, Sleep Hygiene
Administration of sleep optimization, stimulus control therapy, relaxation training, cognitive therapy, and sleep hygiene education (5 interventions)
Sleep Optimization
Automated digital administration of a sleep optimization module via mobile or web application, lasting approximately six weeks. Based on the participant's situation and needs, sleep restriction, sleep compression, or circadian-rhythm normalization is advised and conducted. The aim is to optimise the participant's sleep efficiency.
Stimulus Control Therapy
Automated digital administration of a stimulus control therapy module via mobile or web application, lasting approximately six weeks. The aim is to strengthen associations between sleep and the sleep environment and to eliminate conditioning of non-sleep behavior and the sleep environment.
Relaxation Training
Automated digital administration of a relaxation training module via mobile or web application, lasting approximately six weeks. The aim is to reduce somatic tension and limit intrusive thought processes that interfere with sleep.
Cognitive Therapy
Automated digital administration of a cognitive therapy module via mobile or web application, lasting approximately six weeks. The aim is to identify, challenge, and modify dysfunctional beliefs about sleep.
Sleep Hygiene Education
Automated digital administration of a sleep hygiene education module via mobile or web application, lasting approximately six weeks. The aim is to identify and modify environmental and lifestyle factors that may interfere with sleep.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sleep Optimization
Automated digital administration of a sleep optimization module via mobile or web application, lasting approximately six weeks. Based on the participant's situation and needs, sleep restriction, sleep compression, or circadian-rhythm normalization is advised and conducted. The aim is to optimise the participant's sleep efficiency.
Stimulus Control Therapy
Automated digital administration of a stimulus control therapy module via mobile or web application, lasting approximately six weeks. The aim is to strengthen associations between sleep and the sleep environment and to eliminate conditioning of non-sleep behavior and the sleep environment.
Relaxation Training
Automated digital administration of a relaxation training module via mobile or web application, lasting approximately six weeks. The aim is to reduce somatic tension and limit intrusive thought processes that interfere with sleep.
Cognitive Therapy
Automated digital administration of a cognitive therapy module via mobile or web application, lasting approximately six weeks. The aim is to identify, challenge, and modify dysfunctional beliefs about sleep.
Sleep Hygiene Education
Automated digital administration of a sleep hygiene education module via mobile or web application, lasting approximately six weeks. The aim is to identify and modify environmental and lifestyle factors that may interfere with sleep.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Individuals who report moderate-to-severe insomnia symptoms (a score ≥10 on the Insomnia Severity Index, ISI)
* Individuals with access to a smartphone or computer with internet connection
* Individuals who report sufficient technological proficiency (e.g., ability to download apps)
Exclusion Criteria
* Individuals who report mild or no clinically relevant insomnia symptoms (a score \<10 on the ISI)
* Individuals who have a shift-work schedule or are on maternity/paternity leave, if this impacts their sleep quality or amount of sleep
* Individuals who are unable to read Danish
* Individuals who report severe physical or psychological comorbidity with known effects on sleep (e.g., psychosis, cardiovascular disease, cancer, COPD)
* Individuals who report other diagnosed sleep or circadian rhythm disorders (e.g., sleep apnea, narcolepsy)
* Individuals who have previously used the "Hvil®"-app
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TrygFonden, Denmark
INDUSTRY
Enversion A/S
UNKNOWN
University of Aarhus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Zachariae, DMSc, MSc
Role: PRINCIPAL_INVESTIGATOR
Aarhus University, Aarhus University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aarhus University
Aarhus, Central Jutland, Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
van Straten A, van der Zweerde T, Kleiboer A, Cuijpers P, Morin CM, Lancee J. Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. Sleep Med Rev. 2018 Apr;38:3-16. doi: 10.1016/j.smrv.2017.02.001. Epub 2017 Feb 9.
Morin CM, Benca R. Chronic insomnia. Lancet. 2012 Mar 24;379(9821):1129-41. doi: 10.1016/S0140-6736(11)60750-2. Epub 2012 Jan 20.
Liu TZ, Xu C, Rota M, Cai H, Zhang C, Shi MJ, Yuan RX, Weng H, Meng XY, Kwong JS, Sun X. Sleep duration and risk of all-cause mortality: A flexible, non-linear, meta-regression of 40 prospective cohort studies. Sleep Med Rev. 2017 Apr;32:28-36. doi: 10.1016/j.smrv.2016.02.005. Epub 2016 Mar 3.
Hertenstein E, Feige B, Gmeiner T, Kienzler C, Spiegelhalder K, Johann A, Jansson-Frojmark M, Palagini L, Rucker G, Riemann D, Baglioni C. Insomnia as a predictor of mental disorders: A systematic review and meta-analysis. Sleep Med Rev. 2019 Feb;43:96-105. doi: 10.1016/j.smrv.2018.10.006. Epub 2018 Nov 16.
Virta JJ, Heikkila K, Perola M, Koskenvuo M, Raiha I, Rinne JO, Kaprio J. Midlife sleep characteristics associated with late life cognitive function. Sleep. 2013 Oct 1;36(10):1533-41, 1541A. doi: 10.5665/sleep.3052.
Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.
Daley M, Morin CM, LeBlanc M, Gregoire JP, Savard J. The economic burden of insomnia: direct and indirect costs for individuals with insomnia syndrome, insomnia symptoms, and good sleepers. Sleep. 2009 Jan;32(1):55-64.
Daley M, Morin CM, LeBlanc M, Gregoire JP, Savard J, Baillargeon L. Insomnia and its relationship to health-care utilization, work absenteeism, productivity and accidents. Sleep Med. 2009 Apr;10(4):427-38. doi: 10.1016/j.sleep.2008.04.005. Epub 2008 Aug 26.
Bjorvatn B, Meland E, Flo E, Mildestvedt T. High prevalence of insomnia and hypnotic use in patients visiting their general practitioner. Fam Pract. 2017 Feb;34(1):20-24. doi: 10.1093/fampra/cmw107. Epub 2016 Oct 27.
Riemann D, Perlis ML. The treatments of chronic insomnia: a review of benzodiazepine receptor agonists and psychological and behavioral therapies. Sleep Med Rev. 2009 Jun;13(3):205-14. doi: 10.1016/j.smrv.2008.06.001. Epub 2009 Feb 7.
Kripke DF. Hypnotic drug risks of mortality, infection, depression, and cancer: but lack of benefit. F1000Res. 2016 May 19;5:918. doi: 10.12688/f1000research.8729.3. eCollection 2016.
Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008 Oct 15;4(5):487-504.
Wilson S, Anderson K, Baldwin D, Dijk DJ, Espie A, Espie C, Gringras P, Krystal A, Nutt D, Selsick H, Sharpley A. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: An update. J Psychopharmacol. 2019 Aug;33(8):923-947. doi: 10.1177/0269881119855343. Epub 2019 Jul 4.
Morgenthaler T, Kramer M, Alessi C, Friedman L, Boehlecke B, Brown T, Coleman J, Kapur V, Lee-Chiong T, Owens J, Pancer J, Swick T; American Academy of Sleep Medicine. Practice parameters for the psychological and behavioral treatment of insomnia: an update. An american academy of sleep medicine report. Sleep. 2006 Nov;29(11):1415-9.
Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Aug 4;163(3):191-204. doi: 10.7326/M14-2841.
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.
Perils ML, Smith MT. How can we make CBT-I and other BSM services widely available? J Clin Sleep Med. 2008 Feb 15;4(1):11-3. No abstract available.
Thomas A, Grandner M, Nowakowski S, Nesom G, Corbitt C, Perlis ML. Where are the Behavioral Sleep Medicine Providers and Where are They Needed? A Geographic Assessment. Behav Sleep Med. 2016 Nov-Dec;14(6):687-98. doi: 10.1080/15402002.2016.1173551. Epub 2016 May 9.
Zachariae R, Lyby MS, Ritterband LM, O'Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia - A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016 Dec;30:1-10. doi: 10.1016/j.smrv.2015.10.004. Epub 2015 Oct 24.
Kaldo V, Jernelov S, Blom K, Ljotsson B, Brodin M, Jorgensen M, Kraepelien M, Ruck C, Lindefors N. Guided internet cognitive behavioral therapy for insomnia compared to a control treatment - A randomized trial. Behav Res Ther. 2015 Aug;71:90-100. doi: 10.1016/j.brat.2015.06.001. Epub 2015 Jun 3.
Dozeman E, Verdonck-de Leeuw IM, Savard J, van Straten A. Guided web-based intervention for insomnia targeting breast cancer patients: Feasibility and effect. Internet Interv. 2017 Apr 19;9:1-6. doi: 10.1016/j.invent.2017.03.005. eCollection 2017 Sep.
Horsch CH, Lancee J, Griffioen-Both F, Spruit S, Fitrianie S, Neerincx MA, Beun RJ, Brinkman WP. Mobile Phone-Delivered Cognitive Behavioral Therapy for Insomnia: A Randomized Waitlist Controlled Trial. J Med Internet Res. 2017 Apr 11;19(4):e70. doi: 10.2196/jmir.6524.
Guastaferro K, Collins LM. Achieving the Goals of Translational Science in Public Health Intervention Research: The Multiphase Optimization Strategy (MOST). Am J Public Health. 2019 Feb;109(S2):S128-S129. doi: 10.2105/AJPH.2018.304874. No abstract available.
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.
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.
Dziak JJ, Nahum-Shani I, Collins LM. Multilevel factorial experiments for developing behavioral interventions: power, sample size, and resource considerations. Psychol Methods. 2012 Jun;17(2):153-75. doi: 10.1037/a0026972. Epub 2012 Feb 6.
National Institutes of Health. National Institutes of Health State of the Science Conference statement on Manifestations and Management of Chronic Insomnia in Adults, June 13-15, 2005. Sleep. 2005 Sep;28(9):1049-57. doi: 10.1093/sleep/28.9.1049. No abstract available.
Kyle SD, Aquino MR, Miller CB, Henry AL, Crawford MR, Espie CA, Spielman AJ. Towards standardisation and improved understanding of sleep restriction therapy for insomnia disorder: A systematic examination of CBT-I trial content. Sleep Med Rev. 2015 Oct;23:83-8. doi: 10.1016/j.smrv.2015.02.003. Epub 2015 Feb 18.
Bootzin RR, Perlis ML. Nonpharmacologic treatments of insomnia. J Clin Psychiatry. 1992 Jun;53 Suppl:37-41.
Belanger L, Savard J, Morin CM. Clinical management of insomnia using cognitive therapy. Behav Sleep Med. 2006;4(3):179-198. doi: 10.1207/s15402010bsm0403_4.
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.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
Morin CM, Vallieres A, Ivers H. Dysfunctional beliefs and attitudes about sleep (DBAS): validation of a brief version (DBAS-16). Sleep. 2007 Nov;30(11):1547-54. doi: 10.1093/sleep/30.11.1547.
Sinclair SJ, Siefert CJ, Slavin-Mulford JM, Stein MB, Renna M, Blais MA. Psychometric evaluation and normative data for the depression, anxiety, and stress scales-21 (DASS-21) in a nonclinical sample of U.S. adults. Eval Health Prof. 2012 Sep;35(3):259-79. doi: 10.1177/0163278711424282. Epub 2011 Oct 18.
Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
Boot WR, Charness N, Czaja SJ, Sharit J, Rogers WA, Fisk AD, Mitzner T, Lee CC, Nair S. Computer proficiency questionnaire: assessing low and high computer proficient seniors. Gerontologist. 2015 Jun;55(3):404-11. doi: 10.1093/geront/gnt117. Epub 2013 Oct 9.
Collins LM, Dziak JJ, Li R. Design of experiments with multiple independent variables: a resource management perspective on complete and reduced factorial designs. Psychol Methods. 2009 Sep;14(3):202-24. doi: 10.1037/a0015826.
Ritterband LM, Thorndike FP, Ingersoll KS, Lord HR, Gonder-Frederick L, Frederick C, Quigg MS, Cohn WF, Morin CM. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jan 1;74(1):68-75. doi: 10.1001/jamapsychiatry.2016.3249.
Lancee J, van den Bout J, van Straten A, Spoormaker VI. Internet-delivered or mailed self-help treatment for insomnia?: a randomized waiting-list controlled trial. Behav Res Ther. 2012 Jan;50(1):22-9. doi: 10.1016/j.brat.2011.09.012. Epub 2011 Oct 24.
Ritterband LM, Thorndike FP, Gonder-Frederick LA, Magee JC, Bailey ET, Saylor DK, Morin CM. Efficacy of an Internet-based behavioral intervention for adults with insomnia. Arch Gen Psychiatry. 2009 Jul;66(7):692-8. doi: 10.1001/archgenpsychiatry.2009.66.
Espie CA, Emsley R, Kyle SD, Gordon C, Drake CL, Siriwardena AN, Cape J, Ong JC, Sheaves B, Foster R, Freeman D, Costa-Font J, Marsden A, Luik AI. Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Jan 1;76(1):21-30. doi: 10.1001/jamapsychiatry.2018.2745.
Van Houdenhove L, Buyse B, Gabriels L, Van den Bergh O. Treating primary insomnia: clinical effectiveness and predictors of outcomes on sleep, daytime function and health-related quality of life. J Clin Psychol Med Settings. 2011 Sep;18(3):312-21. doi: 10.1007/s10880-011-9250-7.
Kyle SD, Miller CB, Rogers Z, Siriwardena AN, Macmahon KM, Espie CA. Sleep restriction therapy for insomnia is associated with reduced objective total sleep time, increased daytime somnolence, and objectively impaired vigilance: implications for the clinical management of insomnia disorder. Sleep. 2014 Feb 1;37(2):229-37. doi: 10.5665/sleep.3386.
Miller CB, Espie CA, Epstein DR, Friedman L, Morin CM, Pigeon WR, Spielman AJ, Kyle SD. The evidence base of sleep restriction therapy for treating insomnia disorder. Sleep Med Rev. 2014 Oct;18(5):415-24. doi: 10.1016/j.smrv.2014.01.006. Epub 2014 Feb 12.
Harvey L, Inglis SJ, Espie CA. Insomniacs' reported use of CBT components and relationship to long-term clinical outcome. Behav Res Ther. 2002 Jan;40(1):75-83. doi: 10.1016/s0005-7967(01)00004-3.
Adan, A, Almirall, H. Horne & Östberg morningness-eveningness questionnaire: A reduced scale. Personality and Individual Differences. 1991; 12(3): 241-253
Hvidt, JCS, Christensen, LF, Sibbersen, C, Helweg-Jørgensen, S, Hansen, JP, Lichtenstein, MB. Translation and Validation of the System Usability Scale in a Danish Mental Health Setting Using Digital Technologies in Treatment Interventions. 2020; 36(8): 709-716.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-051-000001-2099-2
Identifier Type: -
Identifier Source: org_study_id