Enhancing behavioral sleep care with digital technology: study protocol for a hybrid type 3 implementation-effectiveness randomized trial

Anne Germain, Rachel R Markwald, Erika King, Adam D Bramoweth, Megan Wolfson, Gilbert Seda, Tony Han, Erin Miggantz, Brian O'Reilly, Lars Hungerford, Traci Sitzer, Vincent Mysliwiec, Joseph J Hout, Meredith L Wallace, Anne Germain, Rachel R Markwald, Erika King, Adam D Bramoweth, Megan Wolfson, Gilbert Seda, Tony Han, Erin Miggantz, Brian O'Reilly, Lars Hungerford, Traci Sitzer, Vincent Mysliwiec, Joseph J Hout, Meredith L Wallace

Abstract

Background: Insomnia affects almost one in four military service members and veterans. The first-line recommended treatment for insomnia is cognitive-behavioral therapy for insomnia (CBTI). CBTI is typically delivered in-person or online over one-to-four sessions (brief versions) or five-to-eight sessions (standard versions) by a licensed doctoral or masters-level clinician with extensive training in behavioral sleep medicine. Despite its effectiveness, CBTI has limited scalability. Three main factors inhibit access to and delivery of CBTI including restricted availability of clinical expertise; rigid, resource-intensive treatment formats; and limited capacities for just-in-time monitoring and treatment personalization. Digital technologies offer a unique opportunity to overcome these challenges by providing scalable, personalized, resource-sensitive, adaptive, and cost-effective approaches for evidence-based insomnia treatment.

Methods: This is a hybrid type 3 implementation-effectiveness randomized trial using a scalable evidence-based digital health software platform, NOCTEM™'s Clinician-Operated Assistive Sleep Technology (COAST™). COAST includes a clinician portal and a patient app, and it utilizes algorithms that facilitate detection of sleep disordered patterns, support clinical decision-making, and personalize sleep interventions. The first aim is to compare three clinician- and system-centered implementation strategies on the reach, adoption, and sustainability of the COAST digital platform by offering (1) COAST only, (2) COAST plus external facilitation (EF: assistance and consultation to providers by NOCTEM's sleep experts), or (3) COAST plus EF and internal facilitation (EF/IF: assistance/consultation to providers by NOCTEM's sleep experts and local champions). The second aim is to quantify improvements in insomnia among patients who receive behavioral sleep care via the COAST platform. We hypothesize that reach, adoption, and sustainability and the magnitude of improvements in insomnia will be superior in the EF and EF/IF groups relative to the COAST-only group.

Discussion: Digital health technologies and machine learning-assisted clinical decision support tools have substantial potential for scaling access to insomnia treatment. This can augment the scalability and cost-effectiveness of CBTI without compromising patient outcomes. Engaging providers, stakeholders, patients, and decision-makers is key in identifying strategies to support the deployment of digital health technologies that can promote quality care and result in clinically meaningful sleep improvements, positive systemic change, and enhanced readiness and health among service members.

Trial registration: ClinicalTrials.gov NCT04366284 . Registered on 28 April 2020.

Keywords: Behavioral sleep medicine; Cognitive-behavioral therapy for insomnia; Digital health technologies; Effectiveness; Implementation facilitation; Insomnia; Military personnel; Veterans.

Conflict of interest statement

AG is co-founder and CEO of NOCTEM, LLC. ADB is supported by the Department of Veterans Affairs, Health Services Research and Development Service (IK2 HX-001548, I01 HX003096). VM is consultant for CPAP Medical, Ebb Therapeutics, and NightWare, Inc. ADB, MLW, and VM are paid consultants of NOCTEM, LLC. MW is employed by NOCTEM, LLC.

Figures

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Fig. 1
Design of the hybrid type 3 implementation-effectiveness trial

References

    1. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217.
    1. Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs. Psychiatry Res. 2019;280:112513.
    1. International Classification of Sleep Disorders 3rd Ed. Darien, IL USA: American Academy of Sleep Medicine. 2014.
    1. Bramoweth AD, Germain A. Deployment-related insomnia in military personnel and veterans. Curr Psychiatry Rep. 2013;15(10):401.
    1. Mysliwiec V, Gill J, Lee H, et al. Sleep disorders in US military personnel: a high rate of comorbid insomnia and obstructive sleep apnea. Chest. 2013;144(2):549–557.
    1. McLay RN, Klam WP, Volkert SL. Insomnia is the most commonly reported symptom and predicts other symptoms of post-traumatic stress disorder in US service members returning from military deployments. Mil Med. 2010;175(10):759–762.
    1. Straus LD, Drummond SP, Nappi CM, Jenkins MM, Norman SB. Sleep variability in military-related PTSD: a comparison to primary insomnia and healthy controls. J Trauma Stress. 2015;28(1):8–16.
    1. Moore TM, Risbrough VB, Baker DG, et al. Effects of military service and deployment on clinical symptomatology: the role of trauma exposure and social support. J Psychiatr Res. 2017;95:121–128.
    1. Caldwell JA, Knapik JJ, Shing TL, Kardouni JR, Lieberman HR. The association of insomnia and sleep apnea with deployment and combat exposure in the entire population of US army soldiers from 1997 to 2011: a retrospective cohort investigation. Sleep. 2019;42(8):zsz112.
    1. Gehrman P, Seelig AD, Jacobson IG, et al. Predeployment sleep duration and insomnia symptoms as risk factors for new-onset mental health disorders following military deployment. Sleep. 2013;36(7):1009–1018.
    1. Brooks AT, Wallen GR. Sleep disturbances in individuals with alcohol-related disorders: a review of cognitive-behavioral therapy for insomnia (CBT-I) and associated non-pharmacological therapies. Subst Abuse Res Treat. 2014;8:SART–S18446.
    1. Wright KM, Britt TW, Bliese PD, Adler AB, Picchioni D, Moore D. Insomnia as predictor versus outcome of PTSD and depression among Iraq combat veterans. J Clin Psychol. 2011;67(12):1240–1258.
    1. Ribeiro JD, Pease JL, Gutierrez PM, et al. Sleep problems outperform depression and hopelessness as cross-sectional and longitudinal predictors of suicidal ideation and behavior in young adults in the military. J Affect Disord. 2012;136(3):743–750.
    1. Trockel M, Karlin BE, Taylor CB, Brown GK, Manber R. Effects of cognitive behavioral therapy for insomnia on suicidal ideation in veterans. Sleep. 2015;38(2):259–265.
    1. Seelig AD, Jacobson IG, Donoho CJ, Trone DW, Crum-Cianflone NF, Balkin TJ. Sleep and health resilience metrics in a large military cohort. Sleep. 2016;39(5):1111–1120.
    1. Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD, for the Clinical Guidelines Committee of the American College of Physicians Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2016;165(2):125.
    1. An American Academy of Sleep Medicine Report. Morgenthaler T, Kramer M, et al. Practice parameters for the psychological and behavioral treatment of insomnia: an update. An American Academy of Sleep Medicine Report. Sleep. 2006;29(11):1415–1419.
    1. Riemann D, Baglioni C, Bassetti C, et al. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017;26(6):675–700.
    1. Mysliwiec V, Martin JL, Ulmer CS, et al. The management of chronic insomnia disorder and obstructive sleep apnea: synopsis of the 2019 U.S. Department of Veterans Affairs and U.S. Department of Defense clinical practice guidelines. Ann Intern Med. 2020;172(5):325.
    1. Germain A, Richardson R, Moul DE, et al. Placebo-controlled comparison of prazosin and cognitive-behavioral treatments for sleep disturbances in US Military Veterans. J Psychosom Res. 2012;72(2):89–96.
    1. Germain A, Moul DE, Franzen PL, et al. Effects of a brief behavioral treatment for late-life insomnia: preliminary findings. J Clin Sleep Med JCSM Off Publ Am Acad Sleep Med. 2006;2(4):403–406.
    1. Germain A, Richardson R, Stocker R, et al. Treatment for insomnia in combat-exposed OEF/OIF/OND military veterans: preliminary randomized controlled trial. Behav Res Ther. 2014;61:78–88.
    1. Ellis JG, Cushing T, Germain A. Treating acute insomnia: a randomized controlled trial of a “single-shot” of cognitive behavioral therapy for insomnia. Sleep. 2015;1. 10.5665/sleep.4752.
    1. Germain A, Shear MK, Hall M, Buysse DJ. Effects of a brief behavioral treatment for PTSD-related sleep disturbances: a pilot study. Behav Res Ther. 2007;45(3):627–632.
    1. Taylor DJ, Peterson AL, Pruiksma KE, et al. Impact of cognitive behavioral therapy for insomnia disorder on sleep and comorbid symptoms in military personnel: a randomized clinical trial. Sleep. 2018;41(6). 10.1093/sleep/zsy069.
    1. McCrae CS, Curtis AF, Williams JM, et al. Efficacy of brief behavioral treatment for insomnia in older adults: examination of sleep, mood, and cognitive outcomes. Sleep Med. 2018;51:153–166.
    1. Pulantara IW, Parmanto B, Germain A. Clinical feasibility of a just-in-time adaptive intervention app (iREST) as a behavioral sleep treatment in a military population: feasibility comparative effectiveness study. J Med Internet Res. 2018;20(12):e10124.
    1. Edinger JD, Wohlgemuth WK, Radtke RA, Coffman CJ, Carney CE. Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial. Sleep. 2007;30(2):203–212.
    1. Johnson JA, Rash JA, Campbell TS, et al. A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for insomnia (CBT-I) in cancer survivors. Sleep Med Rev. 2016;27:20–28.
    1. Bramoweth AD, Lederer LG, Youk AO, Germain A, Chinman MJ. Brief behavioral treatment for insomnia vs. cognitive behavioral therapy for insomnia: results of a randomized noninferiority clinical trial among veterans. Behav Ther. 2020;51(4):535–547.
    1. Trockel M, Karlin BE, Taylor CB, Manber R. Cognitive behavioral therapy for insomnia with veterans: evaluation of effectiveness and correlates of treatment outcomes. Behav Res Ther. 2014;53:41–46.
    1. Bastien CH, Vallières A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001;2(4):297–307.
    1. Gellis LA, Gehrman PR. Cognitive behavioral treatment for insomnia in veterans with long-standing posttraumatic stress disorder: a pilot study. J Aggress Maltreatment Trauma. 2011;20(8):904–916.
    1. Jungquist CR, O’Brien C, Matteson-Rusby S, et al. The efficacy of cognitive-behavioral therapy for insomnia in patients with chronic pain. Sleep Med. 2010;11(3):302–309.
    1. van der Zweerde T, Bisdounis L, Kyle SD, Lancee J, van Straten A. Cognitive behavioral therapy for insomnia: a meta-analysis of long-term effects in controlled studies. Sleep Med Rev. 2019;48:101208.
    1. Miller NL, Matsangas P, Shattuck LG. Fatigue and its effect on performance in military environments. Perform Stress. 2007;2008:231–249.
    1. Wilt TJ, MacDonald R, Brasure M, et al. Pharmacologic treatment of insomnia disorder: an evidence report for a clinical practice guideline by the American College of Physicians. Ann Intern Med. 2016;165(2):103–112.
    1. Harrison C, Subhan Z, Hindmarch I. Residual effects of zopiclone and benzodiazepine hypnotics on psychomotor performance related to car driving. Drugs Exp Clin Res. 1985;11(12):823–829.
    1. O’Hanlon JF, Volkerts ER. Hypnotics and actual driving performance. Acta Psychiatr Scand. 1986;74(S332):95–104.
    1. Sivertsen B, Vedaa Ø, Nordgreen T. The future of insomnia treatment--the challenge of implementation. Sleep. 2013;36(3):303-4. 10.5665/sleep.2432.
    1. 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;14(6):687–698.
    1. Perils ML, Smith MT. How can we make CBT-I and other BSM services widely available? J Clin Sleep Med JCSM Off Publ Am Acad Sleep Med. 2008;4(1):11–13.
    1. Taylor DJ, Peterson AL, Pruiksma KE, et al. Internet and in-person cognitive behavioral therapy for insomnia in military personnel: a randomized clinical trial. J Sleep Sleep Disord Res. 2017;40(6):zsx075.
    1. Drerup ML, Ahmed-Jauregui S. Online delivery of cognitive behavioral therapy-insomnia: considerations and controversies. Sleep Med Clin. 2019;14(2):283–290.
    1. Ritterband LM, Bailey ET, Thorndike FP, Lord HR, Farrell-Carnahan L, Baum LD. Initial evaluation of an Internet intervention to improve the sleep of cancer survivors with insomnia. Psychooncology. 2012;21(7):695–705.
    1. 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;30:1–10.
    1. Vedaa Ø, Hagatun S, Kallestad H, et al. Long-term effects of an unguided online cognitive behavioral therapy for chronic insomnia. J Clin Sleep Med. 2019;15(01):101–110.
    1. Espie CA, Kyle SD, Williams C, et al. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012;35(6):769–781.
    1. Cheng P, Kalmbach DA, Tallent G, Joseph CL, Espie CA, Drake CL. Depression prevention via digital cognitive behavioral therapy for insomnia: a randomized controlled trial. Sleep. 2019;42(10):zsz150.
    1. Seyffert M, Lagisetty P, Landgraf J, et al. Internet-delivered cognitive behavioral therapy to treat insomnia: a systematic review and meta-analysis. PLoS One. 2016;11(2):e0149139.
    1. Cheng SK, Dizon J. Computerised cognitive behavioural therapy for insomnia: a systematic review and meta-analysis. Psychother Psychosom. 2012;81(4):206–216.
    1. Pulantara IW, Parmanto B, Germain A. Development of a just-in-time adaptive mHealth intervention for insomnia: usability study. JMIR Hum Factors. 2018;5(2):e21.
    1. Cully JA, Armento ME, Mott J, et al. Brief cognitive behavioral therapy in primary care: a hybrid type 2 patient-randomized effectiveness-implementation design. Implement Sci. 2012;7(1):64.
    1. Perry B, Geoghegan C, Lin L, et al. Patient preferences for using mobile technologies in clinical trials. Contemp Clin Trials Commun. 2019;15. 10.1016/j.conctc.2019.100399.
    1. Epstein DR, Babcock-Parziale JL, Haynes PL, Herb CA. Insomnia treatment acceptability and preferences of male Iraq and Afghanistan combat veterans and their healthcare providers. J Rehabil Res Dev. 2012;49(6):867–878.
    1. Cheung JMY, Bartlett DJ, Armour CL, Saini B. Treating insomnia: a review of patient perceptions toward treatment. Behav Sleep Med. 2016;14(3):235–266.
    1. Shore JH, Aldag M, McVeigh FL, Hoover RL, Ciulla R, Fisher A. Review of mobile health technology for military mental health. Mil Med. 2014;179(8):865–878.
    1. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci IS. 2009;4:50.
    1. Implementation Facilitation Training Manual (Version 2). Accessed February 13, 2020. .
    1. Löwe B, Kroenke K, Gräfe K. Detecting and monitoring depression with a two-item questionnaire (PHQ-2) J Psychosom Res. 2005;58(2):163–171.
    1. Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–1097.
    1. Prins A, Bovin MJ, Smolenski DJ, et al. The primary care PTSD screen for DSM-5 (PC-PTSD-5): development and evaluation within a veteran primary care sample. J Gen Intern Med. 2016;31(10):1206–1211.
    1. Asberg M, Cronholm B, Sjöqvist F, Tuck D. Correlation of subjective side effects with plasma concentrations of nortriptyline. Br Med J. 1970;4(5726):18–21.
    1. Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991;14(6):540–545.
    1. Johns MW. Reliability and factor analysis of the Epworth Sleepiness Scale. Sleep. 1992;15(4):376–381.
    1. Guy W, National Institute of Mental Health (U.S.). Psychopharmacology Research Branch. Division of Extramural Research Programs. ECDEU Assessment Manual for Psychopharmacology. Rockville, Md. : U.S. Dept. of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute of Mental Health, Psychopharmacology Research Branch, Division of Extramural Research Programs; 1976. Accessed December 11, 2019. .
    1. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322–1327.
    1. Krebs EE, Lorenz KA, Bair MJ, et al. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009;24(6):733–738.
    1. Hahn EA, Beaumont JL, Pilkonis PA, et al. The PROMIS satisfaction with social participation measures demonstrated responsiveness in diverse clinical populations. J Clin Epidemiol. 2016;73:135–141.
    1. Hedges LV. Effect sizes in cluster-randomized designs. J Educ Behav Stat. 2007;32(4):341–370.
    1. Wortmann JH, Jordan AH, Weathers FW, et al. Psychometric analysis of the PTSD Checklist-5 (PCL-5) among treatment-seeking military service members. Psychol Assess. 2016;28(11):1392.
    1. Bovin MJ, Marx BP, Weathers FW, et al. Psychometric properties of the PTSD checklist for diagnostic and statistical manual of mental disorders–fifth edition (PCL-5) in veterans. Psychol Assess. 2016;28(11):1379.
    1. Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009;114(1-3):163–173.
    1. Killip S. What is an intracluster correlation coefficient? Crucial concepts for primary care researchers. Ann Fam Med. 2004;2(3):204–208.
    1. Karlin BE, Trockel M, Taylor CB, Gimeno J, Manber R. National dissemination of cognitive behavioral therapy for insomnia in veterans: therapist-and patient-level outcomes. J Consult Clin Psychol. 2013;81(5):912.
    1. Manber R, Simpson N. Dissemination of CBT for insomnia. Curr Sleep Med Rep. 2016;2(3):136–141.
    1. Roth T. Insomnia: definition, prevalence, etiology, and consequences. J Clin Sleep Med JCSM Off Publ Am Acad Sleep Med. 2007;3(5 Suppl):S7–10.
    1. Johnson AL, Jung L, Brown KC, Weaver MT, Richards KC. Sleep Deprivation and error in nurses who work the night shift. JONA J Nurs Adm. 2014;44(1):17–22.
    1. Landrigan CP, Rothschild JM, Cronin JW, et al. Effect of reducing interns’ work hours on serious medical errors in intensive care units. N Engl J Med. 2004;351(18):1838–1848.
    1. Barger LK, Ayas NT, Cade BE, et al. Impact of extended-duration shifts on medical errors, adverse events, and attentional failures. PLoS Med. 2006;3(12):e487.
    1. Babson KA, Wong AC, Morabito D, Kimerling R. Insomnia symptoms among female veterans: prevalence, risk factors, and the impact on psychosocial functioning and health care utilization. J Clin Sleep Med. 2018;14(06):931–939.
    1. Chakravorty S, Grandner MA, Mavandadi S, Perlis ML, Sturgis EB, Oslin DW. Suicidal ideation in veterans misusing alcohol: relationships with insomnia symptoms and sleep duration. Addict Behav. 2014;39(2):399–405.
    1. Pigeon WR, Britton PC, Ilgen MA, Chapman B, Conner KR. Sleep disturbance preceding suicide among veterans. Am J Public Health. 2012;102(Suppl 1):S93–S97.
    1. Boyko EJ, Seelig AD, Jacobson IG, et al. Sleep characteristics, mental health, and diabetes risk: a prospective study of U.S. military service members in the Millennium Cohort Study. Diabetes Care. 2013;36(10):3154–3161.

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