Randomized Noninferiority Trial of Telehealth Delivery of Cognitive Behavioral Treatment of Insomnia Compared to In-Person Care

Philip Gehrman, PhD^a,b,c ; Paul Gunter, MS^a ; James Findley, PhD^d ; Rosemarie Frasso, PhD^e ; Aalim M. Weljie, PhD^c,f ; Samuel T. Kuna, MD^b,c,d ; Matthew S. Kayser, MD, PhD^a,c

J Clin Psychiatry 2021;82(5):20m13723

ABSTRACT

Objective: Insomnia is prevalent and is associated with a range of negative sequelae. Cognitive behavioral treatment for insomnia (CBT-I) is the recommended intervention, but availability is limited. Telehealth provides increased access, but its efficacy is not certain. The objective of this study was to compare the efficacy of CBT-I delivered by telehealth to in-person treatment and to a waitlist control.

Methods: Individuals with DSM-5 insomnia disorder (n = 60) were randomized to telehealth CBT-I, in-person CBT-I, or 8-week waitlist control. CBT-I was delivered over 6–8 weekly sessions by video telehealth or in-person in an outpatient clinic. Follow-up assessments were at 2 weeks and 3 months posttreatment. The Insomnia Severity Index (ISI) was the primary outcome. Change in ISI score was compared between the CBT-I group in an intent-to-treat, noninferiority analysis using an a priori margin of −3.0 points. All analyses were conducted using mixed-effects models. Data collection occurred from November 2017–July 2020.

Results: The mean (SD) change in ISI score from baseline to 3-month follow-up was −7.8 (6.1) points for in-person CBT-I, −7.5 (6.9) points for telehealth, and −1.6 (2.1) for waitlist, and the difference between the CBT-I groups was not statistically significant (t₂₈ = −0.98, P = .33). The lower confidence limit of this between-group difference in the mean ISI changes was greater than the a priori margin of −3.0 points, indicating that telehealth treatment was not inferior to in-person treatment. There were significant improvements on most secondary outcome measures but no group differences.

Conclusions: Telehealth CBT-I may produce clinically significant improvements in insomnia severity that are noninferior to in-person treatment. CBT-I is also associated with significant gains across a range of domains of functioning. Telehealth is a promising option for increasing access to treatment without loss of clinical gains.

Trial Registration: ClinicalTrials.gov identifier: NCT03328585

Continue Reading...

Did you know members enjoy unlimited free PDF downloads as part of their subscription? Subscribe today for instant access to this article and our entire library in your preferred format. Alternatively, you can purchase the PDF of this article individually.

Subscribe Now

Already a member? Login

Buy PDF for $40

Please sign in or purchase this PDF for $40.

References (25)

Roth T, Coulouvrat C, Hajak G, et al. Prevalence and perceived health associated with insomnia based on DSM-IV-TR; International Statistical Classification of Diseases and Related Health Problems, Tenth Revision; and Research Diagnostic Criteria/International Classification of Sleep Disorders, Second Edition criteria: results from the America Insomnia Survey. Biol Psychiatry. 2011;69(6):592–600. PubMed CrossRef
Shochat T, Umphress J, Israel AG, et al. Insomnia in primary care patients. Sleep. 1999;22(suppl 2):S359–S365. PubMed
Benca RM. Consequences of insomnia and its therapies. J Clin Psychiatry. 2001;62(suppl 10):33–38. PubMed
Fullerton DS. The economic impact of insomnia in managed care: a clearer picture emerges. Am J Manag Care. 2006;12(8 suppl):S246–S252. PubMed
Mitchell MD, Gehrman P, Perlis M, et al. Comparative effectiveness of cognitive behavioral therapy for insomnia: a systematic review. BMC Fam Pract. 2012;13(1):40. PubMed CrossRef
Smith MT, Perlis ML, Park A, et al. Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry. 2002;159(1):5–11. PubMed CrossRef
Morland LA, Greene CJ, Rosen C, et al. Issues in the design of a randomized noninferiority clinical trial of telemental health psychotherapy for rural combat veterans with PTSD. Contemp Clin Trials. 2009;30(6):513–522. PubMed CrossRef
Morland LA, Greene CJ, Rosen CS, et al. Telemedicine for anger management therapy in a rural population of combat veterans with posttraumatic stress disorder: a randomized noninferiority trial. J Clin Psychiatry. 2010;71(7):855–863. PubMed CrossRef
Morland LA, Mackintosh MA, Rosen CS, et al. Telemedicine versus in-person delivery of cognitive processing therapy for women with posttraumatic stress disorder: a randomized noninferiority trial. Depress Anxiety. 2015;32(11):811–820. PubMed CrossRef
Holmqvist M, Vincent N, Walsh K. Web- vs telehealth-based delivery of cognitive behavioral therapy for insomnia: a randomized controlled trial. Sleep Med. 2014;15(2):187–195. PubMed CrossRef
Arnedt JT, Conroy DA, Mooney A, et al. Telemedicine versus face-to-face delivery of cognitive behavioral therapy for insomnia: a randomized controlled noninferiority trial. Sleep (Basel). 2021;44(1):zsaa136. PubMed CrossRef
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. PubMed CrossRef
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–613. PubMed CrossRef
Spitzer RL, Kroenke K, Williams JB, et al. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–1097. PubMed CrossRef
Mundt JC, Marks IM, Shear MK, et al. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002;180(5):461–464. PubMed CrossRef
Smets EM, Garssen B, Bonke B, et al. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995;39(3):315–325. PubMed CrossRef
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220–233. PubMed CrossRef
Benz F, Knoop T, Ballesio A, et al. The efficacy of cognitive and behavior therapies for insomnia on daytime symptoms: a systematic review and network meta-analysis. Clin Psychol Rev. 2020;80:101873. PubMed CrossRef
Agarwal N, Jain P, Pathak R, et al. Telemedicine in India: a tool for transforming health care in the era of COVID-19 pandemic. J Educ Health Promot. 2020;9(1):190. PubMed CrossRef
Ramaswamy A, Yu M, Drangsholt S, et al. Patient satisfaction with telemedicine during the COVID-19 pandemic: retrospective cohort study. J Med Internet Res. 2020;22(9):e20786. PubMed CrossRef
Torales J, O’Higgins M, Castaldelli-Maia JM, et al. The outbreak of COVID-19 coronavirus and its impact on global mental health. Int J Soc Psychiatry. 2020;66(4):317–320. PubMed CrossRef
Altena E, Baglioni C, Espie CA, et al. Dealing with sleep problems during home confinement due to the COVID-19 outbreak: practical recommendations from a task force of the European CBT-I Academy. J Sleep Res. 2020;29(4):e13052. PubMed CrossRef
Ho FY, Chan CS, Lo WY, et al. The effect of self-help cognitive behavioral therapy for insomnia on depressive symptoms: an updated meta-analysis of randomized controlled trials. J Affect Disord. 2020;265:287–304. PubMed CrossRef
Grandner MA. Sleep, health, and society. Sleep Med Clin. 2020;15(2):319–340. PubMed CrossRef
Thomas A, Grandner M, Nowakowski S, et al. Where are the behavioral sleep medicine providers and where are they needed? a geographic assessment. Behav Sleep Med. 2016;14(6):687–698. PubMed CrossRef