A pilot feasibility trial of cognitive-behavioural therapy for insomnia in people with inflammatory bowel disease

Jessica K Salwen-Deremer, Michael T Smith, Kelly A Aschbrenner, Hannah G Haskell, Brittany C Speed, Corey A Siegel, Jessica K Salwen-Deremer, Michael T Smith, Kelly A Aschbrenner, Hannah G Haskell, Brittany C Speed, Corey A Siegel

Abstract

Objective: Poor sleep is common in inflammatory bowel disease (IBD), associated with worse overall disease course and predominantly attributable to insomnia. While cognitive-behavioural therapy for insomnia (CBT-I) is the recommended first-line treatment for chronic insomnia, it is untested in IBD. It is unclear if CBT-I will be as effective in this group given the extent of night-time symptoms people with IBD experience. Thus, we evaluated the feasibility and preliminary efficacy of CBT-I in IBD.

Design: We comprehensively assessed sleep in people with mild-to-moderately active IBD using questionnaires, daily diaries and actigraphy. People with significant insomnia symptoms were allocated to a single-arm, uncontrolled pilot feasibility study of gold-standard CBT-I treatment. They were then reassessed post-treatment.

Results: 20 participants with IBD completed a baseline assessment. 10 were experiencing insomnia and were allocated to CBT-I. All participants who were offered CBT-I elected to complete it, and all completed 5/5 sessions. Participants rated treatment acceptability highly and daily diary and actigraphy completion rates were >95%. At baseline, participants with insomnia evidenced significantly worse sleep than participants without insomnia. Following CBT-I, participants reported significant improvements in diary and actigraphy measures of sleep continuity, dysfunctional sleep-related beliefs and IBD disease activity.

Conclusion: CBT-I was feasible and acceptable and demonstrated a signal for efficacy in the treatment of insomnia in IBD. Importantly, the improvements in sleep continuity were consistent with the extant literature. Future fully powered randomised controlled studies should evaluate whether treatment of insomnia can improve other aspects of IBD, including pain and inflammation.

Trial registration number: NCT04132024.

Keywords: crohn's disease; inflammatory bowel disease; psychology; psychotherapy; ulcerative colitis.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
CONSORT (Consolidated Standards of Reporting Trials) diagram. Proceeding to phase II: CBT-I was based on Insomnia Severity Index score. CBT-I, cognitive–behavioural therapy for insomnia.

References

    1. Ananthakrishnan AN, Long MD, Martin CF, et al. . Sleep disturbance and risk of active disease in patients with Crohn's disease and ulcerative colitis. Clin Gastroenterol Hepatol 2013;11:965–71. 10.1016/j.cgh.2013.01.021
    1. Ali T, Madhoun MF, Orr WC, et al. . Assessment of the relationship between quality of sleep and disease activity in inflammatory bowel disease patients. Inflamm Bowel Dis 2013;19:2440–3. 10.1097/MIB.0b013e3182a0ea54
    1. Ranjbaran Z, Keefer L, Farhadi A, et al. . Impact of sleep disturbances in inflammatory bowel disease. J Gastroenterol Hepatol 2007;22:1748–53. 10.1111/j.1440-1746.2006.04820.x
    1. Uemura R, Fujiwara Y, Iwakura N, et al. . Sleep disturbances in Japanese patients with inflammatory bowel disease and their impact on disease flare. Springerplus 2016;5:5. 10.1186/s40064-016-3408-6
    1. Sofia MA, Lipowska AM, Zmeter N, et al. . Poor sleep quality in Crohn's disease is associated with disease activity and risk for hospitalization or surgery. Inflamm Bowel Dis 2020;26:1251–9. 10.1093/ibd/izz258
    1. Graff LA, Vincent N, Walker JR, et al. . A population-based study of fatigue and sleep difficulties in inflammatory bowel disease. Inflamm Bowel Dis 2011;17:1882–9. 10.1002/ibd.21580
    1. Keefer L, Stepanski EJ, Ranjbaran Z, et al. . An initial report of sleep disturbance in inactive inflammatory bowel disease. J Clin Sleep Med 2006;2:409–16. 10.5664/jcsm.26656
    1. Association AP . Dsm 5: American psychiatric association, 2013.
    1. Singareddy R, Vgontzas AN, Fernandez-Mendoza J, et al. . Risk factors for incident chronic insomnia: a general population prospective study. Sleep Med 2012;13:346–53. 10.1016/j.sleep.2011.10.033
    1. Mai E, Buysse DJ. Insomnia: prevalence, impact, pathogenesis, differential diagnosis, and evaluation. Sleep Med Clin 2008;3:167–74. 10.1016/j.jsmc.2008.02.001
    1. Taylor DJ, Mallory LJ, Lichstein KL, et al. . Comorbidity of chronic insomnia with medical problems. Sleep 2007;30:213–8. 10.1093/sleep/30.2.213
    1. Taylor DJ, Pruiksma KE. Cognitive and behavioural therapy for insomnia (CBT-I) in psychiatric populations: a systematic review. Int Rev Psychiatry 2014;26:205–13. 10.3109/09540261.2014.902808
    1. Smith MT, Perlis ML, Smith MS, et al. . Sleep quality and presleep arousal in chronic pain. J Behav Med 2000;23:1–13. 10.1023/A:1005444719169
    1. Morin CM, Gibson D, Wade J. Self-Reported sleep and mood disturbance in chronic pain patients. Clin J Pain 1998;14:311–4. 10.1097/00002508-199812000-00007
    1. Scott AJ, Flowers O, Rowse G. Do specific types of sleep disturbances represent risk factors for poorer health-related quality of life in inflammatory bowel disease? A longitudinal cohort study. Br J Health Psychol 2021;26:90–108. 10.1111/bjhp.12457
    1. Salwen-Deremer JK, Smith MT, Haskell HG, et al. . Poor sleep in inflammatory bowel disease is reflective of distinct sleep disorders. Dig Dis Sci 2021. 10.1007/s10620-021-07176-y. [Epub ahead of print: 30 Jul 2021].
    1. Spielman AJ, Caruso LS, Glovinsky PB. A behavioral perspective on insomnia treatment. Psychiatr Clin North Am 1987;10:541–53. 10.1016/S0193-953X(18)30532-X
    1. Qaseem A, Kansagara D, Forciea MA, et al. . Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of physicians. Ann Intern Med 2016;165:125–33. 10.7326/M15-2175
    1. Jacobs GD, Pace-Schott EF, Stickgold R, et al. . Cognitive behavior therapy and pharmacotherapy for insomnia: a randomized controlled trial and direct comparison. Arch Intern Med 2004;164:1888–96. 10.1001/archinte.164.17.1888
    1. Smith MT, Perlis ML, Park A, et al. . Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry 2002;159:5–11. 10.1176/appi.ajp.159.1.5
    1. Riemann D, Baglioni C, Bassetti C, et al. . European guideline for the diagnosis and treatment of insomnia. J Sleep Res 2017;26:675–700. 10.1111/jsr.12594
    1. Finan PH, Buenaver LF, Coryell VT, et al. . Cognitive-Behavioral therapy for comorbid insomnia and chronic pain. Sleep Med Clin 2014;9:261–74. 10.1016/j.jsmc.2014.02.007
    1. 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;25:559–92. 10.1016/j.cpr.2005.04.004
    1. Trauer JM, Qian MY, Doyle JS, et al. . Cognitive behavioral therapy for chronic insomnia: a systematic review and meta-analysis. Ann Intern Med 2015;163:191–204. 10.7326/M14-2841
    1. Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health Psychol 2006;25:3–14. 10.1037/0278-6133.25.1.3
    1. van Straten A, van der Zweerde T, Kleiboer A, et al. . Cognitive and behavioral therapies in the treatment of insomnia: a meta-analysis. Sleep Med Rev 2018;38:3–16. 10.1016/j.smrv.2017.02.001
    1. Cavanagh RC, Mackey R, Bridges L, et al. . The use of digital health technologies to manage insomnia in military populations. J Technol Behav Sci 2020;5:61–9. 10.1007/s41347-019-00114-w
    1. Edinger JD, Arnedt JT, Bertisch SM, et al. . Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of sleep medicine systematic review, meta-analysis, and grade assessment. J Clin Sleep Med 2021;17:263–98. 10.5664/jcsm.8988
    1. Perlis ML, Jungquist C, Smith MT, et al. . Cognitive behavioral treatment of insomnia: a session-by-session guide. Springer Science & Business Media, 2006.
    1. Kyle SD, Aquino MRJ, Miller CB, et al. . Towards standardisation and improved understanding of sleep restriction therapy for insomnia disorder: a systematic examination of CBT-I trial content. Sleep Med Rev 2015;23:83–8. 10.1016/j.smrv.2015.02.003
    1. Buysse DJ, Ancoli-Israel S, Edinger JD, et al. . Recommendations for a standard research assessment of insomnia. Sleep 2006;29:1155–73. 10.1093/sleep/29.9.1155
    1. Carney CE, Buysse DJ, Ancoli-Israel S, et al. . The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep 2012;35:287–302. 10.5665/sleep.1642
    1. Ancoli-Israel S, Martin JL, Blackwell T, et al. . The SBSM guide to actigraphy monitoring: clinical and research applications. Behav Sleep Med 2015;13 Suppl 1:S4–38. 10.1080/15402002.2015.1046356
    1. Cole RJ, Kripke DF, Gruen W, et al. . Automatic sleep/wake identification from wrist activity. Sleep 1992;15:461–9. 10.1093/sleep/15.5.461
    1. Bastien CH, Vallières A, Morin CM. Validation of the insomnia severity index as an outcome measure for insomnia research. Sleep Med 2001;2:297–307. 10.1016/S1389-9457(00)00065-4
    1. Buysse DJ, Reynolds CF, Monk TH, et al. . The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res 1989;28:193–213. 10.1016/0165-1781(89)90047-4
    1. Morin CM, Vallières A, Ivers H. Dysfunctional beliefs and attitudes about sleep (DBAS): validation of a brief version (DBAS-16). Sleep 2007;30:1547–54. 10.1093/sleep/30.11.1547
    1. Cohen ER, Melmed GY. Making a case for patient-reported outcomes in clinical inflammatory bowel disease practice. Clin Gastroenterol Hepatol 2018;16:603–7. 10.1016/j.cgh.2017.12.027
    1. Bewtra M, Brensinger CM, Tomov VT, et al. . An optimized patient-reported ulcerative colitis disease activity measure derived from the Mayo score and the simple clinical colitis activity index. Inflamm Bowel Dis 2014;20:1–8. 10.1097/MIB.0000000000000053
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006;3:77–101. 10.1191/1478088706qp063oa
    1. Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res 2011;45:626–9. 10.1016/j.jpsychires.2010.10.008
    1. Tew GA, Leighton D, Carpenter R, et al. . High-intensity interval training and moderate-intensity continuous training in adults with Crohn’s disease: a pilot randomised controlled trial. BMC Gastroenterol 2019;19:1–11. 10.1186/s12876-019-0936-x
    1. Vogelaar L, Van't Spijker A, Vogelaar T, et al. . Solution focused therapy: a promising new tool in the management of fatigue in Crohn's disease patients psychological interventions for the management of fatigue in Crohn's disease. J Crohns Colitis 2011;5:585–91. 10.1016/j.crohns.2011.06.001
    1. Siengsukon CF, Alshehri M, Williams C, et al. . Feasibility and treatment effect of cognitive behavioral therapy for insomnia in individuals with multiple sclerosis: a pilot randomized controlled trial. Mult Scler Relat Disord 2020;40:101958. 10.1016/j.msard.2020.101958
    1. Fritz CO, Morris PE, Richler JJ. Effect size estimates: current use, calculations, and interpretation. J Exp Psychol Gen 2012;141:2–18. 10.1037/a0024338
    1. Morin CM, Belleville G, Bélanger L, et al. . The insomnia severity index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep 2011;34:601–8. 10.1093/sleep/34.5.601
    1. Okajima I, Komada Y, INOUE Y. A meta-analysis on the treatment effectiveness of cognitive behavioral therapy for primary insomnia. Sleep Biol Rhythms 2011;9:24–34. 10.1111/j.1479-8425.2010.00481.x
    1. Mitchell LJ, Bisdounis L, Ballesio A, et al. . The impact of cognitive behavioural therapy for insomnia on objective sleep parameters: a meta-analysis and systematic review. Sleep Med Rev 2019;47:90–102. 10.1016/j.smrv.2019.06.002
    1. Morin CM, Colecchi C, Stone J, et al. . Behavioral and pharmacological therapies for late-life insomnia: a randomized controlled trial. JAMA 1999;281:991–9. 10.1001/jama.281.11.991
    1. Hashash JG, Knisely MR, Germain A, et al. . Brief Behavioral Therapy and Bupropion for Sleep and Fatigue in Young Adults With Crohn’s Disease: An Exploratory Open Trial Study. Clinical Gastroenterology and Hepatology 2022;20:96–104. 10.1016/j.cgh.2020.09.047
    1. Onken LS, Carroll KM, Shoham V, et al. . Reenvisioning clinical science: unifying the discipline to improve the public health. Clin Psychol Sci 2014;2:22–34. 10.1177/2167702613497932
    1. Williet N, Sandborn WJ, Peyrin-Biroulet L. Patient-Reported outcomes as primary end points in clinical trials of inflammatory bowel disease. Clin Gastroenterol Hepatol 2014;12:1246–56. 10.1016/j.cgh.2014.02.016
    1. Gîlc-Blanariu G-E, Ștefnescu G, Trifan AV, et al. . Sleep impairment and psychological distress among patients with inflammatory bowel Disease—beyond the obvious. J Clin Med 2020;9:2304. 10.3390/jcm9072304
    1. Irwin MR, Olmstead R, Carrillo C, et al. . Cognitive behavioral therapy vs. tai chi for late life insomnia and inflammatory risk: a randomized controlled comparative efficacy trial. Sleep 2014;37:1543–52. 10.5665/sleep.4008
    1. Irwin MR, Olmstead R, Breen EC, et al. . Cognitive behavioral therapy and tai chi reverse cellular and genomic markers of inflammation in late-life insomnia: a randomized controlled trial. Biol Psychiatry 2015;78:721–9. 10.1016/j.biopsych.2015.01.010
    1. Salwen-Deremer JK, Siegel CA, Smith MT. Cognitive behavioral therapy for insomnia: a promising treatment for insomnia, pain, and depression in patients with IBD. Crohns Colitis 360 2020;2:otaa052. 10.1093/crocol/otaa052

Source: PubMed

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