James M. Trauer, MBBS; Mary Y. Qian, MBBS; Joseph S. Doyle, PhD; Shantha M.W. Rajaratnam, PhD; David Cunnington, MBBS
This article was published online first at www.annals.org on 9 June 2015.
Acknowledgment: The authors thank Kathryn Rough of the Western Hospital and Northern Hospital libraries, who was the chief study librarian and performed the database searches. They also thank the authors of contributing studies who provided additional data and clarification to facilitate this meta-analysis, as well as Dr. Evan Symons, who assessed 1 article and 1 abstract written in German.
Disclosures: Dr. Rajaratnam reports consultancies for VANDA Pharmaceuticals, Philips Respironics, EdanSafe, organizations employing shift workers, the National Transport Commission, The Australian Workers' Union, and Tontine Group; expert testimony for organizations employing shift workers; grants from VANDA Pharmaceuticals, Philips Respironics, and Cephalon; personal fees from VANDA Pharmaceuticals; and equipment from Compumedics, Optalert, Tyco Healthcare, and Philips Lighting outside the submitted work. He also reports that he was 2014 President and board member of the Australasian Sleep Association and Program Leader of the Cooperative Research Centre for Alertness, Safety and Productivity. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-2841.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Reproducible Research Statement:Study protocol: Available at www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42012002863. Statistical code and data set: Available at http://sleephub.com.au/review-of-cognitive-behavioral-therapy-for-insomnia.
Requests for Single Reprints: James M. Trauer, MBBS, Melbourne Sleep Disorders Centre, Suite 508, Level 5, Victoria Parade, East Melbourne, Victoria 3002, Australia.
Current Author Addresses: Drs. Trauer, Qian, and Cunnington: Melbourne Sleep Disorders Centre, Suite 508, Level 5, Victoria Parade, East Melbourne, Victoria 3002, Australia.
Dr. Doyle: The Burnet Institute, 85 Commercial Road, Melbourne, Victoria 3004, Australia.
Dr. Rajaratnam: School of Psychological Sciences, 18 Innovation Walk, Monash University, Wellington Road, Clayton, Victoria 3800, Australia.
Author Contributions: Conception and design: J.M. Trauer, J.S. Doyle, S.M.W. Rajaratnam, D. Cunnington.
Analysis and interpretation of the data: J.M. Trauer, M.Y. Qian, J.S. Doyle, S.M.W. Rajaratnam, D. Cunnington.
Drafting of the article: J.M. Trauer, M.Y. Qian.
Critical revision of the article for important intellectual content: J.M. Trauer, J.S. Doyle, D. Cunnington.
Final approval of the article: J.M. Trauer, M.Y. Qian, J.S. Doyle, S.M.W. Rajaratnam, D. Cunnington.
Statistical expertise: J.M. Trauer, J.S. Doyle.
Administrative, technical, or logistic support: D. Cunnington.
Collection and assembly of data: J.M. Trauer, M.Y. Qian, D. Cunnington.
Trauer J., Qian M., Doyle J., Rajaratnam S., Cunnington D.; Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015;163:191-204. doi: 10.7326/M14-2841
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Published: Ann Intern Med. 2015;163(3):191-204.
Because psychological approaches are likely to produce sustained benefits without the risk for tolerance or adverse effects associated with pharmacologic approaches, cognitive behavioral therapy for insomnia (CBT-i) is now commonly recommended as first-line treatment for chronic insomnia.
To determine the efficacy of CBT-i on diary measures of overnight sleep in adults with chronic insomnia.
Searches of MEDLINE, EMBASE, PsycINFO, CINAHL, the Cochrane Library, and PubMed Clinical Queries from inception to 31 March 2015, supplemented with manual screening.
Randomized, controlled trials assessing the efficacy of face-to-face, multimodal CBT-i compared with inactive comparators on overnight sleep in adults with chronic insomnia. Studies of insomnia comorbid with medical, sleep, or psychiatric disorders were excluded.
Study characteristics, quality, and data were assessed independently by 2 reviewers. Main outcome measures were sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE%).
Among 292 citations and 91 full-text articles reviewed, 20 studies (1162 participants [64% female; mean age, 56 years]) were included. Approaches to CBT-i incorporated at least 3 of the following: cognitive therapy, stimulus control, sleep restriction, sleep hygiene, and relaxation. At the posttreatment time point, SOL improved by 19.03 (95% CI, 14.12 to 23.93) minutes, WASO improved by 26.00 (CI, 15.48 to 36.52) minutes, TST improved by 7.61 (CI, −0.51 to 15.74) minutes, and SE% improved by 9.91% (CI, 8.09% to 11.73%). Changes seemed to be sustained at later time points. No adverse outcomes were reported.
Narrow inclusion criteria limited applicability to patients with comorbid insomnia and other sleep problems, and accuracy of estimates at later time points was less clear.
CBT-i is an effective treatment for adults with chronic insomnia, with clinically meaningful effect sizes.
None. (PROSPERO registration number: CRD42012002863)
Maurits van den Noort, PhD;1,2* Peggy Bosch, MA;1,3,4 Heike Staudte, MD;4 and Sabina Lim, MD, PhD1
1 Kyung Hee University, 2 Free University of Brussels, 3 Radboud University, 4 LVR-Klinik Bedburg-Hau
August 20, 2015
Efficacy of Cognitive Behavioral Therapy in the Treatment of Chronic Insomnia
TO THE EDITOR: In their highly interesting systematic review and meta-analysis, Trauer and colleagues (1) conclude that cognitive behavioral therapy is a very effective treatment for adults suffering from chronic insomnia, producing clinically meaningful effect sizes. In addition, the authors claim that its efficacy seems to be well-maintained over time and leads to a significant decrease of symptoms.
Although we agree with Trauer et al. (1) and Morin (2) that cognitive behavioral therapy seems to be a promising treatment for chronic insomnia, there are three issues that did not receive enough attention, therefore, the conclusions that were drawn by Trauer and colleagues (1) are premature. First, Trauer et al. (1) do not give any information on how “chronic” was defined in their meta-analysis and whether those studies included in their study, use the same criterion for chronic insomnia?
Secondly, there is a bias in the data because, naturally, only published studies are included in the present meta-analysis, leading to higher efficacy scores, because studies that do not find any significant (positive) results probably will not get published. This over-estimation of treatment efficacy is a common problem in meta-analyses (3) and can be better accounted for by including all collected data of registered clinical trials instead of only the published ones (3). However, even more important, with respect to the bias in their data, how did the studies, included in the present meta-analysis; deal with drop-out? This is particularly of importance, because previous research has revealed that cognitive behavioral therapy suffers from high drop-out rates, up to even 34% (4, 5).
Finally, Trauer et al. (1) state that “Its efficacy seems to be well-maintained over time and results in significant alleviation of symptoms” (on page 201). However, if we take a closer look at their data (see page 197-200), we see that they base their statement solely on either 4 or 5 studies at early follow-up and on either 3 or 4 studies at late follow-up, which is a very low number of studies, and even more astonishing is the fact that the authors on the same page state “the improvements at the late follow-up time point were also not statistically significant”. Therefore, to date, it is simply too premature to claim that its efficacy seems to be well-maintained over time; more future studies on the long-term effects of cognitive behavioral therapy in chronic insomnia are required.
Conflict of interest
The authors report no conflict of interest.
1. 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;163:191-204. [PMID: 26054060] doi:10.7326/M14-2841
2. Morin CM. Cognitive behavioral therapy for chronic insomnia: State of the science versus current clinical practices. Ann Intern Med. 2015;163:236-7. [PMID: 26052868] doi:10.7326/M15-1246
3. Schmucker C, Bluemle A, Briel M, Portalupi S, Lang B, Motschall E, et al. A protocol for a systematic review on the impact of unpublished studies and studies published in the gray
James M. Trauer, MBBS, David Cunnington, MBBS
Melborne Sleep Disorders Center
September 9, 2015
TO THE EDITOR: We thank Dr van den Noort and colleagues for their comments.In relation to insomnia definition and duration, the terms that we accepted as indicating chronic insomnia are listed in the Supplemental Appendix and Table 1 presents the texts referenced by individual studies for their definitions. The two studies with insomnia definitions listed as “author-defined” required a duration of one month (Waters) and six months (Lovato), and both DSM-IV and RDC criteria require a duration of at least one month (1, 2). Therefore, the minimum duration of insomnia required for entry into any of the studies of our review would have been one month. Nine of the studies reported a mean duration of insomnia among participants, which ranged from 9.5 to 14.3 months, with the exception of the one study which did not contribute data to pooled estimates (Guilleminault), for which the duration was 4.1 months.Publication bias and loss to follow up are universal concerns in meta-analyses of clinical trials. Our search strategy returned a number of trial protocols, including studies currently underway and yet to report results. We also found no statistical evidence of publication bias. Risk of bias due to incomplete follow up is presented in Table 2 and our approach to assessing this domain is described in the Study Quality section of the manuscript. Only one study had greater than 10% loss to follow up at post-treatment (14% of the treatment cohort) and did not describe a statistical technique to account for these drop outs (Espie 2001), although risk was unclear for a further three.As van den Noort and colleagues also point out, our results at late follow up did not achieve statistical significance using a Knapp-Hartung method for random effect meta-analyses. Although we believe this statistical approach is the most appropriate approach and accords with Annals policy, it is not as commonly used as the standard Laird-Dersimonian method (3). Under the Laird-Dersimonian approach, all outcomes except SOL (i.e. TST, SE% and WASO) were statistically significant at both early and late follow up, but borderline using the Knapp-Hartung method. Moreover, as the point estimates for outcomes remained virtually unchanged over time, we believe our findings are consistent with patients maintaining their skills over time and that the wording “seems to be well-maintained” is justified. Our statement that CBT-i “results in significant alleviation of symptoms” refers to the statistically significant secondary outcome results at post-treatment.James M Trauer and David Cunnington1. Diagnostic and statistical manual for mental disorders, text revision (DSM-IV-TR). 4th ed. ed. Washington, DC: American Psychiatric Association; 1997.2. Edinger JD, Bonnet MH, Bootzin RR, Doghramji K, Dorsey CM, Espie CA, et al. Derivation of research diagnostic criteria for insomnia: report of an American Academy of Sleep Medicine Work Group. Sleep. 2004;27:1567-96.3. Cornell JE, Mulrow CD, Localio R, Stack CB, Meibohm AR, Guallar E, et al. Random-effects meta-analysis of inconsistent effects: a time for change. Ann Intern Med. 2014;160:267-70.
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