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Cognitive Behavioral Therapy for Treatment of Chronic Primary Insomnia: A Randomized Controlled Trial
Abstract
CONTEXT: Use of nonpharmacological behavioral therapy has been suggested for treatment of chronic primary insomnia, but well-blinded, placebo-controlled trials demonstrating effective behavioral therapy for sleep-maintenance insomnia are lacking. OBJECTIVE: To test the efficacy of a hybrid cognitive behavioral therapy (CBT) compared with both a first-generation behavioral treatment and a placebo therapy for treating primary sleep-maintenance insomnia. DESIGN AND SETTING: Randomized, double-blind, placebo-controlled clinical trial conducted at a single academic medical center, with recruitment from January 1995 to July 1997. PATIENTS: Seventy-five adults (n = 35 women; mean age, 55.3 years) with chronic primary sleep-maintenance insomnia (mean duration of symptoms, 13.6 years). INTERVENTIONS: Patients were randomly assigned to receive CBT (sleep education, stimulus control, and time-in-bed restrictions; n = 25), progressive muscle relaxation training (RT; n = 25), or a quasi-desensitization (placebo) treatment (n = 25). Outpatient treatment lasted 6 weeks, with follow-up conducted at 6 months. MAIN OUTCOME MEASURES: Objective (polysomnography) and subjective (sleep log) measures of total sleep time, middle and terminal wake time after sleep onset (WASO), and sleep efficiency; questionnaire measures of global insomnia symptoms, sleep-related self-efficacy, and mood. RESULTS: Cognitive behavioral therapy produced larger improvements across the majority of outcome measures than did RT or placebo treatment. For example, sleep logs showed that CBT-treated patients achieved an average 54% reduction in their WASO whereas RT-treated and placebo-treated patients, respectively, achieved only 16% and 12% reductions in this measure. Recipients of CBT also showed a greater normalization of sleep and subjective symptoms than did the other groups with an average sleep time of more than 6 hours, middle WASO of 26.6 minutes, and sleep efficiency of 85.1%. In contrast, RT-treated patients continued to report a middle WASO of 43.3 minutes and sleep efficiency of 78.8%. CONCLUSIONS: Our results suggest that CBT represents a viable intervention for primary sleep-maintenance insomnia. This treatment leads to clinically significant sleep improvements within 6 weeks and these improvements appear to endure through 6 months of follow-up.
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“Furthermore, previous studies have found that CBT-i results in significantly greater insomnia improvements than a placebo control group [30].”
In the citing paper
“CBT is the standard of care for many psychiatric disorders including depression, anxiety disorders, eating disorders, addiction, chronic pain and sleeping disturbance (insomnia) across the spectrum of acuity.16–20”
In the citing paper
“The low levels of baseline SWS seen in our older participants—similar to other populations of older adults (28)—may have mitigated the detection of increases in those sleep stages.”
From Effects of moderate-intensity exercise on polysomnographic and subjective sleep quality in older adults with mild to moderate sleep complaints (2008) · cites this paper as [28]
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Efficacy of an early intervention for patients with acute temporomandibular disorder–related pain
Gatchel, R. J., Stowell, A. W., Wildenstein, L., Riggs, R., & Ellis, E. (2006) · The Journal of the American Dental Association · doi:10.14219/jada.archive.2006.0183 · Cited by 157
Smith, M. T., Finan, P. H., Buenaver, L. F., Robinson, M., Haque, U. J., Quain, A. M., McInrue, E., Han, D., Leoutsakis, J., & Haythornthwaite, J. A. (2015) · Arthritis & Rheumatology · doi:10.1002/art.39048 · Cited by 159
“Behavioral desensitization has been used successfully as a credible placebo in a clinical trial in primary insomnia (44).”
MethodResultMorin, C. M., Koetter, U., Bastien, C., Ware, J. C., & Wooten, V. (2005) · Sleep · doi:10.1093/sleep/28.11.1465 · Cited by 190
Sleep Hygiene Practices in a Population-Based Sample of Insomniacs
Jefferson, C. D., Drake, C. L., Scofield, H., Myers, E., McClure, T., Roehrs, T., & Roth, T. G. (2005) · SLEEP · doi:10.1093/sleep/28.5.611 · Cited by 158
Nowakowski, S., Meers, J. M., & Heimbach, E. (2013) · Sleep Medicine Research · doi:10.17241/smr.2013.4.1.1 · Cited by 166
Understanding and Treating Insomnia
Bootzin, R. R., & Epstein, D. R. (2011) · Annual Review of Clinical Psychology · doi:10.1146/annurev.clinpsy.3.022806.091516 · Cited by 150
“Other CBT-I studies include cognitive components in educational instruction that address misconceptions about sleep, sleep requirements, sleep and aging, sleep loss, sleep drive, and circadian rhythms (e.g., Edinger et al. 2001, Epstein & Dirksen 2007).”
BackgroundMethodBhat, S., & Chokroverty, S. (2021) · Sleep Medicine · doi:10.1016/j.sleep.2021.07.021 · Cited by 153
“Cognitive behavioral therapy (CBT) [28] has been shown to have long-term efficacy in cases of primary insomnia or insomnia precipitated by stressors; COVID-19 would certainly qualify for this label, but CBT has yet to be studied in this particular context.”
BackgroundSweetman, A., Lack, L., Catcheside, P. G., Antic, N. A., Smith, S., Chai-Coetzer, C. L., Douglas, J., O’grady, A., Dunn, N., Robinson, J., et al. (2019) · Sleep · doi:10.1093/sleep/zsz178 · Cited by 149
Brasure, M., Fuchs, E. L., MacDonald, R. H., Nelson, V. A., Koffel, E., Olson, C. M., Khawaja, I. S., Diem, S. J., Carlyle, M. H., Wilt, T. J., et al. (2016) · Annals of Internal Medicine · doi:10.7326/m15-1782 · Cited by 148
“Other Comparisons Several trials compared different intervention types (29, 31, 34, 45, 46, 51, 53, 63, 72, 77, 79) or similar interventions with different delivery characteristics (24, 26, 48, 61, 67, 79) or reported on special populations (88).”
BackgroundSchwartz, D. R., & Carney, C. E. (2012) · Clinical Psychology Review · doi:10.1016/j.cpr.2012.06.006 · Cited by 137
“…al., 2001b; Morin et al., 2002; Rybarczyk et al., 2005b), and (c) at post-treatment and follow-up, reductions in DBAS scores were associated with a range of subjective and objective sleep outcomes (Edinger et al., 2001b; Jansson-Fröjmark & Linton, 2008; Morin et al., 2002; Tremblay et al., 2009).”
BackgroundResultInfluentialArnedt, J. T., Conroy, D. A., Armitage, R., & Brower, K. J. (2011) · Behaviour Research and Therapy · doi:10.1016/j.brat.2011.02.003 · Cited by 147
Cognitive Behavioral Therapy for Prenatal Insomnia: A Randomized Controlled Trial
Manber, R., Bei, B., Simpson, N., Asarnow, L., Rangel, E., Sit, A., & Lyell, D. (2019) · Obstetrics & Gynecology · doi:10.1097/aog.0000000000003216 · Cited by 145
Identifying critical beliefs about sleep in primary insomnia.
Carney, C., & Edinger, J. (2006) · Sleep · doi:10.1093/sleep/29.3.342 · Cited by 136
Self-citationRelationship Between Sleep Quality and Mood: Ecological Momentary Assessment Study
Triantafillou, S., Saeb, S., Lattie, E. G., Mohr, D. C., & Kording, K. P. (2018) · JMIR Mental Health · doi:10.2196/12613 · Cited by 165
“Specifically for insomnia, cognitive behavioral therapy for insomnia (CBT-I) has been established as a gold standard treatment [36,37].”
BackgroundSleep Disorders in the Elderly
Yaremchuk, K. (2018) · Clinics in Geriatric Medicine · doi:10.1016/j.cger.2018.01.008 · Cited by 141
Chen, H.-Y., Cheng, I.-C., Pan, Y.-J., Chiu, Y.-L., Hsu, S.-P., Pai, M.-F., Yang, J.-Y., Peng, Y.-S., Tsai, T.-J., & Wu, K.-D. (2011) · Kidney International · doi:10.1038/ki.2011.151 · Cited by 140
A Brief Behavioral Sleep Intervention for Family Caregivers of Persons With Cancer
Carter, P. A. (2006) · Cancer Nursing · doi:10.1097/00002820-200603000-00003 · Cited by 135
Kuhn, E., Weiss, B. J., Taylor, K. L., Hoffman, J. E., Ramsey, K. M., Manber, R., Gehrman, P., Crowley, J. J., Ruzek, J. I., & Trockel, M. (2016) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.5700 · Cited by 135
Silber, M. H. (2005) · New England Journal of Medicine · doi:10.1056/nejmcp043762 · Cited by 136
Buscemi, N., Vandermeer, B., Friesen, C., Bialy, L. M., Tubman, M., Ospina, M. B., Klassen, T. P., & Witmans, M. (2005) · PsycEXTRA Dataset · doi:10.1037/e439752005-001 · Cited by 134
Sleep disturbances, TBI and PTSD: Implications for treatment and recovery
Stavitsky, K., Kark, S. M., Gehrman, P., & Bogdanova, Y. (2015) · Clinical Psychology Review · doi:10.1016/j.cpr.2015.05.008 · Cited by 143
Červená, K., Dauvilliers, Y. A., Espa, F., Touchon, J., Matouŝek, M., Billiard, M. M., & Besset, A. (2004) · Journal of Sleep Research · doi:10.1111/j.1365-2869.2004.00431.x · Cited by 136
“The ISI scale was found to be a robust measure of treatment outcome as changes over time were found to converge with both objective and subjective measures (PSG, sleep diary) consistent with results obtained by previous studies (Bastien et al., 2001a; Edinger et al., 2001b; Morin et al., 2002).”
MethodResult
Metadata
- Authors
- Edinger, J. D., Wohlgemuth, W. K., Radtke, R. A., Marsh, G. R., & Quillian, R. E.
- Affiliations
- Durham VA Medical Center (US)
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2001-04-11
- Volume
- 285
- Issue
- 14
- Pages
- 1856
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2090423345
- Cited by
- 625
- References
- 37
- Citations by year
- 2026: 7 · 2025: 14 · 2024: 21 · 2023: 19 · 2022: 16 · 2021: 29 · 2020: 25 · 2019: 29 · 2018: 22 · 2017: 29 · 2016: 37 · 2015: 38 · 2014: 40 · 2013: 43 · 2012: 20
- FWCI
- 28.87
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute of Mental Health (R01MH48187, R01MH048187)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Health Sciences › Medicine › Physiology (medical) › Obstructive Sleep Apnea Research
- Keywords
- cognitive behavioral therapy, chronic primary insomnia, sleep maintenance insomnia, progressive muscle relaxation, stimulus control, sleep education, wake after sleep onset, sleep efficiency, non-pharmacological treatment
- MeSH terms
- Adult, Aged, Double-Blind Method, Female, Humans, Sleep Initiation and Maintenance Disorders, Male, Middle Aged, Surveys and Questionnaires, Relaxation Therapy, Cognitive Behavioral Therapy, Polysomnography
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