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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Previous studies have found that CBT-i results in significantly greater insomnia improvements than a placebo control group.
“Furthermore, previous studies have found that CBT-i results in significantly greater insomnia improvements than a placebo control group [30].”
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.
“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”
The low baseline levels of slow-wave sleep in these older participants may have reduced the ability to detect increases in those sleep stages.
“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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Insomnia and its treatment in women with breast cancer
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Cognitive-behavioral approaches to the treatment of insomnia.
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The evidence base of sleep restriction therapy for treating insomnia disorder
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By the numbers: ratings and utilization of behavioral health mobile applications
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“In addition, several studies had also suggested that traditional CBT-i could improve the comorbid depression [10,45,47].”
BackgroundDissemination of CBTI to the Non-Sleep Specialist: Protocol Development and Training Issues
Manber, R., Carney, C., Edinger, J., Epstein, D., Friedman, L., Haynes, P. L., Karlin, B. E., Pigeon, W., Siebern, A. T., & Trockel, M. (2012) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.1786 · Cited by 178 · see citing works
“) Subsequently, we expanded the CBTI training program to meet the needs of all mental health providers (regardless of their background in CBTI) within the VHA if they meet the following prerequisites: (1) they are licensed, credentialed, and routinely provide psychotherapy; (2) they receive approval and release time f…”
Self-citationA Cognitive Theory and Therapy for Chronic Insomnia
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“…formal cognitive therapy component of CBT-I, typically administered in one session, involves attempting to alter faulty beliefs about sleep by education and discussion about sleep requirements, the biological clock and the effects of sleep loss on sleep-wake functions (e.g., Edinger et al., 2001a).”
BackgroundSleep and Mental Health in Undergraduate Students with Generally Healthy Sleep Habits
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“behavioural treatment for insomnia [36, 48, 50].”
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Ballesio, A., Aquino, M. R. J. V., Feige, B., Johann, A. F., Kyle, S. D., Spiegelhalder, K., Lombardo, C., Rücker, G., Riemann, D., & Baglioni, C. (2018) · Sleep Medicine Reviews · doi:10.1016/j.smrv.2017.01.006 · Cited by 172 · see citing works
Measuring outcomes in randomized clinical trials of insomnia treatments
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“There are several additional self-report measures of insomnia, including the Sleep Disturbance Questionnaire (SDQ; [67, 68]), Dysfunctional Beliefs and Attitudes about Sleep (DBAS; [29]), Pre-Sleep Arousal Scale [69], and the Sleep Hygiene Awareness and Practice Scale [70].”
BackgroundMethodInfluentialPsychological Interventions for the Treatment of Chronic Pain in Adults
Driscoll, M. A., Edwards, R. R., Becker, W. C., Kaptchuk, T. J., & Kerns, R. D. (2021) · Psychological Science in the Public Interest · doi:10.1177/15291006211008157 · Cited by 176 · see citing works
Who is at risk for dropout from group cognitive-behavior therapy for insomnia?
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Increased Insula Coactivation with Salience Networks in Insomnia
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Examining maladaptive beliefs about sleep across insomnia patient groups
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“These data have been published in both peerreviewed manuscripts [13,14] and abstract format [15].”
Self-citationCognitive behaviour therapy for primary insomnia: Can we rest yet?
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“Behavioral desensitization has been used successfully as a credible placebo in a clinical trial in primary insomnia (44).”
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Sleep Hygiene Practices in a Population-Based Sample of Insomniacs
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Understanding and Treating Insomnia
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“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).”
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“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 · see citing works
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“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 · see citing works
“…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).”
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Cognitive Behavioral Therapy for Prenatal Insomnia: A Randomized Controlled Trial
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Identifying critical beliefs about sleep in primary insomnia.
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Self-citationRelationship Between Sleep Quality and Mood: Ecological Momentary Assessment Study
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“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
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Clinical practice. Chronic insomnia.
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Sleep disturbances, TBI and PTSD: Implications for treatment and recovery
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“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
- 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 › 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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