Cited by 625Sleep and related disordersAnxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesObstructive Sleep Apnea Research

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Cognitive Behavioral Therapy for Treatment of Chronic Primary Insomnia: A Randomized Controlled Trial

Edinger, Jack D., Wohlgemuth, William K., Radtke, Rodney A., Marsh, Gail R., Quillian, Ruth E.·2001·JAMA

DOI 10.1001/jama.285.14.1856

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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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Method
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Background
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Background
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Self-citation
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Method
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“28 Stimulus control aims to break the association between bed and sleep-incompatible activities.”
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Background
Assessing cognitive behavioral therapy for insomnia in individuals with cannabis use disorder utilizing actigraphy and serum biomarkers: A pilot study
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“These thresholds were chosen because 30 min has been commonly used as a minimum WASO threshold in insomnia trials [16], 45 min has been used as an alternative, stricter criterion in some studies [5,11,6–9], and 90 min defines a very high WASO, clinically severe population lacking a precedent.”
Method
Examining the Variability of Sleep Patterns during Treatment for Chronic Insomnia: Application of a Location-Scale Mixed Model
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“15 The data analyses were guided by two research questions.”
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Chapter 9. Alcohol and Drug Problems
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Primary insomnia: A disorder of sleep, or primarily one of wakefulness?
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Tragedy and Insomnia
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Neurobiological Correlates of Psychological Treatments for Insomnia
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Evaluation of Sleep Training Effectiveness on the Quality of Sleep in Cancer Patients during Chemotherapy
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The management of insomnia by Australian psychologists: a qualitative study
Haycock, J., Hoon, E. A., Sweetman, A., Lack, L. C., & Lovato, N. (2022) · Australian Psychologist · doi:10.1080/00050067.2022.2089544 · Cited by 11
“Although these strategies are part of CBTi, they are not recommended as effective stand-alone treatments for insomnia (Chung et al., 2018; Edinger et al., 2001).”
Background
Are Cardiometabolic and Endocrine Abnormalities Linked to Sleep Difficulties in Schizophrenia? A Hypothesis Driven Review
Robillard, R., Rogers, N. L., Whitwell, B. G., & Lambert, T. J. R. (2012) · Clinical Psychopharmacology and Neuroscience · doi:10.9758/cpn.2012.10.1.1 · Cited by 10
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“Several studies have demonstrated the efficacy of alternative treatments, such as cognitive behavioural therapy, [1–5] but the problem in general practice is usually not whether the pharmacological approach is better than the non-pharmacological approach, but rather how to combine both in an era of managed care.”
Background
Exercise as an Adjunct Treatment to Cognitive Behavior Therapy for Insomnia
Passos, G. S., Youngstedt, S. D., & Santana, M. G. (2023) · Sleep Medicine Clinics · doi:10.1016/j.jsmc.2022.09.001 · Cited by 9
From Bedside Back to Bench? A Commentary on: “The Future of Cognitive Behavioral Therapy for Insomnia: What Important Research Remains to Be Done?”
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Insomnia: A Therapeutic Review for Pharmacists
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Insomnia: Sleep Restriction Therapy
Spielman, A. J., Yang, C., & Glovinsky, P. B. (2016) · doi:10.3109/9781420080803-27 · Cited by 9
A Multimethod Examination of the Effect of Insomnia Symptoms on Anxious Responding to a Social Stressor
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Cognitive and Behavioral Treatment Options for Insomnia
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Disease-specific self-efficacy in the eosinophilic gastrointestinal disorders
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“Specifically, cognitive behavioral therapy (CBT) interventions are shown to increase SE in patients with many chronic conditions (Edinger et al., 2001; O’Leary et al., 1988; Redondo et al., 2004), and may benefit patients with EGIDs.”
Background
Managed Mental Health Care in Large Jails: Empirical Outcomes on Cost and Quality
Szykula, S. A., & Jackson, D. F. (2005) · Journal of Correctional Health Care · doi:10.1177/107834580401100302 · Cited by 9
Sleep and Quality of Life in Chronic Pain
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“Multicomponent cognitive behavioral treatment for chronic insomnia focuses on stimulus control and sleep restriction therapies that have demonstrated significant efficacy in a number of well-controlled clinical trials using both subjective and objective measures of sleep ( 94 ).”
Method
Diagnostic Tools for Insomnia
Ong, J. C., & Suh, S. A. (2013) · Elsevier eBooks · doi:10.1016/b978-0-12-378610-4.00196-0 · Cited by 9
A Pilot Randomized Trial of Combined Cognitive-Behavioral Therapy and Exercise Training Versus Exercise Training Alone for the Management of Chronic Insomnia in Obstructive Sleep Apnea
Cammalleri, A., Perrault, A. A., Hillcoat, A., Carrese‐Chacra, E., Tarelli, L., Patel, R. S., Baltzan, M., Chouchou, F., Dang‐Vu, T. T., Gouin, J., et al. (2024) · Journal of Sport and Exercise Psychology · doi:10.1123/jsep.2023-0139 · Cited by 9
The aetiology, impact and management of cancer-related fatigue in patients with advanced cancer
Chan, R. J., Yates, P. M., & McCarthy, A. L. (2011) · QUT ePrints (Queensland University of Technology) · Cited by 8
What are patients completing Cognitive Behavioral Insomnia Therapy telling us with their post-treatment Insomnia Severity Index scores?
Marway, O. S., Lau, P. H., Carmona, N. E., & Carney, C. E. (2023) · Sleep Medicine · doi:10.1016/j.sleep.2023.02.008 · Cited by 8
The Treatment of Primary Insomnia
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Brief CBT-I for Insomnia Comorbid with Social Phobia: A Case Study
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Chapter 2. Psychopharmacology
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Reprint of “The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016: Explanation and Elaboration”
Tate, R. L., Perdices, M., Rosenkoetter, U., McDonald, S., Togher, L., Shadish, W. R., Horner, R. H., Kratochwill, T. R., Barlow, D. H., Kazdin, A. E., et al. (2019) · Pratiques Psychologiques · doi:10.1016/j.prps.2019.03.001 · Cited by 10
From guidelines to bedside - insomnia treatment practices in South Korea: a nationwide cohort study
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“Meta-analyses have demonstrated that CBT-I leads to signi ﬁ cant improvements in insomnia symptoms, sleep ef ﬁ ciency, and sleep quality across a wide array of clinical populations (25 – 28).”
Background
Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop
Okun, M. L., & Glidewell, R. N. (2022) · Behavioral Sleep Medicine · doi:10.1080/15402002.2022.2036741 · Cited by 7
“These data are in line with other studies that have evaluated CBT-I in various formats, durations, or populations (C. Alessi et al., 2016; Buysse et al., 2011; Carney et al., 2017; Castronovo et al., 2018; Edinger et al., 2001; Sadler et al., 2018; Swift et al., 2012).”
Result
Sleep in Patients with ESRD Undergoing Hemodialysis
Mollaoğlu, M. (2011) · InTech eBooks · doi:10.5772/21597 · Cited by 7
“It is important to understand that successful treatment is only possible if the patient complies with suggestions to improve sleep hygiene (Edinger et al., 2001).”
Background
Assessment and Treatment of Insomnia in Adults: A Guide for Clinicians
Milner, C. E., & Belicki, K. (2010) · Journal of Counseling & Development · doi:10.1002/j.1556-6678.2010.tb00015.x · Cited by 7
Early Intervention to Prevent the Development of Chronic Musculoskeletal Pain Disorders and Disability
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A feasibility study: Use of actigraph to monitor and follow-up sleep/wake patterns in individuals attending community pharmacy with sleeping disorders
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“[35,36] One study which evaluated the effectiveness of CBTI (by evaluating changes in the ISI mean scores), found that the scores for the CBTI group was significantly reduced from pre‑treatment to post‑treatment.”

Authors: Edinger, J. D., Wohlgemuth, W. K., Radtke, R. A., Marsh, G. R., & Quillian, R. E.
Affiliations: Durham VA Medical Center (US)
ORCID: Edinger, Jack D.
Radtke, Rodney A.
Venue: JAMA
Publisher: American Medical Association (AMA)
Published: 2001-04-11
Volume: 285
Issue: 14
Pages: 1856
ISSN: 0002-9955 (ISSN-L)
0098-7484
DOI: 10.1001/jama.285.14.1856
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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Cognitive Behavioral Therapy for Treatment of Chronic Primary Insomnia: A Randomized Controlled Trial

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