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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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“Effect sizes for MBTI are comparable to those found for other behavioral interventions for insomnia [ 42 , 43 ], and MBTI appears to be superior to MBSR for reducing selfreported severity of insomnia symptoms over the long term.”
MethodInsomnia: Sleep Restriction Therapy
Spielman, A. J., Yang, C., & Glovinsky, P. B. (2010) · Medical psychiatry · doi:10.3109/9781420080803.025 · Cited by 7
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“Several studies have shown that CBT has a positive and long-lasting effect on primary insomnia [29, 36 ].”
BackgroundUsefulness of psychoeducational intervention in chronic insomnia: an actigraphic study
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BackgroundMethodInfluentialSommeil, insomnie et psychopathologie.
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“The authors also propose that Behavioral Activation (Martell et al., 2001) may assist in increasing the participation in social activities and lead to building greater social connections, while the reduction in insomnia in CBT for Insomnia (Edinger et al., 2001) might improve symptoms of isolation and thwarted belongi…”
BackgroundInsomnia treatments: moving from efficacy to effectiveness
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State of the Art Reviews: Nonpharmacologic Approaches for the Treatment of Insomnia
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Chapter 4. Dementia and Milder Cognitive Syndromes
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NHG-Standaard Slaapproblemen en slaapmiddelen
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“Chemotherapy-induced side effects, such as fatigue, nausea, and neuropathy, may lead to sleep disturbances, while the psychological burden of aggressive treatment may exacerbate anxiety and depression (47, 48).”
Prather, A. A., Krystal, A. D., Emsley, R., Carl, J. R., Ball, T. M., Tarnai, K., Aguilera, A., Espie, C. A., & Henry, A. L. (2025) · JMIR Mental Health · doi:10.2196/84323 · Cited by 8
“Initial analyses revealed that study participants, on average, reported at least seven hours of sleep, which is higher than in several other similar trials [33,66,67] and could indicate minimal room for improvement in SOL and WASO despite high overall insomnia severity.”
Adjunctive smart ring monitoring during digital cognitive behavioral therapy for insomnia
Moon, D. U., Lee, Y., Lütt, A., Lee, S., & Lee, E. M. (2025) · Scientific Reports · doi:10.1038/s41598-025-24312-0 · Cited by 4
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“Generally, most cognitive therapy occurs over a 12- to 16-week period and has been noted to have both immediate and lasting effect upon sleep measures—even up to a year following cessation of formal therapy.(38,42,46) One of the advantages of CBT is that it is a standardized psychotherapy technique, and cognitive and…”
BackgroundTherapeutic efficacy of zolpidem combined with cognitive-behavioral therapy on primary insomnia
Song, Y., & Liang, B. (2019) · Medicine · doi:10.1097/md.0000000000017122 · Cited by 3
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The Efficacy and Safety of Long-Term Use of Hypnotics
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“CBT에 대한 RCT에서는 CBT가 SOL 감소 및 수면의 효 율성(sleep efficiency, SE) 증가에 유의한 것으로 나타났 다.(8,9) 수면 유지가 어려운 만성 불면증 환자 75명을 대상으”
Clinical Handbook of Insomnia (Current Clinical Neurology)
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Self-citationCognitive-Behavioral Therapy for Insomnia
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Cognitive Behavioral Treatment of Chronic Insomnia
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“Second, patients treated with CBT-I continue to improve over followup periods as long as 24 months [ 9 , 10 ].”
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“If the above measures fail to resolve chronic insomnia, a variety of other behavioral measures, collectively termed cognitive-behavioral therapy (CBT), have been shown to be helpful and are comparable to drug treatment.(17,18) CBT includes techniques for relaxation, NEUROPHARMACOLOGY OF SLEEP DISORDERS”
MethodChanging perspectives in the nutritional management of disease
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The management of insomnia: an update
Tiller, J. W. G. (2003) · Australian Prescriber · doi:10.18773/austprescr.2003.061 · Cited by 5
“Cognitive behaviour therapy techniques can also assist some patients.(2,3,4)”
BackgroundNew Approaches in Managing Chronic Insomnia
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“En las intervenciones combinadas se encontró que 26 (70%) utilizaron técnicas cognitivo conductuales (TCC) o una combinación de algunas de sus técnicas, como higiene de sueño (HS) más restricción de sueño (RS), y biblioterapia cognitivo conductual más consultas telefónicas semanales (21,22,25-28,30,31,33,35-51).”
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“These methods are not recommended by cognitive behavioral therapy for insomnia [18].”
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Evaluating Acceptance and Commitment Therapy for Insomnia: A Randomized Controlled Trial
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“Pharmacologic treatment has a high chance of producing side effects [2], but nonpharmacologic therapies could bring a long-lasting and reliable increase in the quality of sleep among people with chronic insomnia and have minimal side effects [3].”
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Xie, X., Xu, Y., Wang, R., Lei, X., & Yu, J. (2021) · Experimental Aging Research · doi:10.1080/0361073x.2021.1985359 · Cited by 4
Cognitive Behavioral Therapy for Insomnia
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Chapter 10. Individual and Group Psychotherapy
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Online treatment of insomnia using behavioral techniques
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“The effectiveness of CBT has been supported in clinical trials, but the therapy is not available in all medical centers.(20,21) In addition to CBT, the NP can educate the patient about healthy sleep practices and sleep hygiene measures that promote sleep.”
BackgroundChapter 8. Sleep and Circadian Rhythm Disorders
Krystal, A. D., Edinger, J. D., & Wohlgemuth, W. K. (2013) · American Psychiatric Association Publishing eBooks · doi:10.1176/appi.books.9781615370016.mt08 · Cited by 4
Self-citationNature and Treatment of Insomnia
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“Cognitive Behavioural Therapy for Insomnia (CBT-I) has been used in numerous studies and its long-term efficacy has been recognized (6-9).”
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“Multiple studies have confirmed its long-term effectiveness in improving sleep outcomes, with benefits extending beyond symptom management to reducing reliance on pharmacological treatments (Koffel et al., 2015; Wu et al., 2015; Smith et al., 2002; Edinger et al., 2001; Backhaus et al., 2001).”
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“현재 불면증에 대한 인지행동치료의 최신기법은 수면위생, 자극조절치료, 수면제한법, 인지치료를 연합시킨 복합 프로그램을 말한다 [36,42].”
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Cognitive-Behavioral Therapy in Insomnia
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“…32% – 58% remission rates and significantly improves sleep outcomes such as sleep latency (SL), wake after sleep onset (WASO), sleep efficiency (SE), and total sleep time (TST), with significant immediate and long-term efficacy (Edinger et al., 2001; Mitchell et al., 2012; Perlis et al., 2022).”
Sleep Treatment Education Program for Cancer Survivors: Protocol for an Efficacy Trial
Bice, B., Michaud, A. L., McCormick, K. G., Miklos, E. M., Descombes, I. D., Medeiros-Nancarrow, C., Zhou, E. S., & Recklitis, C. J. (2024) · JMIR Research Protocols · doi:10.2196/60762 · Cited by 2
Milner, A. E., Hache, R. E., Oliver, S., Sarfan, L. D., Spencer, J. M., Cogan, A. B., Jiang, Y., Agnew, E. R., Zieve, G. G., Martin, J. L., et al. (2024) · Trials · doi:10.1186/s13063-024-08468-0 · Cited by 2
“Following previous research in the field [137], a checklist of treatment elements specific to TranS-C was devised.”
MethodMerchant, A. M., Gray, S. R., Gray, C. M., Finlayson, G., Manyara, A. M., Trisotti, M. F. G., & Gill, J. M. R. (2025) · Appetite · doi:10.1016/j.appet.2025.108022 · Cited by 3
“…by the PSQI and ESS, consistent with other studies finding that CBTi is an effective intervention to improve a range of subjective sleep variables (Edinger et al., 2001; Edinger & Means, 2005; Haynes et al., 2018; Krystal & Edinger, 2008; Lovato et al., 2016; Lovato & Lack, 2019; Morgenthaler et…”
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Nichtmedikamentöse Verfahren in der Insomniebehandlung. Verhaltenstherapie bietet eine Alternative
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Agyemang, A. A. (2016) · VCU Scholars Compass (Virginia Commonwealth University) · doi:10.25772/vstx-e507 · Cited by 2
Brown, L. A., Narine, K., Asnaani, A., Bredemeier, K., & Mu, W. (2022) · Journal of Behavioral and Cognitive Therapy · doi:10.1016/j.jbct.2021.12.006 · Cited by 2
Behavioral Treatment of Insomnia
Edinger, J. D., & Carney, C. E. (2008) · CRC Press eBooks · doi:10.3109/9781420019926-8 · Cited by 2
Self-citationManber, R., Ong, J. C., & Carlyle, E. (2008) · CRC Press eBooks · doi:10.3109/9781420019926-6 · Cited by 2
Sleep Disorder Management in Developing Countries
Safwan, J., Shrayteh, Z., Akel, M., Hajj, A., & Sacre, H. (2023) · Springer eBooks · doi:10.1007/978-3-030-74786-2_42-1 · Cited by 2
Symptom Cluster Profiles in Adults with Chronic Obstructive Pulmonary Disease and Insomnia
Jun, J., Park, C. G., Fritschi, C., Izci‐Balserak, B., Martyn-Nemeth, P. A., Kuna, S. T., & Kapella, M. C. (2023) · Western Journal of Nursing Research · doi:10.1177/01939459231184709 · Cited by 2
Khankeh, H. R., Ahmadi, S., Mohammadi, F., Fallahi, M., Khodaie, M., & Alipour, F. (2013) · Europe PMC (PubMed Central) · Cited by 2
Nature, Evaluation, and Treatment of Insomnia
Morin, C. M., & Benca, R. M. (2017) · Springer eBooks · doi:10.1007/978-1-4939-6578-6_37 · Cited by 4
The Effects of Changes in Sleep Schedule Variability on First-Year College Students
Blank, Y. (2015) · UA Campus Repository (The University of Arizona) · Cited by 2
The options available in cognitive behavioral therapy to prevent chronification of insomnia
Crönlein, T., & Zulley, J. (2011) · The EPMA Journal · doi:10.1007/s13167-011-0095-9 · Cited by 2
“Studies so far show that CBT-I is more effective than no treatment [49, 50] and than PMR and Placebo [51].”
BackgroundShort-Term and Group Treatment Approaches
McCrae, C. S., Dautovich, N. D., & Dzierzewski, J. M. (2010) · Medical psychiatry · doi:10.3109/9781420080803.028 · Cited by 2
Morin, C. M. (2003) · Springer eBooks · doi:10.1007/978-1-4615-0217-3_17 · Cited by 2
Cognitive therapy for insomnia
Soehner, A., Kaplan, K., Kanady, J., & Harvey, A. G. (2023) · Encyclopedia of Sleep and Circadian Rhythms · doi:10.1016/b978-0-12-822963-7.00016-5 · Cited by 1
A History of Nonpharmacological Treatments for Insomnia
Spielman, A. J., & Glovinsky, P. B. (2015) · Springer eBooks · doi:10.1007/978-1-4939-2089-1_58 · Cited by 1
Insomnia: An Update on Epidemiology, Diagnosis and Non-pharmacological Management
Francis, A. (2024) · Indian Journal of Sleep Medicine · doi:10.5005/jp-journals-10069-0131 · Cited by 1
“69 Cognitive behavior therapy-I has been found to be superior to medical management in obtaining long-term results.”
Garland, S. N., Kutana, S., Piedalue, K.-A. L., Lee, R. M., Rash, J. A., & Cerallo, G. (2025) · JMIR Cancer · doi:10.2196/74387 · Cited by 1
Ein neues standardisiertes Kurzzeitprogramm zur Behandlung von Schlafstörungen bei Tinnituspatienten
Crönlein, T., Langguth, B., Täuber, S., Kurzbuch, K., Kleinjung, T., Geisler, P., Klein, H. E., & Hajak, G. (2010) · University of Regensburg Publication Server (University of Regensburg) · doi:10.5283/pf.42 · Cited by 1
“Schlafstörung [3, 12, 33].”
Etscheidt, M. A., & Sloan, P. A. (2014) · Cambridge University Press eBooks · doi:10.1017/cbo9781107281950.067 · Cited by 1
Cognitive Strategies for Managing Anxiety and Insomnia
Carney, C. E., & Edinger, J. D. (2010) · Springer eBooks · doi:10.1007/978-1-4419-1434-7_8 · Cited by 1
“Early CBT trials used psychoeducation exclusively as a cognitive tool ( Edinger, Wohlgemuth, Radtke, Marsh, & Quillian, 2001 ).”
MethodSelf-citation
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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