Cognitive behavioral therapy for patients with primary insomnia or insomnia associated predominantly with mixed psychiatric disorders: a randomized clinical trial.

OBJECTIVE: This study was conducted to evaluate the efficacy of cognitive behavioral therapy (CBT) against a sleep hygiene education control therapy in patients with primary or comorbid insomnia. DESIGN AND SETTING: Randomized, parallel-group, clinical trial conducted at a single Veterans Affairs medical center, with recruitment from March 2001 to June 2005. PARTICIPANTS: Eighty-one adults (n = 11 women; mean age, 54.2 years) with chronic primary (n = 40) or comorbid insomnia associated predominantly with mixed psychiatric disorders (n = 41). INTERVENTIONS: Patients, screened via structured interviews and diagnostic polysomnography, were randomly assigned to receive CBT (sleep education, stimulus control, and time-in-bed restrictions; 20 patients with primary and 21 with comorbid insomnia), or sleep hygiene (SH: education about aspects of lifestyle and the bedroom environment that affect sleep; 20 patients with primary and 20 with comorbid insomnia). Outpatient treatment included 4 biweekly sessions with a posttreatment assessment and a follow-up conducted at 6 months. MEASURES AND RESULTS: Participants completed actigraphy and sleep diaries for 2 weeks prior to therapy, during a 2-week posttreatment assessment, and during 2 weeks at follow-up. They also completed questionnaires measuring global insomnia symptoms, general sleep quality, and sleep-disruptive beliefs before treatment, immediately following treatment, and at the follow-up time point. Consistent with previous studies, CBT outperformed sleep hygiene across several study outcome measures for the sample as a whole. Statistical analyses showed no significant 3-way interaction of treatment group, time, and insomnia type for any of the sleep or questionnaire measures, suggesting the benefits of CBT over sleep hygiene were comparable for patients with primary insomnia and comorbid insomnia. Moreover, only 1 of several indexes of clinically notable improvement suggested a significantly better response to CBT by patients with primary insomnia, as compared with those with comorbid insomnia. CONCLUSIONS: A fixed 4-session "dose" of CBT produced similar benefits for patients with primary and those with comorbid insomnia across most measures examined. Thus, CBT appears to be a viable psychological insomnia therapy both for those with primary insomnia and for groups composed mainly of patients with insomnia and nonpsychotic psychiatric conditions.

Defining insomnia: quantitative criteria for insomnia severity and frequency.

STUDY OBJECTIVE: Recent efforts have been made to develop quantitative frequency, duration, and severity criteria for insomnia. The current study was conducted to test a range of frequency and severity criteria sets for discriminating primary insomnia sufferers from normal sleepers. PARTICIPANTS: Seventy-two adults with primary insomnia and 88 age-matched normal sleepers. METHODS: Participants completed 14 consecutive nights of sleep logs to monitor their home sleep patterns. Receiver-operator characteristic curve analyses were used to compare a range of severity and frequency criteria sets for discriminating the insomnia and normal-sleeper groups. In addition, sensitivity and specificity tests were conducted for a range of wake-time severity cutoffs based on 2-week mean sleep-log data. RESULTS: Receiver-operator characteristic curve analyses showed that no 1 combination of severity and frequency criteria maximized sensitivity and specificity. Rather, the optimal frequency cutoff decreased as the severity criterion increased. Analyses of mean sleep-log data showed that an average sleep-onset latency or middle-of-the-night wake time (ie, time awake between sleep onset and final morning awakening) cutoff of 20 minutes or longer over 2 weeks of sleep-log monitoring appeared to best maximize sensitivity (94.4%) and specificity (79.6%) for insomnia classification. CONCLUSIONS: The optimal quantitative insomnia criteria found herein differ from those previously proposed. Nonetheless, results suggest that quantitative criteria derived from sleep-log data may be useful for classification of primary insomnia.

Testing the reliability and validity of DSM-IV-TR and ICSD-2 insomnia diagnoses. Results of a multitrait-multimethod analysis.

CONTEXT: Distinctive diagnostic classification schemes for insomnia diagnoses are available, but the optimal insomnia nosology has yet to be determined. OBJECTIVES: To test the reliability and validity of insomnia diagnoses listed in the American Psychiatric Association's DSM-IV-TR and the International Classification of Sleep Disorders, second edition (ICSD-2). DESIGN: Multitrait-multimethod correlation design. SETTING: Two collaborating university medical centers, with recruitment from January 2004 to February 2009. PARTICIPANTS: A total of 352 adult volunteers (235 of whom were women) who met research diagnostic criteria for insomnia disorder. MAIN OUTCOME MEASURES: Goodness-of-fit ratings of 10 DSM-IV-TR and 37 ICSD-2 insomnia diagnoses for each patient. Ratings were provided by 3 clinician pairs who used distinctive assessment methods to derive diagnostic impressions. Correlations computed within and across clinician pairs were used to test reliability and validity of diagnoses. RESULTS: Findings suggested that the best-supported DSM-IV-TR insomnia categories were insomnia related to another mental disorder, insomnia due to a general medical condition, breathing-related sleep disorder, and circadian rhythm sleep disorder. The category of primary insomnia appeared to have marginal reliability and validity. The best-supported ICSD-2 categories were the insomnias due to a mental disorder and due to a medical condition, obstructive sleep apnea, restless legs syndrome, idiopathic insomnia, and circadian rhythm sleep disorder-delayed sleep phase type. Psychophysiological insomnia and inadequate sleep hygiene received much more variable support across sites, whereas the diagnosis of paradoxical insomnia was poorly supported. CONCLUSIONS: Both the DSM-IV-TR and ICSD-2 provide viable insomnia diagnoses, but findings support selected subtypes from each of the 2 nosologies. Nonetheless, findings regarding the frequently used DSM-IV-TR diagnosis of primary insomnia and its related ICSD-2 subtypes suggest that their poor reliability and validity are perhaps due to significant overlap with comorbid insomnia subtypes. Therefore, alternate diagnostic paradigms should be considered for insomnia classification.

Nonpharmacologic treatment of insomnia.

Insomnia is a widespread and debilitating disorder. Regardless of the initial cause, it may assume a chronic course perpetuated by psychological and behavioral factors. Although sedative-hypnotic medications are the most common treatment for insomnia, they pose certain risks such as adverse effects and dependence. Furthermore, medications target symptoms and fail to address the underlying perpetuating mechanisms. There are many nonpharmacologic treatment options for insomnia, including cognitive/behavioral methods, relaxation strategies, and complementary and alternative medicine (CAM) approaches. Most CAM therapies lack sufficient scientific evidence to recommend their use. Over the past 30 years, cognitive-behavioral therapies have emerged as the treatment of choice for chronic insomnia. These therapies target behavioral, cognitive, and conditioning factors underlying insomnia, thereby restoring normal sleep-wake functioning. The effectiveness of these therapies is well established. They compare favorably to pharmacologic approaches, with the added benefits of few or no adverse effects and no risk of abuse or dependence. Perhaps most importantly, behavioral insomnia therapies offer a potential cure for the insomnia, instead of the symptom-focused approach provided by medications. Despite the proven success of cognitive-behavioral therapies, they are not widely available to patients with insomnia because of a paucity of behavioral sleep specialists. Efforts are now being made to disseminate these treatments to meet the demand. Emerging therapies hold promise for further refinement and development of successful treatments.