A preliminary validation of the pediatric adaptation of the Insomnia Severity Index.

INTRODUCTION: The prevalence of insomnia in children aged 5 to 12 years old is 20% to 31%. Currently, there is no well-validated questionnaire assessing all the components of insomnia in school-aged children. The present study aims to introduce an adaptation of the Insomnia Severity Index for this purpose. METHOD: Fifty-nine children aged 8- to 12-years-old with at least one anxiety disorder were recruited from youth mental health care settings. Their parents completed the pediatric adaptation of the Insomnia Severity Index which includes two scales used to report insomnia symptoms in children and their impact on the child (ISI-Child) and parents (ISI-Parent), My Child's Sleep Habits questionnaire, and the Child Behavior Checklist. RESULTS: Both the ISI-Child and the ISI-Parent scales presented adequate factorial structure (RMSEA ≤ 0.05) and internal consistency (ISI-Child: α=0.87; ISI-Parent: α=0.88). Furthermore, the results of the two scales were strongly correlated (r=0.91, P<0.001). The convergent validity was assessed using the Waking During the Night scale of the My Child's Sleep Habits questionnaire and was adequate for the ISI-Child (r=0.52, P<0.001) and the ISI-Parent (r=0.53, P<0.001). Finally, the Rule-Breaking Behavior (r ≤ 0.26, P ≥ 0.05) and Aggressive Behavior (r ≤ 0.19, P ≥ 0.19) scales of the Child Behavior Checklist showed small correlations with both subscales, indicating good divergent validity. CONCLUSION: The pediatric adaptation of the Insomnia Severity Index is a potentially reliable and valid measure for screening and assessing insomnia in children.

Sleep Disturbances During the Menopausal Transition: The Role of Sleep Reactivity and Arousal Predisposition.

BACKGROUND: Sleep disturbances are common during the menopausal transition and several factors can contribute to this increased incidence. This study examined the association between sleep reactivity, arousal predisposition, sleep disturbances, and menopause. METHODS: Data for this study were derived from a longitudinal, population-based study on the natural history of insomnia. A total of 873 women (40-60 years) were divided into two groups according to their menopausal status at baseline: reproductive (n = 408) and postmenopausal (n = 465). Participants were evaluated annually throughout the five-year follow-up period. Four questionnaires were used to examine sleep quality, insomnia severity, sleep reactivity, and arousal predisposition. The data were analyzed using two approaches: cross-sectional with a multivariate analysis and binary regression, and longitudinal with a linear mixed models using menopausal groups (3) x time (5) design. RESULTS: Cross-sectional analyses showed that postmenopausal women reported significantly more severe insomnia and poorer sleep quality than reproductive women. Sleep reactivity and arousal predisposition were significant predictors of sleep disturbances. Longitudinal analyses revealed increased sleep disturbances in the two years before and after the menopausal transition. Sleep reactivity and arousal predisposition did not moderate the temporal relationship between menopausal transition and sleep disturbances. CONCLUSION: More sleep disturbances were reported during the menopausal transition, but those difficulties were not explained by sleep reactivity and arousal predisposition. These results suggest the involvement of other psychophysiological factors in the development of sleep disturbances during the menopause.

Investigating non-inferiority of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial (iSleep well).

BACKGROUND: Insomnia is a highly prevalent disorder associated with numerous adverse health outcomes. Cognitive behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment by clinical guidelines but is accessible to only a minority of patients suffering from insomnia. Internet-delivered CBT-I (iCBT-I) could contribute to the widespread dissemination of this first-line treatment. As there is insufficient evidence regarding non-inferiority, this study directly aims to compare therapist-guided internet-delivered versus face-to-face CBT-I in terms of insomnia severity post-treatment. Furthermore, a health-economic evaluation will be conducted, and potential benefits and disadvantages of therapist-guided iCBT-I will be examined. METHODS: This study protocol describes a randomised controlled two-arm parallel-group non-inferiority trial comparing therapist-guided iCBT-I with face-to-face CBT-I in routine clinical care. A total of 422 patients with insomnia disorder will be randomised and treated at 16 study centres throughout Germany. Outcomes will be assessed at baseline, 10 weeks after randomisation (post), and 6 months after randomisation (follow-up). The primary outcome is insomnia severity measured using the Insomnia Severity Index. Secondary outcomes include depression-related symptoms, quality of life, fatigue, physical activity, daylight exposure, adverse events related to treatment, and a health-economic evaluation. Finally, potential moderator variables and several descriptive and exploratory outcomes will be assessed (e.g. benefits and disadvantages of internet-delivered treatment). DISCUSSION: The widespread implementation of CBT-I is a significant healthcare challenge. The non-inferiority of therapist-guided iCBT-I versus face-to-face CBT-I will be investigated in an adequately powered sample in routine clinical care, with the same therapeutic content and same level of therapist qualifications provided with both interventions. If this trial demonstrates the non-inferiority of therapist-guided iCBT-I, healthcare providers may be more confident recommending this treatment to their patients, contributing to the wider dissemination of CBT-I. TRIAL REGISTRATION: Trial registration number in the German Clinical Trials Register: DRKS00028153 ( https://drks.de/search/de/trial/DRKS00028153 ). Registered on 16th May 2023.

Network Intervention Analyses of cognitive therapy and behavior therapy for insomnia: Symptom specific effects and process measures.

Cognitive therapy (CT) and behavior therapy (BT) are both effective for insomnia. In this study we applied Network Intervention Analysis to investigate specific effects of CT and BT on outcomes and process measures. The analysis was based on a randomized controlled trial comparing CT (n = 65), BT (n = 63) and cognitive behavioral therapy for insomnia (n = 60; not included in this study). In the first networks, the separate items of the Insomnia Severity Index and sleep efficiency were included. In the second networks, the pre-specified process measures for BT and CT, sleep efficiency, and the sum-score of the Insomnia Severity Index were included. At the different time points, we found CT-effects on worry, impaired quality of life, dysfunctional beliefs, and monitoring sleep-related threats, and BT-effects on sleep efficiency, difficulty maintaining sleep, early morning awakening, time in bed, sleep incompatible behaviors and bed- and rise time variability. These observed effects of CT and BT were consistent with their respective theoretical underpinnings. This study provided new information on the mechanisms of change in CT and BT. In the future, this may guide us to the most effective treatment modules or even subsets of interventions.

Emotion coping strategies and dysfunctional sleep-related beliefs are associated with objective sleep problems in young adults with insomnia.

BACKGROUND: Though insomnia is associated with affected emotion regulation and dysfunctional ideas about sleep, little is known about the relation of these problems with objective sleep disruption. We aimed to explore this relationship in young adults with and without insomnia. METHODS: Twenty young adults with diagnosed insomnia disorder (aged 27.7 ± 8.6 years) and twenty age-matched individuals without insomnia (26.7 ± 7.0 years) completed questionnaires, measuring sleep-related thoughts and emotions and emotion regulation. Objective sleep measurements were collected through 10-days actigraphy as a representative sample of nights, and analyzed for sleep onset latency, sleep efficiency total sleep time. T-tests and multivariate analyses of variance (MANOVA) were conducted for sample characterization and analysis of the association of sleep-related thoughts and emotions and emotion regulation with objective sleep data. RESULTS: As expected, young people showed more dysfunctional sleep-related thoughts and emotions (all ps ≤ 0.025) and dysfunctional emotion regulation strategies (all ps ≤ 0.040). Surprisingly, MANOVA results showed that only emotion coping strategies after a stressful event (p = 0.017) and dysfunctional beliefs about sleep (p = 0.012), but not other factors of arousal or sleep reactivity, were associated with overall worse sleep, especially sleep onset latency (all ps ≤ 0.012) and sleep efficiency (all ps ≤ 0.010). CONCLUSIONS: Maladaptive emotion coping strategies after a stressful event and dysfunctional sleep-related beliefs and attitudes affect objective sleep onset latency and sleep efficiency in young adults, highlighting the importance of targeting these features in the prevention and treatment of chronic insomnia and improving actual sleep quality.

Natural history of excessive daytime sleepiness: a population-based 5-year longitudinal study.

STUDY OBJECTIVES: To document the rates of persistent, remitted, and intermittent excessive daytime sleepiness (EDS) in a longitudinal 5-year community study of adults and to assess how changes in risk factors over time can predict improvement of daytime sleepiness (DS). METHODS: Participants were recruited in 2007-2008 as part of a population-based epidemiological study implemented in Canada. They completed postal assessments at baseline and at each yearly follow-up. An Epworth Sleepiness Scale total score >10 indicated clinically significant EDS; a 4-point reduction between two consecutive evaluations defined DS improvement. Socio-demographic, lifestyle, health characteristics, and sleep-related measures (e.g. insomnia symptoms, sleep duration, sleep medication) were self-reported at each time point. Cox proportional-hazard models were used to predict EDS and DS remissions over 5 years. RESULTS: Among the 2167 participants, 33% (n = 714) met criteria for EDS at baseline, of whom 33% had persistent EDS, 44% intermittent EDS, and 23% remitted EDS over the follow-up. Furthermore, 61.4% of 2167 initial participants had stable DS, 27.1% sustained DS improvement and 8.5% transient improvement over the follow-up. The main predictors of EDS remission or DS improvement were normal weight, taking less hypnotics, having hypertension, increased nighttime sleep duration, and decreased insomnia, and depressive symptoms. CONCLUSIONS: EDS waxes and wanes over time with frequent periods of remission and is influenced by behavioral characteristics and changes in psychological, metabolic, and nighttime sleep patterns. Targeting these predictors in future interventions is crucial to reduce DS in the general adult population.

Insomnia and its relationship to health-care utilization, work absenteeism, productivity and accidents.

BACKGROUND AND PURPOSE: To document and provide a micro analysis of the relationship between insomnia and health problems, health-care use, absenteeism, productivity and accidents. PARTICIPANTS AND METHODS: A population-based sample of 953 French-speaking adults from Québec, Canada. Participants were categorized as having insomnia syndrome (SYND) or insomnia symptoms (SYMPT) or as good sleepers (GS). They completed questionnaires on sleep, health, use of health-care services and products, accidents, work absences and reduced work productivity. Data were also obtained from the Québec-government-administered health insurance board on selected variables (e.g., consultations with health-care professionals, diagnoses). RESULTS: There were significantly more individuals in the SYND group relative to the GS group reporting at least one chronic health problem (83% vs. 53%; OR: 2.78) and who had consulted a health-care professional in the past year (81% vs. 60%; OR: 2.8). There were also higher proportions of individuals in the SYND group than in the GS group who had used prescription medications (57% vs. 30.7%; OR: 2.8), most notably to treat insomnia, mood and anxiety disorders, or who had used over-the-counter products (75.6% vs. 62.0%; OR: 1.8) and alcohol as a sleep aid (17.8% vs. 3.9%; OR: 4.6). In terms of daytime function, 25.0% of the SYND had been absent from work relative to 17.1% of GS (OR: 1.7), 40.6% reported having experienced reduced productivity compared to 12.3% of GS (OR: 4.8) and non-motor-vehicle accidents occurred at higher rates in the SYND group (12.5% vs. 6.4% for GS; OR: 2.4). No differences were found for hospitalisations or motor-vehicle accidents. Most of the associations remained significant even after controlling for psychiatric comorbidity. Rates for the SYMPT group were situated between SYND and GS on all major dependent variables. Furthermore, insomnia and fatigue were perceived as contributing significantly to accidents, absences and decreased work productivity, regardless of insomnia status. CONCLUSIONS: This study indicates that insomnia is associated with significant morbidity in terms of health problems and health-care utilization, work absenteeism and reduced productivity, and risk of non-motor-vehicle accidents. Future studies should evaluate whether treating insomnia can reverse this morbidity.

[Sensitivity and specificity of the worry and anxiety questionnaire (WAQ) in a sample of health-care users in the province of Quebec]. / Sensibilité et spécificité du questionnaire sur les inquiétudes et l'anxiété (QIA) dans un échantillon d'utilisateurs de soins de santé au Québec.

INTRODUCTION: Generalized anxiety disorder (GAD) is a prevalent anxiety disorder characterized by persistent, excessive worrying. Even if GAD's ill consequences on health and quality of life are well documented, this disorder is still difficult to identify in primary care. The worry and anxiety questionnaire (WAQ) is a questionnaire assessing specific GAD symptoms, as defined by the Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV). OBJECTIVES: This study aimed at assessing the capacity of the French version of the WAQ's to identify individuals with GAD in a sample of individuals reporting a certain level of anxiety. A second objective was to identify which of its items better distinguish individuals with GAD from those without. According to these results, different scoring algorithms have been developed and their effect on the WAQ's sensitivity and specificity indicators has been explored. DESIGN OF THE STUDY: The sample was drawn from a mother study in which 1110 health-care users completed questionnaires while waiting for a medical consultation with a family physician. Of those, a subsample of 219 individuals reported anxiety symptoms typical of GAD, as assessed by the WAQ. Among those who agreed to participate in the study's second phase (n=176), 100 were randomly selected and invited within one to three months to a clinical interview assessing their anxiety symptoms more thoroughly. Thirty-three individuals accepted and thus formed the present sample. The clinical interview was the anxiety disorders interview schedule (ADIS). The ADIS is a semi-structured diagnostic interview following the DSM-IV criteria. It assesses all anxiety disorders and includes screening questions on mood, substance use and psychotic disorders. Participants also completed the WAQ for a second time at the time of the interview. RESULTS: Nineteen individuals received a diagnosis of GAD after completing the ADIS while 13 did not. Sixteen of the 19 individuals with GAD were correctly identified with the WAQ, compared to eight out of 13 for individuals without GAD. Sensitivity of the WAQ's actual scoring algorithm is thus of 84.2% and its specificity of 61.5%. The number of false negatives produced by the WAQ in this sample (3/19, 15.8%) was lower than the number of false positives (5/13, 38.5%). Positive and negative predictive power is thus of 76.2% and 72.7%, respectively. Receiver-operating characteristic (ROC) curves analyses indicated that the most useful items to identify individuals with GAD were those assessing the presence of excessive worrying, the number of days disturbed by worries, the degree with which worries interfere with daily functioning and the degree of control over worries. Knowing an individual's outcome on the WAQ increases the probability of correctly identifying an individual with or without GAD by 8.5 times compared to mere chance. A new scoring algorithm, where the cut-off score on the excessive worrying item was increased by one unit, considerably improves the WAQ's specificity (84.6%), without altering its sensitivity by much (78.9%). This new scoring algorithm thus increases the probability of correctly identifying individuals with and without GAD to 20.6 times (again compared to chance). CONCLUSION: The WAQ is thus a useful instrument in screening GAD, even in a sample of anxious individuals. Its original scoring algorithm shows excellent sensitivity, a valued quality in an instrument used for screening. On the other hand, it is possible to increase the specificity of the WAQ by raising the cut-off point on the excessive worrying item, making the instrument useful as a diagnostic aid or as a screening questionnaire for GAD, in particular among a sample displaying anxiety. This questionnaire is thus an easy-to-complete and adaptable instrument that can be used by family physicians to help them identifying individuals with GAD.

Incidence, worsening and risk factors of daytime sleepiness in a population-based 5-year longitudinal study.

Excessive daytime sleepiness (EDS) is highly prevalent in the general population; however little is known about its evolution and predictors. Our objectives were to document its natural history, provide estimates of its prevalence, incidence and persistence rates, and to identify predictors of increased daytime sleepiness (DS) in a longitudinal community study of 2157 adults over 5 years. Participants completed postal assessment at baseline and at each yearly follow-up. DS was evaluated by the Epworth Sleepiness scale (ESS). At baseline, 33% reported EDS (ESS > 10) with 33% of them reported persistent EDS. Of those without EDS at baseline, 28% developed incident EDS (15% were persistent) and 31% increased DS (augmentation ≥4-points between two consecutive evaluations). Younger age and depression were independent predictors of incident EDS and DS increase while lower coffee consumption, smoking, insomnia, tiredness and chronic pain were associated with incident EDS, and living alone with DS increase only. Persistent vs transient EDS or DS showed association with poor general health including metabolic diseases. Thus, sleepiness fluctuated over time and it was predicted by common lifestyle and psychological factors potentially modifiable. However, persistent sleepiness was associated with chronic medical diseases thus highlighting a homogeneous group at risk requiring a dedicated management.

Epidemiology of insomnia: prevalence, self-help treatments, consultations, and determinants of help-seeking behaviors.

BACKGROUND AND PURPOSE: To estimate the prevalence of insomnia symptoms and syndrome in the general population, describe the types of self-help treatments and consultations initiated for insomnia, and examine help-seeking determinants. PATIENTS AND METHODS: A randomly selected sample of 2001 French-speaking adults from the province of Quebec (Canada) responded to a telephone survey about sleep, insomnia, and its treatments. RESULTS: Of the total sample, 25.3% were dissatisfied with their sleep, 29.9% reported insomnia symptoms, and 9.5% met criteria for an insomnia syndrome. Thirteen percent of the respondents had consulted a healthcare provider specifically for insomnia in their lifetime, with general practitioners being the most frequently consulted. Daytime fatigue (48%), psychological distress (40%), and physical discomfort (22%) were the main determinants prompting individuals with insomnia to seek treatment. Of the total sample, 15% had used at least once herbal/dietary products to facilitate sleep and 11% had used prescribed sleep medications in the year preceding the survey. Other self-help strategies employed to facilitate sleep included reading, listening to music, and relaxation. CONCLUSIONS: These findings confirm the high prevalence of insomnia in the general population. While few insomnia sufferers seek professional consultations, many individuals initiate self-help treatments, particularly when daytime impairments such as fatigue become more noticeable. Improved knowledge of the determinants of help-seeking behaviors could guide the development of effective public health prevention and intervention programs to promote healthy sleep.

Insomnia in the context of cancer: a review of a neglected problem.

This article reviews the evidence on the diagnosis, epidemiology, etiology, and treatment of insomnia in the context of cancer and proposes several areas for future research. Clinical and diagnostic features of insomnia are described and prevalence estimates of insomnia complaints in cancer patients are summarized. Then, potential etiologic factors (ie, predisposing, precipitating, and perpetuating factors) and consequences of insomnia (ie, psychologic, behavioral, and health impact) in the context of cancer are discussed. Finally, pharmacologic and psychologic treatments previously shown effective to treat insomnia in healthy individuals are discussed as valuable treatment options for cancer patients as well. Because long-term use of hypnotic medications is associated with some risks (eg, dependence), it is argued that psychologic interventions (eg, stimulus control, sleep restriction, cognitive therapy) are the treatment of choice for sleep disturbances in the context of cancer, especially when it has reached a chronic course. However, the efficacy of these treatments has yet to be verified specifically in cancer patients.

Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy.

OBJECTIVE: Because of the role of psychological factors in insomnia, the shortcomings of hypnotic medications, and patients' greater acceptance of nonpharmacological treatments for insomnia, the authors conducted a meta-analysis to examine the efficacy and durability of psychological treatments for the clinical management of chronic insomnia. METHOD: A total of 59 treatment outcome studies, involving 2,102 patients, were selected for review on the basis of the following criteria: 1) the primary target problem was sleep-onset, maintenance, or mixed insomnia, 2) the treatment was nonpharmacological, 3) the study used a group design, and 4) the outcome measures included sleep-onset latency, time awake after sleep onset, number of nighttime awakenings, or total sleep time. RESULTS: Psychological interventions, averaging 5.0 hours of therapy time, produced reliable changes in two of the four sleep measures examined. The average effect sizes (i.e., z scores) were 0.88 for sleep latency and 0.65 for time awake after sleep onset. These results indicate that patients with insomnia were better off after treatment than 81% and 74% of untreated control subjects in terms of sleep induction and sleep maintenance, respectively. Stimulus control and sleep restriction were the most effective single therapy procedures, whereas sleep hygiene education was not effective when used alone. Clinical improvements seen at treatment completion were well maintained at follow-ups averaging 6 months in duration. CONCLUSIONS: The findings indicate that nonpharmacological interventions produce reliable and durable changes in the sleep patterns of patients with chronic insomnia.

The effect of temazepam on respiration in elderly insomniacs with mild sleep apnea.

This study evaluated the respiratory effect of temazepam in elderly subjects (mean age 65 +/- 3.8 years), with mild sleep apnea. The 15 subjects of this report were enrolled in a larger randomized trial comparing pharmacological and behavioral treatments for insomnia. Seven subjects received temazepam 15-30 mg/day either alone or in combination with behavior therapy, and eight subjects received placebo or behavior therapy. The mean baseline respiratory disturbance index (RDI) was 9.2 +/- 2.8 for the nondrug and 8.8 +/- 5.3 for the temazepam group. There were no significant time, group or interaction effects. There was no increase in the RDI in elderly subjects with mild respiratory apnea receiving 15-30 mg of temazepam.

Patients' acceptance of psychological and pharmacological therapies for insomnia.

This study evaluated the acceptance of psychological and pharmacological therapies among chronic insomniacs and noncomplaining good sleepers. After reading a brief written description of two treatment methods commonly used for persistent insomnia (i.e. cognitive-behavior therapy and pharmacotherapy), the subjects rated in a counter-balanced order several dimensions of these two treatment modalities. The results showed that the psychological intervention was rated as more acceptable and more suitable than the pharmacological one among both insomniacs and their noncomplaining significant others. Behavior therapy was also expected to be more effective on a long-term basis and to produce fewer side effects as well as more benefits on daytime functioning. The clinical implications and relevance of treatment acceptance in the management of insomnia are discussed.

Sleep restriction for the inpatient treatment of insomnia.

This study evaluates the efficacy of sleep restriction therapy for treating insomnia on an inpatient psychiatric unit. A depressed patient with concomitant chronic pain and severe insomnia was treated with a sleep restriction procedure. This procedure consisted of curtailing the amount of time spent in bed and then gradually increasing it contingent upon improved sleep efficiency. The treatment was found to be effective for increasing total sleep time from an initial baseline of 2.5 h of sleep per night to 6 h of sleep per night at discharge time. Clinical gains were well maintained immediately after discharge and at a 4-month follow-up.

Evaluation of chronic insomnia. An American Academy of Sleep Medicine review.

Insomnia is a condition which affects millions of individuals, giving rise to emotional distress, daytime fatigue, and loss of productivity. Despite its prevalence, it has received scant clinical attention. An adequate evaluation of persistent insomnia requires detailed historical information as well as medical, psychological and psychiatric assessment. Use of a classification system for sleep disorders and familiarity with major diagnostic groups will facilitate the clinician's evaluation and treatment. Thorough assessment also requires attention to the unique aspects of presentation and specific set of etiologies which are associated with particular age groups.

Prevalence, clinical characteristics, and risk factors for insomnia in the context of breast cancer.

STUDY OBJECTIVES: To estimate the prevalence of insomnia, describe clinical characteristics of sleep difficulties, assess the influence of cancer on the insomnia course, and identify potential risk factors involved in the development of insomnia among women who had received radiotherapy for non metastatic breast cancer. DESIGN: A sample of 300 consecutive women who had been treated with radiotherapy for non metastatic breast cancer first completed an insomnia screening questionnaire. Participants who reported sleep difficulties were subsequently interviewed over the phone to evaluate further the nature, severity, duration, and course of their insomnia. SETTING: N/A. PATIENTS OR PARTICIPANTS: N/A. INTERVENTIONS: N/A. MEASUREMENTS AND RESULTS: Nineteen percent (n=56) of the participants met diagnostic criteria for an insomnia syndrome. In most cases (95%), insomnia was chronic. The onset of insomnia followed the breast cancer diagnosis in 33% of the patients and 58% of the patients reported that cancer either caused or aggravated their sleep difficulties. Factors associated with an increased risk for insomnia were sick leave, unemployment, widowhood, lumpectomy, chemotherapy, and a less severe cancer stage at diagnosis. Among women with insomnia symptoms, the risk to meet diagnostic criteria for an insomnia syndrome was higher in those who were separated and had a university degree. CONCLUSIONS: Insomnia is a prevalent and often chronic problem in breast cancer patients. Although it is not always a direct consequence of cancer, pre-existing sleep difficulties are often aggravated by cancer. It is therefore important to better screen breast cancer patients with insomnia and offer them an appropriate treatment.

How "blind" are double-blind placebo-controlled trials of benzodiazepine hypnotics?

This study examined the accuracy of insomnia patients and their treating physicians in rating whether an active hypnotic drug or a placebo was given in treatment. Forty older adults with primary insomnia were randomly assigned to either an active (temazepam) or a placebo condition using a double-blind strategy. Ratings of treatment conditions were obtained at 1 week (early treatment), 4 weeks (midtreatment), and 8 weeks (late treatment). Patients were able to accurately discriminate (beyond chance levels) between the active and placebo medications at the early (76.9% accuracy) and late treatment assessment timepoints (78.1% accuracy), but not at midtreatment (51.5% accuracy). Therapists, however, were able to make accurate discriminations at the late treatment assessment timepoint only (80% accuracy); early (69.2% accuracy) and midtreatment (47.2% accuracy) ratings did not exceed chance levels. Patients who had used hypnotic drugs prior to this trial were more accurate in their judgments of treatment conditions than those without prior exposure. The findings raise an important issue about the internal validity of the double-blind strategy, which may in fact be only a single-blind procedure.

Nonpharmacologic treatment of chronic insomnia. An American Academy of Sleep Medicine review.

This paper reviews the evidence regarding the efficacy of nonpharmacological treatments for primary chronic insomnia. It is based on a review of 48 clinical trials and two meta-analyses conducted by a task force appointed by the American Academy of Sleep Medicine to develop practice parameters on non-drug therapies for the clinical management of insomnia. The findings indicate that nonpharmacological therapies produce reliable and durable changes in several sleep parameters of chronic insomnia sufferers. The data indicate that between 70% and 80% of patients treated with nonpharmacological interventions benefit from treatment. For the typical patient with persistent primary insomnia, treatment is likely to reduce the main target symptoms of sleep onset latency and/or wake time after sleep onset below or near the 30-min criterion initially used to define insomnia severity. Sleep duration is also increased by a modest 30 minutes and sleep quality and patient's satisfaction with sleep patterns are significantly enhanced. Sleep improvements achieved with these behavioral interventions are sustained for at least 6 months after treatment completion. However, there is no clear evidence that improved sleep leads to meaningful changes in daytime well-being or performance. Three treatments meet the American Psychological Association (APA) criteria for empirically-supported psychological treatments for insomnia: Stimulus control, progressive muscle relaxation, and paradoxical intention; and three additional treatments meet APA criteria for probably efficacious treatments: Sleep restriction, biofeedback, and multifaceted cognitive-behavior therapy. Additional outcome research is needed to examine the effectiveness of treatment when it is implemented in clinical settings (primary care, family practice), by non-sleep specialists, and with insomnia patients presenting medical or psychiatric comorbidity.