Overcoming insomnia: protocol for a large-scale randomised controlled trial of online cognitive behaviour therapy for insomnia compared with online patient education about sleep.

INTRODUCTION: Insomnia is a major public health concern. While cognitive behaviour therapy for insomnia (CBT-I) is acknowledged as the best available intervention, there are unanswered questions about its wider dissemination, socioeconomic benefits and its impact on health resource utilisation. The aim of this randomised controlled trial (RCT) is to investigate the effectiveness of a fully automated online version of CBT-I compared with online patient education about sleep (PE). Outcome measures comprise changes in symptoms of insomnia, time off work due to sick leave as well as medication and health resource utilisation. Also, we will examine (i) putative mediators of the effects of CBT-I on insomnia severity and (ii) selected potential psycho-bio-social moderators of the effects of the interventions. METHODS AND ANALYSIS: A parallel-group RCT will be conducted in a target sample of about 1500 adults recruited across Norway. Participants will complete an online screening and consent process. Those who meet eligibility criteria will be randomised to receive direct access to fully automated online CBT-I or to an online PE programme. The primary outcome is change in insomnia severity immediately postintervention; secondary outcomes are change in daytime functioning and other sleep measures postintervention and at 6-month and 24-month follow-up. Objective data from national registries will be obtained at two time points (1 year and 2 years post-treatment), allowing a mirror image study of preintervention and postintervention rates of sick leave, and of medication and healthcare utilisation by condition. ETHICS AND DISSEMINATION: The study protocol was approved by the Regional Committee for Medical and Health Research Ethics in South East Norway (2015/134). Findings from the RCT will be disseminated in peer-reviewed publications and conference presentations. Exploratory analyses of potential mediators and moderators will be reported separately. User-friendly outputs will be disseminated to patient advocacy and other relevant organisations. TRIAL REGISTRATION NUMBER: NCT02558647; Pre-results.

Durability of treatment response to zolpidem with three different maintenance regimens: a preliminary study.

BACKGROUND AND AIM: At present, there is no consensus regarding how to medically manage chronic insomnia in the long term. The unstated standard of practice is for patients to use hypnotics intermittently. The present study aimed to compare a partial reinforcement strategy with nightly and intermittent dosing strategies for its potential as a maintenance therapy. METHODS: A mixed model was used in the study. One between-subjects factor: group (n = 4). One repeated-measures factor: time (12 weekly assessments). A total of 74 subjects with chronic Insomnia were treated with 10 mg zolpidem for 4 weeks. Treatment respondents were randomized to nightly dosing with 10 mg or 5 mg (QHS-10 and QHS-5), intermittent dosing with 10 mg (IDS-10 [3-5 days weekly]), or partial reinforcement dosing with 10 mg (PRS-10 [nightly pill use with 50% active medication and 50% placebos]) for 12 weeks. RESULTS: It was found, in compliant subjects (n = 55), that all four strategies evaluated maintained treatment response over time (ie, prevented or delayed relapse). For the subjects that remained in remission, the subjects in the intermittent dosing group (IDS-10) group exhibited poorer sleep continuity. CONCLUSIONS: While best considered a preliminary study, the present findings suggest that the partial reinforcement strategy may be a viable means toward maintaining treatment gains over time with less active medication.

The timing of activity rhythms in patients with dementia is related to survival.

BACKGROUND: Older adults with dementia often have disruptions in circadian rhythms, including disruptions of the rest-activity rhythm. These disruptions are a product of internal neuronal activity and external environmental influences, both of which are deficient in dementia. However, the consequences of disturbed rhythms are unknown. This study examined the relationship between rest-activity rhythms and death in patients with dementia. METHODS: The authors recruited 149 older adults with dementia (104 women; mean age, 84.1 years) from nursing homes. Activity was recorded with wrist actigraphs from each participant for 3 days. Survival was determined by examining public death records. Cox proportional hazards models were used to determine which aspects of rest-activity rhythms were related to survival. RESULTS: The timing of each participant's rest-activity rhythm compared with a sample of persons without dementia was related to survival, such that those who more closely resembled the persons without dementia lived longer. CONCLUSIONS: Although rest-activity rhythms as a whole were not related to survival, the timing of the rhythm was. Patients with dementia appear to develop an abnormal timing of their rhythms, which is predictive of shorter survival. It may be possible to intervene with these patients to correct the timing of their rhythms and possibly prolong their lives.

Who is predisposed to insomnia: a review of familial aggregation, stress-reactivity, personality and coping style.

Insomnia is a common health complaint world-wide. Insomnia is a risk factor in the development of other psychological and physiological disorders. Therefore understanding the mechanisms which predispose an individual to developing insomnia has great transdiagnostic value. However, whilst it is largely accepted that a vulnerable phenotype exists there is a lack of research which aims to systematically assess the make-up of this phenotype. This review outlines the research to-date, considering familial aggregation and the genetics and psychology of stress-reactivity. A model will be presented in which negative affect (neuroticism) and genetics (5HTTLPR) are argued to lead to disrupted sleep via an increase in stress-reactivity, and further that the interaction of these variables leads to an increase in learned negative associations, which further increase the likelihood of poor sleep and the development of insomnia.

Neurobiological Mechanisms In Chronic Insomnia.

This article grapples with the notion that insomnia can or should be defined in physiologic terms. It is proposed that insomnia is better understood from a neurobiological perspective. A review of the neurobiology of sleep and wakefulness is provided with a special emphasis on the implications for insomnia. Following the review it is suggested that a complete understanding of insomnia will require that the neurobiologic characterization of insomnia be informed by modern cognitive concepts and methods.

The relationship between dementia severity and rest/activity circadian rhythms.

Patients with dementia have been shown to have disturbed sleep/wake rhythms. There is evidence of impairment in endogenous generation of rhythms and deficient environmental cues in this population. This study sought to examine patterns of rest/activity rhythms as they relate to dementia severity. Three days of actigraphy were collected from 150 nursing-home patients with dementia and used to compute rhythm parameters. Dementia severity was estimated with the Mini-Mental State Examination (MMSE). The relationship between rhythm parameters and dementia severity was examined. Rhythm parameters were not associated with dementia in the sample as a whole, but relationships emerged when the sample was divided on the basis of overall rhythm robustness (F-statistic). Within the group with less robust rhythms, those with stronger rhythms had less severe dementia. In the group with more robust rhythms, milder dementia was associated with having an earlier acrophase (timing of the peak of the rhythm) and narrower peak of the rhythm (shorter duration of peak activity). These results suggested a three-stage model of rest/activity rhythm changes in dementia in which dementia patients have a rapid decline in rhythmicity followed by a slight return to stronger rhythms. In the later stages of dementia, rhythms decline even further.