Group cognitive behavioural treatment for insomnia in primary care: a randomized controlled trial.

BACKGROUND: Insomnia disorder is common and often co-morbid with mental health conditions. Cognitive behavioural therapy (CBT) for insomnia is effective, but is rarely implemented as a discrete treatment. The aim of this study was to evaluate the effectiveness of brief CBT groups for insomnia compared to treatment as usual (TAU) for insomnia delivered by mental health practitioners in a primary-care mental health service. METHOD: A total of 239 participants were randomized to either a five-session CBT group or to TAU. Assessments of sleep and of symptoms of depression and anxiety were carried out at baseline, post-treatment and at 20 weeks. Primary outcome was sleep efficiency post-treatment. RESULTS: Group CBT participants had better sleep outcomes post-treatment than those receiving TAU [sleep efficiency standardized mean difference 0.63, 95% confidence interval (CI) 0.34-0.92]. The effect at 20 weeks was smaller with a wide confidence interval (0.27, 95% CI -0.03 to 0.56). There were no important differences between groups at either follow-up period in symptoms of anxiety or depression. CONCLUSIONS: Dedicated CBT group treatment for insomnia improves sleep more than treating sleep as an adjunct to other mental health treatment.

Managing acute medical admissions: the plight of the medical boarder.

In an ideal system, patients admitted acutely to hospital should have their care provided in an area with the most appropriate ward-based medical, nursing and allied professional staff profile. Frequently this does not happen due to the physical structure and organisation of our hospitals in Scotland. Acute medical admissions may be fitted in to the end of many different speciality ward areas while still under the care of a single internal medicine team - as 'medical boarders'. A survey of local medical and nursing staff revealed that a majority would not wish their relatives to be cared for in this way. It remains important to provide speciality beds for those patients who require them, but it is also necessary to develop a system that enables more patients to receive optimal care in the correct environment. In this article, we describe the issue, the problems created and some possible solutions.

Chronic insomnia: clinical and research challenges--an agenda.

Chronic insomnia afflicts up to 10% of the population in Western industrialized countries. It is characterized by delayed sleep onset, problems in maintaining sleep, early morning awakening or the feeling of non-restorative sleep coupled with significant daytime impairments on an emotional, social or professional level. It can occur as a co-morbid condition in any other medical or mental disorder, but also as a primary condition. Within the last decade new diagnostic and differential diagnostic approaches have been suggested that enhance diagnostic precision. Epidemiological data and data relating to the health care and cost situation of chronic insomnia suggest a huge burden for society. Chronic insomnia leads to a clear-cut increased risk for psychopathology (i. e., affective disorders) and probably also for cardiovascular and metabolic dysfunction. The pathophysiology of the condition is still poorly understood and will profit from integrating modern neuroscientific approaches (animal studies, molecular biology, neuroimaging, neurophysiology, etc.). Current treatment strategies are mainly based on cognitive behavioural interventions (CBT-I) and hypnotic treatment with benzodiazepine receptor agonists and sedating antidepressants. Although the effectiveness of these treatments has been clearly demonstrated, a substantial proportion of patients proves to be treatment-resistant or profits only poorly. The question of long-term pharmaceutical treatment of chronic insomnia, at least in Europe, is unresolved and urgently needs answers. Novel rational treatment avenues require clues on causes and mechanisms from integrated neuroscientific approaches. The important issues concerning insomnia treatment in the future especially in Europe will be reviewed and discussed critically.

Efficacy of digital cognitive behavioural therapy for symptoms of generalised anxiety disorder: a study protocol for a randomised controlled trial.

BACKGROUND: Generalised anxiety disorder (GAD) is a chronic and disabling condition with considerable personal and economic impact. Cognitive behavioural therapy (CBT) is a recommended psychological therapy for GAD; however, there are substantial barriers to accessing treatment. Digital CBT, in particular smartphone-delivered CBT, has the potential to improve accessibility and increase dissemination of CBT. Despite the emerging evidence of smartphone-based psychological interventions for reducing anxiety, effect size scores are typically smaller than in-person interventions, and there is a lack of research assessing the efficacy of smartphone-delivered digital interventions specifically for GAD. METHODS: In the DeLTA trial (DigitaL Therapy for Anxiety), we plan to conduct a parallel-group superiority randomised controlled trial examining the efficacy of a novel smartphone-based digital CBT intervention for GAD compared to a waitlist control. We aim to recruit 242 adults (aged 18 years or above) with moderate-to-severe symptoms of GAD. This trial will be conducted entirely online and will involve assessments at baseline (week 0; immediately preceding randomisation), mid-intervention (week 3), post-intervention (week 6; primary end point) and follow-up (week 10). The primary objective is to evaluate the efficacy of the intervention on GAD symptom severity compared to a waitlist control at post-intervention. Secondary objectives are to examine between-group effects on GAD at follow-up, and to examine the following secondary outcomes at both post-intervention and follow-up: 1) worry; 2) depressive symptoms; 3) wellbeing; 4) quality of life; and 5) sleep difficulty. DISCUSSION: This trial will report findings on the initial efficacy of a novel digital CBT intervention for GAD. Results have the potential to contribute towards the evidence base for digital CBT for GAD and increase the dissemination of CBT. TRIAL REGISTRATION: ISRCTN, ISRCTN12765810. Registered on 11 January 2019.

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.

Predicting clinically significant response to cognitive behavior therapy for chronic insomnia in general medical practice: analysis of outcome data at 12 months posttreatment.

The clinical efficacy of cognitive behavior therapy (CBT) for chronic insomnia has been established, yet clinical effectiveness is less clear. This study presents data on 109 patients from general practice during a formal evaluation of clinical effectiveness. Two thirds achieved normative values of < or =30 min for sleep latency and wakefulness during the night after CBT. Furthermore, almost half of the sample reduced sleeplessness by > or =50%. Logistic regression revealed that initial severity did not contraindicate good outcome. Rather, greater sleep disturbance was positively associated with large symptom reduction, although lower endpoint scores were less likely. Similarly, symptoms of anxiety, depression, and thinking errors positively predicted good outcome. Hypnotic using patients responded equally well to CBT, and demographic factors were of no significant predictive value. It is concluded that CBT is clinically and durably effective for persistent insomnia in routine practice.

Insomniacs' attributions. psychometric properties of the Dysfunctional Beliefs and Attitudes about Sleep Scale and the Sleep Disturbance Questionnaire.

OBJECTIVE: Mental overactivity has been widely implicated in the development and maintenance of insomnia, making the accurate and valid measurement of cognitive variables of some importance. The purpose of this study was to investigate the psychometric properties of two existing attributional scales. METHODS: Data are presented from 178 clinic attending insomniacs who completed the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) and the Sleep Disturbance Questionnaire (SDQ). Standard procedures for the psychometric evaluation of scales were adopted. RESULTS: The internal consistency of the DBAS (30 items) was reasonable (Cronbach's alpha = 0.72); however, a revised ten-item short form (DBAS-10) demonstrated a more robust principal component structure than the original scale (three relatively "pure" factors explained 55% of the variance). The derived subscales achieved satisfactory internal consistency, and the DBAS-10 demonstrated treatment-related measurement sensitivity. The DBAS-10, nevertheless, correlated highly (r = 0.826) with the DBAS. A four-factor solution for the SDQ is also presented (61% explained variance) with alpha = 0.67. Internal consistency of these subscales ranged from 0.59 to 0.82. The association between the SDQ and DBAS-10 was modest (r = 0.28), suggesting that the scales have some independence. CONCLUSIONS: The scales offer potential for clinical and research work on insomnia and possible applications are discussed.

Psychological distress at follow-up after major surgery for intra-oral cancer.

A cohort of patients who had received major intra-oral surgery, up to 10 yr (mean 3.5 yr) prior to this study were reviewed and assessed for evidence of current psychological disturbance. Forty-one per cent of patients were found to have significant levels of psychological distress comprising mood disorder, social dysfunction or both types of difficulty. Prevalence of clinical anxiety and depression per se was within the range 22-32%, but few patients were receiving any form of active therapy for these problems. Investigation of predictors revealed that females and younger people were more at risk to psychological distress. Tentative evidence for variability in psychological outcome in relation to tumour site is also reported. Results are discussed with reference to service provision needs and further research priorities.

Intrusive thoughts and their relationship to actigraphic measurement of sleep: towards a cognitive model of insomnia.

Although cognitive over-arousal has been hypothesised as a causal factor in sleep-onset insomnia, relatively little is known about the specific pre-sleep intrusions which delay sleep. To investigate this relationship adequately 'live', verifiable, unobtrusive and independent monitoring of thought process and sleep pattern is essential. This study was designed with these requirements in mind. Voice-activated audiotape recordings of spontaneous thoughts, and actigraphic data from which to estimate sleep parameters, were obtained over three consecutive nights from 21 participants (63 subject nights). Content analysis of transcribed audiotapes yielded eight categories of pre-sleep intrusion. Results from correlational and regression analyses indicate that thinking about sleep and the anticipated consequences of poor sleep, along with general problem-solving are the strongest predictors of objective sleep latency. Principal Components Analysis suggests that intrusions can be subsumed under one of three factors: 'active problem-solving', 'present state monitoring' and 'environmental reactivity'. Implications for cognitive models and treatments of insomnia are discussed.

The clinical effectiveness of cognitive behaviour therapy for chronic insomnia: implementation and evaluation of a sleep clinic in general medical practice.

Chronic insomnia is a very common clinical condition which may respond well to non-pharmacological treatment. Indeed, the literature supports the efficacy of cognitive behaviour therapy (CBT). However, there has been no substantial study of clinical effectiveness. Since insomniacs typically present in general medical practice this is a crucial gap in the outcome research. This study, therefore, specifically investigated the clinical effectiveness of CBT delivered by Health Visitors (primary care nurses) trained as therapists. One hundred and thirty-nine insomniacs (mean age 51 yr) were randomised to CBT or Self-Monitoring Control (SMC) in a controlled trial. CBT comprised six group sessions (n=4 to 6 patients). After the controlled phase, SMC patients entered deferred treatment (CBT-DEF), allowing both treatment replication and long-term outcome to be investigated for a sizeable, treated sample. Repeated measures ANOVAs demonstrated superiority of CBT over SMC in substantially reducing sleep latency and wakefulness during the night. CBT-DEF replicated similar effects and maintained improvement was observed in both groups one year later. Furthermore, total sleep increased significantly during follow-up and 84% of patients initially using hypnotics remained drug-free. Results suggest that CBT administered by Health Visitors offers a clinically effective treatment for insomnia.

A controlled comparative investigation of psychological treatments for chronic sleep-onset insomnia.

A sample of physician-referred chronic insomniacs was randomly allocated to either progressive relaxation, stimulus control, paradoxical intention, placebo or no treatment conditions. Treatment process and outcome were investigated in terms of mean and standard deviation (night to night variability) measures of sleep pattern and sleep quality. Only active treatments were associated with significant improvement, but the nature of treatment gains varied. In particular, stimulus control improved sleep pattern, whereas relaxation affected perception of sleep quality. All improvements were maintained at 17 month follow-up. Results are discussed with reference to previous research and guidelines are given for clinical practice.

Learning disability and epilepsy. 1, towards common outcome measures.

A major component of the population of people who have epilepsy are people with a learning disability. As a group, such individuals often have complex epilepsy which is refractory to treatment. Current available measures to assess the outcomes of therapeutic interventions in epilepsy are based on seizure frequency, seizure severity and quality-of-life measures, but have not been validated in people with a learning disability. Thus, we do not know if such measures of outcome serve the needs of this group. This review examines how able we are to assess the efficacy of our interventions to control epilepsy in people with learning disability. It is suggested that a standard data set is necessary as the basis of the assessment of any therapeutic intervention. Central components of this data set would encompass a definition of important characteristics of an individual, a description of their epilepsy and an assessment of the impact of their condition on both their own and their carer's health. The approach to obtaining this information should employ a methodology which can allow for environmental influences.

The development of a questionnaire to assess knowledge of epilepsy: 1--General knowledge of epilepsy.

It is well documented that knowledge is a vital factor in the ability to cope successfully with epilepsy. Misconceptions and deficits in knowledge have implications not only for psychosocial well-being but also for medical compliance. However, at present there is no commonly accepted objective measure of knowledge of epilepsy. The development of the Epilepsy Knowledge Profile--General (E.K.P.--G) is presented in this paper. Fifty-five true/false items (34 medical knowledge items, 21 social knowledge items) were selected by a range of experts in the field of epilepsy. A clinical trial of the questionnaire was then completed by 82 people with epilepsy attending a city centre outpatient clinic. Results indicated that the scale has both good internal reliability and test-retest reliability. Also the range of scores indicates that it is sensitive to differences in knowledge. Potential uses of the questionnaire are discussed.

The development of a questionnaire to assess knowledge of epilepsy: 2--Knowledge of own condition.

In a previous paper, a questionnaire to assess general knowledge of epilepsy (E.K.P.--G) was described (same authors). In the present paper, the development of a complementary questionnaire providing a profile of the individual's knowledge of his or her own condition is described. Results from external validation, item refinement and a clinical trial suggest this measure (the Epilepsy Knowledge Profile--Personal) provides a valid and comprehensive assessment profile which has considerable practical applications.

Adults with learning disabilities and epilepsy: knowledge about epilepsy before and after an educational package.

The understanding individuals have about their epilepsy may influence the success with which that individual copes with his/her epilepsy. This paper presents the first evaluation of a video-assisted brief educational package for adults with mild learning disabilities and epilepsy ("Epilepsy and You"; Paul, 1996 21). Utilizing a deferred entry to treatment design to evaluate intervention effects eighteen subjects participated in the study. Their knowledge about epilepsy before and after training was assessed using a checklist of knowledge and the Epilepsy Knowledge Questionnaire-Revised for use with people with learning disabilities. Results demonstrated significant gains in knowledge which were durable over a short follow-up period (1 month). "Epilepsy and You" was found to be suitable for use with a wide range of individuals and subjects' opinions demonstrated they enjoyed taking part. This study is a preliminary investigation from which other research can develop. Therefore, criticisms and suggestions for further research have been made.

Learning disability and epilepsy. 2, a review of available outcome measures and position statement on development priorities.

People with epilepsy plus learning disabilities pose a challenge in terms of clinical management and research investigation, and, to date, the measurement of outcomes in this population has been limited. There have been uncertainties concerning both the 'what' and the 'how' of assessment. This paper presents a comprehensive review of available outcome measures across nine domains, i.e. relating to seizures, drugs, cognitive function, behaviour, social functioning, carer functioning, attitudes, motivation and 'quality of life'. This last domain reflects more global measures designed to encompass several assessment strands. The uses and limitations of each scale is discussed and, where data are available, psychometric properties are also presented. The paper concludes with suggestions for the further development of outcome measures in this population.

Cognitive functioning in people with epilepsy plus severe learning disabilities: a systematic analysis of predictors of daytime arousal and attention.

In spite of the high prevalence of epilepsy and the importance of preserving cognitive function in people with learning disabilities, this population has received relatively little research attention. This study sets out systematically to investigate possible predictive factors of inter-ictal states of arousal and attention. The daytime function of 28 people with epilepsy and severe learning disabilities was assessed by performance on a two-choice reaction time vigilance task, behavioural analysis of time-sampled video recordings taken in naturalistic settings, and carer ratings on visual analogue scales. This methodology yielded eight discrete functional measures, from which two further index measures were derived after principal components analysis. A range of clinical and psychosocial assessments was completed and subjects had 36 hour ambulatory EEG and sleep EEG monitoring. Regression models identified significant predictors of cognitive function from a range of potential explanatory variables i.e. demographic, clinical, pharmacological, background EEG rhythms and sleep parameters. Results indicated that greater severity of learning disability, longer bedtime periods, poor sleep efficiency, frequent seizures and antiepileptic drug polytherapy were significant predictor variables. Explained variance (adjusted R2) was greater than 50% for six of 10 outcome variables (range up to 85%). Furthermore, significant regression equations (P < 0.05) were obtained for all but one variable. Thus, these results appear reasonably robust. Results support an interactional model of daytime arousal and attention in people with epilepsy plus severe learning disabilities. Inter-ictal cognitive function appears to be mediated by a combination of organic, circadian (sleep wake), clinical and pharmacological factors.

A controlled trial of treatments for generalized anxiety.

Treatments for chronic anxiety have received considerable interest recently. Firstly, there is a body of research which has shown problems of dependence and habituation in the long-term use of anti-anxiety drugs. A second development is that of psychological treatments for anxiety. Because of the problems involved in the use of benzodiazepines, it is important to determine whether or not psychological treatments are a reasonable alternative when treating chronic anxiety. This study was designed to test the relative effectiveness of cognitive-behavioural therapy, anxiety management training and treatment by benzodiazepines against a waiting list control. Measures were taken on both the process and outcome of treatment. The most immediate and greatest improvements in anxiety were seen in the group receiving drugs. However, these improvements reduced as the trial progressed and were minimal at the end of therapy. Both psychological treatment groups improved as the trial progressed with the most significant and consistent changes seen in the cognitive-behaviour therapy group. However, at follow-up there was no difference between the two groups receiving psychological treatments. Because of their lack of sustained improvement, over half of the group receiving drugs refused to wait without treatment until the follow-up assessment.

Sleep studies of adults with severe or profound mental retardation and epilepsy.

Sleep patterns of people with mental retardation have received little research attention. This is an important gap in knowledge because understanding the relation between sleep and wakefulness may be critical to care provision. Descriptive sleep information on 28 people with severe or profound mental retardation and epilepsy was presented here. Sleep EEG data, studied both conventionally and by means of a neural network-based sleep analysis system suggest atypical sleep stages with significant depletion of REM sleep and a predominance of "indiscriminate" non-REM sleep. Sleep diaries completed by caregivers reveal lengthy sleep period times, especially among those with profound mental retardation. Possible explanations for these results and their implications were discussed.

Substituting behavioural treatment for drugs in the treatment of insomnia: an exploratory study.

There is need to investigate directly the generalizability of psychological treatment effects to clinical populations of insomniacs; especially to those who are chronic hypnotic users and are drug-dependent. This paper present two methodological models, based upon the pharmacological literature, which permit the selection of such subjects for research studies. The usefulness of the models is discussed with reference to a preliminary investigation based on 10 cases, and recommendations are made both for further research and clinical practice.