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.

European guideline for the diagnosis and treatment of insomnia

This European guideline for the diagnosis and treatment of insomnia was developed by a task force of the European Sleep Research Society, with the aim of providing clinical recommendations for the management of adult patients with insomnia. The guideline is based on a systematic review of relevant meta-analyses published till June 2016. The target audience for this guideline includes all clinicians involved in the management of insomnia, and the target patient population includes adults with chronic insomnia disorder. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system was used to grade the evidence and guide recommendations. The diagnostic procedure for insomnia, and its co-morbidities, should include a clinical interview consisting of a sleep history (sleep habits, sleep environment, work schedules, circadian factors), the use of sleep questionnaires and sleep diaries, questions about somatic and mental health, a physical examination and additional measures if indicated (i.e. blood tests, electrocardiogram, electroencephalogram; strong recommendation, moderate- to high-quality evidence). Polysomnography can be used to evaluate other sleep disorders if suspected (i.e. periodic limb movement disorder, sleep-related breathing disorders), in treatment-resistant insomnia, for professional at-risk populations and when substantial sleep state misperception is suspected (strong recommendation, high-quality evidence). Cognitive behavioural therapy for insomnia is recommended as the first-line treatment for chronic insomnia in adults of any age (strong recommendation, high-quality evidence). A pharmacological intervention can be offered if cognitive behavioural therapy for insomnia is not sufficiently effective or not available. Benzodiazepines, benzodiazepine receptor agonists and some antidepressants are effective in the short-term treatment of insomnia (≤4 weeks; weak recommendation, moderate-quality evidence). Antihistamines, antipsychotics, melatonin and phytotherapeutics are not recommended for insomnia treatment (strong to weak recommendations, low- to very-low-quality evidence). Light therapy and exercise need to be further evaluated to judge their usefulness in the treatment of insomnia (weak recommendation, low-quality evidence). Complementary and alternative treatments (e.g. homeopathy, acupuncture) are not recommended for insomnia treatment (weak recommendation, very-low-quality evidence).

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.

Metacognitive beliefs relate specifically to sleep quality in primary insomnia: a pilot study.

OBJECTIVE: To identify whether metacognitive aspects are a specific mental pattern of primary insomnia (PI) or an aspecific correlate of sleep alterations. METHODS: Sleep quality (Pittsburgh Sleep Quality Index: PSQI), anxiety (Self-rating Anxiety State: SAS), depression (Beck Depression Inventory: BDI) and metacognition (Metacognitions Questionnaire - Insomnia: MCQ-I) were evaluated in 24 PI patients, 13 snorers and 17 healthy controls. Rank-transformed PSQI, BDI, SAS and MCQ-I scores were submitted to one-way analysis of variance with group as a between-factor. PSQI was submitted to three-way analysis of covariance (ANCOVA) with MCQ-I, BDI or SAS as covariate and group as a between-factor. Post-hoc analyses were conducted using pairwise comparisons with Sidak correction. RESULTS: As expected, PSQI scores significantly differentiated the three groups, one from another: PI had highest scores followed by snorers and healthy controls. PI subjects had MCQ-I scores significantly higher than those of snorers and healthy controls; no difference between the latter groups was found. The ANCOVA on PSQI with MCQ-I as a covariate abolished the difference in sleep quality between PI and snorers, whereas covarying for BDI or SAS left the differences in sleep quality between the groups unchanged. CONCLUSION: These preliminary results lead to two main conclusions: (i) metacognitive aspects are more prominent in PI when compared to snorers and healthy controls; (ii) MCQI shows higher sensitivity in defining PI patients, with respect to PSQI. If these findings are confirmed and expanded by further studies, the development of a specific metacognitive model of primary insomnia may be warranted.

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.

British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders.

Sleep disorders are common in the general population and even more so in clinical practice, yet are relatively poorly understood by doctors and other health care practitioners. These British Association for Psychopharmacology guidelines are designed to address this problem by providing an accessible up-to-date and evidence-based outline of the major issues, especially those relating to reliable diagnosis and appropriate treatment. A consensus meeting was held in London in May 2009. Those invited to attend included BAP members, representative clinicians with a strong interest in sleep disorders and recognized experts and advocates in the field, including a representative from mainland Europe and the USA. Presenters were asked to provide a review of the literature and identification of the standard of evidence in their area, with an emphasis on meta-analyses, systematic reviews and randomized controlled trials where available, plus updates on current clinical practice. Each presentation was followed by discussion, aimed to reach consensus where the evidence and/or clinical experience was considered adequate or otherwise to flag the area as a direction for future research. A draft of the proceedings was then circulated to all participants for comment. Key subsequent publications were added by the writer and speakers at draft stage. All comments were incorporated as far as possible in the final document, which represents the views of all participants although the authors take final responsibility for the document.

The clock as a focus of selective attention in those with primary insomnia: an experimental study using a modified Posner paradigm.

Espie and colleagues [(2006). The attention-intention-effort pathway in the development of psychophysiological insomnia: a theoretical review. Sleep Medicine Reviews, 10, 215-245] propose a route into psychophysiological insomnia along the attention-intention-effort pathway which focuses on the inhibition of sleep-wake automaticity. A contributing factor to this is selective attention to sleep (alongside explicit intention to sleep and effort in the sleep engagement process). Following on from previous work on selective attention to sleep [Marchetti, L. M., Biello, S. M., Broomfield, N. M., MacMahon, K. M. A., & Espie, C. A. (2006). Who is pre-occupied with sleep?. A comparison of attention bias in people with psychphysiological insomnia, delayed sleep phase syndrome and good sleepers using the induced change blindness paradigm. Journal of Sleep Research, 15, 212-221; MacMahon, K., Broomfield, N., Macphee, L., & Espie, C. A. (2006). Attention bias for sleep related stimuli in primary insomnia and delayed sleep phase syndrome using the dot-probe task. Sleep, 29, 11] and considering the importance of monitoring both internal and external cues in the maintenance of insomnia, as highlighted in the cognitive model of insomnia [Harvey, A. G. (2002). A cognitive model of insomnia. Behaviour Research and Therapy, 40, 869-893], a cognitive probe task was employed to investigate further the role of the clock as a focus of selective attention in those with primary insomnia. A 2 x 2 between participants design comparing reaction time of individuals with primary insomnia (n=22) and normal sleepers (n=22) on a modified Posner paradigm. Responses obtained from a computer task presenting times which fall within a normal sleep period were analysed. Individuals with primary insomnia demonstrated delayed disengagement to the clock (F(1,84)=6.9, p<0.05) which is taken as further support for previous research demonstrating that individuals with primary insomnia exhibit an attentional bias to sleep related stimuli. These results lend support to the attention-intention-effort model (Espie et al., 2006) and the cognitive model (Harvey, 2002) both of which recognise the importance of selective attention towards salient stimuli in the maintenance of insomnia. Possible clinical implications of attentional bias to sleep as a marker of psychopathology progression and treatment efficacy are discussed.

Development of a measure to assess the impact of epilepsy on people with an intellectual disability: the Glasgow Epilepsy Outcome Scale - Client version (GEOS-C).

BACKGROUND: Epilepsy is common in people with intellectual disability, yet clinicians and researchers seldom obtain information directly from the client. The development and preliminary validation of a novel measure for use with people with mild to moderate intellectual disabilities is described. METHODS: Focus group methods (6 groups; 24 participants) identified issues of concern, and qualitative analysis (NUD*IST) was applied to derive items and themes for a draft scale. Psychometric scale development techniques were then used in a pilot study and subsequent field-testing to investigate validity and reliability (n = 46). RESULTS: A total of 148 issues of concern was reduced initially to 52 and then to 42 items using these methods. The derived scale comprised sub-scales reflecting (1) concerns about having seizures; (2) about injury; (3) about issues during; and (4) after seizures; (5) about medication; (6) about what people think; and (7) about daily life. Cronbach alpha for the Glasgow Epilepsy Outcome Scale - Client version (GEOS-C) was 0.92, and ranged from 0.64-0.81 for the sub-scales. Relatively weak associations (r

The safety of antiepileptic drug withdrawal in patients with non-epileptic seizures.

BACKGROUND: To determine whether withdrawal of anticonvulsant drugs (AED) can be carried out safely in patients with non-epileptic seizures (NES). METHODS: Prospective evaluation of safety and outcome in 78 patients with NES who satisfied a standardised set of criteria for excluding the diagnosis of coexisting or underlying epilepsy. FINDINGS: The patients were taking from one to three AED. Sixty four patients were withdrawn as outpatients, 14 as inpatients. Five patients stopped their drugs abruptly, and two had AED restarted and had to be withdrawn again. Otherwise all patients adhered to withdrawal schedules. A new type of attack in addition to NES was seen in three patients (complex partial seizures in all three cases). NES frequency declined in the group as a whole over the period of the study (follow up 6-12 months) in all individuals except for eight patients in whom there was a transient increase. Fourteen patients reported new physical symptoms after withdrawal; however, no serious adverse events were reported. CONCLUSIONS: With appropriate diagnostic investigation and surveillance during follow up withdrawal of AED can be achieved safely in patients with NES.

Can psychological factors help us to determine adherence to CPAP? A prospective study.

The present study objective was to establish whether pretreatment social cognitive variables may contribute to the explanation of variance in adherence to continuous positive airway pressure (CPAP) treatment for patients with obstructive sleep apnoea/hypopnoea syndrome (OSAHS). A total of 119 of 180 consecutive OSAHS patients were recruited to the study prior to initial CPAP titration. Patients completed psychological measures of health value, health locus of control (incorporating internality, chance, powerful others) and self-efficacy prior to CPAP titration. Objective adherence data were measured by CPAP unit time clocks and collected at 3-month follow-up. Average nightly use was calculated over this period. Logistic regression of prospective predictors of adherence produced a model comprising psychological (health value, internality, powerful others), as well as clinical variables (Epworth score, body mass index, apnoea/hypopnoea index, CPAP pressure). This model explained 24% of the variance in CPAP use, and correctly identified 75% of adherers and 53% of nonadherers. Although the psychological variables explained only a small amount of the overall variance in adherence behaviour, this result provides further support for the hypothesis that psychological variables contribute, in part, to continuous positive airway pressure adherence. Future research should focus on highlighting discrete variables, which may helpfully inform psychologically based interventions aimed at improving the use of continuous positive airway pressure by patients with obstructive sleep apnoea/hypopnoea syndrome at risk of discontinuance.

Mind-reading difficulties in the siblings of people with Asperger's syndrome: evidence for a genetic influence in the abnormal development of a specific cognitive domain.

BACKGROUND: Previous research suggests that the phenotype associated with Asperger's syndrome (AS) includes difficulties in understanding the mental states of others, leading to difficulties in social communication and social relationships. It has also been suggested that the first-degree relatives of those with AS can demonstrate similar difficulties, albeit to a lesser extent. This study examined 'theory of mind' (ToM) abilities in the siblings of children with AS relative to a matched control group. METHOD: 27 children who had a sibling with AS were administered the children's version of the 'Eyes Test' (Baron-Cohen, Wheelwright, Stone, & Rutherford, 1999). The control group consisted of 27 children matched for age, sex, and a measure of verbal comprehension, and who did not have a family history of AS/autism. RESULTS: A significant difference was found between the groups on the Eyes Test, the 'siblings' group showing a poorer performance on this measure of social cognition. The difference was more pronounced among female siblings. DISCUSSION: These results are discussed in terms of the familial distribution of a neuro-cognitive profile associated with AS, which confers varying degrees of social handicap amongst first-degree relatives. The implication of this finding with regard to the autism/AS phenotype is explored, with some discussion of why this neuro-cognitive profile (in combination with corresponding strengths) may have an evolutionary imperative.

Psychopathology in people with epilepsy and intellectual disability; an investigation of potential explanatory variables.

OBJECTIVES: There are few studies on epilepsy and psychopathology in people with intellectual disability (mental retardation) despite epilepsy prevalence rates that are thirty times higher than in the general population. The aims of this study, therefore, were to identify reliable, epilepsy-specific predictors of psychiatric and behavioural disorder in these patients, and to investigate reliable predictors of carer stress. METHODS: A database of 685 patients was compiled, from which 250 were randomly selected. Structured interviews were completed on 186 of these 250 patients (74%) (108 men, 78 women; mean age (SD) 35.5 (10.1)) comprising descriptive, clinical and functional components, and validated measures of psychopathology for which comparative data were available. Logistic and linear regression methods were used to identify predictors. RESULTS: One-third of patients with epilepsy and intellectual disability met criteria for possible psychiatric disorder, particularly affective/neurotic disorder; twice the comparison rates for intellectual disability alone. Behavioural problem levels, however, were lower than population norms. Regression models explaining modest amounts of variance (R(2)< or =24%) suggested certain seizure phenomena (greater seizure severity, more seizures in past month, lesser tendency to loss of consciousness during seizures) as particular risk factors for psychiatric disorder. General disability factors such as level of intellectual, sensory or motor disability and side effects of medication, however, contributed more to explaining behavioural problems. Around half of the family carers reported significant stress, and one-third exhibited clinically significant anxiety symptoms. Younger carers were more stressed, and side effects from patients' medication also contributed to carer stress. CONCLUSIONS: Although epilepsy in itself may be a risk factor for psychopathology in a minority of people with intellectual disability, some epilepsy-specific factors may predict psychiatric disorder. Behavioural problems need to be considered separately from psychiatric disorder because general factors, more closely associated with disability, are stronger predictors of their occurrence.

Psychological treatment of reported sleep disorder in adults with intellectual disability using a multiple baseline design.

BACKGROUND: The literature on sleep disturbance in adults with intellectual disability (ID) is sparse. Although prevalence rates for sleep disorders appear similar to those of non-disabled populations, previous treatment studies have largely been comprised of uncontrolled cases. Therefore, the present study adopted a single-case experimental methodology to evaluate behavioural sleep intervention. METHODS: A screening questionnaire was posted to 384 adults with ID and the sleep pattern of respondents with possible sleep disorders was further assessed using a structured diagnostic schedule. From the sleep-disordered subgroup, 12 participants were selected for a 4-week behavioural sleep intervention that was evaluated using randomly allocated, multiple-baseline, across-subjects designs and within-subject interrupted time series analyses (ITSAs). RESULTS: A total of 155 adults with ID (83 females and 72 males; mean age = 32 years, SD = 16.5 years), or their carers, completed the questionnaire (return rate = 40%). The application of sleep diagnostic criteria revealed that 17% had clinically significant difficulty getting to sleep and 11% had difficulty remaining asleep. Nine out of the 12 participants recruited for the intervention completed all the experimental phases, thus providing three sets of three multiple-baseline designs. Visual inspection of within- and between-subject effects suggested beneficial treatment-specific effects across a range of target variables. The ITSA confirmed significant effects (P < 0.05) or trends (P < 0.10) for six out of the nine participants. CONCLUSIONS: Behavioural sleep management may improve sleep pattern or sleep-related functioning in the majority of adults with ID who have significant sleep problems. The single-case methodology is helpful in addressing the heterogeneity of individual presentation, although clinical trial methodology is required to confirm these findings on a larger scale.

Glasgow Anxiety Scale for people with an Intellectual Disability (GAS-ID): development and psychometric properties of a new measure for use with people with mild intellectual disability.

BACKGROUND: Self-rating scales are widely used in general adult practice; however, there is no reliable and valid method for assessing state anxiety in people with intellectual disability (ID). The present study describes the development and psychometric evaluation of a new scale, the Glasgow Anxiety Scale for People with an Intellectual Disability (GAS-ID). METHODS: First, an item pool was generated from focus groups, a review of the literature and clinician feedback. Secondly, a draft scale was administered to 19 anxious and 16 non-anxious people with ID for further validation and appraisal of reliability. Thirdly, the scale was completed by 19 anxious, non-ID people for cross-validation with the Beck Anxiety Inventory (BAI). Finally, physiological concomitants were validated by pulse-oximetry. RESULTS: The 27-item GAS-ID discriminated anxious from non-anxious participants, had good test-retest reliability (r = 0.95) and internal consistency (alpha = 0.96), and was reasonably correlated with the BAI (rho = 0.75). The correlation between the physiological subscale of the GAS-ID and changes in pulse rate was moderately significant (rho = 0.52). CONCLUSIONS: This preliminary study suggests that the GAS-ID offers a psychometrically robust and practical (5-10 min) approach to the appraisal of anxiety in this population.

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.

Development and validation of the Glasgow Epilepsy Outcome Scale (GEOS): a new instrument for measuring concerns about epilepsy in people with mental retardation.

PURPOSE: To develop a measure for use with adults with epilepsy and mental retardation, capable of assessing both clinical and care concerns and of quantifying treatment outcomes. METHODS: Extensive validational and other psychometric evaluation was undertaken, comprising initial scale development work with 48 carers and 46 health practitioners, followed by formal field testing on a sample of 186 patients, using 384 respondents (160 clinicians, 141 staff, 83 family). Recognised qualitative methods were applied to identify central themes, and psychometric procedures generated data on validity, reliability, and component structure. RESULTS: A total of 1,007 items of concern was generated, which was reduced systematically to a representative set of 90 items. The GEOS-90 comprises four subscales: concerns about "seizures," "treatment," "caring," and "social impact," each explaining approximately 70% of variance. Subscales and factor scales had strong internal consistency (alpha > or = 0.82). Stepwise linear regression was applied to derive a short-form version with similar structure. Thirty-five items were retained (GEOS-35; alpha > or = 0.89). Both scales discriminated moderately on clinical variables (number of seizure types, mono- vs. polytherapy, seizure frequency; all values of p < 0.05) and demonstrated concurrent validity with interview ratings from the ELDQOL (p < 0.05). CONCLUSIONS: The GEOS scales appear valid and reliable for use with clinical populations of people with mental retardation.

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.

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.

Controlled, prospective trial of psychosocial function before and after continuous positive airway pressure therapy.

The aim of the study was to investigate psychosocial function before and after continuous positive airway pressure (CPAP) therapy, and establish the determinants and consequences of objective CPAP use. In a prospective, parallel-group study, changes in psychosocial scores were compared with conservative management or CPAP therapy for the sleep apnoea/hypopnoea syndrome (SAHS). Patient/partner couples from the top (CPAP treated, n=44) or bottom (conservatively treated, n=25) of a CPAP waiting list rated marital satisfaction (evaluation and nurturing relationship issues, communication and happiness (ENRICH), behavioural questionnaire), health/functional status (Short-Form-36 Health Survey, functional outcomes of sleep questionnaire) and sleepiness (Epworth sleepiness scale). Both groups' ratings at baseline were completed while on conservative therapy. Baseline variables did not differ between groups. At follow-up, all seven summary psychosocial scores were statistically better in CPAP-treated patients, effect sizes (ES) ranging from moderate (0.5 SD: marital satisfaction) to very large (>1.0 SD: patients health, functional status and sleepiness scores). Scores in conservatively-treated patients deteriorated to a small or moderate degree (ES -0.2- -0.7 SD), while those in the CPAP-treated group improved to a larger degree (0.3-1.3 SD). Baseline polysomnographical and psychosocial scores, including marital satisfaction, did not predict objective CPAP use (r<0.3). CPAP use was modestly correlated (r=0.3-0.6) with improvement in all psychosocial areas. Continuous positive airway pressure produced statistically and clinically significant psychosocial improvements, some of large magnitude, in psychosocial function. Determinants of usage were not identified, but benefits and usage were positively correlated.