Background Placebo treatments have been reported to help patients with many diseases, but the quality of the evidence supporting this finding has not been rigorously evaluated. Methods We conducted a systematic review of clinical trials in which patients were randomly assigned to either placebo or no treatment. A placebo could be pharmacologic (e.g., a tablet), physical (e.g., a manipulation), or psychological (e.g., a conversation). Results We identified 130 trials that met our inclusion criteria. After the exclusion of 16 trials without relevant data on outcomes, there were 32 with binary outcomes (involving 3795 patients, with a median of 51 patients per trial) and 82 with continuous outcomes (involving 4730 patients, with a median of 27 patients per trial). As compared with no treatment, placebo had no significant effect on binary outcomes, regardless of whether these outcomes were subjective or objective. For the trials with continuous outcomes, placebo had a beneficial effect, but the effect decreas...

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Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment.

A cognitive model of insomnia.

Background Recognition that psychological and behavioral factors play an important role in insomnia has led to increased interest in therapies targeting these factors. A review paper published in 1999 summarized the evidence regarding the efficacy of psychological and behavioral treatments for persistent insomnia. The present review provides an update of the evidence published since the original paper. As with the original paper, this review was conducted by a task force commissioned by the American Academy of Sleep Medicine in order to update its practice parameters on psychological and behavioral therapies for insomnia. Methods A systematic review was conducted on 37 treatment studies (N = 2246 subjects/patients) published between 1998 and 2004 inclusively and identified through Psyclnfo and Medline searches. Each study was systematically reviewed with a standard coding sheet and the following information was extracted: Study design, sample (number of participants, age, gender), diagnosis, type of treatments and controls, primary and secondary outcome measures, and main findings. Criteria for inclusion of a study were as follows: (a) the main sleep diagnosis was insomnia (primary or comorbid), (b) at least 1 treatment condition was psychological or behavioral in content, (c) the study design was a randomized controlled trial, a nonrandomized group design, a clinical case series or a single subject experimental design with a minimum of 10 subjects, and (d) the study included at least 1 of the following as dependent variables: sleep onset latency, number and/or duration of awakenings, total sleep time, sleep efficiency, or sleep quality. Results Psychological and behavioral therapies produced reliable changes in several sleep parameters of individuals with either primary insomnia or insomnia associated with medical and psychiatric disorders. Nine studies documented the benefits of insomnia treatment in older adults or for facilitating discontinuation of medication among chronic hypnotic users. Sleep improvements achieved with treatment were well sustained over time; however, with the exception of reduced psychological symptoms/ distress, there was limited evidence that improved sleep led to clinically meaningful changes in other indices of morbidity (e.g., daytime fatigue). Five treatments met criteria for empirically-supported psychological treatments for insomnia: Stimulus control therapy, relaxation, paradoxical intention, sleep restriction, and cognitive-behavior therapy. Discussion These updated findings provide additional evidence in support of the original review's conclusions as to the efficacy and generalizability of psychological and behavioral therapies for persistent insomnia. Nonetheless, further research is needed to develop therapies that would optimize outcomes and reduce morbidity, as would studies of treatment mechanisms, mediators, and moderators of outcomes. Effectiveness studies are also needed to validate those therapies when implemented in clinical settings (primary care), by non-sleep specialists. There is also a need to disseminate more effectively the available evidence in support of psychological and behavioral interventions to health-care practitioners working on the front line.

Psychological and behavioral treatment of insomnia:update of the recent evidence (1998-2004).

These new guideline recommendations from the American College of Physicians provide evidence-based advice for the management of chronic insomnia disorder in adults. Implementation of these guidelin...

Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians

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.

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

The present paper sets out to review the literature on several aspects of sex offenders with intellectual and developmental disabilities, including the relationship between sex offending and developmental disabilities, the prevalence and characteristics of sex offenders in this client group, assessment, treatment, and outcome of intervention. Several important variables were identified as influencing the disparate results found in different prevalence studies. These include variations in inclusion criteria, differences in the source of the sample, differences in determination of IQ, the impact of deinstitutionalization, and the effect of changing social and penal policies in the area where studies have been conducted. Although some studies have suggested an increasing incidence, there is no clear evidence for the over- or under-representation of people with developmental disabilities amongst sex offenders. One of the main methodological flaws in several reports listing the characteristics of sex offenders is that considerations are based on clinical samples. Therefore, there is no control group to show that these characteristics do not exist in other samples of individuals with intellectual disability (ID). It does appear that sex offenders with ID are more likely to commit offences across categories and to be less discriminating in their victims. There may also be an association with sexual abuse in childhood. The primary issue considered has been assessment of competency, in that people with ID are considered to be disadvantaged by the criminal justice process. While several authors have delineated the important areas for assessment, there are few assessment measures with robust psychometric properties. Pharmacological, behavioural, educational and cognitive treatments are reviewed. Several comprehensive treatments which include all of the aforementioned methods are also considered. Although most studies do not report particularly positive outcomes, several authors have found better outcomes with treatment lasting at least 2 years.

Research and literature on sex offenders with intellectual and developmental disabilities

An evaluation of tailored psychological treatment of insomnia

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

The present study compares the responses to treatment of sex offenders with intellectual disability receiving 1- and 2-year probationary sentences. There were seven subjects in each group. There were no differences between subjects with regard to age, IQ or previous offences. All subjects received group treatment which addressed issues of: denial, minimization and responsibility for the offence; harm done to the victim; behaviour consistent with offending; and victim awareness and confidentiality. The subjects were assessed on a standard questionnaire designed to assess attitudes consistent with sex offending. All subjects were convicted of either indecent exposure or offences against children. There was a significant difference between the groups at the end of the probation period with subjects sentenced to 2 years' probation showing greater improvement. Subjects receiving 1 years' probation retained a number of attitudes consistent with denial and minimization of their offence. Furthermore, follow-up data underlined the poorer response to treatment for the 1-year probation group in terms of re-offending rates and assessment of attitudes consistent with sex offending. The authors recommend that a court order for a 1-year period of probation with treatment is of little value when dealing with sex offenders with intellectual disability. Rather, a period of at least 2 years' probation with a treatment recommendation is suggested.

Responses to treatment for sex offenders with intellectual disability: a comparison of men with 1- and 2-year probation sentences

Historically people with intellectual disabilities have not been offered or received cognitive behavioural interventions that have been shown to be effective for mental health and emotional problems experienced by those without such disabilities. This is despite many people with intellectual disabilities having life experiences that potentially result in them having an increased risk to such problems. This paper discusses whether such therapeutic disdain is justified based on the evidence that is available and emerging concerning the application of cognitive behavioural interventions for this population. Issues concerning access to services, the ability of people with intellectual disabilities to engage in and benefit from the cognitive components of CBT, and the effect of cognitive abilities and IQ level on treatment effectiveness are explored in relation to this question.

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William R. Lindsay

Papers

Research and literature on sex offenders with intellectual and developmental disabilities

An evaluation of tailored psychological treatment of insomnia

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

Responses to treatment for sex offenders with intellectual disability: a comparison of men with 1- and 2-year probation sentences

CBT for People with Intellectual Disabilities: Emerging Evidence, Cognitive Ability and IQ Effects