High quality protocols facilitate proper conduct, reporting, and external review
 of clinical trials. However, the completeness of trial protocols is often
 inadequate. To help improve the content and quality of protocols, an
 international group of stakeholders developed the SPIRIT 2013 Statement
 (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT
 Statement provides guidance in the form of a checklist of recommended items to
 include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important
 information to promote full understanding of the checklist recommendations. For
 each checklist item, we provide a rationale and detailed description; a model
 example from an actual protocol; and relevant references supporting its
 importance. We strongly recommend that this explanatory paper be used in
 conjunction with the SPIRIT Statement. A website of resources is also available
 (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement,
 should help with the drafting of trial protocols. Complete documentation of key
 trial elements can facilitate transparency and protocol review for the benefit
 of all stakeholders.

https://www.bmj.com/content/bmj/346/bmj.e7586.full.pdf

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

Criticism and the Growth of Knowledge. Edited by I. Lakatos and A. Musgrave. Pp. viii, 282. £3·50, paperback £1. 1970. (Cambridge University Press.)

Mental health of young people: a global public-health challenge

Cognitive behavioral therapy (CBT) refers to a popular therapeutic approach that has been applied to a variety of problems. The goal of this review was to provide a comprehensive survey of meta-analyses examining the efficacy of CBT. We identified 269 meta-analytic studies and reviewed of those a representative sample of 106 meta-analyses examining CBT for the following problems: substance use disorder, schizophrenia and other psychotic disorders, depression and dysthymia, bipolar disorder, anxiety disorders, somatoform disorders, eating disorders, insomnia, personality disorders, anger and aggression, criminal behaviors, general stress, distress due to general medical conditions, chronic pain and fatigue, distress related to pregnancy complications and female hormonal conditions. Additional meta-analytic reviews examined the efficacy of CBT for various problems in children and elderly adults. The strongest support exists for CBT of anxiety disorders, somatoform disorders, bulimia, anger control problems, and general stress. Eleven studies compared response rates between CBT and other treatments or control conditions. CBT showed higher response rates than the comparison conditions in seven of these reviews and only one review reported that CBT had lower response rates than comparison treatments. In general, the evidence-base of CBT is very strong. However, additional research is needed to examine the efficacy of CBT for randomized-controlled studies. Moreover, except for children and elderly populations, no meta-analytic studies of CBT have been reported on specific subgroups, such as ethnic minorities and low income samples.

/pdf/the-efficacy-of-cognitive-behavioral-therapy-a-review-of-txe8rqmfum.pdf

The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses

We performed a quantitative review of associations between the higher order personality traits in the Big Three and Big Five models (i.e., neuroticism, extraversion, disinhibition, conscientiousness, agreeableness, and openness) and specific depressive, anxiety, and substance use disorders (SUD) in adults. This approach resulted in 66 meta-analyses. The review included 175 studies published from 1980 to 2007, which yielded 851 effect sizes. For a given analysis, the number of studies ranged from three to 63 (total sample size ranged from 1,076 to 75,229). All diagnostic groups were high on neuroticism (mean Cohen's d = 1.65) and low on conscientiousness (mean d = -1.01). Many disorders also showed low extraversion, with the largest effect sizes for dysthymic disorder (d = -1.47) and social phobia (d = -1.31). Disinhibition was linked to only a few conditions, including SUD (d = 0.72). Finally, agreeableness and openness were largely unrelated to the analyzed diagnoses. Two conditions showed particularly distinct profiles: SUD, which was less related to neuroticism but more elevated on disinhibition and disagreeableness, and specific phobia, which displayed weaker links to all traits. Moderator analyses indicated that epidemiologic samples produced smaller effects than patient samples and that Eysenck's inventories showed weaker associations than NEO scales. In sum, we found that common mental disorders are strongly linked to personality and have similar trait profiles. Neuroticism was the strongest correlate across the board, but several other traits showed substantial effects independent of neuroticism. Greater attention to these constructs can significantly benefit psychopathology research and clinical practice.

Linking "big" personality traits to anxiety, depressive, and substance use disorders: a meta-analysis.

Reason for withdrawal from publication


Authors have made no progress with this protocol in over a year due to difficulties with identifying potentially suitable studies. The protocol has been withdrawn. To view the published versions of this article, please click the 'Other versions' tab.

Pharmacological interventions for people with histrionic personality disorder

Particular strengths of the MRC Needs for Care Assessment Schedule have been used to investigate the treatment status of patients with persistent psychiatric disability in ways that other needs assessment tools are unable to One hundred and seventy-nine such patients from three settings; a private sector psychiatric hospital, two public sector day hospitals situated in the same town, and a high security hospital, were found to have a high level of need Although there were differences between settings, overall these needs were well met in all three The high level of persistent disability found amongst these patients could not be attributed to failure on the part of those treating them to use the best available methods, or to failures to comply or engage with treatment on the patient's part In some two thirds of instances persistent disability was best explained by the fact that even the most suitable available treatments have to be considered only partially effective

Using Needs Assessment to Understand Continuing Disability in Patients with Enduring Mental Illness. Implications for Considerations of Service Development

Obsessive-compulsive disorder (OCD) is one of a series of disorders in which the predominant symptom is anxiety. This anxiety arises either from thoughts (i.e., obsessions) or the need to carry out certain behaviors (i.e., compulsions). Most presentations involve a combination of obsessions and compulsions; single obsessions or compulsions are less common (Marks, 1987). Classifying OCD on the basis of the stimulus is generally not helpful, because this tends to produce an almost endless list. Nevertheless, certain groups of concerns in OCD naturally coalesce and hence are useful in practice. Obsessions, for instance, commonly center around thoughts of contamination, violence, doubting, and worries about sexual or religious prohibitions. Compulsions commonly involve checking, washing, and counting (Rasmussen & Eisen, 1988).

Obsessive-Compulsive Disorder

Looking in from the outside, what would the ordinary person expect of forensic mental health services? I suggest that there are three questions he or she would ask: (a) Are there public health measures that can be introduced to prevent those with mental disorder going on to commit crimes? (b) Can we identify in advance the individual who is likely to go on and commit a violent act because of his or her mental health difficulties, and prevent that or limit damage? (c) If a seriously harmful act has already been committed, what interventions might prevent a repetition? All of these questions are about prevention of an untoward event in the future and anticipate knowledge. How secure can we be that current forensic mental health practitioners can make adequately evidenced responses? I fear that examination of current literature would indicate that they and their academic colleagues would fall short of these expectations. Reasons for this are undoubtedly numerous. The issues are complex, with the interplay of many variables from the vagaries of human nature through varying presentations of disorders, still often classified rather than diagnosed, to widely differing environments which, further, may suddenly change in a critical way. The impact of a serious offence can be so catastrophic that officialdom often decides that "something must be done." Yet, without a good evidence base, such decision-making is often ineffective and wasteful of resources. The limited evidence base has not been helped by the virtual extinction of an academic forensic psychiatry infrastructure and funding within British universities and the National Health Service. This does not bode well for the future.

https://www.onlinelibrary.wiley.com/doi/pdf/10.1002/cbm.2129

Looking from the outside: No substitute for rigorous evaluation.

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Conor Duggan

Papers

Pharmacological interventions for people with histrionic personality disorder

Using Needs Assessment to Understand Continuing Disability in Patients with Enduring Mental Illness. Implications for Considerations of Service Development

Obsessive-Compulsive Disorder

Looking from the outside: No substitute for rigorous evaluation.

Alan Lee, FRCPsych