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.

Background The concept of psychopathy, as measured by the Psychopathy Checklist-Revised (PCL-R), has good reliability and validity and there is a small amount of literature relating it to more general personality traits. Such relationships have not, however, been demonstrated across a variety of populations.



Aim To examine the relationship between the PCL-R and the NEO-Five Factor Inventory (NEO-FFI) in a sample of men detained in a secure hospital unit because of personality disorder and having been convicted of at least one criminal offence.



Method PCL-R and NEO-FFI measures were obtained for 100 men as part of a pre-admission assessment to a specialist personality disorder treatment unit.



Results After controlling for Intelligence Quotient (IQ) and scores on the other four NEO-FFI domains, PCL-R total scores were significantly negatively correlated with agreeableness (r = −0.36) and neuroticism (r = −0.22). No other correlations with total scores were significant. PCL-R Factor 1 scores were significantly negatively correlated with agreeableness (r = −0.31) and with neuroticism (r = −0.26) whereas Factor 2 scores were significantly positively correlated with extraversion (r = 0.22) and negatively with agreeableness (r = −0.21).



Conclusions Results were in line with findings from previous studies and were explained in part by considering how facets of the NEO-FFI map onto the concept of psychopathy. Further research is needed to ascertain whether similar relationships also apply among women, and to examine the relationship between psychopathy and specific facets of the five factor model. Copyright © 2008 John Wiley & Sons, Ltd.

Psychopathy and personality. An investigation of the relationship between the NEO-Five Factor Inventory (NEO-FFI) and the Psychopathy Checklist-Revised (PCL-R) in a hospitalized sample of male offenders with personality disorder.

Three males with factor-IX deficiency (Christmas disease) in one pedigree all had severe affective disorder. This apparent cosegregation, if true, would support the hypothesis that in some pedigrees, a gene for major affective disorder is located on the X chromosome.

Cosegregation of Christmas disease and major affective disorder in a pedigree.

This paper examines the evidence to justify intervening in those with personality disorder, specifically antisocial personality disorder (ASPD) as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV, American Psychiatric Association 1994). The evidence from randomized controlled trials in the mental health literature is reviewed and found to be deficient with only five trials satisfying Cochrane criteria, all of which had a reduction in substance misuse as their primary outcome, rather than a change in the personality disorder per se.Next, I consider the contribution of Thomas Kuhn to explain why it is difficult to develop a scientific basis in forensic mental health. I argue that, because forensic mental health is inclusive in its purpose (interacting with the law, social services and the penal system, all of which have different rules and agendas), it is difficult to develop a consensus on fundamentals, this consensus being a hallmark of a science.Finally, I argue that despite the absence of evidence from mental health, providers for ASPD are in a fortunate position in being able to draw upon the correctional literature. This is relevant, provided that we agree that a reduction in offending is the primary outcome. While mental health can learn much from correctional practice, it can also enhance the efficacy of the latter by, for instance, drawing attention to the specific vulnerabilities of the personality structure that might impede programme delivery in correctional settings. Means of achieving a conjunction of mental health and correctional practice are urgently required as this would be beneficial to both.

Why are programmes for offenders with personality disorder not informed by the relevant scientific findings

Early-onset alcohol abuse (EOAA) was previously found to both mediate and moderate the effect of childhood conduct disorder (CD) on adult antisocial behavior (ASB) in an American community sample of young adults (Howard, R., Finn, P. R., Gallagher, J., & Jose, P. (2011). Adolescent-onset alcohol abuse exacerbates the influence of childhood conduct disorder on late adolescent and early adult antisocial behavior. Journal of Forensic Psychiatry and Psychology. Advance online publication. doi:10.1080/14789949.2011.641996). This study tested whether this result would generalize to a British forensic sample comprising 100 male forensic patients with confirmed personality disorder. Results confirmed that those in whom EOAA co-occurred with CD showed the highest level of personality pathology, particularly Cluster B traits and antisocial/borderline comorbidity. Those with co-occurring CD with EOAA, compared with those showing only CD, showed more violence in their criminal history and greater recreational drug use. Regression analysis showed that both EOAA and CD predicted adult ASB when covariates were controlled. Further analysis showed that EOAA significantly mediated but did not moderate the effect of CD on ASB. The failure to demonstrate an exacerbating effect of EOAA on the relationship between CD and ASB likely reflects the high prevalence of CD in this forensic sample. Some implications of these findings are discussed.

https://psycnet.apa.org/journals/per/3/4/423.pdf

Conor Duggan

Papers

Psychopathy and personality. An investigation of the relationship between the NEO-Five Factor Inventory (NEO-FFI) and the Psychopathy Checklist-Revised (PCL-R) in a hospitalized sample of male offenders with personality disorder.

Cosegregation of Christmas disease and major affective disorder in a pedigree.

Why are programmes for offenders with personality disorder not informed by the relevant scientific findings

The relationship between childhood conduct disorder and adult antisocial behavior is partially mediated by early-onset alcohol abuse.

Developing a National Institute of Clinical Excellence and health guideline for antisocial personality disorder