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.

Arnold Lodge Regional Secure Unit has provided medium secure psychiatric care for the Trent Regional Health Authority since July 1983. We examined a series of 504 first admissions to Arnold Lodge in order to explore trends in demographic and service utilization characteristics over 16 years. We found an increase in the admission of more serious offenders; a reduction in the length of stay; a decline in the proportion of psychopathically disordered patients; and a sixfold increase in the ratio of men to women.

First admissions to a regional secure unit over a 16-year period: changes in demographic and service characteristics

Background The new programme for assessing those with dangerous and severe personality disorder relies heavily on psychological assessments of personality disorder
and risk.

Methods The temporal reliability of assessments of psychopathy (PCL-R), risk (HCR-20) and persoruility was assessed using the International Personality Disorder
Examination (IPDE) in 15 randomly selected mak prisoners in a high secure hospital carried out at intervals varying between a mean of nine and 19 months after initial
assessments by a variety of assessors.
Results Using the intra-class correlation coefficient the agreement varied between 0.57 (HCR'2O), 0.58 (PCL-R) and 0.38-0.70 for IPDE personality disorders, with the best agreement for antisocial personality disorder (0.70).
Comment TKese levels of agreement are consistent with other recent work on temporal reliability of personality instruments but are a little too low for confidence in
these measures alone in the assessment process.

Temporal reliability of psychological assessments for patients in a special hospital with severe personality disorder: a preliminary note.

Background: Evidence suggests the relationship between personality disorder (PD) and violence in offenders might be clarified by considering sub-groups of PD offenders defined by patterns of PD comorbidity. Aim: to identify patterns of PD comorbidity associated with severe violence, defined by its severity, quantity and age of onset (Violence Index: VI) in a forensic sample of 100 PD offenders. Methods: Correlations were first computed between VI and a range of personality and criminological variables; next, patients with antisocial/borderline comorbidity were compared with other PD patients; finally, regression analysis was conducted to identify unique predictors of VI. Results: The antisocial deviance factor of psychopathy and antisocial/borderline comorbidity were each significantly and independently associated with severe violence. Patients showing both a high psychopathy score and antisocial/borderline comorbidity had a significantly greater VI than those without these characteristics. Conclusion: PD...

Antisocial personality disorder comorbid with borderline pathology and psychopathy is associated with severe violence in a forensic sample

In this paper, we describe the progress of four male, legally-detained personality disordered offenders in a group treatment programme for angry aggression. “Controlling angry aggression” is a 15-session, structured, cognitive-behavioural programme that is part of a wider integrated, multidisciplinary treatment programme run within a specialist personality disorder treatment unit. Psychometric tests showed that three of the four patients improved over the course of the treatment programme. Behaviour ratings of staff and patients concurred, allowing confidence in patients' self-report of anger. No change in behaviour was evident over time for any patient, but initial low rates of aggression allowed little room for improvement. Self-monitored anger and aggression scores did vary markedly over time, and since behaviour remains stable despite anger, this indicates that these patients can control their behaviour. One patient did not improve, and reasons for this are examined, concluding with a reminder of the need for rigorous selection of patients for treatment programmes.

https://www.cambridge.org/core/services/aop-cambridge-core/content/view/S1352465801004076

Conor Duggan

Papers

First admissions to a regional secure unit over a 16-year period: changes in demographic and service characteristics

Temporal reliability of psychological assessments for patients in a special hospital with severe personality disorder: a preliminary note.

Antisocial personality disorder comorbid with borderline pathology and psychopathy is associated with severe violence in a forensic sample

Controlling angry aggression: a pilot group intervention with personality disordered offenders

Evaluation of the assessment procedure at two pilot sites in the DSPD programme (IMPALOX Study)