Sustained benefit of cognitive behaviour therapy for health anxiety in medical patients (CHAMP) over 8 years: a randomised-controlled trial.

BACKGROUND: Health anxiety is an under-recognised but a frequent cause of distress. It is particularly common in general hospitals. METHODS: We carried out an 8-year follow-up of medical out-patients with health anxiety (hypochondriasis) enrolled in a randomised-controlled trial in five general hospitals in London, Middlesex and Nottinghamshire. Randomisation was to a mean of six sessions of cognitive behaviour therapy adapted for health anxiety (CBT-HA) or to standard care in the clinics. The primary outcome was a change in score on the Short Health Anxiety Inventory, with generalised anxiety and depression as secondary outcomes. Of 444 patients aged 16-75 years seen in cardiology, endocrinology, gastroenterology, neurology and respiratory medicine clinics, 306 (68.9%) were followed-up 8 years after randomisation, including 36 who had died. The study is registered with controlled-trials.com, ISRCTN14565822. RESULTS: There was a significant difference in the HAI score in favour of CBT-HA over standard care after 8 years [1.83, 95% confidence interval (CI) 0.25-3.40, p = 0.023], between group differences in generalised anxiety were less (0.54, 95% CI -0.29 to 1.36), p = 0.20, ns), but those for depression were greater at 8 years (1.22, 95% CI 0.42-2.01, p < 0.003) in CBT-HA than in standard care, most in standard care satisfying the criteria for clinical depression. Those seen by nurse therapists and in cardiology and gastrointestinal clinics achieved the greatest gains with CBT-HA, with greater improvement in both symptoms and social function. CONCLUSIONS: CBT-HA is a highly long-term effective treatment for pathological health anxiety with long-term benefits. Standard care for health anxiety in medical clinics promotes depression. Nurse therapists are effective practitioners.

Nidotherapy compared with enhanced care programme approach training for adults with aggressive challenging behaviour and intellectual disability (NIDABID): cluster-randomised controlled trial.

BACKGROUND: Aggressive challenging behaviour is very common in care homes for people with intellectual disability, and better psychological treatments are needed. Nidotherapy aims to change the environment of people with mental illness and is an appropriate treatment for this group of disorders. METHOD: The design was a cluster randomised trial of 20 care homes in which the staff either received training in nidotherapy or the enhanced care programme approach (ECPA), with equivalent duration of treatment in each arm. Cluster randomisation of care homes was carried out at the beginning of the study by an independent statistician. Primary and secondary outcomes were not specified exactly in view of absence of previous study data, but changes over time in scores on two scales, the Modified Overt Aggression Scale and the Problem Behaviour Check List were the main outcome measures. Serious violent incidents were recorded using the Quantification of Violence Scale. All these measures were recorded monthly by research assistants who were carefully kept blind to the allocation of treatment. RESULTS: A total of 200 residents entered the trial, 115 allocated to the ECPA arm and 85 to the nidotherapy one. Seven residents left the care homes in the course of the study, and six were replaced; these were included 79 in the analysis as the trial was a pragmatic one. There were no material reductions in challenging behaviour in the first 8 months of the trial in either group, but in the last 7 months, those allocated to nidotherapy had a 33% reduction in Modified Overt Aggression Scale (MOAS) scores and a 43% reduction in Problem Behaviour Check List scores compared with 5% and 13%, respectively, for the ECPA group, differences which for the MOAS were close to statistical significance. DISCUSSION: Nidotherapy shows promise in the management of aggressive challenging behaviour in care homes, but a delay in its benefit might be expected if given to staff only. The treatment is worthy of further evaluation and development.

Prevalence of aggressive challenging behaviours in intellectual disability and its relationship to personality status: Jamaican study.

BACKGROUND: Both the classification of personality disorder in intellectual disability (ID) and its identification in practice are deemed to be difficult. A simpler approach to classification and its relationship to challenging behaviours were tested in an adult Jamaican population with ID. METHOD: The study was carried out in Kingston, Jamaica, as part of a programme of field trials to determine the utility of the proposed revision of personality disorders in the 11th Revision of the International Classification of Diseases (ICD-11), in a population of adults with ID living with their families or in supported care homes. Thirty-eight people with borderline (n = 5), mild (n = 16), moderate (n = 14) and severe (n = 3) ID were assessed at face-to-face interview and with relatives or staff using the provisional criteria for severity of personality disorder and its associated domain traits, and challenging behaviour was assessed using the Problem Behaviour Check List (PBCL) (a 5-point, 7-item scale). RESULTS: Using the severity scale 18 patients (47%) had no personality disorder, 7 (18%) had personality difficulty, 9 (24%) had mild personality disorder, and 4 (11%) had moderate personality disorder. None of the sample had severe personality disorder in which there is high risk of harm to self or others. Of the four major trait domains, provisionally named anankastic, detached, emotional and dissocial, three were evenly distributed in those with personality disturbance with the antagonistic (antisocial) trait less commonly shown (6 only). Scores on the PBCL were higher in those with increasing severity of personality disorder (P = 0.03) and those in the antagonistic personality trait domain had the highest PCL scores. CONCLUSIONS: Despite previous difficulties in assessing personality disorder in intellectual difficulties the ICD-11 classification was easy to administer in practice in this population, and the higher problem behaviour scores in those with greater severity of personality disturbance support its construct validity.

Ethnicity as a predictor of detention under the Mental Health Act.

BACKGROUND: There has been major concern about the 'over-representation' of Black and ethnic minority groups amongst people detained under the Mental Health Act (MHA). We explored the effect of patient ethnicity on detention following an MHA assessment, once confounding variables were controlled for. METHOD: Prospective data were collected for all MHA assessments over 4-month periods in the years 2008, 2009, 2010 and 2011 each in three regions in England: Birmingham, West London and Oxfordshire. Logistic regression modelling was conducted to predict the outcome of MHA assessments - either resulting in 'detention' or 'no detention'. RESULTS: Of the 4423 MHA assessments, 2841 (66%) resulted in a detention. A diagnosis of psychosis, the presence of risk, female gender, level of social support and London as the site of assessment predicted detention under the MHA. Ethnicity was not an independent predictor of detention. CONCLUSIONS: There is no evidence for that amongst those assessed under the MHA, ethnicity has an independent effect on the odds of being detained.

The advance of research governance in psychiatry: one step forward, two steps back.

Purpose. To investigate the reasons behind difficulties in recruiting patients to randomized controlled trials (RCTs) in psychiatry and to examine a database of RCTs for differences between studies in mental health and other specialities. Methods. A discussion of recent changes in research governance in the UK and Europe followed by an examination of the database of all trials supported by the Health Technology Assessment programme of the National Institute of Health Research in the UK between 1993 and 2007 to determine if three different measures, (i) time between grant approval and study start date, (ii) percentage of additional time given to extend recruitment and (iii) percentage of planned recruitment achieved, changed over the time period studied and differed between mental health, cancer and other medical disciplines. Findings. Despite attempts in the UK to accelerate the process of clinical trials in recent years, there was a significant increase in the extension time for trials to be completed (p = 0.038) and the percentage of planned recruitment to mental health studies (71%) was significantly less than for cancer (90.3%) and other studies (86.1%) (p = 0.032). Summary. These results suggest that, despite the priority afforded to the advancement of RCTs in healthcare, such studies are encountering increasing difficulty in recruiting to time and target. We suggest that this difficulty can be attributed, at least in part, to the excessively byzantine regulation and governance processes for health research in the UK, and unnecessary bureaucracy in the current National Health Service system. Mental health studies appear particularly vulnerable to delay and better systems to facilitate recruitment are required urgently for the evidence base to be improved and facilitate new cost-effective interventions.

Criminal offending before and after the onset of psychosis: examination of an offender typology.

OBJECTIVE: Clinicians often consider whether or not offenders with psychosis have a history of offending pre-dating the onset of their illness. The typology of offenders based on age at first offence, developed in the field of criminology, has been recently extended to mentally disordered groups, but this ignores the potential role of illness onset. METHOD: Using a large UK cohort of individuals with both psychosis and offending histories (n=331), we compared those with a history of offending pre-dating their illness (pre-morbid offenders) to those who commenced offending after becoming unwell (post-morbid offenders). We compared the demographic, clinical and offending pattern characteristics of the two groups. RESULTS: 198 (60%) had offended before the onset of psychosis. These pre-morbid offenders were more likely to be male, have a lower pre-morbid IQ and have had a history of neurological abnormality. Pre-morbid offenders also committed more crime overall, but this was due to an excess of acquisitive, drug and minor offending, rather than violent offending, which was comparable to the post-morbid offending group. CONCLUSION: Currently, standardised clinical risk assessment tools view offenders with mental illness as a homogenous group with respect to life-course patterns of offending in relation to illness. Taking account of an individual's pathway to offending may improve risk assessment and management.

Group art therapy as an adjunctive treatment for people with schizophrenia: a randomised controlled trial (MATISSE).

OBJECTIVE: To examine the clinical effectiveness and cost-effectiveness of referral to group art therapy plus standard care, compared with referral to an activity group plus standard care and standard care alone, among people with schizophrenia. DESIGN: A three-arm, parallel group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by study centre. SETTING: Study participants were recruited from secondary care mental health and social services in four UK centres. PARTICIPANTS: Potential participants were aged 18 years or over, had a clinical diagnosis of schizophrenia, confirmed by an examination of case notes, and provided written informed consent. We excluded those who were unable to speak sufficient English to complete the baseline assessment, those with severe cognitive impairment and those already receiving arts therapy. INTERVENTIONS: Group art therapy was delivered by registered art therapists according to nationally agreed standards. Groups had up to eight members, lasted for 90 minutes and ran for 12 months. Members were given access to a range of art materials and encouraged to use these to express themselves freely. Activity groups were designed to control for the non-specific effects of group art therapy. Group facilitators offered various activities and encouraged participants to collectively select those they wanted to pursue. Standard care involved follow-up from secondary care mental health services and the option of referral to other services, except arts therapies, as required. MAIN OUTCOME MEASURES: Our co-primary outcomes were global functioning (measured using the Global Assessment of Functioning Scale - GAF) and mental health symptoms (measured using the Positive and Negative Syndrome Scale - PANSS) at 24 months. The main secondary outcomes were level of group attendance, social functioning, well-being, health-related quality of life, service utilisation and other costs measured 12 and 24 months after randomisation. RESULTS: Four hundred and seventeen people were recruited, of whom 355 (85%) were followed up at 2 years. Eighty-six (61%) of those randomised to art therapy and 73 (52%) of those randomised to activity groups attended at least one group. No differences in primary outcomes were found between the three study arms. The adjusted mean difference between art therapy and standard care at 24 months was -0.9 [95% confidence interval (CI) -3.8 to 2.1] on the GAF Scale and 0.7 (95% CI -3.1 to 4.6) on the PANSS Scale. Differences in secondary outcomes were not found, except that those referred to an activity group had fewer positive symptoms of schizophrenia at 24 months than those randomised to art therapy. Secondary analysis indicated that attendance at art therapy groups was not associated with improvements in global functioning or mental health. Although the total cost of the art therapy group was lower than the cost of the two comparison groups, referral to group art therapy did not appear to provide a cost-effective use of resources. CONCLUSIONS: Referring people with established schizophrenia to group art therapy as delivered in this randomised trial does not appear to improve global functioning or mental health of patients or provide a more cost-effective use of resources than standard care alone. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 46150447. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 8. See the HTA programme website for further project information.

The 5/95 gap in the indexation of psychiatric journals of low- and middle-income countries.

OBJECTIVE: To investigate the relationship between science production and the indexation level of low- and middle-income countries (LAMIC) journals in international databases. METHOD: Indicators of productivity in research were based on the number of articles produced over the 1994-2004 period. A survey in both Medline and ISI/Thomson was conducted to identify journals according to their country of origin. A WPA Task Force designed a collaborative process to assess distribution and quality of non-indexed LAMIC journals. RESULTS: Twenty LAMIC were found to present more than 100 publications and a total of 222 indexed psychiatric journals were found, but only nine were from LAMIC. The Task Force received 26 questionnaires from editors of non-indexed journals, and concluded that five journals would meet criteria for indexation. CONCLUSION: Barriers to indexation of journals contribute to the difficulties in achieving fair representation in the main literature databases for the scientific production in these countries.

Overcoming the barriers experienced in conducting a medication trial in adults with aggressive challenging behaviour and intellectual disabilities.

BACKGROUND: Aggressive challenging behaviour in people with intellectual disability (ID) is frequently treated with antipsychotic drugs, despite a limited evidence base. METHOD: A multi-centre randomised controlled trial was undertaken to investigate the efficacy, adverse effects and costs of two commonly prescribed antipsychotic drugs (risperidone and haloperidol) and placebo. RESULTS: The trial faced significant problems in recruitment. The intent was to recruit 120 patients over 2 years in three centres and to use a validated aggression scale (Modified Overt Aggression Scale) score as the primary outcome. Despite doubling the period of recruitment, only 86 patients were ultimately recruited. CONCLUSIONS: Variation in beliefs over the efficacy of drug treatment, difficulties within multidisciplinary teams and perceived ethical concerns over medication trials in this population all contributed to poor recruitment. Where appropriate to the research question cluster randomised trials represent an ethically and logistically feasible alternative to individually randomised trials.

The 5/95 Gap on the dissemination of mental health research: The World Psychiatric Association (WPA) task force report on project with editors of low and middle income (LAMI) countries.

The World Psychiatric Association (WPA) Task Force and a small group previously convened by the WPA publications committee initiated three activities between 2006-2008 that aimed to respond to the need for greater support for psychiatry journals in LAMI countries. In a joint venture with participants from the Global Mental Health Movement the Task Force editors from LAMI countries in Africa, Asia, Eastern Europe and Latin America were contacted to identify potential journals to target for indexation (Medline and ISI). The committee analyzed the editors' applications on the following criteria: a) geographical representativeness; b) affiliation to a professional mental health society; c) regular publication of at least 4 issues per year over the past few years; d) comprehensive national and international editorial boards; e) publication of original articles, or at least abstracts, in English; f) some level of current indexation; g) evidence of a good balance between original and review articles in publications; and h) a friendly access website. The committee received 26 applications (11 from Latin America, 7 from Central Europe, 4 from Asia and 4 from Africa), and selected 8 journals, 2 from each geographical area, on the basis of the overall scores obtained for the items mentioned, to participate in an editors meeting held in Prague in September 2008. The aims of the committee are twofold: a) to concentrate support for those selected journals; and b) to assist all LAMI mental health editors in improving the quality of their journals and fulfilling the requirements for full indexation. This report summarizes the procedures conducted by the committee, the assessment of the current non-indexed journals, and offers suggestions for further action.

The treatment of challenging behaviour in intellectual disabilities: cost-effectiveness analysis.

BACKGROUND: Antipsychotic drugs are used in the routine treatment of adults with intellectual disabilities (ID) and challenging behaviour in the UK despite limited evidence of their effectiveness. There is no evidence on their cost-effectiveness. METHODS: The relative cost-effectiveness of risperidone, haloperidol and placebo in treating individuals with an ID and challenging behaviour was compared from a societal perspective in a 26-week, double-blind, randomised controlled trial. Outcomes were changes in aggression and quality of life. Costs measured all service impacts and unpaid caregiver inputs. RESULTS: After 26 weeks, patients randomised to placebo had lower costs compared with those in the risperidone and haloperidol treatment groups. Aggression was highest for patients treated with risperidone and lowest for patients treated with haloperidol; however, quality of life was lowest for patients treated with haloperidol and highest for patients treated with risperidone. CONCLUSION: The treatment of challenging behaviour in ID with antipsychotic drugs is not a cost-effective option.

Neuroleptics in the treatment of aggressive challenging behaviour for people with intellectual disabilities: a randomised controlled trial (NACHBID).

OBJECTIVE(S): To assess the effects and cost-effectiveness of haloperidol, risperidone and placebo on aggressive challenging behaviour in adults with intellectual disability. DESIGN: A double-blind randomised controlled trial of two drugs and placebo administered in flexible dosage, with full, independent assessments of aggressive and aberrant behaviour, global improvement, carer burden, quality of life and adverse drug effects at baseline, 4, 12 and 26 weeks, and comparison of total care costs in the 6 months before and after randomisation. At 12 weeks, patients were given the option of leaving the trial or continuing until 26 weeks. Assessments of observed aggression were also carried out with key workers at weekly intervals throughout the trial. SETTING: Patients were recruited from all those being treated by intellectual disability services in eight sites in England, one in Wales and one in Queensland, Australia. PARTICIPANTS: Patients from all severity levels of intellectual disability; recruitment was extended to include those who may have been treated with neuroleptic drugs in the past. EXCLUSION CRITERIA: treatment with depot neuroleptics/another form of injected neuroleptic medication within the last 3 months; continuous oral neuroleptic medication within the last week; those under a section of the Mental Health Act 1983 or Queensland Mental Health Act 2000. INTERVENTIONS: Randomisation to treatment with haloperidol (a typical neuroleptic drug), risperidone (an atypical neuroleptic drug) or placebo using a permuted blocks procedure. Dosages were: haloperidol 1.25-5.0 mg daily; risperidone 0.5-2.0 mg daily. MAIN OUTCOME MEASURES: Primary: reduction in aggressive episodes between baseline and 4 weeks using Modified Overt Aggression Scale. Secondary: Aberrant Behaviour Checklist; Uplift/Burden Scale; 40-item Quality of Life Questionnaire; Udvalg for Kliniske Undersøgelser scale; Clinical Global Impressions scale. Economic costs recorded using a modified version of Client Service Receipt Inventory for 6 months before and after randomisation. RESULTS: There were considerable difficulties in recruitment because of ethical and consent doubts. Twenty-two clinicians recruited a total of 86 patients. Mean daily dosages were 1.07 mg rising to 1.78 mg for risperidone and 2.54 mg rising to 2.94 mg for haloperidol. Aggression declined dramatically with all three treatments by 4 weeks, with placebo showing the greatest reduction (79%, versus 57% for combined drugs) (p = 0.06). Placebo-treated patients showed no evidence of inferior response in comparison to patients receiving neuroleptic drugs. An additional study found that clinicians who had not participated in clinical trials before were less likely to recruit. Mean total cost of accommodation, services, informal care and treatment over the 6 months of the trial was 16,336 pounds for placebo, 17,626 pounds for haloperidol and 18,954 pounds for risperidone. CONCLUSIONS: There were no significant important benefits conferred by treatment with risperidone or haloperidol, and treatment with these drugs was not cost-effective. While neuroleptic drugs may be of value in the treatment of aggressive behaviour in some patients with intellectual disability, the underlying pathology needs to be evaluated before these are given. The specific diagnostic indications for such treatment require further investigation. Prescription of low doses of neuroleptic drugs in intellectual disability on the grounds of greater responsiveness and greater liability to adverse effects also needs to be re-examined.

Engagement and retention in specialist services for people with personality disorder.

OBJECTIVE: To quantify levels of engagement and retention in specialist services for people with personality disorder (PD). METHOD: Demographic and clinical data were collected on referrals to 10 specialist services for people with PD. Follow-up data on retention and drop-out from services were collected over the following 30 months. RESULTS: Seven hundred and thirteen (60.1%) of 1186 people referred to services were taken by them, of whom 164 (23.0%) subsequently dropped out prior to the completion of an episode of care. Men, younger people and those with higher levels of personality disturbance were less likely to complete a package of care. CONCLUSION: Specialist community-based services for adults with PD are able to engage most of those that are referred to them, but further efforts need to be made to find ways to engage younger people and men with PD.

Cognitive behaviour therapy for violent men with antisocial personality disorder in the community: an exploratory randomized controlled trial.

BACKGROUND: Little information exists on treatment effectiveness in antisocial personality disorder (ASPD). We investigated the feasibility and effectiveness of carrying out a randomized controlled trial of cognitive behaviour therapy (CBT) in men with ASPD who were aggressive. METHOD: This was an exploratory two-centre, randomized controlled trial in a community setting. Fifty-two adult men with a diagnosis of ASPD, with acts of aggression in the 6 months prior to the study, were randomized to either treatment as usual (TAU) plus CBT, or usual treatment alone. Change over 12 months of follow-up was assessed in the occurrence of any act of aggression and also in terms of alcohol misuse, mental state, beliefs and social functioning. RESULTS: The follow-up rate was 79%. At 12 months, both groups reported a decrease in the occurrence of any acts of verbal or physical aggression. Trends in the data, in favour of CBT, were noted for problematic drinking, social functioning and beliefs about others. CONCLUSIONS: CBT did not improve outcomes more than usual treatment for men with ASPD who are aggressive and living in the community in this exploratory study. However, the data suggest that a larger study is required to fully assess the effectiveness of CBT in reducing aggression, alcohol misuse and improving social functioning and view of others. It is feasible to carry out a rigorous randomized controlled trial in this group.

Community mental health teams for people with severe mental illnesses and disordered personality.

BACKGROUND: Closure of asylums and institutions for the mentally ill, coupled with government policies focusing on reducing the number of hospital beds for people with severe mental illness in favor of providing care in a variety of nonhospital settings, underpins the rationale behind care in the community. A major thrust toward community care has been the development of community mental health teams.

The prevalence of personality disorder in schizophrenia and psychotic disorders: systematic review of rates and explanatory modelling.

BACKGROUND: Personality disorder (PD) in psychosis is poorly studied. As PD can affect outcome in mental disorders, it is important to understand its prevalence in order to plan services, understand prognosis more fully and maximize management options. MethodLiterature searching revealed 3972 potential papers. Twenty papers including 6345 patients were included in the final analysis. There was great variation in prevalence and multilevel modelling was used to identify possible reasons for this heterogeneity. RESULTS: The prevalence of PD varied from 4.5% to 100%. Multilevel analysis suggested country of study, study type, the instruments used to diagnose PD and patient care correlated with the prevalence data explaining the study level heterogeneity, with 34.2, 33.4, 17.0 and 4.5% by each variable respectively. Personality studies in Canada and Sweden reported lower PD prevalence, whereas in Spain it was higher than the multinational study. Compared with randomized controlled trials, case-control studies reported lower prevalence [odds ratio (OR)=0.35, 95% confidence interval (CI) 0.15-0.79] and observational studies higher prevalence (OR 70.5, 95% CI 8.5-583). Primary-care patients were less likely to be diagnosed (OR 0.02, 95% CI 0-0.19) than hospital patients, and out-patients had higher prevalence (OR 12.5, 95% CI 1.77-88.6). CONCLUSIONS: The reported prevalence of PD in schizophrenia varies significantly. Statistical modelling suggests care, country, study type and diagnostic tools for PD all bias prevalence rates. The number of papers reaching the inclusion criteria, the relative paucity of information and the difficulties in developing an accurate statistical model limited interpretation from the study.

Predictors of violent victimization amongst those with psychosis.

OBJECTIVE: The aim of this study was to establish the prevalence and predictors of violent victimization amongst a community-dwelling sample of individuals with psychosis. METHOD: The 2-year prevalence of self-reported violent victimization was estimated for a sample of 708 individuals with chronic psychosis living in the community in four urban UK centres. Baseline socio-demographic and clinical factors were examined as possible risk factors for victimization over the 2-year follow-up period. RESULTS: The 2-year prevalence of violent victimization in the sample was 23%. Four factors were found to be independently predictive of victimization - history of victimization, less than daily family contact, young age at illness onset and the presence of co-morbid Cluster B personality disorder. CONCLUSION: Those with psychotic illnesses are at elevated risk of being assaulted. Given the likely adverse health implications, clinicians should routinely enquire about victimization in their assessments of those with psychotic disorders particularly amongst those who are socially isolated, with a younger age of illness onset and in those with co-morbid personality disorder.