Angelo Barbato

Efficacy of Couple Therapy as a Treatment for Depression: A Meta-Analysis

Data from clinical trials of couple therapy for depression have never been subjected to systematic analyses. We performed a meta-analysis of eight controlled trials involving 567 subjects. No difference was found on depressive symptoms between couple therapy and individual psychotherapy. Relationship distress was significantly reduced in the couple therapy group. Too few data are available for comparisons with drug therapy and no treatment. The findings are weakened by small sample sizes, assessments at the end of treatment or short follow-up, unclear sample representativeness, heterogeneity among studies. The mediating role of improvement in quality of couple relationships is not supported by data. However, it has not been adequately tested. Evidence on efficacy of couple therapy as a treatment for depression is inconclusive. The evidence for improvement in couple relationships may favor the choice of couple therapy when relational distress is a major problem.

Assessing reliable and clinically significant change on Health of the Nation Outcome Scales: method for displaying longitudinal data

OBJECTIVEnMany authors recommended that reliable and clinically significant change (RCSC) should be calculated when reporting results of interventions. To test the reliability of the Health of the Nation Outcome Scales (HoNOS) in identifying RCSC, we applied the Jacobson and Truax model to two HoNOS assessments in a large group of people evaluated in 10 community mental health services in Lombardy, Italy, in 2000.nnnMETHODnThe HoNOS was administered to 9817 patients; of these, 4759 (48%) were re-assessed. Reliable change (RC) was calculated using Cronbachs alpha (alpha), as a parameter of the reliability of the measure. Clinical significance cut-offs were calculated using a classification of severity based on HoNOS items.nnnRESULTSnIn the whole sample, the clinical improvement cut-off was 11 and the remission cut-off was 5. Considering the severe patients, the clinical improvement cut-off was 12. The RC index calculated on the whole group and on the subgroup of severe patients indicated that eight-point and seven-point changes, respectively, were needed to be confident that a real change had occurred. Longitudinal changes were depicted on two-dimensional graphs as examples of reporting RCSC on HoNOS total scores in a routine data collection: 91.6% of the whole sample (4361) was stable, 5.6% (269) improved and 1.8% (129) worsened.nnnCONCLUSIONnOur study proposes a methodological framework for computing RCSC normative data on a widely used outcome scale and for identifying different degrees of clinical change.

Psychiatry in transition: outcomes of mental health policy shift in Italy

Objective: To assess the outcomes of changes in mental health policy introduced in Italy in 1978. Methods: Data on psychiatric services, before and after the policy change, are presented. Effects of change are evaluated through indicators related to four issues: transfer of care, criminalisation of the mentally ill, suicides, and homelessness. Results: Admissions of new patients to mental hospitals have been stopped and the size of the mental hospital population is now very low (26 per 100 000 population). Psychiatric care has been shifted to community services including general hospital psychiatric units. There has been an overall reduction of psychiatric hospitalisation. However, the provision of residential facilities is inadequate and community services are unevenly distributed across the country. Few negative effects of changing patterns of care have been reported, although the low quality of data limits the validity of such a conclusion. Outcome of care in areas where the full range of community services is available has been rated as satisfactory. Conclusions: Although care of the mentally ill has been shifted to community services, we lack hard data on the social and clinical outcome of communty care at the nation-wide level. Long-term monitoring and evaluation of community services is a high priority in Italy.

An evidence map of psychosocial interventions for the earliest stages of bipolar disorder

Depression, schizophrenia, and bipolar disorder are three of the four most burdensome problems in people aged under 25 years. In psychosis and depression, psychological interventions are effective, low-risk, and high-benefit approaches for patients at high risk of first-episode or early-onset disorders. We review the use of psychological interventions for early-stage bipolar disorder in patients aged 15-25 years. Because previous systematic reviews had struggled to identify information about this emerging sphere of research, we used evidence mapping to help us identify the extent, distribution, and methodological quality of evidence because the gold standard approaches were only slightly informative or appropriate. This strategy identified 29 studies in three target groups: ten studies in populations at high risk for bipolar disorder, five studies in patients with a first episode, and 14 studies in patients with early-onset bipolar disorder. Of the 20 completed studies, eight studies were randomised trials, but only two had sample sizes of more than 100 individuals. The main interventions used were family, cognitive behavioural, and interpersonal therapies. Only behavioural family therapies were tested across all of our three target groups. Although the available interventions were well adapted to the level of maturity and social environment of young people, few interventions target specific developmental psychological or physiological processes (eg, ruminative response style or delayed sleep phase), or offer detailed strategies for the management of substance use or physical health.

The mental health system in Lombardy, Italy: access to services and patterns of care

PurposeThe psychiatric reform in Italy devolved to the regions the responsibility of implementing community psychiatric care. The aim of this paper is to evaluate the mental health system in Lombardy by assessing changes in accessibility and patterns of care occurred between 1999 and 2009.MethodsData on mental health services were collected through the regional mental health information system and analyzed in terms of treated prevalence, treated incidence, continuity of care and packages of care.ResultsBoth treated incidence and treated prevalence in Lombardy increased between 1999 and 2009. There was an increasing access to psychiatric services of people with a better social integration. Incidence of schizophrenic and personality disorders decreased and that of affective and neurotic disorders increased dramatically, while increase in prevalence concerned all diagnostic groups. The percentage of patients in continuous care remained stable and was generally low. The majority of cases, even those with schizophrenia, are cared for on outpatient basis. The percentage of patients receiving integrated multiprofessional care declined. Rates of admission to inpatient services remained low and within the inpatient sector a shift from hospital towards residential care emerged, with decreasing hospital utilization and an increase in size of patient population entering community residences. Treatment gap is still a problem in schizophrenic disorders.ConclusionsThe Lombardy mental health system is strongly based on community care. However, it is reaching a turning point and it needs to be improved in some key areas: the shifting balance towards the care of common mental disorders, in the absence of resource allocations targeted to severely mentally ill, may hinder the system ability to deal with more disabled people. A focus on early intervention and an improvement of continuity of care for people with severe mental disorder, by strengthening community teams, is a priority.

Measuring clinical change in routine mental health care: differences between first time and longer term service users

Objective: The aims were to assess the feasibility of routinely collecting outcome data in everyday mental health services across Italy and to evaluate clinical change in a cohort of patients stratified by illness duration. Method: A prevalence sample of patients attending nine Italian community mental health services (CMHS) was assessed over one year with the Health of the Nation Outcome Scales (HoNOS). The patients were classified on the basis of the duration of their contact with services. Clinical outcome was evaluated taking into account parameters of reliable and clinically significant change (RCSC). Predictors of change included clinical and socio-demographic characteristics at first assessment and six month reliable improvement. Results: 2059 patients were evaluated with only 3% attrition at follow up; 22% of first time and about 7% of longer term users achieved reliable improvement at one year. First contacts had a better outcome than longer term users and significant differences were seen at both group and individual level. Reliable improvement at six months was the best predictor of clinical improvement at one year for the whole cohort. Conclusion: The study demonstrated the feasibility of routine outcome assessment and gave an expected and realistic picture of the one-year outcome of a representative sample of patients attending a group of Italian CMHS. RCSC showed potential utility as a means of communicating with clinicians and decision makers.

European Network of Bipolar Research Expert Centre (ENBREC): a network to foster research and promote innovative care

Bipolar disorders rank as one of the most disabling illnesses in working age adults worldwide. Despite this, the quality of care offered to patients with this disorder is suboptimal, largely due to limitations in our understanding of the pathology. Improving this scenario requires the development of a critical mass of expertise and multicentre collaborative projects. Within the framework of the European FP7 programme, we developed a European Network of Bipolar Research Expert Centres (ENBREC) designed specifically to facilitate EU-wide studies. ENBREC provides an integrated support structure facilitating research on disease mechanisms and clinical outcomes across six European countries (France, Germany, Italy, Norway, Spain and the UK). The centres are adopting a standardised clinical assessment that explores multiple aspects of bipolar disorder through a structured evaluation designed to inform clinical decision-making as well as being applicable to research. Reliable, established measures have been prioritised, and instruments have been translated and validated when necessary. An electronic healthcare record and monitoring system (e-ENBREC©) has been developed to collate the data. Protocols to conduct multicentre clinical observational studies and joint studies on cognitive function, biomarkers, genetics, and neuroimaging are in progress; a pilot study has been completed on strategies for routine implementation of psycho-education. The network demonstrates ‘proof of principle’ that expert centres across Europe can collaborate on a wide range of basic science and clinical programmes using shared protocols. This paper is to describe the network and how it aims to improve the quality and effectiveness of research in a neglected priority area.

The GiSAS study: Rationale and design of a pragmatic randomized controlled trial on aripiprazole, olanzapine and haloperidol in the long-term treatment of schizophrenia☆

Given the controversy about the comparative efficacy of first- compared with second-generation antipsychotics in the treatment of schizophrenia, more large-scale evidence is needed to guide clinicians in their prescriptions. Most randomized controlled trials (RCTs) were conducted in centers of excellence on highly selected samples, poorly representative of real-world patients, and often suffered conflicts of interest as they were sponsored by drug companies. The primary aim of the present study is to compare the effectiveness of haloperidol, olanzapine and aripiprazole in a representative sample of schizophrenia patients. The GiSAS trial is an open-label, independent, pragmatic RCT in Italian community-based public psychiatric services. At least 260 patients meeting the DSM-IV criteria for schizophrenia will be randomly allocated to one of the study drugs and followed up for one year. A two-year observational phase will follow. The primary outcome for tolerability will be the onset of metabolic syndrome. The primary endpoint for effectiveness will be discontinuation of antipsychotic monotherapy. Secondary measures include global functioning, time to discontinuation due to side-effects, change of lipid profile, extrapyramidal symptoms and other adverse effects. In the last four years, the GiSAS study group has been working to implement this multicenter RCT. The trial mechanism is now fully functional and working. As of end of February 2011, 260 subjects were randomized by 54 study investigators in 33 out of 43 participating centers.

P01-255 - Do patients with bipolar disorders receive evidence-based psychosocial interventions? a survey in Italy

Introduction Research evidence on bipolar disorder supports the importance of patients’ active role to improve outcome and the efficacy of a number of psychosocial interventions. The lower cost and potential ease of dissemination of group psychoeducation suggest that this should be a first line approach, with more complex interventions, requiring highly specialized skills, reserved to selected patients. However, to what extent research models can be transferred to everyday practice remains to be seen. Objectives To explore the delivery of psychosocial interventions to bipolar disorders patients in routine mental health care. Aims To estimate the treated prevalence of bipolar disorders in Milan and to collect data about the variety of psychosocial interventions patients received by mental health services. Methods A survey of psychosocial interventions received by bipolar patients in three mental health services of Milan (catchment area 867,000 inhabitants) was conducted in 2009. Data from the Regional Mental Health Information System were retrieved to calculate the number of patients involved in psychosocial interventions and the kind of intervention provided. Results The treated prevalence rate was low, showing a probable treatment gap. Only 20% of 636 bipolar patients received at least one psychosocial intervention. The interventions provided were: family psychoeducation (3,8%), individual social skills training (11,5%), group social skills training (1,4%), and relatives group (3,0%). Conclusions Few bipolar patients receive psychosocial interventions in the MHS of Milan. Moreover, the interventions received were not specifically designed for bipolar disorder. Treatment gap could be reduced providing psychoeducation especially designed for bipolar patients.

W08-02 - Effective strategies for health information, self-help and psychoeducation in bipolar disorder

Introduction Many patients with bipolar disorders do not achieve clinical and functional recovery, even with good pharmacotherapy compliance. The influence of patients’ attitudes, behavior, subjective state and interpersonal environment on course of the disorder points out the importance of psychosocial interventions and patients’ active role to improve outcome. Methods A survey of recent guidelines, systematic reviews and clinical trials of psychosocial interventions for bipolar disorders was performed. Results Research evidence supports the efficacy and likely effectiveness of a number of psychosocial treatments: Individual and group psychoeducation, family-focused therapy, interpersonal and social rhythm therapy, cognitive behavior therapy. The lower cost and potential ease of dissemination of group psychoeducation suggest that this should be the first-line approach, with more complex interventions reserved to selected subgroups of patients. The following elements should be included in a basic psychoeducation package: information about the disorder and available treatment options, identification of early warning signs, encouragement of structured routines and healthy lifestyles, use of a mood diary and life-event charting to monitor mood patterns and effectiveness of intervention, improvement of communication skills, emotional self-regulation and social skills, reduction of self-stigmatization, stabilization of sleep/wake cycles, awareness of medication effects and improvement of decision-making skills on drug treatment in a collaborative way, acquisition of balanced attitudes towards the self in relation to the illness. Conclusion The introduction of psychoeducation interventions with a focus on self-help strategies and patients empowerment and the adaptation of research models to everyday practice, can improve the outcome of bipolar disorders in real world.