Identifying an optimal treatment for schizophrenia: a 2-year randomized controlled trial comparing integrated care to a high-quality routine treatment.

OBJECTIVE: This study used repeated outcome measures over a 2-year period to compare the clinical and social benefits of routine schizophrenia treatment with those of evidence-based pharmacological and psychosocial treatment strategies. METHOD: One hundred patients who were diagnosed with schizophrenia according to DSM-IV criteria were randomly assigned to 24 months of either optimal case management (OCM) or routine case management (RCM). OCM involved minimally effective doses of antipsychotic medication with compliance training, an identical treatment programme with the addition of manual-based communication and problem solving training to help patients and caregivers manage stress, social skills training, supported employment, cognitive-behavioural strategies for residual psychotic and non-psychotic symptoms, as well as anger management and substance use counselling. RCM involved minimally effective doses of antipsychotic medication with compliance training, the monitoring of side effects, education about schizophrenia and its optimal treatment, detection of early warning signs and supportive psychotherapy to address practical problems. The symptoms, impairment, disability, unmet needs, quality of life of the patients were examined by blinded researchers every 6 months. RESULTS: Statistically and clinically significant advantages were observed for OCM versus RCM on all measures. Most of these advantages increased throughout the 24-month period. CONCLUSIONS: This study helps demonstrate the importance of psychosocial interventions in the treatment of schizophrenia. Recent advances in evidence-based psychosocial strategies can be implemented into routine clinical practice with additional clinical and social benefits.

The questionnaire of family functioning: a preliminary validation of a standardized instrument to evaluate psychoeducational family treatments.

The aim of the study was to develop and preliminarily validate a self-completed questionnaire that could help in the assessment of families before and during psycho-educational interventions. The questionnaire was developed according to the cognitive-behavioural psycho-educational model. From an initial 38-item version of the questionnaire, a final shorter 24-item version was derived. The validation study of the final version was conducted on relatives of schizophrenic and schizoaffective patients: 31 for the test-retest reliability study and 92 for the confirmation of the subscales and convergent validity study vs. SF-36 and the questionnaire on Family Problems, PF. The final questionnaire showed good psychometric properties. The three-core dimensions of Problem-Solving, Communication Skills, and Personal Goals were clearly outlined in the items correlation analysis. The association with family burden and health-related quality of life was as expected. The FF provides a promising assessment of the family functioning pattern that is the object of psychoeducational family interventions. Further studies are needed to confirm the validity of the instrument, that could be helpful both in planning and in monitoring psycho-educational interventions and in mental health promotion projects.

The VADO approach in psychiatric rehabilitation: a randomized controlled trial.

OBJECTIVE: This study investigated whether a specific structured planning and evaluation approach called VADO (in English, Skills Assessment and Definition of Goals) resulted in improved personal and social functioning among patients with chronic schizophrenia. METHODS: A total of 85 patients with chronic schizophrenia who were under a stable medication regimen were randomly allocated to the VADO-based intervention or to routine care; 78 completed the program. Interventions were carried out in nine Italian day treatment or residential rehabilitation facilities. Assessment at the beginning of the study and at the one-year follow-up included the Personal and Social Performance scale (PSP) and Brief Psychiatric Rating Scale Version 4.0 (BPRS). Clinically significant improvement was defined as an increase of at least 10 points on the PSP or a decrease of at least 20 percent on the BPRS total score. RESULTS: At baseline, average PSP scores in the experimental group and in the control group were 33.9+/-8.1 and 34.0+/-11.2, respectively (possible scores range from 1 to 100, with higher scores indicating better functioning). At six months, the score improved markedly in the experimental group (40.8+/-10.9) and minimal change was observed in the control group (35.3+/-11.6); the difference between groups was significant (difference of 6.9 points compared with 1.3 points; t=2.21, df=81, p<.05). At 12 months, the same trend was observed (difference of 12.0 points compared with 3.5 points), and the difference between groups was both statistically and clinically significant (t=2.99, df=75, p<.01). CONCLUSIONS: A statistically and clinically significant improvement in functioning was observed among patients treated with the VADO approach.

Effectiveness of cognitive-behavioural group therapy for inpatients.

OBJECTIVE: To measure the effectiveness of manualized cognitive-behavioural group therapy (CBGT) when it is integrated into the routine care on a general hospital psychiatric inpatient unit. METHODS: A pre-post design is used to measure the "process", "results" and "outcome" indicators in the year before CBGT was introduced (2001) in contrast to the subsequent two years (2002, 2003). Readmission to hospital, compulsory admissions, ward atmosphere (i.e. the use of physical restraint, episodes of violent behaviour) and patients' satisfaction were assessed. RESULTS: 90% of all inpatients in the years 2002-2003 attended the group therapy. In the years after CBGT was introduced the rate of readmission declined from 38% to 27% and 24% (p < .04), compulsory admissions were reduced from 17% to 4% (p < .03), the ward atmosphere and patients' satisfaction were both excellent (p < .01). CONCLUSION: It is probable that the improvements observed were attributable to the group therapy. These results and those observed in an earlier study are promising and further investigations of this approach are indicated.

Deinstitutionalization of long-stay patients with schizophrenia: the 2-year social and clinical outcome of a comprehensive intervention program in Japan.

OBJECTIVES: The Sasagawa Project aimed to investigate the effects of deinstitutionalization and evidence-based strategies for the treatment of mental disorders among long-stay patients after their discharge from a mental hospital using a quasi-experimental longitudinal study design and to assess the patients' social and clinical outcomes over a 2-year post-discharge period. METHOD: Seventy-eight patients with schizophrenia were transferred to a community facility (Sasagawa Village) following the closure of Sasagawa Hospital in Koriyama in March 2002. The patients had undergone psychosocial training following the protocol outlined by the Optimal Treatment Project. All evaluations were performed prior to the patients' discharge and were repeated 12 and 24 months after discharge using the Positive and Negative Syndrome Scales, the Global Assessment for Functioning, the Schedule for Assessment of Insight, the Rehabilitation Evaluation Hall and Baker Scale, the Social Functioning Scale, the Drug Attitude Inventory, and the Mini-Mental State Examination. RESULTS: During the 24-month study period, 18 residents had incidents that made their continued stay at Sasagawa Village impossible. Only four (5.1%) of these residents were readmitted to psychiatric wards because of exacerbations of their conditions. Twelve residents were admitted to hospital because of serious physical illnesses. The 60 residents who remained in the community facility for 2 years demonstrated significant improvements in not only their psychiatric symptoms, but also their social functioning, as evidenced by their scores for Social Activity, Speech Skills, Disturbed Speech, Self-Care and General Behaviour on the Rehabilitation Evaluation Hall and Baker Scale and Withdrawal, Independence (Performance), Independence (Competence), and Employment on the Social Functioning Scale. CONCLUSIONS: Careful planning that minimized social and clinical dislocation may have contributed to the successful transition from mental hospital to community facility assessed in this study. Patients with a long history of illness showed favourable outcomes with little clinical deterioration and various improvements in their psychiatric symptoms and social functioning.

[Randomised controlled trial of a behavioural family intervention: 1 year and 11-years follow-up]. / Studio controllato randomizzato di un intervento psicoeducativo familiare: esito ad 1 e a 11 anni.

AIM: To test the efficacy of a Behavioural Family Therapy (BFT) in a routine setting, both short and long term, of a community mental health service (CMHS). METHODS: In a randomised clinical trial 24 patients with a diagnosis of schizophrenia, as confirmed by PSE-IX, were assigned to the BFT according to Falloon (n = 12) or to individual usual treatment (n = 12). They were assessed before and at the end of the active treatment (after one year), and after an 11-years follow-up with compared on basic indicators (hospitalisations, length of stay, drop-out rate) and standardised instruments of psychopathological symptoms, social functioning, family burden. RESULTS: At one-year follow-up clinical important and statistically significant differences were observed for psychotic positive symptoms (p<0.01), self-care (p<0.01), autonomy in daily life (p<0.001), subjective/objective family burden (p<0.001). Other psychosocial variables showed positive outcomes non reaching statistical significance. At the 11-year follow-up, marked differences were observed only in hospitalisations and drop-outs. CONCLUSIONS: The BFT was rather easy to implement in a CMHS and very cost effective. However, as it has been shown in other studies, to keep all the benefits a consistent program of monitoring with booster sessions is essential.

The environment and staff of residential facilities: findings from the Italian 'progres' national survey.

We administered structured interviews to managers and staff of a random sample of 265 Italian psychiatric Residential Facilities (RFs). Most are independent buildings, located in urban and suburban areas. The median number of residents is 10. The few RFs (5.7%) with more than 20 beds have a higher rate of drop-outs and escapes. The average indoor space per resident is 36 square meters, there is often a garden, and residents generally live in two-bed rooms. Most facilities are located within walking distance of shopping centers or recreational facilities. Three-quarters have 24-hour staff coverage. On average, each facility has about 10 full-time equivalent workers, with a staff:resident ratio of 0.92. Most of the professional input is provided by nurses and auxiliary staff. Critical issues to be considered in planning facilities include the physical environment, the size, and the staffing patterns.

Outcome assessment of the VADO approach in psychiatric rehabilitation: a partially randomised multicentric trial.

BACKGROUND: Recent studies on representative samples of psychiatric services have shown that low proportions of cases received effective rehabilitation interventions. The following are likely to be the most important causes: the scarcity of mental health workers trained in social and work skills strategies and the absence of a structured framework to formulate rehabilitation practices. The aim of this study was to assess if a specific structured planning and evaluation manual, called VADO (Valutazione delle Abilità e Definizione degli Obiettivi--in english: Skills Assessment and Definition of Goals), is more effective than routine interventions in reducing disability in patients with schizophrenia. METHOD: Each of 10 mental health services were invited to recruit 10 patients with a schizophrenic disorder. Altogether 98 patients were recruited. Of these, 62 patients were randomly allocated to the intervention/experimental or a control group. The remaining group of 36 patients was not randomised and it was considered as a parallel effectiveness study. Assessment measures at the beginning of the study and at the one-year follow-up included the FPS scale of social functioning and the BPRS 4.0. Between group (VADO vs. Routine) and time effects were examined with ANOVA, Chi-square or Fisher exact. Clinical "improvement" was defined as an increase of at least ten points on the FPS or a decrease of at least 20% on BPRS scores. RESULTS: 31 of the 62 randomized patients received the experimental interventions, while 31 followed the routine ones. At follow-up, the experimental group showed statistically and clinically greater improvements in psychopathology and social functioning. Better outcomes of both social functioning and symptom severity were observed in non randomised patients (parallel effectiveness study). CONCLUSION: The results suggest that setting personalised and measurable objectives, as recommended by the manual, can improve the outcome of rehabilitation of severe mental disorders. Better outcomes in the parallel effectiveness study could be attributed to the greater confidence and enthusiasm of staff in centres where the VADO approach originated.

Problem-solving skills for cognitive rehabilitation among persons with chronic psychotic disorders in Italy.

Studies have shown that teaching persons with mental illness to identify and cope with their real-life problems yields substantial clinical improvements. In Italy a structured problem-solving group was established in a day treatment center in 2003. This column describes the approach and focuses on the outcomes achieved by 15 patients with severe mental illness who were in this group. After completion of the problem-solving program, significant improvements were noted in symptom scores on the Positive and Negative Syndrome Scale and in problem-solving and neurocognitive test performance, with further improvements six months after completion of the group sessions. Problem-solving training may contribute to improved neurocognition and symptoms.

The clinical strategies implementation scale to measure implementation of treatment in mental health services.

OBJECTIVE: The authors describe the development of the Clinical Strategies Implementation Scale (CSI), an instrument designed to help providers measure the extent to which evidence-based strategies have been implemented in the treatment of persons with schizophrenia spectrum disorders. METHODS: Nine ordinal scales were devised to measure key aspects of treatment strategies that have been associated with clinical and social recovery from schizophrenia: goal- and problem-oriented assessment, medication strategies, assertive case management, mental health education, caregiver-based problem solving, living skills training, psychological strategies for residual problems, crisis prevention and intervention, and booster sessions. A study of interrater reliability was conducted with 15 trained raters from participating centers in Athens, Auckland, Bonn, Budapest, Gothenburg, and Tokyo who assessed 54 cases. Each treatment strategy was weighted according to its effect size in clinical trials. Correlation analyses were conducted to explore associations between the total CSI score and ratings of clinical, social, and caregiver outcomes each year over four years of continued treatment of 51 patients. RESULTS: Interrater reliability ranged from .93 to .99. Four annual total CSI ratings were significantly correlated with impairment, disability, functioning, work activity, and an index of recovery. Most correlations were stronger in years 3 and 4 than in years 1 and 2. CONCLUSIONS: Reliable and valid assessment of the implementation of evidence-based strategies in clinical practice is feasible. The quality of integrated program implementation may be associated with improved clinical and social recovery from schizophrenic disorders.

Clinical and social outcomes five years after closing a mental hospital: a trial of cognitive behavioural interventions.

BACKGROUND: To investigate the outcome of patients transferred from hospital to community care in Como, Italy after 6 months intensive psychosocial rehabilitation prior to discharge. METHOD: All 149 residents with a primary psychiatric diagnosis were assigned to receive either a 6-month pre-discharge course of goal-oriented rehabilitation, (IT), or routine management, (RT). BPRS and GAF ratings were made by blind, independent assessors before and at 12, 24, 36, 48, and 60 months after discharge and the results examined with repeated measures analysis of variance. RESULTS: Overall change in residence was achieved without any major detriment to the health and welfare of most patients. The cohort of patients who received intensive rehabilitation, (IT), prior to discharge showed significantly lower impairment and disability throughout the five years compared to the cohort receiving routine management, (RT), prior to discharge. Total BPRS scores remained significant when initial differences in the cohorts were covaried, whereas GAF failed to remain significant (p = 0.051). CONCLUSION: The treatment provided prior to transfer from long-stay hospital to community residence may have long-term clinical benefits for chronically disabled patients.

The Sasagawa project: a model for deinstitutionalisation in Japan.

Japanese psychiatric services are still typically hospital-based. The Sasagawa Project is the first systematized deinstitutionalization project in Japan that aims to make the transition from hospital to residential living while ensuring both the quality and continuity of care for the patients. Seventy-eight (51 males) patients (mean age 54.6) with chronic schizophrenia, who were considered appropriate for discharge received continuous cognitive behavioural therapies based on the Optimal Treatment Project manualised protocol, both before and after the hospital closure. During the first 12 months after the deinstitutionalisation was initiated on April 1st, 2002, ten people had incidents that interrupted their stay in the residential Sasagawa Village. A common criticism of many treatment outcome trials is that evaluation is focused on changes in clinical severity. In the Sasagawa project the transition appeared to have been smooth and relatively few incidents occurred could be related to the transition to a less intensive residential care. This project might be a useful model for effecting and monitoring transition from hospital to community care in Japan and other countries where such changes have been proposed.

The process of care in residential facilities--a national survey in Italy.

BACKGROUND: Although residential facilities (RFs) have largely replaced mental hospitals (MHs) in most developed countries for the long-term residential care of severely impaired patients, the process of care in RFs has not been well studied. The aim of this paper is to investigate the process of care in 265 RFs, representing 19.3% of all RFs in Italy, and to devise a classification of RFs based on process characteristics. METHODS: Structured interviews were conducted with the manager and staff of each RF. Residents were evaluated using standardized rating instruments. RESULTS: Most RFs had specific admission criteria, with one third having a waiting list that averaged about 3 months. There was no formal limitation to the length of stay in three quarters of RFs, and turnover rates were very low. Although a homelike atmosphere was found in many RFs, most facilities had restrictive rules on patients' daily lives and behaviours. RFs carried out several external activities targeted at integrating patients within the local community. Standardized assessment instruments and written treatment plans were rarely used. A cluster analysis based on the levels of restrictiveness and the standardization of the process of care classified RFs into five groups that differed with respect to daily staff coverage, size, geographical distribution and proportion of former MH residents. No significant intercluster differences were associated with the current clinical and psychosocial characteristics of residents, or with several other outcome variables. CONCLUSIONS: This study provides naturalistic evidence of the heterogeneity of the process of residential care on a large scale. Future efforts should focus on developing an empirical classification of RFs, as well as on national and international standards of care and staffing to address patients' needs.

The prevalence and correlates of nonaffective psychosis in the National Comorbidity Survey Replication (NCS-R).

BACKGROUND: To estimate the prevalence and correlates of clinician-diagnosed DSM-IV nonaffective psychosis (NAP) in a national household survey. METHODS: Data came from the United States National Comorbidity Survey Replication (NCS-R). A screen for NAP was followed by blinded sub-sample clinical reappraisal interviews. Logistic regression was used to impute clinical diagnoses to respondents who were not re-interviewed. The method of Multiple Imputation (MI) was used to estimate prevalence and correlates. RESULTS: Clinician-diagnosed NAP was well predicted by the screen (area under the curve [AUC] = .80). The MI prevalence estimate of NAP (standard error in parentheses) is 5.0 (2.6) per 1000 population lifetime and 3.0 (2.2) per 1000 past 12 months. The vast majority (79.4%) of lifetime and 12-month (63.7%) cases met criteria for other DSM-IV hierarchy-free disorders. Fifty-eight percent of 12-month cases were in treatment, most in the mental health specialty sector. CONCLUSIONS: The screen for NAP in the NCS-R greatly improved on previous epidemiological surveys in reducing false positives, but coding of open-ended screening scale responses was still needed to achieve accurate prediction. The lower prevalence estimate than in total-population incidence studies raises concerns that systematic nonresponse bias causes downward bias in survey prevalence estimates of NAP.

Violence, misconduct and schizophrenia: Outcome after four years of optimal treatment.

BACKGROUND: Aggressive behaviour in patients with schizophrenic disorders is an ongoing source of concern to community-based services. It has been suggested that optimal treatment may reduce the risk of serious misconduct. OBJECTIVE: To assess prospectively aggressive and sexual misconduct in a cohort of patients receiving continued evidence-based community treatment. METHOD: Fifty patients with a DSM-IV diagnosis of a schizophrenic disorder were treated for 4 years with integrated biomedical and psychosocial strategies. The frequency and context of all aggressive and sexually inappropriate behaviour were assessed throughout. Correlations between an index of misconduct and demographic and clinical variables were examined. RESULTS: Levels of serious misconduct were low at the start of the project and declined as treatment progressed. Close examination of predictors of misconduct supported larger epidemiological studies imputing persistent psychotic symptoms, personality disorders and substance use. CONCLUSION: The study supports the hypothesis that effective treatment reduces aggressive and sexual misconduct in schizophrenic disorders.

The severely mentally ill in residential facilities: a national survey in Italy.

BACKGROUND: In Italy, Residential Facilities (RFs) have completely replaced Mental Hospitals (MHs) for the residential care of mentally ill patients. We studied all patients resident in 265 randomly sampled Italian RFs (20% of the total). METHOD: Structured interviews focusing on each patient were conducted by trained research assistants with the manager and staff of each RF. Patients were rated with the HoNOS and the GAF, and comprehensive information about their sociodemographic and clinical status and care history were gathered. RESULTS: Of the 2962 patients living in the sampled facilities, most were males (63.2%) who had never married, more than 70% were over 40 years; 85% on a pension, most commonly because of psychiatric disability. A substantial proportion (39.8%) had never worked and very few were currently employed (2.5%); 45% of the sample was totally inactive, not even assisting with domestic activities in the facility. Two-thirds had a diagnosis of schizophrenia; co-morbid or primary substance abuse were uncommon. Twenty-one per cent had a history of severe interpersonal violence, but violent episodes in the RFs were infrequent. The managers judged almost three-quarters appropriately placed in their facilities and considered that very few had short-term prospects of discharge. CONCLUSIONS: Italian RFs cater for a large patient population of severely mentally ill requiring residential care. Discharge to independent accommodation is uncommon. Future studies should attempt to clarify how to match residential programmes with patients' disabilities.

Implementation of evidence-based treatment for schizophrenic disorders: two-year outcome of an international field trial of optimal treatment.

According to clinical trials literature, every person with a schizophrenic disorder should be provided with the combination of optimal dose antipsychotics, strategies to educate himself and his carers to cope more efficiently with environmental stresses, cognitive-behavioural strategies to enhance work and social goals and reducing residual symptoms, and assertive home-based management to help prevent and resolve major social needs and crises, including recurrent episodes of symptoms. Despite strong scientific support for the routine implementation of these 'evidence-based' strategies, few services provide more than the pharmacotherapy component, and even this is seldom applied in the manner associated with the best results in the clinical trials. An international collaborative group, the Optimal Treatment Project (OTP), has been developed to promote the routine use of evidence-based strategies for schizophrenic disorders. A field trial was started to evaluate the benefits and costs of applying evidence-based strategies over a 5-year period. Centres have been set up in 18 countries. This paper summarises the outcome after 24 months of 'optimal' treatment in 603 cases who had reached this stage in their treatment by the end of 2002. On all measures the evidence-based OTP approach achieved more than double the benefits associated with current best practices. One half of recent cases had achieved full recovery from clinical and social morbidity. These advantages were even more striking in centres where a random-control design was used.