London-East Anglia randomised controlled trial of cognitive-behavioural therapy for psychosis. I: effects of the treatment phase. Substance abuse and personality disorders in homeless drop-in center clients: symptom severity and psychotherapy retention in a randomized clinical trial. Randomized trial of coordinated psychosocial interventions based on patient self-assessments versus standard care to improve the psychosocial functioning of patients with cancer. Cognitive--behavioural therapy and family intervention for relapse prevention and symptom reduction in psychosis: randomised controlled trial. Comparative effectiveness of three approaches to serving people with severe mental illness and substance abuse disorders. Exploratory cluster randomised controlled trial of shared care development for long-term mental illness. A trial of two cognitive-behavioural methods of treating drug-resistant residual psychotic symptoms in schizophrenic patients: I. Outcome. Outcomes of an effectiveness trial of cognitive-behavioural intervention by mental health nurses in schizophrenia. Examination of the analytic quality of behavioral health randomized clinical trials. Conducting a randomized clinical trial of an psychological intervention for parents/caregivers of children with cancer shortly after diagnosis. A randomized clinical trial of a new behavioral treatment for drug abuse in people with severe and persistent mental illness. A pilot study evaluating the effectiveness of individual inpatient cognitive-behavioural therapy in early psychosis. An outreach intervention to implement evidence based practice in residential care: a randomized controlled trial [ISRCTN67855475]. A pilot study of functional Cognitive Behavioral Therapy (fCBT) for schizophrenia. Psychoeducational psychotherapy for schizophrenic patients and their key relatives or care-givers: results of a 2-year follow-up. Evaluation of an alternative program for MMTP drop-outs: impact on treatment re-entry. Two-year follow-up of cognitive--behavioral therapy and supportive counseling in the treatment of persistent symptoms in chronic schizophrenia.
A series of small, mainly uncontrolled, studies have suggested that techniques adapted from cognitive-behavioural therapy (CBT) for depression can improve outcome in psychosis, but no large randomised controlled trial of intensive treatment for medication-resistant symptoms of psychosis has previously been published.
                Sixty participants who each had at least one positive and distressing symptom of psychosis that was medication-resistant were randomly allocated between a CBT and standard care condition (n = 28) and a standard care only control condition (n = 32). Therapy was individualised, and lasted for nine months. Multiple assessments of outcome were used.
                Over nine months, improvement was significant only in the treatment group, who showed a 25% reduction on the BPRS. No other clinical, symptomatic or functioning measure changed significantly. Participants had a low drop-out rate from therapy (11%), and expressed high levels of satisfaction with treatment (80%). Fifty per cent of the CBT group were treatment responders (one person became worse), compared with 31% of the control group (three people became worse and another committed suicide).
                CBT for psychosis can improve overall symptomatology. The findings provide evidence that even a refractory group of clients with a long history of psychosis can engage in talking about psychotic symptoms and their meaning, and this can improve outcome. This study evaluated the psychiatric symptoms, psychosocial problems, and treatment response of personality-disordered substance abusers receiving services within a homeless drop-in center. Fifty-two homeless clients were assessed after program admission and randomly assigned to receive either individual psychotherapy focused on personality disorder and substance abuse relapse prevention (dual-focus schema therapy [DFST]) or standard group substance abuse counseling (SAC). Client functioning was assessed using measures of personality disorder, psychiatric symptoms, early maladaptive schemas, interpersonal problems, and addiction-related psychosocial impairment. Therapy retention (total weeks in treatment) and utilization (number of weeks in which sessions were attended) were the primary outcomes. Although rates of cluster B personality disorders were comparable to other substance dependent samples, clusters A and C disorders were disproportionately more common. Clients reported significant psychiatric symptoms, criminality, and psychosocial impairment, yet made limited lifetime use of mental health services. Overall, there was greater utilization of individual DFST than group SAC. However, clients with more severe personality disorder symptoms demonstrated better utilization of SAC than DFST. To determine whether making patient-reported cancer needs, quality-of-life (QOL), and psychosocial information available to the health care team, allowing coordinated specifically targeted psychosocial interventions, resulted in reduced cancer needs, improved QOL, and increased satisfaction with care received.
                Self-reported cancer needs, QOL, and psychosocial information was collected from 450 people with cancer, using standardized questionnaires via a touch-screen computer. For a randomly chosen two thirds, this information was made available to the health care team who coordinated targeted psychosocial interventions. Information from the remaining one third was not seen. Patients were assessed 2 and 6 months after randomization for changes in their cancer needs, QOL, and psychosocial functioning and satisfaction with overall care received.
                There were no significant differences between the two arms with respect to changes in cancer needs, QOL, or psychosocial functioning between the baseline and follow-up assessments, nor with respect to satisfaction with care. However, for the subgroup of patients who were moderately or severely depressed at baseline, there was a significant reduction in depression for the intervention arm relative to the control arm at the 6-month assessment (P =.001).
                Making patient-reported cancer needs, QOL, and psychosocial data available to the health care team at a single consultation together with coordinated psychosocial interventions does not seem to reduce cancer needs nor improve QOL, psychosocial functioning, or satisfaction with the care received. However, identification of patients with moderate or severe levels of depression may be valuable in reducing subsequent levels of depression. Family intervention reduces relapse rates in psychosis. Cognitive-behavioural therapy (CBT) improves positive symptoms but effects on relapse rates are not established.
                To test the effectiveness of CBT and family intervention in reducing relapse, and in improving symptoms and functioning in patients who had recently relapsed with non-affective psychosis.
                A multicentre randomised controlled trial (ISRCTN83557988) with two pathways: those without carers were allocated to treatment as usual or CBT plus treatment as usual, those with carers to treatment as usual, CBT plus treatment as usual or family intervention plus treatment as usual. The CBT and family intervention were focused on relapse prevention for 20 sessions over 9 months.
                A total of 301 patients and 83 carers participated. Primary outcome data were available on 96% of the total sample. The CBT and family intervention had no effects on rates of remission and relapse or on days in hospital at 12 or 24 months. For secondary outcomes, CBT showed a beneficial effect on depression at 24 months and there were no effects for family intervention. In people with carers, CBT significantly improved delusional distress and social functioning. Therapy did not change key psychological processes.
                Generic CBT for psychosis is not indicated for routine relapse prevention in people recovering from a recent relapse of psychosis and should currently be reserved for those with distressing medication-unresponsive positive symptoms. Any CBT targeted at this acute population requires development. The lack of effect of family intervention on relapse may be attributable to the low overall relapse rate in those with carers. This study examines the rationale for and relative effectiveness of three intervention models for treating people with severe mental illness and substance abuse disorders: Twelve Step recovery, behavioral skills training, and intensive case management. Using clinical trial methods, 132 dually diagnosed clients were assigned to three service approaches. Changes in client psychosocial outcomes, and psychiatric and substance abuse symptomatology were tracked over a 24-month period. Differential effectiveness was evident, with clients in the behavioral skills group demonstrating the most positive and significant differences in psychosocial functioning and symptomatology, compared with the Twelve Step recovery approach. However, the case management intervention also resulted in several positive and important differences compared with the Twelve Step recovery approach. We also found significant changes over time, not only at 6 months but increasingly positive changes in psychosocial functioning at 12 and 18 months as well. These results underscore the need for clinical trials to further examine the relative cost effectiveness of treatment approaches for dually disordered clients and to incorporate means of assessing subgroup differences so that the interventions being tested can be further refined and targeted to a broad set of needs among the dually diagnosed. Primary care clinicians have a considerable amount of contact with patients suffering from long-term mental illness. The United Kingdom's National Health Service now requires general practices to contribute more systematically to care for this group of patients.
                To determine the effects of Mental Health Link, a facilitation-based quality improvement programme designed to improve communication between the teams and systems of care within general practice. Design of study: Exploratory cluster randomised controlled trial.
                Twenty-three urban general practices and associated community mental health teams.
                Practices were randomised to service development as usual or to the Mental Health Link programme. Questionnaires and an audit of notes assessed 335 patients' satisfaction, unmet need, mental health status, processes of mental and physical care, and general practitioners' satisfaction with services and beliefs about service development. Service use and intervention costs were also measured.
                There were no significant differences in patients' perception of their unmet need, satisfaction or general health. Intervention patients had fewer psychiatric relapses than control patients (mean = 0.39 versus 0.71, respectively, P = 0.02) but there were no differences in documented processes of care. Intervention practitioners were more satisfied and services improved significantly for intervention practices. There was an additional mean direct cost of pound 63 per patient with long-term mental illness for the intervention compared with the control.
                Significant differences were seen in relapse rates and practitioner satisfaction. Improvements in service development did not translate into documented improvements in care. This could be explained by the intervention working via the improvements in informal shared care developed through better link working. This type of facilitated intervention tailored to context has the potential to improve care and interface working. Despite neuroleptic medication, many schizophrenic patients continue to experience residual positive psychotic symptoms. These residual symptoms cause distress and disability. We report a controlled trial of two cognitive-behavioural treatments to alleviate residual hallucinations and delusions. Forty-nine patients were recruited into the trial, of whom 27 entered the trial and completed post-treatment assessment, and 23 were reassessed at six-month follow-up. Patients were randomly allocated to either coping strategy enhancement (CSE) or problem solving (PS). Half the patients were allocated to a high-expectancy positive demand condition and half to a counter-demand condition to evaluate expectation of improvement. Patients receiving either cognitive-behavioural treatment showed significant reductions in psychotic symptoms compared with those in the waiting period, who showed no improvement. There was some evidence, although equivocal, that patients receiving CSE improved more than those receiving PS. There was no evidence that improvements generalised to negative symptoms or social functioning, nor was there evidence that expectancy of treatment benefit contributed to the treatment effect. Little is known about the medium-term durability of cognitive-behavioural therapy (CBT) in a community sample of people with schizophrenia.
                To investigate whether brief CBT produces clinically important outcomes in relation to recovery, symptom burden and readmission to hospital in people with schizophrenia at 1-year follow-up.
                Participants (336 of 422 randomised at baseline) were followed up at a mean of 388 days (s.d. = 53) by raters masked to treatment allocation (CBT or usual care).
                At 1-year follow-up, participants who received CBT had significantly more insight (P = 0.021) and significantly fewer negative symptoms (P = 0.002). Brief therapy protected against depression with improving insight and against relapse; significantly reduced time spent in hospital for those who did relapse and delayed time to admission. It did not improve psychotic symptoms or occupational recovery, nor have a lasting effect on overall symptoms or depression at follow-up.
                Mental health nurses should be trained in brief CBT for schizophrenia to supplement case management, family interventions and expert therapy for treatment resistance. Adoption of evidence-based practice (EBP) policy has implications for clinicians and researchers alike. In fields that have already adopted EBP, evidence-based practice guidelines derive from systematic reviews of research evidence. Ultimately, such guidelines serve as tools used by practitioners. Systematic reviews of treatment efficacy and effectiveness reserve their strongest endorsements for treatments that are supported by high-quality randomized clinical trials (RCTs). It is unknown how well RCTs reported in behavioral science journals fare compared to quality standards set forth in fields that pioneered the evidence-based movement. We compared analytic quality features of all behavioral health RCTs (n = 73) published in three leading behavioral journals and two leading medical journals between January 2000 and July 2003. A behavioral health trial was operationalized as one employing a behavioral treatment modality to prevent or treat an acute or chronic physical disease or condition. Findings revealed areas of weakness in analytic aspects of the behavioral health RCTs reported in both sets of journals. Weaknesses were more pronounced in behavioral journals. The authors offer recommendations for improving the analytic quality of behavioral health RCTs to ensure that evidence about behavioral treatments is highly weighted in systematic reviews.
                (c) 2006 Wiley Periodicals, Inc. To report acceptability, feasibility, and outcome data from a randomized clinical trial (RCT) of a brief intervention for caregivers of children newly diagnosed with cancer.
                Eighty-one families were randomly assigned following collection of baseline data to Intervention or Treatment as Usual (TAU). Recruitment and retention rates and progression through the protocol were tracked. Measures of state anxiety and posttraumatic stress symptoms served as outcomes.
                Difficulties enrolling participants included a high percentage of newly diagnosed families failing to meet inclusion criteria (40%) and an unexpectedly low participation rate (23%). However, movement through the protocol was generally completed in a timely manner and those completing the intervention provided positive feedback. Outcome data showed no significant differences between the arms of the RCT.
                There are many challenges inherent in conducting a RCT shortly after cancer diagnosis. Consideration of alternative research designs and optimal timing for interventions are essential next steps. Drug abuse by people with severe mental disorder is a significant public health problem for which there is no empirically validated treatment.
                To evaluate the efficacy of a new behavioral treatment for drug abuse in this population: Behavioral Treatment for Substance Abuse in Severe and Persistent Mental Illness (BTSAS).
                Participants were randomly assigned to 6 months of treatment in either BTSAS or a manualized control condition: Supportive Treatment for Addiction Recovery (STAR).
                Treatment was conducted in community-based outpatient clinics and a Veterans Affairs medical center in Baltimore, Md.
                Participants were 129 stabilized outpatients meeting DSM criteria for drug dependence (cocaine, heroin, or cannabis) and serious mental illness: 39.5% met DSM-IV criteria for schizophrenia or schizoaffective disorder; 55.8%, for major affective disorders; and the remainder met criteria for severe and persistent mental illness and other Axis I disorders.
                Both treatments were administered by trained health care professionals in small groups, twice a week for 6 months. The BTSAS program is a social learning intervention that includes motivational interviewing, a urinalysis contingency, and social skills training. The control condition, STAR, is a supportive group discussion treatment. Main Outcome Measure The primary outcome measure was urinalysis results from twice-weekly treatment sessions.
                The BTSAS program was significantly more effective than STAR in percentage of clean urine test results, survival in treatment, and attendance at sessions. The BTSAS program also had significant effects on important community-functioning variables, including hospitalization; money available for living expenses; and quality of life.
                The BTSAS program is an efficacious treatment. Further work needs to be done to increase the proportion of eligible patients who are able to become engaged in treatment. Recent research indicates that cognitive-behaviour therapy (CBT) can be effective in ameliorating persistent positive symptoms in chronic psychotic patients. The effectiveness of CBT in acute and recent-onset psychosis has been little explored, although a recent pilot study indicated that CBT could significantly improve recovery in acutely psychotic inpatients.
                Short-term individual CBT was compared to supportive counselling/psychoeducation (SC) as an adjunct to standard inpatient hospital care and medication in 21 inpatients experiencing a recent-onset acute schizophrenic episode.
                Both groups showed significant reductions in Brief Psychiatric Rating Scale (BPRS) scores following treatment, although there were no group differences. Time to discharge did not differ significantly between the groups, although there was a greater variance for the SC patients. Two-year follow-up showed no significant differences between the groups, although the number of patients who relapsed, the number of relapses and the time to recurrence of psychotic symptoms was lower in the CBT group than the SC group. Interestingly, the time to readmission was shorter in the CBT group.
                CBT and SC are acceptable treatments for recent-onset acutely psychotic inpatients. A larger randomised controlled trial over multiple hospital sites is warranted. The aim of this project was to assess whether outreach visits would improve the implementation of evidence based clinical practice in the area of falls reduction and stroke prevention in a residential care setting.
                Twenty facilities took part in a randomized controlled trial with a seven month follow-up period. Two outreach visits were delivered by a pharmacist. At the first a summary of the relevant evidence was provided and at the second detailed audit information was provided about fall rates, psychotropic drug prescribing and stroke risk reduction practices (BP monitoring, aspirin and warfarin use) for the facility relevant to the physician. The effect of the interventions was determined via pre- and post-intervention case note audit. Outcomes included change in percentage patients at risk of falling who fell in a three month period prior to follow-up and changes in use of psychotropic medications. Chi-square tests, independent samples t-test, and logistic regression were used in the analysis.
                Data were available from case notes at baseline (n = 897) and seven months follow-up (n = 902), 452 residential care staff were surveyed and 121 physicians were involved with 61 receiving outreach visits. Pre-and post-intervention data were available for 715 participants. There were no differences between the intervention and control groups for the three month fall rate. We were unable to detect statistically significant differences between groups for the psychotropic drug use of the patients before or after the intervention. The exception was significantly greater use of "as required" antipsychotics in the intervention group compared with the control group after the pharmacy intervention (RR = 4.95; 95%CI 1.69-14.50). There was no statistically significant difference between groups for the numbers of patients "at risk of stroke" on aspirin at follow-up.
                While the strategy was well received by the physicians involved, there was no change in prescribing patterns. Patient care in residential settings is complex and involves contributions from the patient's physician, family and residential care staff. The project highlights challenges of delivering evidence based care in a setting in which there is a paucity of well controlled trial evidence but where significant health outcomes can be attained. The feasibility and preliminary efficacy of a novel cognitive behavioral treatment for decreasing psychotic symptoms and improving social functioning was evaluated in a pilot study. This represents the first treatment outcome study of CBT for psychosis with a manualized, active comparison condition.
                Thirty outpatients with schizophrenia or schizoaffective disorder, depressed type with residual psychotic symptoms were randomly assigned to either 16 weekly sessions of functional cognitive behavioral therapy (fCBT) or psychoeducation (PE) with assessments conducted at baseline and post-treatment by blind evaluators.
                Attrition was only 7% and did not differ between fCBT and PE, indicating good tolerability of both treatments. For this sample with persistent symptoms, between groups effects were not significantly different, but within group effect sizes indicated greater treatment benefit for fCBT on positive symptoms, particularly for the PSYRATS voices subscale.
                The results suggest that fCBT is well tolerated and holds promise for reducing persistent positive symptoms. Psychoeducational medication management training (PMT), cognitive psychotherapy (CP) and key-person counselling (KC) were carried out in various combinations in this randomized, controlled intervention study of schizophrenic out-patients (according to DSM-III-R). Special design characteristics of the study were a control group consisting of non-specifically treated patients and a 2-year follow-up after completion of treatment in order to evaluate medium-term effects. A total of 132 patients underwent a follow-up examination 2 years after completion of treatment and were evaluated with an intention-to-treat approach. In the second follow-up year, all treatment groups had lower but not significantly different relapse rates compared to the control group. The most intensive treatment (PMT+CP+KC) produces a clinically relevant reduction in rehospitalization rate (a 26% reduction compared to the control group). In comparison with the non-specifically treated control group, whose original effect decreased, at least a medium-term therapeutic effect was recorded in the treatment groups. Retention in a Methadone Maintenance Treatment Program (MMTP) is predictive of abstaining from heroin and has other benefits. Many individuals leave treatment before they experience these positive outcomes.
                This research project targeted MMTP drop-outs with an intervention designed to assist them in returning to drug treatment.
                Subjects who had left MMTP within the prior 12 months were randomly assigned to intervention or comparison groups. The 3-month long intervention consisted of street outreach, cognitive behavioral groups, and individual counseling. Data were analyzed for 175 subjects who were out of treatment at baseline and who returned for a 6-month follow-up interview (Intervention group, N=111; Comparison group, N=64).
                A total of 87% of subjects assigned to the intervention condition participated in at least one component. Intervention subjects who attended two or more cognitive behavioral group sessions were more likely than those who attended 0-1 sessions or those in the comparison group to have returned to treatment during the 6 month follow up time period (72 vs. 53 vs. 50%, respectively, P<0.05, chi square test).
                MMTP drop-outs need not be lost to the drug treatment system if special efforts are made to engage them in interventions developed to encourage treatment re-entry. The article reports the 2-year follow-up of patients suffering persistent symptoms of schizophrenia who entered a single blind randomized controlled trial. Patients were randomly allocated to cognitive-behavioral therapy (CBT) plus routine care (RC), supportive counseling (SC) plus RC, or RC alone. Treatment took place over 3 months, and follow-up was made 12 and 24 months after treatment finished. Sixty-one patients were available to the 2-year follow-up and assessed for positive and negative symptoms and clinical improvement; all of the 87 patients who entered the trial were assessed for relapse over the follow-up period. On all measures, patients who received RC alone did significantly worse at 2 years. There were no significant differences at 2 years between the CBT and SC groups.
We included 25 RCTs and found no compelling evidence to support any one psychosocial treatment over another to reduce substance use (or improve mental state) by people with serious mental illnesses. Furthermore, methodological difficulties exist which hinder pooling and interpreting results; high drop out rates, varying fidelity of interventions, varying outcome measures, settings and samples and comparison groups may have received higher levels of treatment than standard care. Further studies are required which address these concerns and improve the evidence in this important area.