Stigma experienced as worse than symptoms of schizophrenia: A qualitative study about The OpusPanel.

AIM: Former patients and relatives of people who have received treatment in OPUS, a Danish specialized early intervention for first episode psychosis, have since 2009 worked to reduce stigma and increase hope related to schizophrenia and psychosis. They established The OpusPanel to share their own stories of living with an invisible disorder with new patients, health care professionals, politicians, and members of the public. The impact of The OpusPanel on stigma has not previously been explored or evaluated. The article aims to evaluate and gain an in-depth understanding of The OpusPanel's anti-stigma impact. METHODS: In a qualitative design, 27 people with different affiliations to The OpusPanel were interviewed using semi-structured interview guides to capture their individual experiences of listening to, interacting with, or being part of The OpusPanel. Interview guides were constructed following a focus group interview with members of The OpusPanel. Analysis of the multi-perspectival dataset was facilitated through an interpretative phenomenological approach with investigator triangulation. Preliminary results were returned to the focus group members to ensure relevance and accuracy. RESULTS: The study found that almost all interviewees described a sense of hopefulness and decreased stigma after having experienced a member from The OpusPanel present their story or participating as panel members themselves. CONCLUSION: The findings suggest that attending presentations or participating in The OpusPanel reduces stigmatizing views about others or oneself. The study may inform The OpusPanel and similar initiatives for challenging stigma related to schizophrenia or psychosis.

Home environment of 11-year-old children born to parents with schizophrenia or bipolar disorder - a controlled, 4-year follow-up study: The Danish High Risk and Resilience Study - VIA 11.

BACKGROUND: The home environment has a major impact on child development. Parental severe mental illness can pose a challenge to the home environment of a child. We aimed to examine the home environment of children of parents with schizophrenia or bipolar disorder and controls longitudinally through at-home assessments. METHODS: Assessments were conducted within The Danish High Risk and Resilience Study, a nationwide multi-center cohort study of children of parents with schizophrenia or bipolar disorder and population-based controls. The level of at-home stimulation and support was measured at age 7 (N = 508 children) and age 11 (N = 430 children) with the semi-structured HOME Inventory. Results from the 11-year follow-up study were analyzed and compared with 7-year baseline results to examine change across groups. RESULTS: At age 11, children of parents with schizophrenia and bipolar disorder had lower levels of stimulation and support than controls (mean (s.d.) = 46.16 (5.56), 46.87 (5.34) and 49.25 (4.37) respectively, p < 0.001). A higher proportion of children with parental schizophrenia or bipolar disorder lived in inadequate home environments at age 11, compared with controls (N (%) = 24 (15.0), 12 (12.2) and 6 (3.5) respectively, p < 0.003). The changes in home environment scores did not differ across groups from age 7 to age 11. CONCLUSIONS: Assessed longitudinally from the children's age of 7 to 11, children of parents with schizophrenia or bipolar disorder had lower levels of stimulation and support in their homes than controls. Integrated support which can target practical, economic, social and health issues to improve the home environment is indicated.

Self-reported reasons for discontinuation or continuation of antipsychotic medication in individuals with first-episode schizophrenia.

AIM: Many individuals with schizophrenia discontinue initially prescribed antipsychotics. Knowledge on reasons for discontinuation among individuals with first-episode schizophrenia is sparse. We aimed to describe reasons for discontinuation and continuation, differences between individuals discontinuing and continuing, and factors predicting reasons for discontinuation or continuation. METHODS: This was a prospective cohort study with a post hoc design. Individuals with first-episode schizophrenia were included from early intervention teams in Denmark from 2009-2012. Sociodemographic and clinical variables were collected at baseline and reasons for discontinuation and continuation of antipsychotics were assessed at 3.5-year follow-up. RESULTS: Among 215 patients, 76 reported reasons for discontinuation and 139 for continuation. The most frequent reasons for discontinuation were "side effects" and "patient believed he/she no longer needed the medication because he/she was now better". The most frequent reasons for continuation were "benefits for positive symptoms" and "another person told them to". Individuals who discontinued antipsychotics were at baseline younger, had longer DUP, less negative symptoms, better social function, lower compliance, higher self-belief of coping, and fewer used antipsychotics compared to those continuing antipsychotics. CONCLUSIONS: The effect of antipsychotics is the main reason to continue, whereas side effects were the main reason to discontinue. Knowledge of reasons to discontinue or continue is helpful in shared decision-making, identifying individuals with high odds of discontinuation, improving adherence, and helping with safe discontinuation.

Experiences of helplessness and fear among caregivers diagnosed with severe mental illness and co-caregivers: The Danish High Risk and Resilience Study - VIA 7.

This study investigates indicators of disorganized caregiving among caregivers of children who have a familial predisposition of schizophrenia spectrum psychosis (SZ) or bipolar disorder (BP), and whether indicators of disorganized caregiving are associated with the caregivers' and children's level of functioning as well as the children's internalizing and externalizing behavior problems. Indicators of disorganized caregiving were assessed with the Caregiving Helplessness Questionnaire (CHQ). Level of functioning was evaluated using the Children's Global Assessment Scale and the Personal and Social Performance Scale, while dimensional psychopathology were measured with the Child Behavior Checklist. 185 caregivers belonging to a SZ combined group (i.e., SZ-I + SZ co-caregiver), 110 caregivers to a BP combined group (i.e., BP-I + BP co-caregiver), and 184 caregivers to a population-based control group provided data on CHQ. Having a history of SZ or BP or being a co-caregiver to a parent with SZ or BP was associated with higher levels of experiences of helplessness and fear. Higher scores on helplessness were associated with lower level of functioning among caregivers and children and with children having externalizing/internalizing behavior problems. These results emphasize the need for interventions addressing indicators of disorganized caregiving in families with SZ or BP.

International application of standards for health care quality, access and evaluation of services for early intervention in psychotic disorders.

AIM: Standards for health care quality, access and evaluation of early intervention in psychosis services are required to assess implementation, provide accountability to service users and funders and support quality assurance. The aim of this article is to review the application of standards in Europe and North America. METHODS: Descriptive methods will be used to illustrate the organizational context in which standards are being applied and used, specific measures being applied and results so far. RESULTS: Both fidelity scales and quality indicators of health care are being used. Fidelity scales are being applied in Australia, Canada, Denmark, Italy and United States. In England, quality indicators derived from the National Institute for Health and Care Excellence guidance are being used. CONCLUSION: In the last 4 years, significant progress has been made in the development and application of measures that assess quality and access to evidence-based practices for early intervention in psychosis services. This represents an important step towards providing accountability, improving outcomes and service user experience. The methods used allow for comparison between the services that are assessed with the same methods, but there is a need to compare the different methods. Further research is also required to explore links between quality of care and outcomes for community mental health services that deliver early intervention in psychotic disorders.

Development of a fidelity scale for Danish specialized early interventions service.

BACKGROUND: The efficacy of the Specialized Early Intervention (SEI) treatment in Denmark, the OPUS treatment, has in a randomized clinical trial proved to be very effective compared to treatment as usual, and the dissemination of SEI services is increasing in Denmark. A prerequisite for upholding positive effects along with creating new teams and preserving critical components is to ensure fidelity to the model. Currently there is no Danish fidelity scale for SEI services. AIM: To establish a fidelity scale for SEI teams, in a brief and easily manageable form, for the use of evaluating and assessing the critical components in Danish SEI services. METHOD: We identified essential evidence-based components of SEI services internationally and interviewed experts from five Danish SEI teams, using an adapted version of the Delphi Consensus method. RESULTS: An 18-point fidelity scale was constructed. The scale was divided into two dimensions: one relating to the structure of the SEI team and one relating to the character and content of the SEI treatment. Each component can be rated either 1 or 0 (1 point = fulfilling the requirements for the components; and 0 point = the requirements were not met). The maximum score was a total of 18 points with 5 of the components being mandatory. CONCLUSION: The development of the fidelity scale is an important tool for securing the quality of SEI treatment in Denmark.

Programme fidelity of specialized early intervention in Denmark.

AIM: Specialized early intervention (SEI) treatment in meta-analysis has proven to be effective, compared to usual treatment, in treating first-episode psychosis, and the dissemination of SEI services is increasing. A prerequisite for upholding positive effects is to ensure fidelity to the treatment concept once tested. The aim of this study was to map programme fidelity of SEI teams in Denmark by testing a newly developed fidelity scale. METHODS: The 18-item SEI fidelity scale was assessed by visiting SEI teams in person. The scale is divided into 2 dimensions: one concerning the structure and the other concerning the character and content of the treatment. Interviews were conducted with team leaders, patients and members of the staff, and team conferences were observed. Satisfactory fidelity can be obtained at 2 levels: an elite level and an adequate level. RESULTS: In total, 96% (n = 22) of the Danish SEI teams participated in the fidelity study. An elite fidelity score was achieved by 32% of the teams, scoring 15 or 16 on the 18-point scale; 27% reached adequate level. With regard to the structural domain of the scale, we found variation among the teams. CONCLUSIONS: The multimodal approach was found to be very efficient in evaluating elements critical to SEI teams in Denmark. A low score on the structural domain could, in the long term, lead to an inability to maintain a well-functioning team and provide high-quality treatment.

Cognitive functioning following discontinuation of antipsychotic medication. A naturalistic sub-group analysis from the OPUS II trial.

BACKGROUND: The effect of antipsychotics medication on cognitive functioning in patients diagnosed with schizophrenia is poorly understood. Some studies of second generation antipsychotics indicated that they improved cognitive functioning while other studies have found that they decrease the level of cognitive functioning. METHOD: We included patients with schizophrenia who were in treatment with antipsychotics 1.5 years (baseline) after initiation of treatment and followed them up 3.5 years later (n = 189). At follow-up 60 (32%) had discontinued their antipsychotic treatment and 129 (68%) were still taking antipsychotics. Using the Brief Assessment of Cognition in Schizophrenia (BACS) we assessed cognition at baseline and follow-up. RESULTS: The patients who discontinued their medication had a higher level of cognitive functioning in all domains at baseline, as well as Global cognitive function [mean z-score -1.50 (s.d. 1.24) v. -2.27 (s.d. 1.30), p = 0.00015]. After controlling for relevant confounders those who discontinued antipsychotic medication improved significantly more than those who remained on antipsychotic medication during the course of the follow-up on the Token Motor task [estimated mean change difference -0.46 (95% CI -0.89 to -0.04)], the Speed of Processing Domain [estimated mean change difference -0.38 (95% CI -0.68 to -0.08)] and global cognition [estimated mean change difference -0.36 (95% CI -0.66 to -0.07)]. CONCLUSION: Due to the naturalistic design, we cannot conclude on the direction of the relationship between antipsychotics and cognition. There is no evidence that discontinuation of medication had a negative effect on cognitive functioning. Rather, we found that that discontinuation of medication was associated with better cognitive functioning.

Fidelity scales and performance measures to support implementation and quality assurance for first episode psychosis services.

AIM: The purpose of this paper is to review fidelity and outcome measures which can be used to support broad implementation of first episode psychosis services and ensure quality of existing services. First episode psychosis services use a combination of evidence-based practices to improve the outcome of a first episode of psychosis and the early stages of schizophrenia. Now that there is an established international evidence base to show that they are effective, efforts are being made to make such services widely available as a routine part of health care. METHODS: We provide an overview of the literature from the perspective of an expert task force that was commissioned to report to the board of the International Early Psychosis Association IEPA. First, we examined the evidence-based components that underpin first episode psychosis services and identified common elements. Next, we reviewed the availability of fidelity measures and outcome indicators, finally we reviewed how broadly these services are delivered internationally, and the barriers to ensuring broad access to quality services. RESULTS: There is a growing consensus about the elements required to deliver effective services. Fidelity scales and performance measures are available to assess quality, access, and outcome. First episode psychosis services are variably offered in high-income countries and rarely with attention to access and quality of services. Several strategies to promote implementation are identified. CONCLUSIONS: Fidelity scales and outcome measure are valuable resources to support widespread implementation and quality assurance for first episode psychosis services.

The Danish High Risk and Resilience Study-VIA 11: Study Protocol for the First Follow-Up of the VIA 7 Cohort -522 Children Born to Parents With Schizophrenia Spectrum Disorders or Bipolar Disorder and Controls Being Re-examined for the First Time at Age 11.

Introduction: Offspring of parents with severe mental illness have an increased risk of developing mental illnesses themselves. Familial high risk cohorts give a unique opportunity for studying the development over time, both the illness that the individual is predisposed for and any other diagnoses. These studies can also increase our knowledge of etiology of severe mental illness and provide knowledge about the underlying mechanisms before illness develops. Interventions targeting this group are often proposed due to the potential possibility of prevention, but evidence about timing and content is lacking. Method: A large, representative cohort of 522 7-year old children born to parents with schizophrenia, bipolar disorder or controls was established based on Danish registers. A comprehensive baseline assessment including neurocognition, motor functioning, psychopathology, home environment, sociodemographic data, and genetic information was conducted from January 1, 2013 to January 31, 2016. This study is the first follow-up of the cohort, carried out when the children turn 11 years of age. By assessing the cohort at this age, we will evaluate the children twice before puberty. All instruments have been selected with a longitudinal perspective and most of them are identical to those used at inclusion into the study at age 7. A diagnostic interview, motor tests, and a large cognitive battery are conducted along with home visits and information from teachers. This time we examine the children's brains by magnetic resonance scans and electroencephalograms. Measures of physical activity and sleep are captured by a chip placed on the body, while we obtain biological assays by collecting blood samples from the children. Discussion: Findings from the VIA 7 study revealed large variations across domains between children born to parents with schizophrenia, bipolar and controls, respectively. This study will further determine whether the children at familial risk reveal delayed developmental courses, but catch up at age 11, or whether the discrepancies between the groups have grown even larger. We will compare subgroups within each of the familial high risk groups in order to investigate aspects of resilience. Data on brain structure and physical parameters will add a neurobiological dimension to the study.

The effect of duration of untreated psychosis and treatment delay on the outcomes of prolonged early intervention in psychotic disorders.

The duration of untreated psychosis (DUP) has been shown to have an effect on outcome after first-episode psychosis. The premise of specialized early intervention (SEI) services is that intervention in the early years of illness can affect long-term outcomes. In this study, we investigate whether DUP affects treatment response after 5 years of SEI treatment compared to 2 years of SEI treatment. As part of a randomized controlled trial testing the effect of prolonged SEI treatment 400 participants diagnosed within the schizophrenia spectrum were recruited. For this specific study participants were dichotomized based on DUP, treatment delay, and time from first symptom until start of SEI treatment. The groups were analyzed with regard to treatment response on psychopathology, level of functioning, and cognitive functioning. The participants with a short DUP had a tendency to respond better to the prolonged treatment with regards to disorganized and negative dimension. For participants with short duration from first symptom until start of SEI treatment there was a significant difference on the negative dimension favoring the prolonged OPUS treatment. The finding of an effect of prolonged treatment for participants with a short total treatment delay could mean that prolonged SEI treatment is more beneficial than treatment as usual (TAU) so long as it is provided in the early years of illness and not just in the early years after diagnosis. TREATMENT TIMING: THE EARLIER THE BETTER: The duration of untreated psychosis influences the long-term outcomes of treatment. Nikolai Albert, at the Copenhagen Mental Health Centre, and a team of Danish researchers have investigated the effects of a specialized early intervention program (OPUS) in 400 patients diagnosed with schizophrenia spectrum disorders and compared the effects of OPUS after two and five years. Their findings suggest that five years of specialized early intervention was most beneficial when the total duration from symptom start to treatment was shorter than 6 months. The treatment was particularly effective at improving patients' disorganized behavior and negative symptoms such as blunted emotions and lack of motivation. These findings support previous studies suggesting that patients are more responsive to treatment in the early years of illness and highlight the importance of avoiding delays within the mental health service provision.

When the healthcare does not follow the evidence: The case of the lack of early intervention programs for psychosis in Spain. / Cuando la asistencia no sigue a la evidencia: el caso de la falta de programas de intervención temprana en psicosis en España.

There is now sufficient evidence to support the importance of interventions in the early stages of psychosis. The delay in the detection and treatment of the first-episode psychosis is related to a lower and slower recovery, as well as a higher risk of relapse. Despite this fact, early intervention units or teams are still not regularly implemented in mental health service settings in Spain. In this opinion article, a review is presented of the main arguments for defending the need to implement these programs and strategies in order to achieve this aim. There are a number of programs for early intervention for psychosis currently working in other countries, with a therapeutic program that includes pharmacological and psychosocial interventions, together with public awareness, information dissemination, and family-professional collaboration activities. Published literature on the experience of these programs indicates that early intervention is not only effective in terms of the improvement of health status, but is also economically efficient. The main steps and recommendations needed to implement such early intervention programs in our country are described.

Five years of specialised early intervention versus two years of specialised early intervention followed by three years of standard treatment for patients with a first episode psychosis: randomised, superiority, parallel group trial in Denmark (OPUS II).

OBJECTIVE: To compare the effects of five years of specialised early intervention (SEI) treatment for first episode schizophrenia spectrum disorder with the standard two years of SEI plus three years of treatment as usual. DESIGN: Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site. SETTING: Participants were recruited from six OPUS teams in Denmark between 2009 and 2012. OPUS teams provide SEI treatment to all patients diagnosed with a schizophrenia spectrum disorder in Denmark. PARTICIPANTS: 400 participants (51% women) with a mean age of 25.6 (standard deviation 4.3) were randomised to five years of SEI (experimental intervention; n=197) or to two years of SEI plus three years of treatment as usual (control; n=203). INTERVENTIONS: OPUS treatment consists of three core elements-modified assertive community treatment, family involvement, and social skill training-with a patient-case manager ratio of no more than 12:1. For participants randomised to five years of OPUS treatment, the treatment was largely unchanged. Participants randomised to the control group were mostly referred to community health centres after two years of SEI treatment. MAIN OUTCOMES: Follow-up assessments were conducted five years after start of OPUS treatment. Primary outcome was negative symptoms measured on the scale for assessment of negative symptoms (avolition-apathy, anhedonia, alogia, and affective blunting). Secondary outcomes were remission of both negative and psychotic symptoms, psychotic symptoms, suicidal ideation, substance abuse, compliance with medical treatment, adherence with treatment, client satisfaction, days in hospital care, and labour market affiliation. RESULTS: Levels of negative symptoms did not differ between the intervention group and control group (1.72 v 1.81 points; estimated mean difference -0.10 (95% confidence interval -0.33 to 0.13), P=0.39). Participants receiving five years of OPUS treatment were more likely to remain in contact with specialised mental health services (90.4% v 55.6%, P<0.001), had higher client satisfaction (estimated mean difference 2.57 points (95% confidence interval 1.36 to 3.79), P<0.001), and had a stronger working alliance (estimated mean difference 5.56 points (95% confidence interval 2.30 to 8.82), P=0.001) than the control group. CONCLUSIONS: This trial tests SEI treatment for up to five years for patients with first episode schizophrenia spectrum disorder; previous trials have found treatment effects for programmes lasting from one to three years. The prolonged SEI treatment had few effects, which could be due to the high level of treatment provided to control participants and the late start of specialised treatment.Trial registration Clinicaltrial.gov NCT00914238.

Course of illness in a sample of patients diagnosed with a schizotypal disorder and treated in a specialized early intervention setting. Findings from the 3.5year follow-up of the OPUS II study.

BACKGROUND: Previous studies report that 20% to 30% of those initially diagnosed with schizotypal disorder go on to develop a psychotic disorder (predominantly schizophrenia). Schizotypal disorder share some traits of those used to identify patients at ultra-high risk for psychosis. METHOD: As part of a randomized clinical trial testing the effect of prolonged specialized early intervention, we recruited 83 participants diagnosed with a schizotypal disorder. Participants were recruited 18 months into their two-year treatment program, and follow-up interviews were conducted three and a half year later. They were randomized to either discontinuation after the standard two year treatment or continuation of the specialized treatment for totally five year. The study investigated whether prolonged treatment could affect the rate of transition to psychosis and other clinical outcomes, and what would predict transition to psychosis. RESULTS: Of those 59 who attended the follow-up interview 19 (32%) developed a psychotic disorder at follow-up. There were no differences between the two treatment groups on transition rates or clinical outcomes. We found that lower level of functioning at baseline predicted transition to psychosis. DISCUSSION: Comparable to previous ultra-high risk studies, we found that level of functioning was the strongest predictor of transition to psychosis. Prior studies have found effect of specialized early intervention on transition rates, but we were not able to reproduce this finding. This may be attributable to the intervention in our study occurring at a later stage in the illness than prior studies.

The association between working alliance and clinical and functional outcome in a cohort of 400 patients with first-episode psychosis: a cross-sectional study.

OBJECTIVE: Working alliance between patients with a first-episode psychosis and their case manager is regarded as a key element in specialized early intervention services. The impact of this patient-case manager dyad on functional and clinical outcome is unknown. We aimed to investigate if a strong working alliance was associated with fewer clinical symptoms and better social functioning. METHOD: In a cross-sectional design, patients with first-episode schizophrenia spectrum disorders (ICD-10, F20-29) were included after 18 months of treatment (N = 400). Baseline data were collected between June 2009 and December 2011. Symptoms were assessed using Scale for the Assessment of Positive Symptoms (SAPS), Scale for the Assessment of Negative Symptoms (SANS), Global Assessment of Functioning (GAF), Brief Assessment of Cognition in Schizophrenia (BACS), Working Alliance Inventory (WAI), and General Self-Efficacy (GSE). Linear regression analyses were adjusted for age, sex, cognition, and self-efficacy. RESULTS: Results revealed significant associations between working alliance and fewer negative (ß = -0.12; 95% CI, -0.19 to -0.04) and disorganized symptoms (ß = -0.06; 95% CI, -0.11 to -0.01), and between working alliance and better social functioning (ß = 1.45; 95% CI, 0.55 to 2.36). General self-efficacy mediated the effect of working alliance, explaining 14%-18% of the variance in associated outcomes. Global level of cognitive functioning, compliance, and self-efficacy influenced clinical and functional outcome more strongly than working alliance. CONCLUSIONS: Better working alliance was weakly associated with fewer negative and disorganized symptoms and better social functioning. A strong working alliance may be a prerequisite for adherence to the specialized early intervention services treatment, providing the basis for positive treatment outcome. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00914238.

From research to practice: how OPUS treatment was accepted and implemented throughout Denmark.

BACKGROUND: The early phases of psychosis have been hypothesized to constitute a critical period, a window of opportunity. At the same time, the early phases of psychosis are associated with increased risk of unwanted outcome, such as suicidal behaviour and social isolation. This was the background for the emergence of early intervention services, and in Denmark, the OPUS trial was initiated as part of that process. METHODS: Modified assertive community treatment, together with family involvement and social skills training, constituted the core elements in the original programme. A total of 547 patients with first-episode psychosis were included in the trial. RESULTS: To summarize briefly the results of the OPUS trial: the OPUS treatment was superior to standard treatment in reducing psychotic and negative symptoms and substance abuse, in increasing user satisfaction and adherence to treatment, and in reducing use of bed days and days in supported housing. Moreover, relatives included in the OPUS treatment were less strained and had a higher level of knowledge about schizophrenia and higher user satisfaction. DISCUSSION: The OPUS treatment was implemented throughout Denmark. Training courses were developed and manuals and books were published. Regional health authorities had access to national grants for implementing early intervention services; as a result, OPUS teams were disseminated throughout the country. The content of the treatment is now further developed, and new elements are being tried out - such as individual placement and support, lifestyle changes, cognitive remediation, specialized treatment for substance abuse and different kinds of user involvement.

How successful are first episode programs? A review of the evidence for specialized assertive early intervention.

PURPOSE OF REVIEW: It has been hypothesized that the first 5 years after first episode of psychosis are a critical period with opportunities for ameliorating the course of illness. On the basis of this rationale, specialized assertive early intervention services were developed. We wanted to investigate the evidence basis for such interventions. RECENT FINDINGS: The evidence for the effectiveness of specialized assertive early intervention services is mainly based on one large randomized clinical trial, the OPUS trial, but it is supported by the findings in smaller trials, such as the Lambeth Early Onset trial, the Croydon Outreach and Assertive Support Team trial and the Norwegian site of Optimal Treatment trial. There are positive effects on psychotic and negative symptoms, on substance abuse and user satisfaction, but the clinical effects are not sustainable when patients are transferred to standard treatment. However, the positive effects on service use and ability to live independently seem to be durable. SUMMARY: Implementation of specialized assertive early intervention services is recommended, but the evidence basis needs to be strengthened through replication in large high-quality trials. Recommendation regarding the duration of treatment must await results of ongoing trials comparing 2 years of intervention with extended treatment periods.

Cognitive and clinical predictors of functional capacity in patients with first episode schizophrenia.

BACKGROUND: The predictors of functional capacity in first episode schizophrenia among seven separable cognitive domains and clinical variables are unknown. AIM: To investigate predictors of functional capacity in first episode schizophrenia and the associations between functional capacity and measures of real-world functioning. METHODS: Socio-demographic, clinical, and cognitive measures from a sample of patients with first episode schizophrenia spectrum disorders aged 18-34years (N=117) were examined at baseline, 4-month follow-up, and 10-month follow-up and used to predict concurrent and longitudinal functional capacity. Symptoms were assessed with the Positive and Negative Syndrome Scale, cognitive functioning with the MATRICS Cognitive Consensus Battery, and functional capacity with the brief version of the University of California San Diego Performance-based Skills Assessment. Linear and logistic regression analyses were adjusted for age, gender, and site. RESULTS: Working memory, negative symptoms, and social cognition accounted for 41% of the variance in functional capacity at baseline. Longitudinally, verbal learning, working memory, and negative symptoms predicted 4-month functional capacity. Working memory and visual learning predicted 10-month functional capacity. Functional capacity was associated to global functioning in the univariate analysis, but in multivariable analyses global functioning, financial independence, and independent living were predicted by negative symptoms or general symptoms explaining 15-23% of the variance. CONCLUSIONS: The strongest single predictor of functional capacity is working memory, followed by negative symptoms. Clinical symptoms, but not functional capacity, predicted real-world functioning. The usability of the UPSA-B in first episode schizophrenia is discussed. Neurocom, ClinicalTrials.gov Identifier: NCT00472862, http://clinicaltrials.gov/ct2/show/NCT00472862?term=neurocom&rank=1.

The effect of five years versus two years of specialised assertive intervention for first episode psychosis - OPUS II: study protocol for a randomized controlled trial.

BACKGROUND: The Danish OPUS I trial randomized 547 patients with first-episode psychosis to a two-year early-specialised assertive treatment programme (OPUS) versus standard treatment. The two years OPUS treatment had significant positive effects on psychotic and negative symptoms, secondary substance abuse, treatment adherence, lower dosage of antipsychotic medication, and a higher treatment satisfaction. However, three years after end of the OPUS treatment, the positive clinical effects were not sustained, except that OPUS-treated patients were significantly less likely to be institutionalised compared with standard-treated patients. The major objective of the OPUS II trial is to evaluate the effects of five years of OPUS treatment versus two years of OPUS treatment. METHODS: The OPUS II trial is designed as a randomized, open label, parallel group trial with blinded outcome assessment. Based on our sample size estimation, 400 patients treated in OPUS for two years will be randomized to further three years of OPUS treatment versus standard treatment. The specialized assertive OPUS treatment consists of three core elements: assertive community treatment, psycho-educational family treatment, and social skills training. DISCUSSION: It has been hypothesized that there is a critical period from onset up to five years, which represents a window of opportunity where a long-term course can be influenced. Extending the specialized assertive OPUS treatment up to five years may allow the beneficial effects to continue beyond the high-risk period, through consolidation of improved social and functional outcome. TRIAL REGISTRATION: Clinical Trial.gov NCT00914238.

Cognitive training plus a comprehensive psychosocial programme (OPUS) versus the comprehensive psychosocial programme alone for patients with first-episode schizophrenia (the NEUROCOM trial): a study protocol for a centrally randomised, observer-blinded multi-centre clinical trial.

BACKGROUND: Up to 85% of patients with schizophrenia demonstrate cognitive dysfunction in at least one domain. Cognitive dysfunction plays a major role in functional outcome. It is hypothesized that addition of cognitive training to a comprehensive psychosocial programme (OPUS) enhances both cognitive and everyday functional capacity of patients more than the comprehensive psychosocial programme alone. METHODS: The NEUROCOM trial examines the effect on cognitive functioning and everyday functional capacity of patients with schizophrenia of a 16-week manualised programme of individual cognitive training integrated in a comprehensive psychosocial programme versus the comprehensive psychosocial programme alone. The cognitive training consists of four modules focusing on attention, executive functioning, learning, and memory. Cognitive training involves computer-assisted training tasks as well as practical everyday tasks and calendar training. It takes place twice a week, and every other week the patient and trainer engage in a dialogue on the patient's cognitive difficulties, motivational goals, and progress in competence level. Cognitive training relies on errorless learning principles, scaffolding, and verbalisation in its effort to improve cognitive abilities and teach patients how to apply compensation strategies as well as structured problem solving techniques. At 16-week post-training and at ten-months follow-up, assessments are conducted to investigate immediate outcome and possible long-term effects of cognitive training. We conduct blinded assessments of cognition, everyday functional capacity and associations with the labour market, symptom severity, and self-esteem. DISCUSSION: Results from four-month and ten-month follow-ups have the potential of reliably providing documentation of the long-term effect of CT for patients with schizophrenia. TRIAL REGISTRATION: Clinicaltrials.gov NCT00472862.