Developing an International Standard Set of Patient-Reported Outcome Measures for Psychotic Disorders.

OBJECTIVE: The objective of this project was to develop a set of patient-reported outcome measures for adolescents and adults who meet criteria for a psychotic disorder. METHODS: A research team and an international consensus working group, including service users, clinicians, and researchers, worked together in an iterative process by using a modified Delphi consensus technique that included videoconferencing calls, online surveys, and focus groups. The research team conducted systematic literature searches to identify outcomes, outcome measures, and risk adjustment factors. After identifying outcomes important to service users, the consensus working group selected outcome measures, risk adjustment factors, and the final set of outcome measures. International stakeholder groups consisting of >100 professionals and service users reviewed and commented on the final set. RESULTS: The consensus working group identified four outcome domains: symptoms, recovery, functioning, and treatment. The domains encompassed 14 outcomes of importance to service users. The research team identified 131 measures from the literature. The consensus working group selected nine measures in an outcome set that takes approximately 35 minutes to complete. CONCLUSIONS: A set of patient-reported outcome measures for use in routine clinical practice was identified. The set is free to service users, is available in at least two languages, and reflects outcomes important to users. Clinicians can use the set to improve clinical decision making, and administrators and researchers can use it to learn from comparing program outcomes.

Improving Access to psychological therapies for people with severe mental illness (IAPT-SMI): Lessons from the South London and Maudsley psychosis demonstration site.

Implementation of evidence-based cognitive behavioural therapy for psychosis (CBTp) remains low in routine services. The United Kingdom Improving Access to Psychological Therapies for people with Severe Mental Illness (IAPT-SMI) initiative aimed to address this issue. The project evaluated whether existing services could improve access to CBTp and demonstrate effectiveness using a systematic approach to therapy provision and outcome monitoring (in a similar way to the Improving Access to Psychological Therapies (IAPT) model for people with anxiety and depression). We report the clinical outcomes and key learning points from the South London and Maudsley NHS Foundation Trust IAPT-SMI demonstration site for psychosis. Additional funding enabled increased therapist capacity within existing secondary care community mental health services. Self-reported wellbeing and psychotic symptom outcomes were assessed, alongside service use and social/occupational functioning. Accepted referrals/year increased by 89% (2011/12: n = 106/year; 2012-2015: n = 200/year); 90% engaged (attended ≥5 sessions) irrespective of ethnicity, age and gender. The assessment protocol proved feasible, and pre-post outcomes (n = 280) showed clinical improvements and reduced service use, with medium effects. We conclude that, with appropriate service structure, investment allocated specifically for competent therapy provision leads to increased and effective delivery of CBTp. Our framework is replicable in other settings and can inform the wider implementation of psychological therapies for psychosis.

The Cost-Effectiveness of the Improving Access to Psychological Therapies (IAPT) Programme in Severe Mental Illness: A Decision Analytical Model Using Routine Data.

This is the first site level economic evaluation of the Improving Access to Psychological Therapies programme for severe mental illness (IAPT-SMI) that is funded by NHS England. It also aims to illustrate the challenges involved in evaluations based on routine data with low internal validity. Six IAPT-SMI pilot sites treated 1 of 2 clinical groups: (i) psychosis or bipolar disorder; (ii) personality disorder. A decision analytical model nested in a before-after framework- the same patients 12 months after treatment versus 12 months before treatment-was used to compare the cost-effectiveness of IAPT-SMI with treatment as usual (TAU). IAPT-SMI appears to be more costly overall but save non-psychological treatment costs. There is evidence it may improve function and lower incidence of harmful behaviour. However, there is a need for evaluations with a more conventional study design that measure a more comprehensive array of resource use and clinical outcomes.

Improving access to psychological therapies (IAPT) for people with bipolar disorder: Summary of outcomes from the IAPT demonstration site.

Access to structured psychological therapy recommended for bipolar disorder (BD) is poor. The UK NHS Improving Access to Psychological Therapies initiative commissioned a demonstration site for BD to explore the outcomes of routine delivery of psychological therapy in clinical practice, which this report summarises. All clinically diagnosed patients with BD who wanted a psychological intervention and were not in acute mood episode were eligible. Patients were offered a 10-session group intervention (Mood on Track) which delivered NICE congruent care. Outcomes were evaluated using an open (uncontrolled), pre-post design. Access to psychological therapy increased compared to preceding 6 years by 54%. 202 people began treatment; 81% completed >5 sessions; median 9 sessions (range 6-11). Pre-post outcomes included personal recovery (primary outcome), quality of life, work and social functioning, mood and anxiety symptoms (secondary outcomes). Personal recovery significantly improved from pre to post-therapy; medium effect-size (d = 0.52). Secondary outcomes all improved (except mania symptoms) with smaller effect sizes (d = 0.20-0.39). Patient satisfaction was high. Use of crisis services, and acute admissions were reduced compared to pre-treatment. It is possible to deliver group psychological therapy for bipolar disorder in a routine NHS setting. Improvements were observed in personal recovery, symptoms and wider functioning with high patient satisfaction and reduced service use.

Cognitive Behavioral Therapy for antipsychotic-free schizophrenia spectrum disorders: Does therapy dose influence outcome?

This study investigated the effect of "dose" and the components of Cognitive Behavioral Therapy (CBT) on treatment effects. It is a secondary analysis of the ACTION (Assessment of Cognitive Therapy Instead of Neuroleptics) trial which investigated CBT for people with schizophrenia spectrum disorders that chose not to take antipsychotic medication. Using instrumental variable methods, we found a "dose-response" such that each CBT session attended, reduced the primary outcome measure (the PANSS total score) by approximately 0.6 points (95% CI -1.20 to -0.06, p = 0.031). This suggests that length of therapy is important for those that receive CBT in the absence of antipsychotic medication. Secondly, using principal stratification we examined the process variables that modified treatment effects. Findings revealed that those who received a longitudinal formulation in the first 4 sessions of CBT had poorer treatment effects than those who did not, however this finding was not statistically significant (95% CI -37.244, 6.677, p = 0.173). However, it is important to note that these findings were evident in an exploratory analysis with a small sample. Future larger scale studies are needed to help understand components of effective treatment.

Self-labelling and stigma as predictors of attitudes towards help-seeking among people at risk of psychosis: 1-year follow-up.

Mental health service use is helpful but rare among young people at risk of psychosis. The label and stigma associated with mental illness may affect attitudes towards help-seeking. We examined 67 individuals at risk of psychosis over the course of 1 year. An increase of self-labelling as "mentally ill" predicted more positive attitudes towards psychiatric medication, while increased perceived stigma and the cognitive appraisal of stigma as a stressor predicted poorer attitudes towards psychotherapy after 1 year. Early intervention could improve non-stigmatizing awareness of at-risk mental state and reduce the public stigma associated with at-risk status to facilitate help-seeking.

Balancing harms in support of recovery.

BACKGROUND: Harm in mental health has traditionally been viewed as "unambiguous" and measured in terms of suicide, self-harm, self-neglect and violence. In order to develop an organisational patient safety strategy, one Trust engaged with service users, carers and senior clinicians and managers in order to understand how they define harm. AIM: To explore the meaning of harm in a mental health and learning disabilities setting. METHOD: This paper describes the outcome of service improvement work with service users, carers, senior clinicians and managers at one Trust to determine what harm meant to them. RESULTS: Harm is a concept which is broader than elements currently seen within organisational patient safety metrics and clinical risk assessments. CONCLUSIONS: Taking into account the diverse feedback received about what constitutes harm, a more inclusive definition emerges which could be incorporated into a new framework for risk management, balancing risk of harms across multiple dimensions. This approach has the potential to bring together consideration of the risk and recovery agendas.

Opportunities and challenges in Improving Access to Psychological Therapies for people with Severe Mental Illness (IAPT-SMI): evaluating the first operational year of the South London and Maudsley (SLaM) demonstration site for psychosis.

Despite its demonstrated clinical and economic effectiveness, access to Cognitive Behavioural Therapy for psychosis (CBTp) in routine practice remains low. The UK National Health Service (NHS England) Improving Access to Psychological Therapies for people with Severe Mental Illness (IAPT-SMI) initiative aims to address this problem. We report 14-month outcomes for our psychosis demonstration site. Primary and secondary care and self-referrals were screened to check the suitability of the service for the person. Psychotic symptoms, distress, service use, functioning and satisfaction were measured before and after therapy, by trained assessors. User-defined wellbeing and goal-attainment were rated sessionally. Access to CBTp increased almost threefold (2011/12 accepted referrals/year n = 106; 2012/13, n = 300). The IAPT-SMI assessment protocol proved feasible and acceptable to service users, with paired primary outcomes for 97% of closed cases. Therapy completion (≥5 sessions) was high (83%) irrespective of ethnicity, age and gender. Preliminary pre-post outcomes showed clinical improvement and reduced service use, with medium/high effect sizes. User-rated satisfaction was high. We conclude that individual psychological interventions for people with psychosis can be successfully delivered in routine services using an IAPT approach. High completion rates for paired outcomes demonstrate good user experience, clinical improvement, and potential future cost savings.

Cognitive therapy for people with schizophrenia spectrum disorders not taking antipsychotic drugs: a single-blind randomised controlled trial.

BACKGROUND: Antipsychotic drugs are usually the first line of treatment for schizophrenia; however, many patients refuse or discontinue their pharmacological treatment. We aimed to establish whether cognitive therapy was effective in reducing psychiatric symptoms in people with schizophrenia spectrum disorders who had chosen not to take antipsychotic drugs. METHODS: We did a single-blind randomised controlled trial at two UK centres between Feb 15, 2010, and May 30, 2013. Participants aged 16-65 years with schizophrenia spectrum disorders, who had chosen not to take antipsychotic drugs for psychosis, were randomly assigned (1:1), by a computerised system with permuted block sizes of four or six, to receive cognitive therapy plus treatment as usual, or treatment as usual alone. Randomisation was stratified by study site. Outcome assessors were masked to group allocation. Our primary outcome was total score on the positive and negative syndrome scale (PANSS), which we assessed at baseline, and at months 3, 6, 9, 12, 15, and 18. Analysis was by intention to treat, with an ANCOVA model adjusted for site, age, sex, and baseline symptoms. This study is registered as an International Standard Randomised Controlled Trial, number 29607432. FINDINGS: 74 individuals were randomly assigned to receive either cognitive therapy plus treatment as usual (n=37), or treatment as usual alone (n=37). Mean PANSS total scores were consistently lower in the cognitive therapy group than in the treatment as usual group, with an estimated between-group effect size of -6.52 (95% CI -10.79 to -2.25; p=0.003). We recorded eight serious adverse events: two in patients in the cognitive therapy group (one attempted overdose and one patient presenting risk to others, both after therapy), and six in those in the treatment as usual group (two deaths, both of which were deemed unrelated to trial participation or mental health; three compulsory admissions to hospital for treatment under the mental health act; and one attempted overdose). INTERPRETATION: Cognitive therapy significantly reduced psychiatric symptoms and seems to be a safe and acceptable alternative for people with schizophrenia spectrum disorders who have chosen not to take antipsychotic drugs. Evidence-based treatments should be available to these individuals. A larger, definitive trial is needed. FUNDING: National Institute for Health Research.

Associations of self-esteem, dysfunctional beliefs and coping style with depression in patients with schizophrenia: a preliminary survey.

Psychological models of depression in schizophrenia have proposed that cognitive structures (e.g., self-esteem, dysfunctional beliefs) may have a role in the development and maintenance of depression. However, it has not been clear what the characteristics of these cognitive structures were in people with schizophrenia and whether they have an independent association with depression, especially in those from a Chinese cultural background. The present investigation examined 133 people with schizophrenia and 50 healthy controls and indicated that compared to the controls people with schizophrenia showed lower self-esteem, higher levels of dysfunctional beliefs and negative coping styles. Multiple linear regression analysis revealed that only low frustration tolerance, problem solving and self-blame were found to be the independent correlates of depression in schizophrenia. Results are discussed with the view of clinical implications of cognitive formulation and therapy for schizophrenia in China.

Outcomes post-discharge from an early intervention in psychosis service.

AIM: To investigate the effectiveness of an early intervention in psychosis (EIP) service on engagement and hospital bed usage, post-discharge. A secondary aim was to identify if there was a subgroup of patients with 'poor outcomes'. METHOD: A naturalistic study comparing engagement and hospital bed day usage of individuals who received treatment from an EIP service (n = 75) with those who presented before the service was established (n = 113). RESULTS: The EIP service demonstrated better engagement with service users in year 5 (P = 0.001). No significant differences were observed on hospital bed day usage. When 'poor outcome' cases were removed, a trend towards lower bed usage in EIP services emerged (P = 0.139). CONCLUSION: EIP services improve engagement with service users. There was not a significant reduction in hospital bed usage. However, advantages could be masked by a relatively small number of individuals with 'poor outcomes'.

Identifying specific interpretations and use of safety behaviours in people with distressing visual hallucinations: an exploratory study.

BACKGROUND: Visual hallucinations (VH) are a common experience and can be distressing and disabling, particularly for people suffering from psychotic illness. However, not everyone with visual hallucinations reports the experience to be distressing. Models of VH propose that appraisals of VH as a threat to wellbeing and the use of safety seeking behaviours help maintain the distress. AIMS: This study investigated whether people with distressing VH report threat appraisals and use safety behaviours. METHOD: The study utilized a single group descriptive design, in which 15 participants with psychosis and VH were asked questions in order to assess the content, distress, appraisals, and behaviours associated with visual hallucinations. RESULTS: People who found visual hallucinations distressing (n = 13) held negative appraisals about those hallucinations and specifically saw them as a threat to their physical or psychological wellbeing. They also engaged in safety seeking behaviours that were logically related to the appraisal and served to maintain the distress. CONCLUSIONS: People with distressing VH regard them as a threat to their wellbeing and use safety seeking behaviours as a result of this perceived threat. These key processes are potential targets for treatments that will alleviate the distress associated with VH.

A preliminary exploration of predictors of outcome and cognitive mechanisms of change in cognitive behaviour therapy for psychosis in people not taking antipsychotic medication.

BACKGROUND: Cognitive behaviour therapy (CBT) has been shown to be effective in an open trial for people with psychotic disorders who have not been taking antipsychotic medication. There is little known about predictors of outcome in CBT for psychosis and even less about hypothesised mechanisms of change. METHOD: 20 participants with schizophrenia spectrum disorders received CBT in an exploratory trial. Our primary outcome was psychiatric symptoms measured using the PANSS. Secondary outcomes were dimensions of hallucinations and delusions, self-rated recovery and social functioning, and hypothesised mechanisms of change included appraisals of psychotic experiences, dysfunctional attitudes and cognitive insight. We also measured patient characteristics that may be associated with outcome. RESULTS: T-tests revealed that several of the hypothesised mechanisms did significantly change over the treatment and follow-up periods. Correlational analyses showed that reductions in negative appraisals of psychotic experiences were related to improvements on outcome measures and that shorter duration of psychosis and younger age were associated with greater changes in symptoms. CONCLUSIONS: CBT based on a specific cognitive model appears to change the hypothesised cognitive mechanisms, and these changes are associated with good outcomes. CBT may be more effective for those who are younger with shorter histories of psychosis.

What makes early intervention in psychosis services effective? A case study.

A number of studies have demonstrated that Early Intervention in Psychosis (EIP) services can produce improved outcomes for service users. However, the essential elements that produce these results remain elusive. This paper considers a number of hypotheses, with a particular focus on one service in the UK, which was designed according to policy guidance. It concludes that the structure of EIP services allows for the effective implementation of evidence based psychosocial interventions, which often fail to be implemented successfully within standard mental health services.

Pervasive developmental disorder and early intervention in psychosis services: a survey of care coordinators' experiences.

AIM: To evaluate the experience of care coordinators encountering clients with co-morbid diagnoses or features of pervasive development disorder (PDD) in an Early Intervention in Psychosis (EIP) service. METHODS: A cross-sectional survey was conducted using a semi-structured face-to-face interview schedule. RESULTS: Thirty-three care coordinators were interviewed. One-third of the care coordinators had previously encountered at least one client with a co-morbid diagnosis of PDD, with the majority feeling confident that they could recognize the features of the syndrome. The estimated reported prevalence of diagnosed PDD in this group was around 4-5%, although social and communication impairments were regularly encountered in clients by at least a quarter of the clinicians interviewed. CONCLUSIONS: Social and communication problems are commonly observed by clinicians in this population and some may represent the presence of a co-morbid PDD. Further efforts should be made to better identify and support this sub-population of EIP clients.

Predictors of outcome in brief cognitive behavior therapy for schizophrenia.

Antipsychotic medications, while effective, often leave patients with ongoing positive and negative symptoms of schizophrenia. Guidelines recommend using cognitive behavior therapy (CBT) with this group. Clearly, mental health professionals require training and supervision to deliver CBT-based interventions. This study tested which antipsychotic-resistant patients were most likely to respond to brief CBT delivered by psychiatric nurses. Staff were trained over 10 consecutive days with ongoing weekly supervision. Training for carers in the basic principles of CBT was also provided. This article represents the secondary analyses of completer data from a previously published randomized controlled trial (Turkington D, Kingdon D, Turner T. Effectiveness of a brief cognitive-behavioural therapy intervention in the treatment of schizophrenia. Br J Psychiatry. 2002;180:523-527) (n = 354) to determine whether a number of a priori variables were predictive of a good outcome with CBT and treatment as usual. Logistic regression was employed to determine whether any of these variables were able to predict a 25% or greater improvement in overall symptoms and insight. In the CBT group only, female gender was found to strongly predict a reduction in overall symptoms (P = .004, odds ratio [OR] = 2.39, 95% confidence interval [CI] = 1.33, 4.30) and increase in insight (P = .04, OR = 1.84, 95% CI = 1.03, 3.29). In addition, for individuals with delusions, a lower level of conviction in these beliefs was associated with a good response to brief CBT (P = .02, OR = 0.70, 95% CI = 0.51, 0.95). Women with schizophrenia and patients with a low level of conviction in their delusions are most likely to respond to brief CBT and should be offered this routinely alongside antipsychotic medications and other psychosocial interventions.