Rory Byrne

Early detection and intervention evaluation for people at risk of psychosis: multisite randomised controlled trial

Objective To determine whether cognitive therapy is effective in preventing the worsening of emerging psychotic symptoms experienced by help seeking young people deemed to be at risk for serious conditions such as schizophrenia. Design Multisite single blind randomised controlled trial. Setting Diverse services at five UK sites. Participants 288 participants aged 14-35 years (mean 20.74, SD 4.34 years) at high risk of psychosis: 144 were assigned to cognitive therapy plus monitoring of mental state and 144 to monitoring of mental state only. Participants were followed-up for a minimum of 12 months and a maximum of 24 months. Intervention Cognitive therapy (up to 26 (mean 9.1) sessions over six months) plus monitoring of mental state compared with monitoring of mental state only. Main outcome measures Primary outcome was scores on the comprehensive assessment of at risk mental states (CAARMS), which provides a dichotomous transition to psychosis score and ordinal scores for severity of psychotic symptoms and distress. Secondary outcomes included emotional dysfunction and quality of life. Results Transition to psychosis based on intention to treat was analysed using discrete time survival models. Overall, the prevalence of transition was lower than expected (23/288; 8%), with no significant difference between the two groups (proportional odds ratio 0.73, 95% confidence interval 0.32 to 1.68). Changes in severity of symptoms and distress, as well as secondary outcomes, were analysed using random effects regression (analysis of covariance) adjusted for site and baseline symptoms. Distress from psychotic symptoms did not differ (estimated difference at 12 months −3.00, 95% confidence interval −6.95 to 0.94) but their severity was significantly reduced in the group assigned to cognitive therapy (estimated between group effect size at 12 months −3.67, −6.71 to −0.64, P=0.018). Conclusions Cognitive therapy plus monitoring did not significantly reduce transition to psychosis or symptom related distress but reduced the severity of psychotic symptoms in young people at high risk. Most participants in both groups improved over time. The results have important implications for the at risk mental state concept. Trial registration Current Controlled Trials ISRCTN56283883.

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.

Early detection and intervention evaluation for people at high-risk of psychosis-2 (EDIE-2): Trial rationale, design and baseline characteristics.

Aims: Much research has begun to focus on the identification of people who are at high risk of developing psychosis, and clinical services have been initiated for this population. However, only a small number of studies have reported on the efficacy of interventions for preventing or delaying the onset of psychosis. The results of prior work suggest that cognitive therapy (CT) may be an effective, well‐tolerated treatment. We report on the rationale and design for a large‐scale, multi‐site randomized, controlled trial of CT for people who are assessed to be at high risk of psychosis because of either state or state‐plus‐trait risk factors.

Priorities and preferences for the outcomes of treatment of psychosis: A service user perspective

Background: It is increasingly argued that mental health service users should be consulted to determine the outcomes of treatment they prioritise, and the elements of treatment they find most helpful. Qualitative research may allow for more complete explorations and expressions of service users’ own perceptions of this topic. Aim: To summarise current qualitative evidence about service users’ priorities and preferences for treatment of psychosis and overall outcomes. Methods: Narrative literature review methods were used to identify qualitative research to obtain service user personal priorities and preferences for valued outcomes in relation to treatment of psychosis. Results: A notable finding was that qualitative evidence about the priorities and preferences directly identified by service users was remarkably scarce. The most relevant articles found presented several central outcome priorities and treatment preferences. Priorities for treatment outcomes included improved social and functional ability and satisfaction, and reduced symptomatology. Treatment preferences included person‐centred, collaborative approaches to care and for adjuncts or alternatives to the traditional medical model of psychosis (e.g. psychological therapy or psychosocial interventions). Conclusions: The implications of these findings are considered for research and practice.

Young people at risk of psychosis: a user-led exploration of interpersonal relationships and communication of psychological difficulties.

Aim: The aim of the present study was to qualitatively explore experiences and perceptions of interpersonal relationships and interpersonal communication among young people at risk of psychosis.

Recovery from psychosis: a user informed review of self-report instruments for measuring recovery

Background Mental health services are being encouraged to adopt a recovery approach, creating a requirement for standardised measures of recovery to be developed and embedded within services. Measurement of this unique concept is inherently difficult, but it is feasible and valid provided that service users and clinicians work collaboratively. Aims To evaluate which measures of recovery have clinical utility and are acceptable to service users. Method Instruments included in this review are (1) quantitative self-report measures, (2) published in a peer reviewed English language journal and (3) designed to measure personal recovery. The review team included two service-user researchers to allow evaluation of acceptability to service users. Results Twenty-five measures of recovery were identified; six of these met the inclusion criteria. A summary table of the measures is included to enable readers to make an informed choice of measure for their specific needs, along with an overview of each measure. Conclusions The Recovery Assessment Scale appears to be the most acceptable and valid measure currently available. No “gold-standard” measure of recovery has been developed to date. Further research is required to examine the longitudinal reliability of existing tools, and their utility within clinical services and as outcome measures.

Impact of cognitive therapy on internalised stigma in people with at-risk mental states

BACKGROUND Internalised stigma in young people meeting criteria for at-risk mental states (ARMS) has been highlighted as an important issue, and it has been suggested that provision of cognitive therapy may increase such stigma. AIMS To investigate the effects of cognitive therapy on internalised stigma using a secondary analysis of data from the EDIE-2 trial. METHOD Participants meeting criteria for ARMS were recruited as part of a multisite randomised controlled trial of cognitive therapy for prevention and amelioration of psychosis. Participants were assessed at baseline and at 6, 12, 18 and 24 months using measures of psychotic experiences, symptoms and internalised stigma. RESULTS Negative appraisals of experiences were significantly reduced in the group assigned to cognitive therapy (estimated difference at 12 months was -1.36 (95% CI -2.69 to -0.02), P = 0.047). There was no difference in social acceptability of experiences (estimated difference at 12 months was 0.46, 95% CI -0.05 to 0.98, P = 0.079). CONCLUSIONS These findings suggest that, rather than increasing internalised stigma, cognitive therapy decreases negative appraisals of unusual experiences in young people at risk of psychosis; as such, it is a non-stigmatising intervention for this population.

Internalized stigma, emotional dysfunction and unusual experiences in young people at risk of psychosis.

To investigate the relationship between internalized stigma, depression, social anxiety and unusual experiences in young people considered to be at risk of developing psychosis.

Psychosocial interventions for internalised stigma in people with a schizophrenia-spectrum diagnosis: A systematic narrative synthesis and meta-analysis

It is acknowledged that people with a schizophrenia-spectrum diagnosis experience higher levels of stigma compared to any other mental health diagnosis. As a consequence, their experience of internalised stigma is likely to be the most detrimental and pervasive. Internalised stigma interventions have shown some benefits in those who experience serious mental illness including those with a schizophrenia-spectrum diagnosis. A systematic narrative review and meta-analysis were conducted examining the efficacy of internalised stigma interventions for people with a schizophrenia-spectrum diagnosis. Randomised Controlled Trials, controlled trials, and cohort studies were included and assessed against quality criteria. The search identified 12 studies; 7 randomised controlled trials, 3 cohort studies and 2 controlled trials. A variety of psychosocial interventions were utilised with the majority employing Cognitive Behaviour Therapy (CBT), psychoeducation and social skills training. The core outcomes used to examine the efficacy of the intervention were internalised stigma, self-esteem, empowerment, and functioning. The meta-analysis revealed an improvement in internalised stigma favouring the internalised stigma intervention but was not significant (5 RCTs, n=200). Self-efficacy and insight were significantly improved favouring the internalised stigma intervention. Internalised stigma interventions show promise in those with schizophrenia-spectrum diagnoses. Existing interventions have demonstrated small effects and employed small samples. Large scale RCTs are required to further develop the evidence base of more targeted interventions.

DSM‐5 and the ‘Psychosis Risk Syndrome’: Whose best interests would it serve?

There are considerable risks associated with including Psychosis Risk Syndrome in DSM‐5, and no obvious benefits for those troubled by at‐risk mental states. There appear to be no obvious advantages for researchers, who already have available perfectly serviceable criteria for selecting participants in research projects. Those with most to gain from the inclusion of this new diagnosis in DSM‐5 would appear to be pharmaceutical companies, whereas those with the least to gain and most to lose would seem to be service users themselves. Hence the Psychosis Risk Syndrome should not be included.