The Cost-Effectiveness of a Novel Online Social Therapy to Maintain Treatment Effects From First-Episode Psychosis Services: Results From the Horyzons Randomized Controlled Trial.

BACKGROUND: Digital interventions have potential applications in promoting long-term recovery and improving outcomes in first-episode psychosis (FEP). This study aimed to evaluate the cost-effectiveness of Horyzons, a novel online social therapy to support young people aged 16-27 years following discharge from FEP services, compared with treatment as usual (TAU) from a healthcare sector and a societal perspective. STUDY DESIGN: A cost-effectiveness analysis (CEA), based on the change in social functioning, and a cost-utility analysis (CUA) using quality-adjusted life years were undertaken alongside a randomized controlled trial. Intervention costs were determined from study records; resources used by patients were collected from a resource-use questionnaire and administrative data. Mean costs and outcomes were compared at 18 months and incremental cost-effectiveness ratios were calculated. Uncertainty analysis using bootstrapping and sensitivity analyses was conducted. STUDY RESULTS: The sample included 170 participants: Horyzons intervention group (n = 86) and TAU (n = 84). Total costs were significantly lower in the Horyzons group compared with TAU from both the healthcare sector (-AU$4789.59; P < .001) and the societal perspective (-AU$5131.14; P < .001). In the CEA, Horyzons was dominant, meaning it was less costly and resulted in better social functioning. In the CUA, the Horyzons intervention resulted in fewer costs but also yielded fewer QALYs. However, group differences in outcomes were not statistically significant. When young people engaged more with the platform, costs were shown to decrease and outcomes improved. CONCLUSIONS: The Horyzons intervention offers a cost-effective approach for improving social functioning in young people with FEP after discharge from early intervention services.

The role of insight, social rank, mindfulness and self-compassion in depression following first episode psychosis.

Gaining awareness of psychosis (i.e., insight) is linked to depression, particularly in the post-acute phase of psychosis. Informed by social rank theory, we examined whether the insight-depression relationship is explained by reduced social rank related to psychosis and whether self-compassion (including uncompassionate self-responding [UCS] and compassionate self-responding [CSR]) and mindfulness buffered the relationship between social rank and depression in individuals with first episode psychosis during the post-acute phase. Participants were 145 young people (Mage  = 20.81; female = 66) with first episode psychosis approaching discharge from an early psychosis intervention centre. Questionnaires and interviews assessed insight, depressive symptoms, perceived social rank, self-compassion, mindfulness and illness severity. Results showed that insight was not significantly associated to depression and thus no mediation analysis was conducted. However, lower perceived social rank was related to higher depression, and this relationship was moderated by self-compassion and, more specifically, UCS. Mindfulness was related to depression but had no moderating effect on social rank and depression. Results supported previous findings that depressive symptoms are common during the post-acute phase. The role of insight in depression for this sample is unclear and may be less important during the post-acute phase than previously considered. Supporting social rank theory, the results suggest that low perceived social rank contributes to depression, and reducing UCS may ameliorate this effect. UCS, social rank and possibly mindfulness may be valuable intervention targets for depression intervention and prevention efforts in the recovery of psychosis.

Experiences of a Digital Mental Health Intervention from the Perspectives of Young People Recovering from First-Episode Psychosis: A Focus Group Study.

Horyzons is a digital health intervention designed to support recovery in young people receiving specialized early intervention services for first-episode psychosis (FEP). Horyzons was developed in Australia and adapted for implementation in Canada based on input from clinicians and patients (Horyzons-Canada Phase 1) and subsequently pilot-tested with 20 young people with FEP (Horyzons-Canada Phase 2). OBJECTIVE: To understand the experiences of young adults with FEP who participated in the pilot study based on focus group data. METHODS: Among the twenty individuals that accessed the intervention, nine participated across four focus groups. Three team members were involved in data management and analysis, informed by a thematic analysis approach. A coding framework was created by adapting the Phase 1 framework to current study objectives, then revised iteratively by applying it to the current data. Once the coding framework was finalized, it was systematically applied to the entire dataset. RESULTS: Four themes were identified: (1) Perceiving Horyzons-Canada as helpful for recovery; (2) Appreciating core intervention components (i.e., peer networking; therapeutic content; moderation) and ease of use; (3) Being unaware of its features; and (4) Expressing concerns, suggestions, and future directions. CONCLUSIONS: Horyzons-Canada was well received, with participants wanting it to grow in scale, accessibility, and functionality.

A randomized controlled trial of moderated online social therapy for family carers of first-episode psychosis patients in a specialist treatment setting.

BACKGROUND: Family members, who provide the majority of informal care during the recovery period from first-episode psychosis (FEP), experience high levels of psychological distress. However, there is a lack of effective and accessible interventions for FEP carers. OBJECTIVE: To determine the effectiveness of an online intervention ("Altitudes") in relation to the primary outcome of FEP-carer stress at 6 months follow-up. METHODS: We conducted a cluster randomized controlled trial in which FEP carers were randomized to Altitudes combined with specialized treatment as usual (STAU) or STAU alone. In addition to questionnaires, we included multiple waves of intensive ecological momentary assessment (EMA) to measure carer stress and family outcomes in 164 carers of young (15-27 years) FEP patients. RESULTS: Both groups improved over time on stress and a range of secondary outcomes, including mental health symptoms, self-efficacy, and expressed emotion with no group by time interactions. At 12 months there were significantly fewer visits to emergency departments by FEP patients in the Altitudes group (p = 0.022). Modelling of multiple EMA waves revealed that more time spent by carers with FEP patients predicted greater worry, expressed emotion, and adaptive coping. CONCLUSIONS: Engagement and usability findings for Altitudes were positive. Further refinements to our online carer interventions may be needed to engage carers in purposeful skill development for improved management of stress and communication with the young person compared with existing specialist family interventions. TRIAL REGISTRATION: ACTRN12616000968471.

A pilot randomised controlled trial of the Peer Tree digital intervention targeting loneliness in young people: a study protocol.

BACKGROUND: Young people are vulnerable to experiencing problematic levels of loneliness which can lead to poor mental health outcomes. Loneliness is a malleable treatment target and preliminary evidence has shown that it can be addressed with digital platforms. Peer Tree is a strength-based digital smartphone application aimed at reducing loneliness. The study aim is to reduce loneliness and assess the acceptability, usability, and feasibility of Peer Tree in young people enrolled at university. METHODS: This will be a pilot randomised controlled trial (RCT) comparing a strength-based digital smartphone application (Peer Tree) with a control condition. Forty-two young people enrolled at university will be recruited for this pilot RCT. Participants with suicidal ideation or behaviours, acute psychiatric symptoms in the past month, or a current diagnosis of a mood or social anxiety disorder will be excluded. Allocation will be made on a 1:1 ratio and will occur after the initial baseline assessment. Assessments are completed at baseline, at post-intervention, and at follow-up. Participants in the control condition complete the same three assessment sessions. The primary outcome of the study will be loneliness. Depression, social anxiety, quality of life, acceptability, usability, feasibility, and safety of Peer Tree will also be measured as secondary outcomes. DISCUSSION: This trial will report the findings of implementing Peer Tree, a smartphone application aimed at reducing loneliness in university students. Findings from this trial will highlight the initial efficacy, acceptability, and feasibility of using digital positive psychology interventions to reduce subthreshold mental health concerns. Findings from this trial will also describe the safety of Peer Tree as a digital tool. Results will contribute evidence for positive psychology interventions to address mental ill-health. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12619000350123. Registered on 6 March 2020.

A protocol for the first episode psychosis outcome study (FEPOS): ≥15 year follow-up after treatment at the Early Psychosis Prevention and Intervention Centre, Melbourne, Australia.

BACKGROUND: Specialist early intervention (SEI) service models are designed to treat symptoms, promote social and vocational recovery, prevent relapse, and resource and up-skill patients and their families. The benefits of SEI over the first few years have been demonstrated. While early recovery can be expected to translate to better long-term outcomes by analogy with other illnesses, there is limited evidence to support this from follow-up studies. The current study involves the long-term follow-up of a sub-set of first episode psychosis (FEP) patients, with a range of diagnoses, who were first treated at Orygen's Early Psychosis Prevention and Intervention Centre (EPPIC) between 1998 and 2000. The aim of this paper is to present the methodology for this follow-up study. METHODS: Between January 1998 and December 2000, 786 patients between the ages of 15-29 years were treated at EPPIC, located in Melbourne, Australia. Our cohort consists of 661 people (82 were transferred/discharged and 43 were not diagnosed with a psychotic disorder at time of discharge). The 18-month treatment characteristics of this cohort have been extensively examined in the First Episode Psychosis Outcome Study (FEPOS). The ≥15 year outcomes of this cohort are being examined in this study, known as FEPOS15. RESULTS: Participant follow-up is ongoing. In order to extend and assess broader outcomes of the cohort, data linkage with health-related databases will be conducted. CONCLUSION: This study will provide a comprehensive evaluation of the long-term trajectory of psychotic disorders after treatment for FEP in a SEI service.

The Horyzons project: a randomized controlled trial of a novel online social therapy to maintain treatment effects from specialist first-episode psychosis services.

This study aimed to determine whether, following two years of specialized support for first-episode psychosis, the addition of a new digital intervention (Horyzons) to treatment as usual (TAU) for 18 months was more effective than 18 months of TAU alone. We conducted a single-blind randomized controlled trial. Participants were people with first-episode psychosis (N=170), aged 16-27 years, in clinical remission and nearing discharge from a specialized service. They were randomly assigned (1:1) to receive Horyzons plus TAU (N=86) or TAU alone (N=84) between October 2013 and January 2017. Horyzons is a novel, comprehensive digital platform merging: peer-to-peer social networking; theory-driven and evidence-informed therapeutic interventions targeting social functioning, vocational recovery and relapse prevention; expert clinician and vocational support; and peer support and moderation. TAU involved transfer to primary or tertiary community mental health services. The primary outcome was social functioning at 18 months as measured by the Personal and Social Performance Scale (PSP). Forty-seven participants (55.5%) in the Horyzons plus TAU group logged on for at least 6 months, and 40 (47.0%) for at least 9 months. Social functioning remained high and stable in both groups from baseline to 18-month follow-up, with no evidence of significant between-group differences (PSP mean difference: -0.29, 95% CI: -4.20 to 3.63, p=0.77). Participants in the Horyzons group had a 5.5 times greater increase in their odds to find employment or enroll in education compared with those in TAU (odds ratio, OR=5.55, 95% CI: 1.09-28.23, p=0.04), with evidence of a dose-response effect. Moreover, participants in TAU were twice as likely to visit emergency services compared to those in the Horyzons group (39% vs. 19%; OR=0.31, 95% CI: 0.11-0.86, p=0.03, number needed to treat, NNT=5). There was a non-significant trend for lower hospitalizations due to psychosis in the Horyzons group vs. TAU (13% vs. 27%; OR=0.36, 95% CI: 0.11-1.08, p=0.07, NNT=7). So, although we did not find a significant effect of Horyzons on social functioning compared with TAU, the intervention was effective in improving vocational or educational attainment, a core component of social recovery, and in reducing usage of hospital emergency services, a key aim of specialized first-episode psychosis services. Horyzons holds significant promise as an engaging and sustainable intervention to provide effective vocational and relapse prevention support for young people with first-episode psychosis beyond specialist services.

Positive and meaningful lives: Systematic review and meta-analysis of eudaimonic well-being in first-episode psychosis.

BACKGROUND: First-episode psychosis typically has its onset during adolescence. Prolonged deficits in social functioning are common in FEP and yet often variance in functioning remains unexplained. Developmental psychology frameworks may be useful for understanding these deficits. Eudaimonic well-being (EWB), or positive self-development, is a developmental psychology construct that has been shown to predict mental health outcomes across multiple populations but has not been systematically reviewed in FEP. AIM: Our aim was to systematically review the evidence for: the predictors of EWB, the effectiveness of EWB interventions and to examine the quality of this research in FEP. METHODS: Selected studies measured either composite or components of EWB. A systematic search produced 2876 abstracts and 122 articles were identified for full screening which produced 17 final papers with 2459 participants. RESULTS: Studies comprised six RCTs, eight prospective follow-up studies and three case-controlled studies. Self-esteem and self-efficacy were the most commonly measured components. A meta-analysis of RCTs revealed no statistically significant effect of interventions on self-esteem. The extant research indicates that character strengths may be associated with higher EWB. Self-esteem may be lower in FEP compared with age matched controls but not different from ultra-high risk patients. Self-esteem appears to be associated with poorer insight and improved therapeutic alliance. Significant problems with both external and internal validity of reviewed studies were apparent. CONCLUSIONS: The hypotheses that lowered EWB is a risk factor for both onset of FEP and for poorer functional outcomes warrant further investigation. There is currently no evidence for effective interventions for EWB in FEP.

A pilot digital intervention targeting loneliness in young people with psychosis.

PURPOSE: Loneliness has been identified as a significant challenge for people with psychosis. Interventions targeting loneliness are lacking but adopting a positive psychology approach may reduce loneliness, promote well-being, and support meaningful social interactions. Together with youth mental health consumers, we developed a digital smartphone application (app) called +Connect, which delivers positive psychology content daily for 6 weeks. MATERIALS AND METHODS: Twelve participants diagnosed with a psychotic disorder were recruited from early psychosis services. Loneliness was assessed pre-intervention, post-intervention, and 3-month post-intervention. Acceptability, feasibility, and usability were measured post-intervention, including a semi-structured interview on the user's experience of +Connect. RESULTS: We found evidence for the feasibility of +Connect. All but two participants completed the +Connect program, completing 95% (40.10 out of 42 days) of the program. Furthermore, 66.67% (8 out of the 12 participants) remained engaged with the program 3-months post-intervention. Our data indicates preliminary evidence that +Connect may reduce loneliness, with scores from pre-intervention (M = 50.00, SD = 8.47) to post-intervention (M = 48.10, SD = 10.38) and 3-months post-intervention (M = 42.89, SD = 7.04). We found that positive reinforcement of in-game rewards and evidence of positive mood changes added to the feasibility of the app. Regarding acceptability, while 10% (1/10 participants) reported not finding +Connect useful or enjoyable, 90% of participants agreed that +Connect helped them to increase their social confidence, enjoy life, look forward to being with other people, and feel more connected with others. Participant interviews supported these results, with participants highlighting the app's strengths in providing useful information, stimulating self-reflection, fostering positive affect, and encouraging transfer of skills into their social interactions. DISCUSSION: While preliminary findings indicated that +Connect yielded high levels of acceptability and feasibility, it is important to consider that we recruited a small and selected sample of lonely young people. Further iterations of this proof of concept app, which can incorporate participant feedback such preferences for increased personalisation, in-app feedback, and gamification, may allow an opportunity to test an improved version in the future.

A Pilot Digital Intervention Targeting Loneliness in Youth Mental Health.

Background: Loneliness is an emerging issue for young people, but yet many interventions to address loneliness in this group focus on providing social opportunities. While these sorts of interventions may appear to increase social connections, loneliness is more related to quality rather than quantity of social relationships. Thus, interventions addressing loneliness should focus on maximizing the quality of current relationships. Together with youth consumers both with mental ill health and those without, we developed a digital smartphone application (app) called +Connect. The 6-week program delivers positive psychology content designed to improve relationship quality. We tested the acceptability, feasibility, and safety of the program in lonely young people with or without a mental health diagnosis of social anxiety disorder. We used a mixed method study design to triangulate pilot quantitative and qualitative data in young people with and without social anxiety disorder (SAD). Method: Nine participants with a diagnosis of social anxiety disorder (M age = 21.00; SD = 1.41) and 11 participants with no mental health conditions (M age = 20.36; SD = 2.16) completed the +Connect digital intervention. Results: Those with social anxiety disorder reported less acceptable ratings on outcomes. Feasibility ratings, measured by uptake and app completion, met a priori threshold criteria in both groups. Those with social anxiety disorder yielded more attrition, with almost double the attrition rate compared with those without the disorder. There were no safety issues elicited during the pilot study. In terms of outcomes, exploratory analyses indicated that the app itself is likely to be beneficial rather than cause harm. Our qualitative data indicated both groups reported no negative outcomes and noted that positive outcomes were driven by three processes: reflection, learning, and real-life application. Further exploratory data on usability indicated room for improvement in terms of giving more support for different components of the app (i.e., challenges). Conclusion: The pilot findings of this proof-of-concept app indicates some promise in terms of a second iterative version of +Connect.

Loneliness in psychosis: a systematic review.

PURPOSE: The aim of the review is to understand the relationships between loneliness and related psychological and social factors in individuals with psychosis. Loneliness is poorly understood in people with psychosis. Given the myriad of social challenges facing individuals with psychosis, these findings can inform psychosocial interventions that specifically target loneliness in this vulnerable group. METHODS: We adhered to the PRISMA guidelines and systematically reviewed empirical studies that measured loneliness either as a main outcome or as an associated variable in individuals with psychosis. RESULTS: A total of ten studies examining loneliness in people diagnosed with a psychotic disorder were examined. Heterogeneity in the assessment of loneliness was found, and there were contradictory findings on the relationship between loneliness and psychotic symptomatology. In individuals with psychosis, loneliness may be influenced by psychological and social factors such as increased depression, psychosis, and anxiety, poor social support, poor quality of life, more severe internalised stigma and perceived discrimination, and low self-esteem. CONCLUSIONS: The relationship between loneliness and psychosis remains poorly understood due to a lack of rigorous studies. Although having strong social relationships is crucial to facilitate recovery from serious mental illness, psychosocial interventions that specifically target loneliness in individuals with psychosis are lacking and sorely needed. Interventions targeting loneliness in those with psychosis will also need to account for additional barriers associated with psychosis (e.g., social skill deficits, impoverished social networks, and negative symptoms).

Loneliness over time: The crucial role of social anxiety.

Loneliness is known to be associated with multiple adverse physical outcomes, including higher mortality and morbidity risk. However, the impact of loneliness on mental health is less well researched, with most studies assessing how loneliness relates to depressive symptoms alone. We hypothesized that 2 mental health symptoms that relate to the fear of others-social anxiety and paranoia-would contribute to loneliness. We examined how loneliness relates to social anxiety, paranoia, and depression symptoms in a general community sample aged 18-87 years old (N = 1,010). We administered online measures over 3 time points across a 6-month period. In a cross-lagged structural equation model controlling for trait levels and prior states, our results indicated that earlier loneliness positively predicted future states of social anxiety, paranoia, and depression. However, in the same model, earlier social anxiety was the only predictor of future loneliness. These results suggest that loneliness may be a potential antecedent to emerging mental health symptoms and that identifying and treating co-occurring social anxiety symptoms may reduce the severity of loneliness. (PsycINFO Database Record

Risk factors associated with impact severity of cyberbullying victimization: a qualitative study of adolescent online social networking.

Cyberbullying victimization is associated with a range of emotional and behavioral outcomes for adolescents. However, previous research has shown that this type of victimization does not affect all individuals negatively. The factors that account for individual differences in reactions to the same online experiences are not well understood. Using a qualitative inductive approach, a set of strong themes relating to factors that either increased the severity of impact of cyberbullying victimization or buffered victims against the impact emerged from interviews with 25 adolescents aged 15-24 years. Themes related to publicity, anonymity of perpetrators, features of the medium, presence of bystanders, and individual level factors were identified as potential influences upon impact severity. The implications of these results for further research and for school/university cyberbullying prevention programs for victims, perpetrators, and bystanders are discussed.

A randomized controlled trial of bibliotherapy for carers of young people with first-episode psychosis.

Caring for young people with first-episode psychosis (FEP) is challenging and can adversely affect carer well-being, with limited evidence-based support materials available. We aimed to examine whether completion of a self-directed problem-solving bibliotherapy among carers of young people with FEP led to a better experience of caring, less distress and expressed emotion, and better general health than carers who only received treatment as usual (TAU). A randomized controlled trial was conducted across two early-intervention psychosis services in Melbourne, Australia. A total of 124 carers were randomized to problem-solving bibliotherapy intervention (PSBI) or TAU and assessed at baseline, 6-week and 16-week follow-up. Intent-to-treat analyses were carried out and indicated that recipients of PSBI had a more favorable experience of caring than those receiving TAU, and these effects were sustained at both follow-up time points. Across the other measures, both groups demonstrated improvements by week 16, although the PBSI group tended to improve earlier. The PSBI group experienced a greater reduction in negative emotional evaluations of the need to provide additional support to young people with FEP than the TAU group by week 6, while the level of psychological distress decreased at a greater rate from baseline to 6 weeks in the PSBI compared with the TAU group. These findings support the use of problem-solving bibliotherapy for first-time carers, particularly as a cost-effective adjunct to TAU.

A randomized controlled trial of relapse prevention therapy for first-episode psychosis patients: outcome at 30-month follow-up.

The effectiveness of a novel 7-month psychosocial treatment designed to prevent the second episode of psychosis was evaluated in a randomized controlled trial at 2 specialist first-episode psychosis (FEP) programs. An individual and family cognitive behavior therapy for relapse prevention was compared with specialist FEP care. Forty-one FEP patients were randomized to the relapse prevention therapy (RPT) and 40 to specialist FEP care. Participants were assessed on an array of measures at baseline, 7- (end of therapy), 12-, 18-, 24-, and 30-month follow-up. At 12-month follow-up, the relapse rate was significantly lower in the therapy condition compared with specialized treatment alone (P = .039), and time to relapse was significantly delayed for those in the relapse therapy condition (P = .038); however, such differences were not maintained. Unexpectedly, psychosocial functioning deteriorated over time in the experimental but not in the control group; these differences were no longer statistically significant when between-group differences in medication adherence were included in the model. Further research is required to ascertain if the initial treatment effect of the RPT can be sustained. Further research is needed to investigate if medication adherence contributes to negative outcomes in functioning in FEP patients who have reached remission, or, alternatively, if a component of RPT is detrimental.

Treating co-occurring first-episode psychosis and borderline personality: a pilot randomized controlled trial.

AIM: First-episode psychosis and borderline personality disorder are severe mental disorders that have their onset in youth. Their co-occurrence is clinically well recognized, is associated with significant risks and is complex to treat. Yet, there is no published specific intervention for this problem. This study reports a pilot randomized controlled trial comparing combined specialist first-episode treatment plus specialist early intervention for borderline personality, entitled Helping Young People Early, with specialist first-episode treatment alone. We aimed to evaluate the safety and feasibility of adding early intervention for borderline personality. METHODS: The study investigated the safety of specialist first-episode treatment plus specialist early intervention for borderline personality in relation to deterioration in psychosis, aggression, self-harm and suicidality, and feasibility in relation to the completion of therapy phases. Sixteen patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for first-episode psychosis and borderline personality (four or more DSM-IV criteria) were randomized either to specialist first-episode treatment alone or specialist first-episode treatment plus specialist early intervention for borderline personality and were followed up at the end of treatment and 6 months later. RESULTS: The results showed that it was feasible to recruit and assess a high risk and complex group of patients who were agreeable to study participation. Specialist first-episode treatment plus specialist early intervention for borderline personality was an acceptable and safe treatment. CONCLUSION: A larger-scale randomized controlled trial of early intervention for borderline personality for young first-episode psychosis patients with co-occurring full or subsyndromal borderline personality is warranted.

Group programmes in early intervention services.

AIM: Group interventions can be a developmentally appropriate treatment option for young people with mental illness; however, there is a paucity of research into these programmes. This study had three aims: (i) to document and compare both clinicians' and clients' reasons for referral to the Orygen Youth Health Recovery Group Program (RGP); (ii) to describe demographic characteristics of patients referred to the RGP; and (iii) to delineate and differentiate characteristics of clients who do and do not engage with the RGP's activities. METHODS: Referral and assessment data from 212 clients referred to the RGP between July 2001 and November 2003 were collated and analysed. RESULTS: Main reasons for referral to the programme were relationships followed by vocational/educational issues. Similarly, the most common goals identified by clients were around relationships, followed by time use and vocational issues. Clients referred to the RGP but who did not attend were more likely to have a psychotic disorder, to be older, unemployed and have difficulties with time management and substance use. CONCLUSIONS: Social functioning and vocation are important considerations in facilitating young people's recovery from mental illness. Such issues can be addressed within the context of psychosocial recovery group programmes. Further research is needed not only to address problems regarding client engagement but also to evaluate outcomes from participation in such programmes.

A systematic review of relapse measurement in randomized controlled trials of relapse prevention in first-episode psychosis.

The prevention of relapse is an important treatment goal in first-episode psychosis. Randomized controlled trials (RCTs) provide the gold standard methodology for evaluating interventions for relapse prevention. Properly designed RCTs which include relapse as a treatment outcome should rigorously operationalize psychotic relapse. The aim of this systematic literature review was to evaluate according to six criteria the operationalization of relapse in RCTs of clinical innovations for the prevention of relapse in first-episode psychosis. Through a systematic literature search of relevant RCTs in first-episode psychosis patients, eight pharmacological and eight non-pharmacological trials, published between 1982 and 2009, were identified. Readmission to a psychiatric hospital was the most common definition of psychotic relapse. Five studies did not measure relapse using any standardized or validated observer-rated instruments. The majority of the studies did not specify a duration criterion for relapse. Only three studies satisfied six criteria for the adequate operationalization of relapse. These results raise concerns regarding the internal and external validity of these research findings. There is an urgent need for a standardized, universally adopted set of criteria for psychotic relapse with appropriate specification of measurement instruments for use in future RCTs.