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BACKGROUND: To provide precision cognitive remediation therapy (CR) for schizophrenia, we need to understand whether the mechanism for improved functioning is via cognition improvements. This mechanism has not been rigorously tested for potential moderator effects. STUDY DESIGN: We used data (nâ =â 377) from a randomized controlled trial using CIRCuiTS, a therapist-supported CR, with participants from first-episode psychosis services. We applied structured equation modeling to test whether: (1) CR hours explain the goal attainment functional outcome (GAS) at posttreatment, (2) global cognitive improvement mediates GAS, and if (3) total symptoms moderate the CR hours to cognitive improvement pathway, and/or negative symptoms moderate the cognition to functioning pathway, testing moderator effects via the mediator or directly on CR hours to functioning path. STUDY RESULTS: CR produced significant functioning benefit for each therapy hour (Coeffâ =â 0.203, 95% CI 0.101-0.304, Pâ <â .001). The mediated path from CR hours to cognition and cognition to functioning was small and nonsignificant (Coeffâ =â 0.014, 95% CIâ =â -0.010, 0.037, Pâ =â .256). Total symptoms did not moderate the path to cognition (Pâ =â .211) or the direct path to outcome (Pâ =â .896). However, negative symptoms significantly moderated the effect of cognitive improvements on functioning (Pâ =â .015) with high negative symptoms reducing the functional gains of improved cognition. CONCLUSIONS: Although cognitive improvements were correlated with functioning benefit, they did not fully explain the positive effect of increased therapy hours on functioning, suggesting additional CR factors also contribute to therapy benefit. Negative symptoms interfere with the translation of cognitive improvements into functional gains so need consideration.
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Deficits in social and occupational function are widely reported in psychosis, yet no one measure of function is currently agreed upon as a gold standard in psychosis research. The aim of this study was to carry out a systematic review and meta-analysis of functioning measures to determine what measures were associated with largest effect sizes when measuring between-group differences, changes over time, or response to treatment. Literature searches were conducted based on PsycINFO and PubMed to identify studies for inclusion. Cross-sectional and longitudinal observational and intervention studies of early psychosis (≤5 years since diagnosis) that included social and occupational functioning as an outcome measure were considered. A series of meta-analyses were conducted to determine effect size differences for between-group differences, changes over time, or response to treatment. Subgroup analyses and meta-regression were carried out to account for variability in study and participant characteristics. One hundred and sixteen studies were included, 46 studies provided data (N = 13 261) relevant to our meta-analysis. Smallest effect sizes for changes in function over time and in response to treatment were observed for global measures, while more specific measures of social and occupational function showed the largest effect sizes. Differences in effect sizes between functioning measures remained significant after variability in study and participant characteristics were accounted for. Findings suggest that more specific measures of social function are better able to detect changes in function over time and in response to treatment.
Subject(s)
Psychotic Disorders , Humans , Cross-Sectional Studies , Outcome Assessment, Health CareABSTRACT
AIM: Psychosis spectrum disorders continue to rank highly among causes of disability. This has resulted in efforts to expand the range of treatment targets beyond symptom remission to include other recovery markers, including social and occupational function and quality of life. Although the efficacy of psychosocial interventions in early psychosis has been widely reported, the acceptability of these interventions is less well-known. This study explores the participant perspective on a novel, psychosocial intervention combining cognitive remediation and social recovery therapy. METHODS: We employed a qualitative research design, based on semi-structured interviews and reflexive thematic analysis. Six participants with early psychosis were recruited from the intervention arm of a randomized pilot study, three women and three men, aged between 22 and 27 years. RESULTS: Four themes were developed through the analytical process, namely, (1) a solid therapeutic foundation, (2) multi-directional flow of knowledge, (3) a tailored toolset, and (4) an individual pathway to recovery. Participants also provided pragmatic feedback about how to improve the delivery of the therapy assessments and intervention. Both the themes and pragmatic feedback are described. CONCLUSIONS: People with early psychosis described the intervention as acceptable, engaging, helpful and person-centred, suggesting its potential role in a multicomponent therapy model of early intervention in psychosis services. Participants in this study also highlight the importance of an individualized approach to therapy, the vital role of the therapeutic relationship and the ecological validity and value of adopting an assertive outreach delivery, providing therapy outside a conventional clinic setting.
Subject(s)
Cognitive Remediation , Psychotic Disorders , Male , Humans , Female , Young Adult , Adult , Quality of Life , Pilot Projects , Psychotic Disorders/psychology , Qualitative ResearchABSTRACT
Limited research has explored the specific impact of voice-hearing experiences upon the social relating of adolescents. This study examined the associations of voice-hearing in youth with social relating, and putative explanatory factors. An observational, cross-sectional design using a clinical comparison group was employed to examine historical and concurrent associations with voice-hearing. Thirty-four young people (age 14-18 years) with voice-hearing experiences and 34 young people who did not hear voices were recruited from NHS mental health services. Participants completed measures about social relating and potential explanatory factors. Analyses of covariance were used to examine between-group differences. Voice-hearers scored higher on negative schematic beliefs (self-beliefs, partial η2 = .163, p = .001; other-beliefs, partial η2 = .152, p =. 002) and depressive and anxiety symptoms (partial η2 = .23 and partial η2 = .24, p-s <. 001 respectively). The two groups did not differ significantly on childhood trauma levels (partial η2 = .02, p = .273), however, the voice-hearing group scored lower on premorbid adjustment (partial η2 = .19, p < .001). Hearing voices in help-seeking youth could be an indicator for social relating issues and holding negative schematic beliefs, and may be an indicator for of increased psychopathological complexity. Although poorer premorbid adjustment might indicate an early vulnerability to social relating difficulties, voice-hearing might be an aggravating factor and one that requires treatment.
Subject(s)
Adverse Childhood Experiences , Mental Health Services , Adolescent , Humans , Cross-Sectional Studies , Hearing , PsychopathologyABSTRACT
Cognitive Remediation (CR) improves cognition and functioning but is implemented in a variety of ways (independent, group and one-to-one). There is no information on whether service users find these implementation methods acceptable or if their satisfaction influences CR outcomes. We used mixed participatory methods, including focus groups, to co-develop a CR satisfaction scale. This was refined using three psychometric criteria (Cronbach's alpha, item discrimination, test-retest agreement) to select items. Factor analysis explored potential substructures. The refined measure was used in structural equation joint modelling to evaluate whether satisfaction with CR is affected by implementation method and treatment engagement or influences recovery outcome, using data from a randomised controlled trial. Four themes (therapy hours, therapist, treatment effects, computer use) generated a 31-item Cognitive Remediation Satisfaction scale (CRS) that reduced to 18 Likert items, 2 binary and 2 open-ended questions following psychometric assessment. CRS had good internal consistency (Alpha = 0.814), test-retest reliability (r= 0.763), and concurrent validity using the Working Alliance Inventory (r = 0.56). A 2-factor solution divided items into therapy engagement and therapy effects. Satisfaction was not related to implementation method but was significantly associated with CR engagement. Therapy hours were significantly associated with recovery, but there was no direct effect of satisfaction on outcome. Although satisfaction is important to therapy engagement, it has no direct effect on outcome. CR therapy hours directly affect outcome irrespective of which implementation model is used, so measuring satisfaction early might help to identify those who are likely to disengage. The study has mixed methods design.
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BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommends that cognitive behaviour therapy (CBT) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBT. This is attributable, in part, to the resource-intensive nature of CBT. One response to this problem has been the development of CBT in brief formats that are targeted at a single symptom and are deliverable by briefly trained therapists. We have developed Guided self-help CBT (the GiVE intervention) as a brief form of CBT for distressing voices and reported evidence for the feasibility of a randomised controlled trial (RCT) when the intervention was delivered by briefly trained therapists (assistant psychologists). This study will investigate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists following a brief training. METHODS: This study is a pragmatic, two-arm, parallel group, superiority RCT comparing the GiVE intervention (delivered by assistant psychologists) and treatment as usual to treatment as usual alone, recruiting across three sites, using 1:1 allocation and blind post-treatment and follow-up assessments. A nested qualitative study will develop a model for implementation. DISCUSSION: If the GiVE intervention is found to be effective when delivered by assistant psychologists, this intervention could significantly contribute to increasing access to evidence-based psychological interventions for psychosis patients. Furthermore, implementation across secondary care services within the UK's National Health Service may pave the way for other symptom-specific and less resource-intensive CBT-informed interventions for psychosis patients to be developed and evaluated. TRIAL REGISTRATION: Current Controlled Trials ISRCTN registration number: 12748453. Registered on 28 September 2022.
Subject(s)
Cognitive Behavioral Therapy , Psychotic Disorders , Humans , Psychotic Disorders/diagnosis , Psychotic Disorders/therapy , Allied Health Personnel , England , Health Behavior , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: Calls have been made to rethink the mental health support currently available for young people. This study aims to help re-focus and reduce the inaccessibility of mental health services by offering an adapted version of a theoretically-driven, evidence-based, guided psychosocial intervention known as 'Groups 4 Health' (G4H). To date, the G4H intervention has mainly been trialled in Australia, with promising positive effects on social connection, mental health and well-being. The present study examines the feasibility of running a randomised controlled trial when delivering the G4H intervention for young people in the UK. METHODS: The TOGETHER study is a feasibility randomised controlled trial of an adapted version of the G4H intervention. Participants are aged 16-25, currently experiencing mental health difficulties and recruited from mental health services. The target sample size is 30, with 15 in each trial arm. Participants are randomly allocated to either G4H plus treatment as usual, or treatment as usual alone. The primary outcomes of interest are the feasibility of recruitment, randomisation, data collection and retention to the study at 10 and 14 week follow up, as well as the acceptability, and accessibility of the study protocol and G4H intervention. DISCUSSION: The results of this study will indicate if further optimisation is required to improve the feasibility, acceptability and accessibility of the intervention and study protocol procedures as perceived by end users and practitioners. This offers a significant opportunity to support the local and national demand for accessible, innovative, and effective psychosocial youth mental health support. TRIAL REGISTRATION: ISRCTN registry (ISRCTN12505807). Registration date: 11/04/2022.
Subject(s)
Mental Health , Social Group , Adolescent , Humans , Feasibility Studies , Social Work , Psychosocial Support Systems , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: There is growing evidence of a beneficial effect of social group processes on well-being and mental health. AIMS: To investigate the role of group membership continuity in reducing mental ill-health among young people who were already vulnerable pre-pandemic, and to understand the social and psychological mechanisms of the benefits of group memberships for vulnerable young people. METHOD: This study takes a cross-sectional design, using survey data from a sample of 105 young people aged 16-35 years, collected approximately 1 year after the global COVID-19 outbreak (January to July 2021). Correlational and path analyses were used to test the associations between group membership continuity and mental health problems (depression, anxiety, psychotic-like experiences) and the mediation of these associations by hope and social connectedness (in-person and online). To correct for multiple testing, the Benjamini-Hochberg procedure was implemented for all analyses. Indirect effects were assessed with coverage of 99% confidence intervals. RESULTS: Multiple prior group memberships were associated with preservation of group memberships during the COVID-19 pandemic. In-person social connectedness, online social connectedness and hope mediated the relationship between group membership continuity and mental health problem symptoms. CONCLUSIONS: The results suggest that clinical and public health practice should support vulnerable young people to foster and maintain their social group memberships, hopefulness and perceived sense of social connectedness as means of helping to prevent exacerbation of symptoms and promote recovery of mental health problems, particularly during significant life events.
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Introduction: Due to the general psychopathological vulnerability of young people who hear distressing voices, research has stressed the importance for clinicians to assess this experience in youth. Nonetheless, the limited literature on the topic comes from studies with clinicians in adult health services and it primarily reports that clinicians do not feel confident in systematically assessing voice-hearing and doubt the appropriateness of doing so. We applied the Theory of Planned Behavior and identified clinicians' job attitudes, perceived behavioral control, and perceived subjective norms as putative predictors of their intent to assess voice-hearing in youth. Method: Nine hundred and ninety-six clinicians from adult mental health services, 467 from Child and Adolescent Mental Health (CAMHS) and Early Intervention in Psychosis (EIP) services and 318 primary care clinicians across the UK completed an online survey. The survey gathered data on attitudes toward working with people who hear voices, stigmatizing beliefs, and self-perceived confidence in voice-related practices (screening for, discussing and providing psychoeducation material about voice-hearing). Responses from youth mental health clinicians were compared with professionals working in adult mental health and primary care settings. This study also aimed to identify what youth mental health clinicians believe about assessing distressing voices in adolescents and how beliefs predict assessment intention. Results: Compared to other clinicians, EIP clinicians reported the most positive job attitudes toward working with young voice-hearers, the highest self-efficacy in voice-hearing practices, and similar levels of stigma. Job attitudes, perceived behavioral control and subjective norms explained a large part of the influences on clinician's intention to assess voice-hearing across all service groups. In both CAMHS and EIP services, specific beliefs relating to the usefulness of assessing voice-hearing, and perceived social pressure from specialist mental health professionals regarding assessment practices predicted clinician intention. Discussion: Clinicians' intention to assess distressing voices in young people was moderately high, with attitudes, subjective norms and perceived behavioral control explaining a large part of its variance. Specifically in youth mental health services, promoting a working culture that encourages opening and engaging in discussions about voice-hearing between clinicians, and with young people, and introducing supportive assessment and psychoeducation material about voice-hearing could encourage conversations about voices.
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BACKGROUND AND HYPOTHESIS: Cognitive remediation (CR) benefits cognition and functioning in psychosis but we do not know the optimal level of therapist contact, so we evaluated the potential benefits of different CR modes. STUDY DESIGN: A multi-arm, multi-center, single-blinded, adaptive trial of therapist-supported CR. Participants from 11 NHS early intervention psychosis services were independently randomized to Independent, Group, One-to-One, or Treatment-as-usual (TAU). The primary outcome was functional recovery (Goal Attainment Scale [GAS]) at 15-weeks post randomization. Independent and TAU arms were closed after an interim analysis, and three informative contrasts tested (Group vs One-to-One, Independent vs TAU, Groupâ +â One-to-One vs TAU). Health economic analyses considered the cost per Quality Adjusted Life Year (QALY). All analyses used intention-to-treat principles. STUDY RESULTS: We analyzed 377 participants (65 Independent, 134 Group, 112 One-to-One, 66 TAU). GAS did not differ for Group vs One-to-One: Cohen's d: 0.07, -0.25 to 0.40 95% CI, Pâ =â .655; Independent vs TAU: Cohen's d: 0.07, -0.41 to 0.55 95% CI, Pâ =â .777. GAS and the cognitive score improved for Groupâ +â One-to-One vs TAU favoring CR (GAS: Cohen's d: 0.57, 0.19-0.96 95% CI, Pâ =â .003; Cognitive score: Cohens d: 0.28, 0.07-0.48 95% CI, Pâ =â .008). The QALY costs were £4306 for Group vs TAU and £3170 for One-to-One vs TAU. Adverse events did not differ between treatment methods and no serious adverse events were related to treatment. CONCLUSIONS: Both active therapist methods provided cost-effective treatment benefiting functional recovery in early psychosis and should be adopted within services. Some individuals benefited more than others so needs further investigation. TRIAL REGISTRATION: ISRCTN14678860 https://doi.org/10.1186/ISRCTN14678860Now closed.
Subject(s)
Cognitive Remediation , Psychotic Disorders , Humans , Psychotic Disorders/therapy , Treatment Outcome , Cognition , Health Care Costs , Cost-Benefit AnalysisABSTRACT
PURPOSE: Psychosis disproportionally affects ethnic minority groups in high-income countries, yet evidence of disparities in outcomes following intensive early intervention service (EIS) for First Episode Psychosis (FEP) is less conclusive. We investigated 5-year clinical and social outcomes of young people with FEP from different racial groups following EIS care. METHOD: Data were analysed from the UK-wide NIHR SUPEREDEN study. The sample at baseline (n = 978) included White (n = 750), Black (n = 71), and Asian (n = 157) individuals, assessed during the 3 years of EIS, and up to 2 years post-discharge (n = 296; Black [n = 23]; Asian [n = 52] and White [n = 221]). Outcome trajectories were modelled for psychosis symptoms (positive, negative, and general), functioning, and depression, using linear mixed effect models (with random intercept and slopes), whilst controlling for social deprivation. Discharge service was also explored across racial groups, 2 years following EIS. RESULTS: Variation in linear growth over time was accounted for by racial group status for psychosis symptoms-positive (95% CI [0.679, 1.235]), negative (95% CI [0.315, 0.783]), and general (95% CI [1.961, 3.428])-as well as for functioning (95% CI [11.212, 17.677]) and depressive symptoms (95% CI [0.261, 0.648]). Social deprivation contributed to this variance. Black individuals experienced greater levels of deprivation (p < 0.001, 95% CI [0.187, 0.624]). Finally, there was a greater likelihood for Asian (OR = 3.04; 95% CI [2.050, 4.498]) and Black individuals (OR = 2.47; 95% CI [1.354, 4.520]) to remain in secondary care by follow-up. CONCLUSION: Findings suggest variations in long-term clinical and social outcomes following EIS across racial groups; social deprivation contributed to this variance. Black and Asian individuals appear to make less improvement in long-term recovery and are less likely to be discharged from mental health services. Replication is needed in large, complete data, to fully understand disparities and blind spots to care.
Subject(s)
Ethnicity , Psychotic Disorders , Humans , Adolescent , Ethnicity/psychology , Aftercare , Minority Groups , Patient Discharge , Psychotic Disorders/psychology , Racial Groups , United Kingdom/epidemiologyABSTRACT
BACKGROUND: Many individuals with first-episode psychosis experience severe and persistent social disability despite receiving specialist early intervention. The SUPEREDEN3 trial assessed whether augmenting early intervention in psychosis services with Social Recovery Therapy (SRT) would lead to better social recovery. AIMS: A qualitative process evaluation was conducted to explore implementation and mechanisms of SRT impact from the perspective of SUPEREDEN3 participants. METHOD: A subsample of SUPEREDEN3 trial participants (n = 19) took part in semi-structured interviews, which were transcribed verbatim and analysed thematically. Trial participants were early intervention service users aged 16-35 years with severe and persistent social disability. Both SRT plus early intervention and early intervention alone arm participants were interviewed to facilitate better understanding of the context in which SRT was delivered and to aid identification of mechanisms specific to SRT. RESULTS: The six themes identified were used to generate an explanatory model of SRT's enhancement of social recovery. Participant experiences highlight the importance of the therapist cultivating increased self-understanding and assertively encouraging clients to face feared situations in a way that is perceived as supportive, while managing ongoing symptoms. The sense of achievement generated by reaching targets linked to personally meaningful goals promotes increased self-agency, and generates hope and optimism. CONCLUSIONS: The findings suggest potentially important processes through which social recovery was enhanced in this trial, which will be valuable in ensuring the benefits observed can be replicated. Participant accounts provide hope that, with the right support, even clients who have persistent symptoms and the most severe disability can make a good social recovery.
Subject(s)
Psychotic Disorders , Social Skills , Humans , Psychotic Disorders/therapy , Psychotic Disorders/diagnosis , Adolescent , Young Adult , Adult , Clinical Trials as TopicABSTRACT
BACKGROUND: Poor clinical insight has been commonly reported in those with First Episode Psychosis (FEP) and thought to be influenced by a range of factors, including neurocognition and symptoms. Clinical insight may be compromised as a result of alterations in higher-level reflective processes, such as metacognitive ability and cognitive insight. AIMS: To explore whether metacognitive ability and cognitive insight are associated with clinical insight while controlling for IQ, depression, and symptoms in FEP. METHODS: 60 individuals with FEP completed measures for clinical insight, metacognitive ability, cognitive insight, positive and negative symptoms, depression, and IQ. RESULTS: Higher levels of metacognitive ability were associated with better clinical insight, even when controlling for IQ, depression, positive and negative symptoms, and medication. Integration subscale of metacognitive ability was most strongly associated with clinical insight. Cognitive insight was associated with clinical insight when controlling for covariates. However, when including metacognitive ability and cognitive insight in the predictive model, only metacognitive ability was significantly related to clinical insight. DISCUSSION: Metacognitive ability, specifically the ability to describe one's evolving mental state to provide a coherent narrative, was significantly related to clinical insight, independent of covariates, and may be a potentially important target for intervention in FEP.
Subject(s)
Metacognition , Psychotic Disorders , Humans , Psychotic Disorders/psychology , Psychotic Disorders/therapy , Adolescent , Young Adult , Adult , Male , FemaleABSTRACT
Atmospheric ammonia (NH3) and ammonium (NH4+) can substantially influence air quality, ecosystems, and climate. NH3 volatilization from fertilizers and wastes (v-NH3) has long been assumed to be the primary NH3 source, but the contribution of combustion-related NH3 (c-NH3, mainly fossil fuels and biomass burning) remains unconstrained. Here, we collated nitrogen isotopes of atmospheric NH3 and NH4+ and established a robust method to differentiate v-NH3 and c-NH3. We found that the relative contribution of the c-NH3 in the total NH3 emissions reached up to 40 ± 21% (6.6 ± 3.4 Tg N yr-1), 49 ± 16% (2.8 ± 0.9 Tg N yr-1), and 44 ± 19% (2.8 ± 1.3 Tg N yr-1) in East Asia, North America, and Europe, respectively, though its fractions and amounts in these regions generally decreased over the past decades. Given its importance, c-NH3 emission should be considered in making emission inventories, dispersion modeling, mitigation strategies, budgeting deposition fluxes, and evaluating the ecological effects of atmospheric NH3 loading.
Subject(s)
Air Pollutants , Air Pollution , Ammonia/analysis , Air Pollutants/analysis , Ecosystem , Environmental Monitoring/methods , Nitrogen/analysis , ChinaABSTRACT
Trials of psychological interventions targeting distressing voices have used a range of variables to measure outcomes. This has complicated attempts to compare outcomes across trials and to evaluate the effectiveness of these interventions. Therefore, this review aimed to identify the variables that have been used to measure the longitudinal course and impact of voice hearing under these interventions and to evaluate how these variables change over time. Inclusion and exclusion criteria were applied, resulting in a total of 66 articles. Of these, 60 studies (28 RCTs, 23 uncontrolled, 9 non-randomised) were published in peer-reviewed journals, whilst 6 were recently completed or currently ongoing. The findings of this review suggest that a range of variables that are not directly relevant to psychological interventions have been used (e.g., depression, characteristics of voice hearing experience), whilst those directly impacted by psychological interventions (e.g., voice-related distress), broader concepts of outcome (e.g., functioning) and specific associated processes (e.g., self-schema) have received less attention. Findings also showed that the majority of variables demonstrated improvements, but effect sizes varied considerably across trials. This may be attributed to methodological differences such as statistical power, blinding, control groups and different methods of measurement. Our review highlights the importance of determining a set of outcomes that are directly targeted and should change under psychological interventions. Recommendations include the use of voice-related distress as a primary outcome. This can ultimately facilitate comparisons across studies and inform the development of psychological interventions.
Subject(s)
Hallucinations , Hearing , Hallucinations/psychology , HumansABSTRACT
BACKGROUND: Marginalized groups are more likely to experience problems with technology-related access, motivation, and skills. This is known as the "digital divide." Technology-related exclusion is a potential barrier to the equitable implementation of digital health. SlowMo therapy was developed with an inclusive, human-centered design to optimize accessibility and bridge the "digital divide." SlowMo is an effective, blended digital psychological therapy for paranoia in psychosis. OBJECTIVE: This study explores the "digital divide" and mobile app engagement in the SlowMo randomized controlled trial. METHODS: Digital literacy was assessed at baseline, and a multidimensional assessment of engagement (ie, adherence [via system analytics and self-report] and self-reported user experience) was conducted at 12 weeks after therapy. Engagement was investigated in relation to demographics (ie, gender, age, ethnicity, and paranoia severity). RESULTS: Digital literacy data demonstrated that technology use and confidence were lower in Black people and older people (n=168). The engagement findings indicated that 80.7% (96/119) of therapy completers met the a priori analytics adherence criteria. However, analytics adherence did not differ by demographics. High rates of user experience were reported overall (overall score: mean 75%, SD 17.1%; n=82). No differences in user experience were found for ethnicity, age, or paranoia severity, although self-reported app use, enjoyment, and usefulness were higher in women than in men. CONCLUSIONS: This study identified technology-related inequalities related to age and ethnicity, which did not influence engagement with SlowMo, suggesting that the therapy design bridged the "digital divide." Intervention design may moderate the influence of individual differences on engagement. We recommend the adoption of inclusive, human-centered design to reduce the impact of the "digital divide" on therapy outcomes. TRIAL REGISTRATION: ISRCTN Registry ISRCTN32448671; https://www.isrctn.com/ISRCTN32448671.
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INTRODUCTION: At least one in four people treated by the primary care improving access to psychological therapies (IAPT) programme in England experiences distressing psychotic experiences (PE) in addition to common mental disorder (CMD). These individuals are less likely to achieve recovery. IAPT services do not routinely screen for nor offer specific treatments for CMD including PE. The Tailoring evidence-based psychological therapY for People with common mental disorder including Psychotic EXperiences study will evaluate the clinical and cost-effectiveness of an enhanced training for cognitive behavioural therapists that aims to address this clinical gap. METHODS AND ANALYSIS: This is a multisite, stepped-wedge cluster randomised controlled trial. The setting will be IAPT services within three mental health trusts. The participants will be (1) 56-80 qualified IAPT cognitive behavioural therapists and (2) 600 service users who are triaged as appropriate for cognitive behavioural therapy in an IAPT service and have PE according to the Community Assessment of Psychic Experiences-Positive 15-items Scale. IAPT therapists will be grouped into eight study clusters subsequently randomised to the control-intervention sequence. We will obtain pseudonymous clinical outcome data from IAPT clinical records for eligible service users. We will invite service users to complete health economic measures at baseline, 3, 6, 9 and 12-month follow-up. The primary outcome will be the proportion of patients with common mental disorder psychotic experiences who have recovered by the end of treatment as measured by the official IAPT measure for recovery. ETHICS AND DISSEMINATION: The study received the following approvals: South Central-Berkshire Research Ethics Committee on 28 April 2020 (REC reference 20/SC/0135) and Health Research Authority (HRA) on 23 June 2020. An amendment was approved by the Ethics Committee on 01 October 2020 and HRA on 27 October 2020. Results will be made available to patients and the public, the funders, stakeholders in the IAPT services and other researchers. TRIAL REGISTRATION NUMBER: ISRCTN93895792.