Understanding the Mechanisms of Cognitive Remediation on Recovery in People With Early Psychosis: A Mediation and Moderation Analysis.

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 (n = 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 (Coeff = 0.203, 95% CI 0.101-0.304, P < .001). The mediated path from CR hours to cognition and cognition to functioning was small and nonsignificant (Coeff = 0.014, 95% CI = -0.010, 0.037, P = .256). Total symptoms did not moderate the path to cognition (P = .211) or the direct path to outcome (P = .896). However, negative symptoms significantly moderated the effect of cognitive improvements on functioning (P = .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.

Increasing access to CBT for psychosis patients: study protocol for a randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE3).

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.

Satisfaction with cognitive remediation therapy: its effects on implementation and outcomes using the cognitive remediation satisfaction scale.

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.

A systematic review and meta-analysis of digital interventions targeted at individuals with borderline personality disorder (BPD), emotionally unstable personality disorder (EUPD), and related symptoms.

OBJECTIVES: The present review investigates the impact of digital interventions for individuals with features of borderline personality disorder (BPD)/emotional unstable personality disorder (EUPD) as digital interventions show promise as therapeutic tools in underserved groups. BPD/EUPD features are identified as clinically relevant, yet previous reviews on the use of digital interventions fail to include subthreshold symptomatology. METHODS: Five online databases were searched for terminology in three categories: BPD/EUPD and related symptoms, mental-health interventions, and digital technology. Additionally, four relevant journals and two trial registers were searched for additional papers meeting the inclusion criteria. RESULTS: Twelve articles met all inclusion criteria. Meta-analyses revealed statistically significant differences in symptom measures between intervention and control groups at postintervention and decreases in BPD/EUPD symptomatology and well-being from pre- to postintervention. Service users' engagement, satisfaction, and acceptability of interventions were high. Results support the previous literature on the value of using digital interventions in populations with BPD/EUPD. CONCLUSION: Overall, it was identified that digital interventions show promise for successful implementation with this population.

Applying the cultural adaption framework to the Early Youth Engagement (EYE-2) approach to early intervention in psychosis.

OBJECTIVES: Disengagement from Early Intervention in Psychosis (EIP) services is pronounced in individuals from racially minoritized or diverse ethnic backgrounds, lesbian, gay, bisexual, transgender, and queer or questioning individuals, and individuals from some religious or spiritual backgrounds. The Early Youth Engagement in first episode psychosis study (EYE-2) is a cluster randomized controlled trial that tests a new engagement intervention. The current study aimed to (i) explore perspectives of service users from diverse backgrounds in relation to spirituality, ethnicity, culture and sexuality on engagement and the EYE-2 approach and (ii) use an evidence-based adaptation framework to incorporate their needs and perspectives into the EYE-2 resources and training. METHODS: This qualitative study used semi-structured interviews to explore service users' experiences and perspectives on EYE-2 approaches and resources. The study was conducted within EIP teams across three inner-city sites in England chosen to reflect diverse urban populations. Topic guides covered participant's identity, perceptions of EYE-2 resources, and experience of using mental health services. Transcribed interviews underwent thematic analysis. RESULTS: In this study, 21 service users aged 18 to 35 (M = 25.4; SD = 5.5) participated in semi-structured interviews. Seven key themes were identified across the four domains of the cultural adaptation framework: Differing cognitions and beliefs; multiple facets of culture; language as a barrier to engagement; stigma and discrimination; adaptations to EYE-2 resources; trust in therapeutic alliance; and individual differences in therapeutic preferences. CONCLUSIONS: The emergent themes highlighted a need to cater to various aspects of cultural diversity when developing EIP materials and services.

Cognitive Remediation Works But How Should We Provide It? An Adaptive Randomized Controlled Trial of Delivery Methods Using a Patient Nominated Recovery Outcome in First-Episode Participants.

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, Group + 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, P = .655; Independent vs TAU: Cohen's d: 0.07, -0.41 to 0.55 95% CI, P = .777. GAS and the cognitive score improved for Group + One-to-One vs TAU favoring CR (GAS: Cohen's d: 0.57, 0.19-0.96 95% CI, P = .003; Cognitive score: Cohens d: 0.28, 0.07-0.48 95% CI, P = .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.

Clinical insight in first episode psychosis: the role of metacognition.

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.

Dietary intake, physical activity and sedentary behaviour patterns in a sample with established psychosis and associations with mental health symptomatology.

BACKGROUND: People with psychosis experience cardiometabolic comorbidities, including metabolic syndrome, coronary heart disease and diabetes. These physical comorbidities have been linked to diet, inactivity and the effects of the illness itself, including disorganisation, impairments in global function and amotivation associated with negative symptoms of schizophrenia or co-morbid depression. METHODS: We aimed to describe the dietary intake, physical activity (PA) and sedentary behaviour patterns of a sample of patients with established psychosis participating in the Improving Physical Health and Reducing Substance Use in Severe Mental Illness (IMPaCT) randomised controlled trial, and to explore the relationship between these lifestyle factors and mental health symptomatology. RESULTS: A majority of participants had poor dietary quality, low in fruit and vegetables and high in discretionary foods. Only 29.3% completed ⩾150 min of moderate and/or vigorous activity per week and 72.2% spent ⩾6 h per day sitting. Cross-sectional associations between negative symptoms, global function, and PA and sedentary behaviour were observed. Additionally, those with more negative symptoms receiving IMPaCT therapy had fewer positive changes in PA from baseline to 12-month follow-up than those with fewer negative symptoms at baseline. CONCLUSION: These results highlight the need for the development of multidisciplinary lifestyle and exercise interventions to target eating habits, PA and sedentary behaviour, and the need for further research on how to adapt lifestyle interventions to baseline mental status. Negative symptoms in particular may reduce patient's responses to lifestyle interventions.

A qualitative process evaluation of social recovery therapy for enhancement of social recovery in first-episode psychosis (SUPEREDEN3).

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.

Crisis-focused Cognitive Behavioural Therapy for psychosis (CBTp) in acute mental health inpatient settings (the CRISIS study): protocol for a pilot randomised controlled trial.

BACKGROUND: Cognitive Behavioural Therapy for psychosis (CBTp) has an established evidence base and is recommended by clinical guidelines to be offered during the acute phases of psychosis. However, few research studies have examined the efficacy of CBTp interventions specifically adapted for the acute mental health inpatient context with most research trials being conducted with white European community populations. AIMS: The aim of this study is to conduct a pilot randomised controlled trial (RCT), which incorporates the examination of feasibility markers, of a crisis-focused CBTp intervention adapted for an ethnically diverse acute mental health inpatient population, in preparation for a large-scale randomised controlled trial. The study will examine the feasibility of undertaking the trial, the acceptability and safety of the intervention and the suitability of chosen outcome measures. This will inform the planning of a future, fully powered RCT. METHODS: A single-site, parallel-group, pilot RCT will be conducted examining the intervention. Drawing on principles of coproduction, the intervention has been adapted in partnership with key stakeholders: service users with lived experience of psychosis and of inpatient care (including those from ethnic minority backgrounds), carers, multi-disciplinary inpatient clinicians and researchers. Sixty participants with experience of psychosis and in current receipt of acute mental health inpatient care will be recruited. Participants will be randomly allocated to either the crisis-focused CBTp intervention or treatment as usual (TAU). DISCUSSION: Findings of this pilot RCT will indicate whether a larger multi-site RCT is needed to investigate the efficacy of the intervention. If the initial results demonstrate that this trial is feasible and the intervention is acceptable, it will provide evidence that a full-scale effectiveness trial may be warranted. TRIAL REGISTRATION: This trial has been prospectively registered on the ISRCTN registry ( ISRCTN59055607 ) on the 18th of February 2021.