ABSTRACT Background Antipsychotic‐induced weight gain is a distressing side effect that most often occurs within the first 3–6 months of pharmacological initiation, significantly increasing cardiometabolic risk and mortality in individuals with severe mental illness. Aims To assess the feasibility of reducing food craving and binge eating using Approach Bias Modification Training (ABMT) combined with real or sham Transcranial Direct Current Stimulation (tDCS). Method In this double‐blind, parallel‐group, two‐arm, sham‐controlled trial, adults with schizophrenia/schizoaffective disorder on stable doses of antipsychotics were randomly allocated to a total of five ABMT sessions together with either real or sham tDCS administered over 3 weeks. Assessments were made at baseline (T0), post‐treatment (T1) and at a 2‐week follow‐up (T2). Feasibility outcomes included recruitment, attendance, retention, tDCS safety, acceptability, tolerability, and blinding. Secondary outcomes were changes in food craving, binge eating, approach bias to food, body mass index, and psychological symptoms. Results Twenty‐eight participants were recruited (93% of target). Retention was high (T1 = 85.7% and T2 = 78.6%); blinding accuracy was 46.4%. Medium effect sizes favoured ‘ABMT + real tDCS’ for reducing binge eating ( d = −0.6, 95% CI −1.5, 0.3), and ‘ABMT + sham tDCS’ for reducing food cravings ( d = 0.5, 95% CI −0.4, 1.4). Within‐groups, only the ‘ABMT + real tDCS’ arm showed reduced approach bias to food and approach‐avoidance bias to food, and increased avoidance bias to food (all p < 0.05). This was followed by reduced binge eating episodes ( p < 0.05). Both groups reported frequent binge‐eating episodes (‘ABMT + tDCS’ = 43%; ‘ABMT + sham tDCS’ = 28.6%). Conclusion The initiation of antipsychotic therapy is a critical clinical window for early intervention to mitigate the long‐term metabolic and psychiatric consequences of antipsychotic‐induced weight gain. Combining ABMT + tDCS is acceptable and may help reduce binge eating in individuals on antipsychotics, with a potential synergistic effect between cognitive training and brain stimulation. A confirmatory trial is needed to assess its effectiveness and should include BED diagnosis as a stratification criterion. Trial Registration: ISRCTN Identifier: 13280178
ABSTRACT Background In high‐income countries, early intervention in psychosis (EIP) services provide treatment for first episode psychosis (FEP) as early as possible, proven to effectively improve health outcomes. These services rarely exist in low‐ and lower‐middle‐income countries (LMICs). The TRANSLATE study aims to evaluate the implementation of the EIP services using the selected indicators and to develop a clinical tool to predict the risk of Treatment‐Resistant Schizophrenia (TRS) in patients with FEP. Methods This is an observational implementation research study conducted across five sites in Pakistan and one in Sri Lanka, recruiting 670 FEP patients. The evaluation of the implementation of the service will include key clinical and process outcomes such as disengagement from services, rates of remission, the level of functioning, quality of life, psychopathology and physical health. Required data will be collected over a 1‐year period at baseline and at 1, 3, 6 and 12‐month intervals. A descriptive analysis of baseline data and service utilisation data will be conducted, stratified by site. Probabilities of disengagement, remission and process evaluation outcomes will be modelled using logistic regression models adjusting for duration of untreated psychosis, baseline symptom severity and geographical location. Selected key clinical outcomes will also be analysed and presented descriptively. To develop a clinical model prediction model for TRS, a penalised multivariable logistic regression model will be fitted to estimate the one‐year risk of TRS following an FEP diagnosis, incorporating up to 15 predictor variables identified within the study cohort. Model performance will be assessed using calibration plots and the C‐statistics for discrimination. Internal validation will be carried out by bootstrapping and the optimism‐adjusted calibration slope will be used as a global shrinkage factor to account for overfitting, with the model intercept re‐estimated to ensure calibration‐in‐the‐large. Discussion This will be the first large study that will evaluate the implementation of EIP service in a LMIC country setting. The findings of this study will inform the adoption and scaling‐up of EIP services in routine clinical practice. The clinical prediction model for the early detection of TRS will help initiate effective treatments for TRS at the earliest possible stage and potentially reduce the significant burden of disease associated with TRS. Trial Registration: ClinicalTrials.gov identifier: ISRCTN16495294.
ABSTRACT Background Psychosis is associated with high disability and societal costs. Early Intervention in Psychosis (EIP) services enhance mental health outcomes, but 15% disengage and more engage intermittently. There is no EIP‐specific therapeutic model for how Key Workers should maximize engagement. Aims To identify factors that define the Early Youth Engagement (EYE) therapeutic model for Key Workers in EIP services and affect implementation. Methods The design was a cross‐sectional qualitative thematic analysis and the final phase of an iterative mixed‐methods model development. Participants were 15 EIP clinicians who took part in the EYE pilot project and were interviewed regarding core therapeutic ingredients and implementation. Results The final EYE‐2 therapeutic model was defined by 10 sub‐themes forming three therapeutic process themes (Psychoeducation; The Motivational–Engagement relationship; An Early Systemic Approach) and an outcome theme (Achieving Meaningful Recovery Outcomes). Fourteen implementation‐related subthemes were mapped onto Normalization Process Theory constructs. They revolved largely but not exclusively around the more tangible psychoeducation component. Conclusions The study defines, for the first time, the key components of a Therapeutic Motivational–Engagement Model for Key Workers in EIP services derived from service user and carer perspectives on needs. The clarity regarding core therapeutic processes to better support engagement enables the potential to standardize and reduce complexity in the Key Worker role. This clarity is important because key workers' role confidence impacts on therapeutic relationships and outcomes. The model is well‐liked, easy to implement and supported by psychoeducational resources adapted for people from minority ethnic populations. Effectiveness and cost‐effectiveness evaluations have revealed positive cost and societal outcomes. The model is highly compatible with the EIP approach but requires organizational support, staff induction and booster training for long‐term sustainability.
ABSTRACT Introduction Individual Placement and Support (IPS) is an evidence‐based intervention to support people with severe mental ill health to engage in work or education. However, how it should be integrated into a service for young people with high levels of exposure to trauma is unclear. This project involved the development of a trauma‐informed training and supervision model to augment IPS training and the implementation of the trauma‐informed‐IPS (TI‐IPS) training and supervision model TI‐IPS into a youth community service in regional Australia. The aim of the research project was to understand how young people experienced receiving the TI‐IPS model. Methods TI‐IPS was implemented at Veritas House. Ten trauma‐exposed young people who had received TI‐IPS participated in in‐depth qualitative interviews about their experiences. Results were analysed using Reflexive Thematic Analysis. Results Young people described how important trust in the TI‐IPS worker was and how trust supported them in being motivated to look for work. They also described feeling safe interacting with their IPS worker. Young people talked about trauma with their IPS workers in a brief and contained way and experienced this as helpful and supportive. Conclusions The trauma‐informed and IPS models of care can be integrated successfully in youth services. Young people highly value the relationship with their worker when undertaking TI‐IPS.
ABSTRACT Background Childhood sexual abuse is a major developmental trauma associated with elevated risk for non‐suicidal self‐injury and suicidal behaviour in adolescence. Yet, it remains unclear whether abused adolescents show distinct motivational profiles for self‐injury and how depression and emotion dysregulation jointly relate to suicide risk. Aims To compare suicide risk, depressive severity, and emotion dysregulation across adolescents with childhood sexual abuse and self‐injury, adolescents with self‐injury without sexual abuse, and controls; to identify unique predictors of suicide risk; and to examine construct‐level symptom and motivation networks using a network analytic approach. Methods This cross‐sectional study included 120 adolescents (12–18 years; n = 40 per group) assessed with measures of suicide risk, depressive symptoms, emotion dysregulation, and self‐injury characteristics/motives. Group differences were tested using appropriate parametric/nonparametric methods. Multiple regression models evaluated predictors of suicide risk. Networks were estimated using regularized partial correlation models. Results Adolescents with childhood sexual abuse and self‐injury showed the highest overall suicide risk, hopelessness, and suicidal ideation, alongside greater depressive severity and emotion dysregulation, particularly in impulse control and limited access to regulation strategies. In regression analyses, depressive severity was the strongest correlate of overall suicide risk, while specific emotion dysregulation facets showed domain‐specific associations with hostility and negative self‐image. Network analysis identified suicidal ideation and limited access to regulation strategies as the most central nodes. Motivation networks appeared more diffuse in the CSA group, although pronounced floor effects and zero‐inflation in this subgroup's responses warrant caution in this interpretation. Conclusions Adolescents with childhood sexual abuse and self‐injury represent a high‐priority early intervention subgroup with elevated suicidality and regulatory difficulties. Rapid assessment should prioritize depressive severity, suicidal ideation, and emotion regulation strategy deficits, while trauma‐informed interventions may be required to address less explicit self‐injury motivations.
