Virtual Reality Therapy for the Negative Symptoms of Schizophrenia (V-NeST): A pilot randomised feasibility trial.

BACKGROUND: Negative symptoms are typically observed in people with schizophrenia and indicate a loss or reduction of normal function (e.g. reduced motivation and affect display). Despite obstructing people's recovery, intervention development has received limited attention. This study tests the feasibility and acceptability of a novel Virtual Reality Supported Therapy for the Negative Symptoms of Schizophrenia (V-NeST). METHOD: A single (rater) blind randomised study with two conditions; V-NeST plus treatment as-usual (TAU) vs. TAU alone, recruiting people with schizophrenia experiencing debilitating negative symptoms. Assessment was at baseline and 3-month post-randomisation. The pre-specified primary outcome was participants' goal attainment, secondary outcomes were negative symptoms and functioning. The study assessed feasibility and acceptability parameters including recruitment, eligibility, treatment adherence and retention. Acceptability was also evaluated qualitatively using a post-therapy feedback interview. Explorative therapy effect on outcomes was estimated. RESULTS: The study recruited to its pre-specified target of 30 participants (15 randomised to V-Nest). Two participants in each trial arm disengaged and did not complete the study. Therapy engagement for those randomised to V-NeST was appropriate and research procedures were feasible. The experience with therapy and VR was described as positive and useful. Preliminary analysis suggested the therapy may have a large effect on participants goals and a possible effect on negative symptoms. CONCLUSION: V-NeST is a feasible and acceptable intervention. This therapy has the potential to support people with schizophrenia achieving their recovery goals and may reduce negative symptoms. The efficacy results need to be evaluated in an appropriately powered efficacy study.

Therapist-supported online cognitive therapy for post-traumatic stress disorder (PTSD) in young people: protocol for an early-stage, parallel-group, randomised controlled study (OPTYC trial).

INTRODUCTION: Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition that affects a significant minority of young people exposed to traumatic events. Effective face-to-face psychological treatments for PTSD exist. However, most young people with PTSD do not receive evidence-based treatment. Remotely delivered digital interventions have potential to significantly improve treatment accessibility. Digital interventions have been successfully employed for young people with depression and anxiety, and for adults with PTSD. However, digital interventions to treat PTSD in young people have not been evaluated. The Online PTSD Treatment for Young People & Carers (OPTYC) trial will evaluate the feasibility, acceptability and initial indications of clinical efficacy of a novel internet-delivered Cognitive Therapy for treatment of PTSD in young people (iCT-PTSD-YP). METHODS AND ANALYSIS: This protocol describes a two-arm, parallel-groups, single-blind (outcome assessor), early-stage randomised controlled trial, comparing iCT-PTSD-YP with a waiting list (WL) comparator. N=34 adolescents (12-17 years old), whose primary problem is PTSD after exposure to a single traumatic event, will be recruited from 14 NHS Child and Adolescent Mental Health Services in London and southeast England, from secondary schools and primary care in the same region, or via self-referral from anywhere in the UK using the study website. Individual patient-level randomisation will allocate participants in a 1:1 ratio, randomised using minimisation according to sex and baseline symptom severity. The primary study outcomes are data on feasibility and acceptability, including recruitment, adherence, retention and adverse events (AEs). The primary clinical outcome is PTSD diagnosis 16 weeks post-randomisation. Secondary clinical outcomes include continuous measures of PTSD, anxiety and depression symptoms. Regression analyses will provide preliminary estimates of the effect of iCT-PTSD-YP on PTSD diagnosis, symptoms of PTSD, anxiety and depression relative to WL. Process-outcome evaluation will consider which mechanisms mediate recovery. Qualitative interviews with young people, families and therapists will evaluate acceptability. ETHICS AND DISSEMINATION: The study was approved by a UK Health Research Authority Research Ethics Committee (19/LO/1354). For participants aged under 16, informed consent will be provided by carers and the young person will be asked for their assent; participants aged 16 years or older can provide informed consent without their parent or caregiver's involvement. Findings will be disseminated broadly to participants, healthcare professionals, the public and other relevant groups. Study findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN16876240.

Targeting maladaptive overcontrol with radically open dialectical behaviour therapy in a day programme for adolescents with restrictive eating disorders: an uncontrolled case series.

BACKGROUND: Radically Open Dialectical Behaviour Therapy (RO-DBT) was developed to target maladaptive overcontrol, a proposed core difficulty of restrictive eating disorders. RO-DBT is now the main group treatment model at the Intensive day Treatment Programme (ITP), Maudsley Hospital. This ITP case series aimed to investigate whether overcontrol is associated with restrictive eating disorder symptoms in adolescents and to evaluate ITP outcomes since RO-DBT skills classes were introduced. METHOD: Self-report measures of eating disorder symptoms and temperament, personality and social characteristics linked to overcontrol were collected at assessment and discharge from ITP for all consecutive adolescents who attended between February 2015 and January 2019 (N = 131). Weight change, global outcomes and treatment needs post-ITP were also recorded. RESULTS: Eating disorder symptoms at assessment were significantly correlated with overcontrol factors, including social connectedness (r = -.67), reward responsivity (r = -.54), and cognitive inflexibility (r = .52). Adolescents stayed in ITP on average 13.40 weeks. 70.8% had a Good-Intermediate outcome on Morgan-Russell scale. 4.6% did not respond and were referred to inpatient treatment from ITP. Significant improvements in drive for thinness (d = .33), depressive mood (d = .41), social connectedness (d = .48), and emotional expressiveness (d = .97) were reported at discharge. No changes were observed in perfectionism or negative temperament. CONCLUSIONS: This study offers preliminary evidence that eating disorder symptoms are associated with overcontrol factors in adolescence and that they can improve with RO-DBT informed day programme treatment. RO-DBT is a promising treatment that offers a new way of conceptualising treatment targets and recovery for adolescent restrictive eating disorders.

Vibrational Spectroscopy: A Valuable Screening and Diagnostic Tool for Obstetric Disorders?

Preeclampsia (PE) is a common obstetric disorder typically affecting 2-8% of all pregnancies and can lead to several adverse obstetric outcomes for both mother and fetus with the greatest burden of severe outcomes in low middle-income countries (LMICs), therefore, screening for PE is vital. Globally, screening is based on maternal characteristics and medical history which are nonspecific for the disorder. In 2004, the World Health Organization acknowledged that no clinically useful test was able to predict the onset of PE, which prompted a universal search for alternative means of screening. Over the past decade or so, emphasis has been placed on the use of maternal characteristics in conjunction with biomarkers of disease combined into predictive algorithms, however these are yet to transition into the clinic and are cost prohibitive in LMICs. As a result, the screening paradigm for PE remains unchanged. It is evident that novel approaches are needed. Vibrational spectroscopy, specifically Raman spectroscopy and Fourier-transform infrared spectroscopy (FTIR), could provide better alternatives suited for implementation in low resource settings as no specialized reagents are required for conventional approaches and there is a drive to portable platforms usable in both urban and rual community settings. These techniques are based on light scattering and absorption, respectively, allowing detailed molecular analysis of samples to produce a unique molecular fingerprint of diseased states. The specificity of vibrational spectroscopy might well make it suited for application in other obstetric disorders such as gestational diabetes mellitus and obstetric cholestasis. In this review, we summarize current approaches sought as alternatives to current screening methodologies and introduce how vibrational spectroscopy could offer superior screening and diagnostic paradigms in obstetric care. Additionally, we propose a real benefit of such tools in LMICs where limited resources battle the higher prevalence of obstetric disorders.

Exploring patients' and carers' views about the clinical use of ketamine to inform policy and practical decisions: mixed-methods study.

BACKGROUND: Only one-third of patients with major depressive disorder achieve remission. One new and promising treatment, ketamine, may prove challenging to implement because of its abuse potential. Although clinicians' views have been sought, we need patients' views before large scale roll-out is considered. AIMS: To explore patients' and carers' views to inform policy and practical decisions about the clinical use of ketamine. METHOD: We carried out a mixed-methods study using data from 44 participants in 21 focus groups in three sessions and an online survey with patients, carers and advocates during a consultation day. Focus groups explored participant's views about ketamine as a form of treatment and the best way for ketamine to be prescribed and monitored. The qualitative data were analysed by two patient-researchers using an exploratory framework analysis and was supplemented by a survey. RESULTS: The ten themes generated were monitoring, information, effect on daily life, side-effects, recreational use, effectiveness, appropriate support, cost, stigma and therapy. Participants wanted better evidence on the safety of ketamine after long-term use and felt that monitoring was required. Collecting this information would provide evidence for ketamine's safe use and administration. There were, however, concerns about the misuse of this information. Practical issues of access were important: repeated travelling to clinics and a lack of sufficiently informed medical staff were key barriers. CONCLUSIONS: Clinicians have some similar and some different views to those of patients, carers and advocates, which need to be considered in any future roll-out of ketamine. DECLARATION OF INTEREST: R.M. has had UK National Institute for Health Research grant funding to study ketamine, is participating in trials of esketamine, runs a clinic that provides ketamine treatment, and has consulted for Johnson & Johnson and Eleusis.

Digital Exclusion Among Mental Health Service Users: Qualitative Investigation.

BACKGROUND: Access to internet-enabled technology and Web-based services has grown exponentially in recent decades. This growth potentially excludes some communities and individuals with mental health difficulties, who face a heightened risk of digital exclusion. However, it is unclear what factors may contribute to digital exclusion in this population. OBJECTIVE: To explore in detail the problems of digital exclusion in mental health service users and potential facilitators to overcome them. METHODS: We conducted semistructured interviews with 20 mental health service users who were deemed digitally excluded. We recruited the participants from a large secondary mental health provider in South London, United Kingdom. We employed thematic analysis to identify themes and subthemes relating to historical and extant reasons for digital exclusion and methods of overcoming it. RESULTS: There were three major themes that appeared to maintain digital exclusion: a perceived lack of knowledge, being unable to access the necessary technology and services owing to personal circumstances, and the barriers presented by mental health difficulties. Specific facilitators for overcoming digital exclusion included intrinsic motivation and a personalized learning format that reflects the individual's unique needs and preferences. CONCLUSIONS: Multiple factors contribute to digital exclusion among mental health service users, including material deprivation and mental health difficulties. This means that efforts to overcome digital exclusion must address the multiple deprivations individuals may face in the offline world in addition to their individual mental health needs. Additional facilitators include fostering an intrinsic motivation to overcome digital exclusion and providing a personalized learning format tailored to the individual's knowledge gaps and preferred learning style.