Search results
Found 12787 matches for
Analysing the effect of early acetazolamide administration on patients with a high risk of permanent cerebrospinal fluid leakage.
In this study, we examined the role of early acetazolamide administration in reducing the risk of cerebrospinal fluid (CSF) leakage in patients with a high risk of permanent CSF leakage. In a randomised clinical trial, 57 patients with a high risk of permanent CSF leakage (rhinorrhea, otorrhea, pneumatocele or imaging-based evidence of severe skull-base fracture) were analysed. In the experimental group, acetazolamide, at 25 mg/kg/day, was started in the first 48 hours after admission. In the control group, acetazolamide was administered after the first 48 hours at the same dose administered to the patients in the experimental group. The following factors were compared between the two groups: duration of CSF leakage, duration of hospital stay, incidence of meningitis, need for surgical intervention and need for lumbar puncture (LP) and lumbar drainage (LD). All of the patients in the experimental group stopped having CSF leakage less than 14 days after the first day of admission, but 6 out of 21 patients (22%) in the control group continued having CSF leakage after 14 days of admission, which was a significant difference (P=0.01). This study showed that early acetazolamide administration can prevent CSF leakage in patients with a high risk of permanent CSF leak.
A 12-year epidemiologic study on primary spinal cord tumors in Isfahan, Iran.
BACKGROUND: Although primary spinal cord tumors (PSCTs) comprise a minority of primary central nervous system tumors, they often impose a great deal of morbidity on their victims. Few epidemiologic studies have addressed PSCTs in Iran. MATERIALS AND METHODS: We analyzed the demographic/clinical features of all primary intraspinal tumors (with a specific focus on primary intradural spinal cord tumors) identified between 1992 and 2004 in three of the major related hospitals in Isfahan, Iran. We also tracked the malignant cases until 2012. RESULTS: 102 patients with primary intraspinal tumors were found; 82 tumors were Intradural (36 intramedullary and 46 extramedullary) and 20 extradural. The principal intradural histological subtypes were nerve sheath tumor (33%), ependymoma (22%), astrocytoma (16%), and meningioma (15%). 20 (19%) of the tumors were malignant. Local pain (43%) and motor disabilities (36%) were the most common first-presenting symptoms in the patients. Male-to-female ratio was significant only in ependymoma (male:female ratio = 3.6, P < 0.05). The mean age in meningioma (57 years, standard error [SE]: 15.7) was significantly higher than other types (one-way ANOVA, P < 0.05). CONCLUSION: Our results reflect analogous frequency of distribution for PSCTs compared with most of the previous counterpart studies worldwide. The only notable exception was the comparatively fewer frequency of spinal cord meningioma in our study.
The Nuffield Early Language Intervention (NELI) programme is associated with lasting improvements in children's language and reading skills.
BACKGROUND: Oral language skills are a critical foundation for education and psychosocial development. Learning to read, in particular, depends heavily on oral language skills. The Nuffield Early Language Intervention (NELI) has been shown to improve the language of 4-5-year-old children entering school with language weaknesses in four robust trials. To date, however, there is limited evidence on the durability of the gains produced by the intervention, and some have argued that the effects of such educational interventions typically fade-out quite rapidly. METHODS: A large-scale effectiveness trial of the NELI intervention implemented under real-world conditions produced educationally meaningful improvements in children's language and reading abilities. Here, we report follow-up testing of children from this study conducted approximately 2 years after the completion of the intervention. RESULTS: At 2-year follow-up, children who had received NELI had better oral language (d = 0.22 or d = 0.33 for children with lower language ability), reading comprehension (d = 0.16 or d = 0.24 for children with lower language ability) and single-word reading skills (d = 0.16 or d = 0.22 for children with lower language ability) than the control group. CONCLUSIONS: Our data show that, although fade-out effects are common in educational research, a widely used language intervention produces durable improvements in language and reading skills, with educationally important effect sizes. These findings have important theoretical and practical implications.
Comparison of a theoretically driven cognitive therapy (the Feeling Safe Programme) with befriending for the treatment of persistent persecutory delusions: a parallel, single-blind, randomised controlled trial.
BACKGROUND: There is a large clinical need for improved treatments for patients with persecutory delusions. We aimed to test whether a new theoretically driven cognitive therapy (the Feeling Safe Programme) would lead to large reductions in persecutory delusions, above non-specific effects of therapy. We also aimed to test treatment effect mechanisms. METHODS: We did a parallel, single-blind, randomised controlled trial to test the Feeling Safe Programme against befriending with the same therapists for patients with persistent persecutory delusions in the context of non-affective psychosis diagnoses. Usual care continued throughout the duration of the trial. The trial took place in community mental health services in three UK National Health Service trusts. Participants were included if they were 16 years or older, had persecutory delusions (as defined by Freeman and Garety) for at least 3 months and held with at least 60% conviction, and had a primary diagnosis of non-affective psychosis from the referring clinical team. Patients were randomly assigned to either the Feeling Safe Programme or the befriending programme, using a permuted blocks algorithm with randomly varying block size, stratified by therapist. Trial assessors were masked to group allocation. If an allocation was unmasked then the unmasked assessor was replaced with a new masked assessor. Outcomes were assessed at 0 months, 6 months (primary endpoint), and 12 months. The primary outcome was persecutory delusion conviction, assessed within the Psychotic Symptoms Rating Scale (PSYRATS; rated 0-100%). Outcome analyses were done in the intention-to-treat population. Each intervention was provided individually over 6 months. This trial is registered with the ISRCTN registry, ISRCTN18705064. FINDINGS: From Feb 8, 2016, to July 26, 2019, 130 patients with persecutory delusions (78 [60%] men; 52 [40%] women, mean age 42 years [SD 12·1, range 17-71]; 86% White, 9% Black, 2% Indian; 2·3% Pakistani; 2% other) were recruited. 64 patients were randomly allocated to the Feeling Safe Programme and 66 patients to befriending. Compared with befriending, the Feeling Safe Programme led to significant end of treatment reductions in delusional conviction (-10·69 [95% CI -19·75 to -1·63], p=0·021, Cohen's d=-0·86) and delusion severity (PSYRATS, -2·94 [-4·58 to -1·31], p<0·0001, Cohen's d=-1·20). More adverse events occurred in the befriending group (68 unrelated adverse events reported in 20 [30%] participants) compared with the Feeling Safe group (53 unrelated adverse events reported in 16 [25%] participants). INTERPRETATION: The Feeling Safe Programme led to a significant reduction in persistent persecutory delusions compared with befriending. To our knowledge, these are the largest treatment effects seen for patients with persistent delusions. The principal limitation of our trial was the relatively small sample size when comparing two active treatments, meaning less precision in effect size estimates and lower power to detect moderate treatment differences in secondary outcomes. Further research could be done to determine whether greater effects could be possible by reducing the hypothesised delusion maintenance mechanisms further. The Feeling Safe Programme could become the recommended psychological treatment in clinical services for persecutory delusions. FUNDING: NIHR Research Professorship and NIHR Oxford Health Biomedical Research Centre.
Automated virtual reality cognitive therapy versus virtual reality mental relaxation therapy for the treatment of persistent persecutory delusions in patients with psychosis (THRIVE): a parallel-group, single-blind, randomised controlled trial in England with mediation analyses.
BACKGROUND: Persecutory delusions are a major psychiatric problem that often do not respond sufficiently to standard pharmacological or psychological treatments. We developed a new brief automated virtual reality (VR) cognitive treatment that has the potential to be used easily in clinical services. We aimed to compare VR cognitive therapy with an alternative VR therapy (mental relaxation), with an emphasis on understanding potential mechanisms of action. METHODS: THRIVE was a parallel-group, single-blind, randomised controlled trial across four UK National Health Service trusts in England. Participants were included if they were aged 16 years or older, had a persistent (at least 3 months) persecutory delusion held with at least 50% conviction, reported feeling threatened when outside with other people, and had a primary diagnosis from the referring clinical team of a non-affective psychotic disorder. We randomly assigned (1:1) patients to either THRIVE VR cognitive therapy or VR mental relaxation, using a permuted blocks algorithm with randomly varying block size, stratified by severity of delusion. Usual care continued for all participants. Each VR therapy was provided in four sessions over approximately 4 weeks, supported by an assistant psychologist or clinical psychologist. Trial assessors were masked to group allocation. Outcomes were assessed at 0, 2 (therapy mid-point), 4 (primary endpoint, end of treatment), 8, 16, and 24 weeks. The primary outcome was persecutory delusion conviction, assessed by the Psychotic Symptoms Rating Scale (PSYRATS; rated 0-100%). Outcome analyses were done in the intention-to-treat population. We assessed the treatment credibility and expectancy of the interventions and the two mechanisms (defence behaviours and safety beliefs) that the cognitive intervention was designed to target. This trial is prospectively registered with the ISRCTN registry, ISRCTN12497310. FINDINGS: From Sept 21, 2018, to May 13, 2021 (with a pause due to COVID-19 pandemic restrictions from March 16, 2020, to Sept 14, 2020), we recruited 80 participants with persistent persecutory delusions (49 [61%] men, 31 [39%] women, with a mean age of 40 years [SD 13, range 18-73], 64 [80%] White, six [8%] Black, one [1%] Indian, three [4%] Pakistani, and six [8%] other race or ethnicity). We randomly assigned 39 (49%) participants assigned to VR cognitive therapy and 41 (51%) participants to VR mental relaxation. 33 (85%) participants who were assigned to VR cognitive therapy attended all four sessions, and 35 (85%) participants assigned to VR mental relaxation attended all four sessions. We found no significant differences between the two VR interventions in participant ratings of treatment credibility (adjusted mean difference -1·55 [95% CI -3·68 to 0·58]; p=0·15) and outcome expectancy (-0·91 [-3·42 to 1·61]; p=0·47). 77 (96%) participants provided follow-up data at the primary timepoint. Compared with VR mental relaxation, VR cognitive therapy did not lead to a greater improvement in persecutory delusions (adjusted mean difference -2·16 [-12·77 to 8·44]; p=0·69). Compared with VR mental relaxation, VR cognitive therapy did not lead to a greater reduction in use of defence behaviours (adjusted mean difference -0·71 [-4·21 to 2·79]; p=0·69) or a greater increase in belief in safety (-5·89 [-16·83 to 5·05]; p=0·29). There were 17 serious adverse events unrelated to the trial (ten events in seven participants in the VR cognitive therapy group and seven events in five participants in the VR mental relaxation group). INTERPRETATION: The two VR interventions performed similarly, despite the fact that they had been designed to affect different mechanisms. Both interventions had high uptake rates and were associated with large improvements in persecutory delusions but it cannot be determined that the treatments accounted for the change. Immersive technologies hold promise for the treatment of severe mental health problems. However, their use will likely benefit from experimental research on the application of different therapeutic techniques and the effects on a range of potential mechanisms of action. FUNDING: Medical Research Council Developmental Pathway Funding Scheme and National Institute for Health and Care Research Oxford Health Biomedical Research Centre.
Exploring stigma, shame, and safety behaviours in social anxiety and paranoia amongst people diagnosed with schizophrenia.
BACKGROUND: Social anxiety and paranoia are connected by a shared suspicion framework. Based on cognitive-behavioural approaches, there is evidence for treating social anxiety and psychosis. However, mechanisms underlying the relationship between social anxiety and paranoia remain unclear. AIMS: To investigate mediators between social anxiety and paranoia in schizophrenia such as negative social appraisals (i.e. stigma or shame; Hypothesis 1), and safety behaviours (i.e. anxious avoidance or in situ safety behaviours; Hypothesis 2). METHOD: A cross-sectional study was conducted among Asian out-patients with schizophrenia (January-April 2020). Data on social anxiety, paranoia, depression, shame, stigma, anxious avoidance, and in situ behaviours were collected. Associations between social anxiety and paranoia were investigated using linear regressions. Mediation analysis via 10,000 bias-corrected bootstrap samples with 95% confidence intervals (CI) was used to test the indirect effects (ab) of mediators. RESULTS: Participants (n=113, 59.3% male) with a mean age of 44.2 years were recruited. A linear relationship between social anxiety and paranoia was found. In multiple mediation analyses (co-varying for depression), stigma and shame (Hypothesis 1) did not show any significant indirect effects with ab=.004 (95%CI=-.013, .031) and -.003 (-.023, .017), respectively, whereas in situ behaviours (Hypothesis 2) showed a significant effect with ab=.110 (.038, .201) through the social anxiety-paranoia relationship. CONCLUSIONS: Social anxiety and paranoia are positively correlated. In situ safety behaviours fully mediated the social anxiety and paranoia relationship. Targeted interventions focusing on safety behaviours could help reduce paranoia in psychosis. Symptom severity should be measured to help characterise the participants' characteristics.
Virtual reality (VR) therapy for patients with psychosis: satisfaction and side effects.
BACKGROUND: Automated virtual reality therapies are being developed to increase access to psychological interventions. We assessed the experience with one such therapy of patients diagnosed with psychosis, including satisfaction, side effects, and positive experiences of access to the technology. We tested whether side effects affected therapy. METHODS: In a clinical trial 122 patients diagnosed with psychosis completed baseline measures of psychiatric symptoms, received gameChange VR therapy, and then completed a satisfaction questionnaire, the Oxford-VR Side Effects Checklist, and outcome measures. RESULTS: 79 (65.8%) patients were very satisfied with VR therapy, 37 (30.8%) were mostly satisfied, 3 (2.5%) were indifferent/mildly dissatisfied, and 1 (0.8%) person was quite dissatisfied. The most common side effects were: difficulties concentrating because of thinking about what might be happening in the room (n = 17, 14.2%); lasting headache (n = 10, 8.3%); and the headset causing feelings of panic (n = 9, 7.4%). Side effects formed three factors: difficulties concentrating when wearing a headset, feelings of panic using VR, and worries following VR. The occurrence of side effects was not associated with number of VR sessions, therapy outcomes, or psychiatric symptoms. Difficulties concentrating in VR were associated with slightly lower satisfaction. VR therapy provision and engagement made patients feel: proud (n = 99, 81.8%); valued (n = 97, 80.2%); and optimistic (n = 96, 79.3%). CONCLUSIONS: Patients with psychosis were generally very positive towards the VR therapy, valued having the opportunity to try the technology, and experienced few adverse effects. Side effects did not significantly impact VR therapy. Patient experience of VR is likely to facilitate widespread adoption.
Catastrophic cognitions about coronavirus: the Oxford psychological investigation of coronavirus questionnaire [TOPIC-Q].
BACKGROUND: Cognitive therapies are developed on the principle that specific cognitive appraisals are key determinants in the development and maintenance of mental health disorders. It is likely that particular appraisals of the coronavirus pandemic will have explanatory power for subsequent mental health outcomes in the general public. To enable testing of this hypothesis we developed a questionnaire assessing coronavirus-related cognitions. METHODS: 12 285 participants completed online a 46-item pool of cognitions about coronavirus and six measures of different mental health problems. The sample was randomly split into derivation and validation samples. Exploratory factor analyses determined the factor structure, selection of items, and model fit in the derivation sample. Confirmatory factor analysis (CFA) then tested this model in the validation sample. Associations of the questionnaire with mental health outcomes were examined. RESULTS: The 26-item, seven-factor, Oxford Psychological Investigation of Coronavirus Questionnaire [TOPIC-Q] was developed. CFA demonstrated a good model fit (χ2 = 2108.43, df = 278, p < 0.001, comparative fit index (CFI) = 0.950, Tucker-Lewis index (TLI) = 0.942, root mean square error of approximation (RMSEA) = 0.033, standardized root mean square residual (SRMR) = 0.038). The factors were: cognitions about (1) safety and vulnerability, (2) negative long-term impact, (3) having the virus, (4) spreading the virus, (5) social judgment, (6) negative self, and (7) being targeted. The questionnaire explained significant variance in depression (45.8%), social anxiety (37.3%), agoraphobia (23.2%), paranoia (27.3%), post-traumatic stress disorder (57.1%), and panic disorder (31.4%). Cognitions about negative long-term impact had the greatest explanatory power across disorders. CONCLUSIONS: TOPIC-Q provides a method to assess appraisals of the pandemic, which is likely to prove helpful both in longitudinal studies assessing mental health outcomes and in delivery of psychological therapy.
Effects of different types of written vaccination information on COVID-19 vaccine hesitancy in the UK (OCEANS-III): a single-blind, parallel-group, randomised controlled trial.
BACKGROUND: The effectiveness of the COVID-19 vaccination programme depends on mass participation: the greater the number of people vaccinated, the less risk to the population. Concise, persuasive messaging is crucial, particularly given substantial levels of vaccine hesitancy in the UK. Our aim was to test which types of written information about COVID-19 vaccination, in addition to a statement of efficacy and safety, might increase vaccine acceptance. METHODS: For this single-blind, parallel-group, randomised controlled trial, we aimed to recruit 15 000 adults in the UK, who were quota sampled to be representative. Participants were randomly assigned equally across ten information conditions stratified by level of vaccine acceptance (willing, doubtful, or strongly hesitant). The control information condition comprised the safety and effectiveness statement taken from the UK National Health Service website; the remaining conditions addressed collective benefit, personal benefit, seriousness of the pandemic, and safety concerns. After online provision of vaccination information, participants completed the Oxford COVID-19 Vaccine Hesitancy Scale (outcome measure; score range 7-35) and the Oxford Vaccine Confidence and Complacency Scale (mediation measure). The primary outcome was willingness to be vaccinated. Participants were analysed in the groups they were allocated. p values were adjusted for multiple comparisons. The study was registered with ISRCTN, ISRCTN37254291. FINDINGS: From Jan 19 to Feb 5, 2021, 15 014 adults were recruited. Vaccine hesitancy had reduced from 26·9% the previous year to 16·9%, so recruitment was extended to Feb 18 to recruit 3841 additional vaccine-hesitant adults. 12 463 (66·1%) participants were classified as willing, 2932 (15·6%) as doubtful, and 3460 (18·4%) as strongly hesitant (ie, report that they will avoid being vaccinated for as long as possible or will never get vaccinated). Information conditions did not alter COVID-19 vaccine hesitancy in those willing or doubtful (adjusted p values >0·70). In those strongly hesitant, COVID-19 vaccine hesitancy was reduced, in comparison to the control condition, by personal benefit information (mean difference -1·49, 95% CI -2·16 to -0·82; adjusted p=0·0015), directly addressing safety concerns about speed of development (-0·91, -1·58 to -0·23; adjusted p=0·0261), and a combination of all information (-0·86, -1·53 to -0·18; adjusted p=0·0313). In those strongly hesitant, provision of personal benefit information reduced hesitancy to a greater extent than provision of information on the collective benefit of not personally getting ill (-0·97, 95% CI -1·64 to -0·30; adjusted p=0·0165) or the collective benefit of not transmitting the virus (-1·01, -1·68 to -0·35; adjusted p=0·0150). Ethnicity and gender were found to moderate information condition outcomes. INTERPRETATION: In the approximately 10% of the population who are strongly hesitant about COVID-19 vaccines, provision of information on personal benefit reduces hesitancy to a greater extent than information on collective benefits. Where perception of risk from vaccines is most salient, decision making becomes centred on the personal. As such, messaging that stresses the counterbalancing personal benefits is likely to prove most effective. The messaging from this study could be used in public health communications. Going forwards, the study highlights the need for future health campaigns to engage with the public on the terrain that is most salient to them. FUNDING: National Institute for Health Research (NIHR) Oxford Biomedical Research Centre and NIHR Oxford Health Biomedical Research Centre.
Coronavirus conspiracy beliefs, mistrust, and compliance with government guidelines in England.
BACKGROUND: An invisible threat has visibly altered the world. Governments and key institutions have had to implement decisive responses to the danger posed by the coronavirus pandemic. Imposed change will increase the likelihood that alternative explanations take hold. In a proportion of the general population there may be strong scepticism, fear of being misled, and false conspiracy theories. Our objectives were to estimate the prevalence of conspiracy thinking about the pandemic and test associations with reduced adherence to government guidelines. METHODS: A non-probability online survey with 2501 adults in England, quota sampled to match the population for age, gender, income, and region. RESULTS: Approximately 50% of this population showed little evidence of conspiracy thinking, 25% showed a degree of endorsement, 15% showed a consistent pattern of endorsement, and 10% had very high levels of endorsement. Higher levels of coronavirus conspiracy thinking were associated with less adherence to all government guidelines and less willingness to take diagnostic or antibody tests or to be vaccinated. Such ideas were also associated with paranoia, general vaccination conspiracy beliefs, climate change conspiracy belief, a conspiracy mentality, and distrust in institutions and professions. Holding coronavirus conspiracy beliefs was also associated with being more likely to share opinions. CONCLUSIONS: In England there is appreciable endorsement of conspiracy beliefs about coronavirus. Such ideas do not appear confined to the fringes. The conspiracy beliefs connect to other forms of mistrust and are associated with less compliance with government guidelines and greater unwillingness to take up future tests and treatment.
"It seems impossible that it's been made so quickly": a qualitative investigation of concerns about the speed of COVID-19 vaccine development and how these may be overcome.
The speed of COVID-19 vaccine development has been identified as a central concern contributing to hesitancy in acceptance. We conducted qualitative interviews to gain a greater understanding into these concerns and to identify what might address them. Twelve qualitative interviews were conducted with participants identifying as hesitant for COVID-19 vaccination and reporting concern about the speed of vaccine development. Interpretative Phenomenological Analysis (IPA) was used. Concerns about speed comprised the linked themes of i) difficulty understanding the pace, and, ii) worry about the implications for vaccine safety. Uncertainties concerning the pandemic led to a notable desire for credible and understandable information regarding the vaccines, which many participants felt was not available. Four routes to resolving uncertainty about whether to be vaccinated were identified. First, waiting for more information about the vaccines, such as about their contents and impact on transmission. Second, a growing perception that the vaccines must be safe given the large numbers already vaccinated. Third, viewing the vaccines as necessary - even if unappealing - for ending the pandemic. Finally, a feeling that there would be no choice but to have a vaccine. Examples of what might reduce hesitancy were given, including interviews with vaccine developers and knowing others of similar age having safely been vaccinated. The pace of development broke expectations set earlier in the pandemic. This was interpreted negatively due to a perceived lack of credible information. Most participants could envisage ways their concerns could be resolved, enough for them to have a vaccine.
Automated Virtual Reality Cognitive Therapy for People With Psychosis: Protocol for a Qualitative Investigation Using Peer Research Methods.
BACKGROUND: Many people with psychosis experience difficulties in everyday social situations. Anxiety can make life challenging, leading to withdrawal. Cognitive therapy, using active in vivo learning, enables people to overcome fears. These treatments are not readily available to people with psychosis. Automated virtual reality (VR) therapy is a potential route to increase accessibility. The gameChange automated VR cognitive therapy is designed to help people overcome anxious avoidance and build confidence in everyday social situations. A virtual coach guides the person through the treatment. Understanding user experience is key to facilitating future implementation. Peer research methods, in which people with lived experience of the issues being studied are involved in collecting and analyzing data, may be useful in developing this understanding. This encourages researchers to draw on their lived experience to explore participant perspectives and co-create knowledge. OBJECTIVE: The primary objective is to use a peer research approach to explore the participant experience of a novel automated VR therapy for anxious social avoidance. This includes understanding (1) the experience of anxious social avoidance in people with psychosis, (2) the experience of the gameChange automated VR cognitive therapy, and (3) any potential impact of the therapy in people's lives. This will inform future implementation strategies. The secondary objective is to explore how peer research can be used to co-create knowledge. METHODS: Semistructured interviews will be conducted with approximately 25 people with psychosis participating in the gameChange trial (ISRCTN17308399). Participants will be recruited from the five trial centers based in National Health Service mental health trusts across England. Interviews will be conducted by two researchers. One is a peer researcher with similar lived experience to the trial participants. The other has lived experiences of mental health issues that do not directly overlap with those of the trial participants. Interview questions will focus on an individual's experience of anxious social avoidance, experiences of participating in the gameChange VR therapy, and any changes or impact following therapy. The interview schedule was developed in collaboration with the gameChange Lived Experience Advisory Panel (LEAP), comprising 10 project advisors with lived experience of psychosis. Interpretative phenomenological analysis and template analysis will be used to explore individual accounts. The LEAP will contribute to the analysis. RESULTS: Data collection will be conducted from April to September 2021, and analysis will be conducted from June to October 2021. As of September 28, 2021, 20 participants had been interviewed, and coding is underway. CONCLUSIONS: The study, employing a peer research approach, may provide a unique insight into the experiences of anxious social avoidance in people with psychosis and its treatment using automated VR therapy. This will inform potential future implementation of VR automated therapies in mental health services. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31742.
Virtual Reality Cognitive Therapy in Inpatient Psychiatric Wards: Protocol for a Qualitative Investigation of Staff and Patient Views Across Multiple National Health Service Sites.
BACKGROUND: Patients in psychiatric wards typically have very limited access to individual psychological therapy. Inpatients often have significant time available, and an important transition back to everyday life to prepare for-but historically, there have been few trained therapists available on wards for the delivery of evidence-based therapy. Automated virtual reality (VR) therapy may be one route to increase the provision of powerful psychological treatments in psychiatric hospitals. The gameChange automated VR cognitive therapy is targeted at helping patients overcome anxious avoidance and re-engage in everyday situations (such as walking down the street, taking a bus, or going to a shop). This treatment target may fit well for many patients preparing for discharge. However, little is known about how VR therapy may be viewed in this setting. OBJECTIVE: The objectives of the study are to explore psychiatric hospital staff and patients' initial expectations of VR therapy, to gather patient and staff views of an automated VR cognitive therapy (gameChange) after briefly experiencing it, and to identify potential differences across National Health Service (NHS) mental health trusts for implementation. Guided by an implementation framework, the knowledge gained from this study will be used to assess the feasibility of VR treatment adoption into psychiatric hospitals. METHODS: Focus groups will be conducted with NHS staff and patients in acute psychiatric wards at 5 NHS mental health trusts across England. Staff and patients will be interviewed in separate groups. Individual interviews will also be conducted when preferred by a participant. Within each of the 5 trusts, 1 to 2 wards will be visited. A total of 8-15 staff and patients per ward will be recruited, with a minimum total of 50 staff and patients recruited across all sites. Focus group questions have been derived from the nonadoption, abandonment, and challenges to the scale-up, spread, and sustainability (NASSS) framework. Focus groups will discuss expectations of VR therapy before participants are given the opportunity to briefly try the gameChange VR therapy. Questions will then focus on opinions about the therapy and investigate feasibility of adoption, with particular consideration given to site specific issues. A thematic analysis will be conducted. RESULTS: As of May 15, 2020, 1 patient focus group has been conducted. CONCLUSIONS: The study will provide unique insight from patients and staff into the potential for implementing automated VR therapy in psychiatric wards. Perspectives will be captured both on the use of immersive technology hardware and therapy-specific issues in such settings. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20300.
Estimating the Economic Value of Automated Virtual Reality Cognitive Therapy for Treating Agoraphobic Avoidance in Patients With Psychosis: Findings From the gameChange Randomized Controlled Clinical Trial.
BACKGROUND: An automated virtual reality cognitive therapy (gameChange) has demonstrated its effectiveness to treat agoraphobia in patients with psychosis, especially for high or severe anxious avoidance. Its economic value to the health care system is not yet established. OBJECTIVE: In this study, we aimed to estimate the potential economic value of gameChange for the UK National Health Service (NHS) and establish the maximum cost-effective price per patient. METHODS: Using data from a randomized controlled trial with 346 patients with psychosis (ISRCTN17308399), we estimated differences in health-related quality of life, health and social care costs, and wider societal costs for patients receiving virtual reality therapy in addition to treatment as usual compared with treatment as usual alone. The maximum cost-effective prices of gameChange were calculated based on UK cost-effectiveness thresholds. The sensitivity of the results to analytical assumptions was tested. RESULTS: Patients allocated to gameChange reported higher quality-adjusted life years (0.008 QALYs, 95% CI -0.010 to 0.026) and lower NHS and social care costs (-£105, 95% CI -£1135 to £924) compared with treatment as usual (£1=US $1.28); however, these differences were not statistically significant. gameChange was estimated to be worth up to £341 per patient from an NHS and social care (NHS and personal social services) perspective or £1967 per patient from a wider societal perspective. In patients with high or severe anxious avoidance, maximum cost-effective prices rose to £877 and £3073 per patient from an NHS and personal social services perspective and societal perspective, respectively. CONCLUSIONS: gameChange is a promising, cost-effective intervention for the UK NHS and is particularly valuable for patients with high or severe anxious avoidance. This presents an opportunity to expand cost-effective psychological treatment coverage for a population with significant health needs. TRIAL REGISTRATION: ISRCTN Registry ISRCTN17308399; https://www.isrctn.com/ISRCTN17308399. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-031606.
A Safe Place to Learn: Peer Research Qualitative Investigation of gameChange Virtual Reality Therapy.
BACKGROUND: Automated virtual reality (VR) therapy has the potential to substantially increase access to evidence-based psychological treatments. The results of a multicenter randomized controlled trial showed that gameChange VR cognitive therapy reduces the agoraphobic avoidance of people diagnosed with psychosis, especially for those with severe avoidance. OBJECTIVE: We set out to use a peer research approach to explore participants' experiences with gameChange VR therapy. This in-depth experiential exploration of user experience may inform the implementation in clinical services and future VR therapy development. METHODS: Peer-led semistructured remote interviews were conducted with 20 people with a diagnosis of psychosis who had received gameChange as part of the clinical trial (ISRCTN17308399). Data were analyzed using interpretative phenomenological analysis and template analyses. A multiperspectival approach was taken to explore subgroups. Credibility checks were conducted with the study Lived Experience Advisory Panel. RESULTS: Participants reported the substantial impact of anxious avoidance on their lives before the VR intervention, leaving some of them housebound and isolated. Those who were struggling the most with agoraphobic avoidance expressed the most appreciation for, and gains from, the gameChange therapy. The VR scenarios provided "a place to practise." Immersion within the VR scenarios triggered anxiety, yet participants were able to observe this and respond in different ways than usual. The "security of knowing the VR scenarios are not real" created a safe place to learn about fears. The "balance of safety and anxiety" could be calibrated to the individual. The new learning made in VR was "taken into the real world" through practice and distilling key messages with support from the delivery staff member. CONCLUSIONS: Automated VR can provide a therapeutic simulation that allows people diagnosed with psychosis to learn and embed new ways of responding to the situations that challenge them. An important process in anxiety reduction is enabling the presentation of stimuli that induce the original anxious fears yet allow for learning of safety. In gameChange, the interaction of anxiety and safety could be calibrated to provide a safe place to learn about fears and build confidence. This navigation of therapeutic learning can be successfully managed by patients themselves in an automated therapy, with staff support, that provides users with personalized control. The clinical improvements for people with severe anxious avoidance, the positive experience of VR, and the maintenance of a sense of control are likely to facilitate implementation.