BACKGROUND: Face-to-face hearing voices peer support groups (HVGs), a survivor-led initiative that enables individuals who hear voices to engage with the support of peers, have a long-standing history in community settings. HVGs are premised on the notion that forming authentic, mutual relationships enables the exploration of one's voice hearing experiences and, in turn, reduces subjective distress. As such, group cohesion is assumed to be a central mechanism of change in HVGs. The rise of digital mental health support, coupled with the COVID-19 pandemic, has resulted in many HVGs adapting to online delivery. However, to date no studies have examined the implementation of these online groups and the adaptations necessary to foster cohesion. OBJECTIVE: This study aims to understand the experience of group cohesion among HVG facilitators in online groups compared with face-to-face groups. Specifically, we examined the ways in which the medium through which groups run (online or face-to-face) impacts group cohesion and how facilitators adapted HVGs to foster group cohesion online. METHODS: Semistructured qualitative interviews were conducted with 11 facilitators with varied experience of facilitating online and face-to-face HVGs. Data were analyzed using reflexive thematic analysis. RESULTS: The findings are organized into 3 themes and associated subthemes: nonverbal challenges to cohesion (lack of differentiation, transitional space, inability to see the whole picture, and expressions of empathy); discursive challenges to cohesion (topic-based conversation and depth of disclosure); and necessary adaptations for online groups (fostering shared experience and using the unique context to demonstrate investment in others). Despite challenges in both the setting and content of online groups, facilitators felt that group cohesion was still possible to achieve online but that it had to be facilitated intentionally. CONCLUSIONS: This study is the first to specifically investigate group cohesion in online HVGs. Participants noted numerous challenges to group cohesion when adapting groups to run online, including the unnaturally linear narrative flow of dialogue in online settings; lack of transitional spaces, and associated small talk before and after the session; ease of disengagement online; inhibited sharing; and absence of shared physical presence online. Although these challenges were significant, facilitators nevertheless emphasized that the benefits provided by the accessibility of online groups outweighed these challenges. Necessary adaptations for cultivating group cohesion online are outlined and include capitalizing on moments of humor and spontaneity, using group activities, encouraging information sharing between participants using the chat and screen-sharing features, and using objects from participants' environments to gain deeper insight into their subjective worlds.
AIMS: Many patients diagnosed with esophageal cancer have dysphagia from their primary tumor and de novo metastatic disease. The purpose of this study was to test the safety and efficacy of nivolumab given concurrently with hypofractionated chemoradiotherapy to patients with oligometastatic and obstructing esophageal tumors. METHODS: Patients were enrolled in a planned single-arm, phase 2 clinical trial. Eligible participants had previously untreated oligometastatic (≤5 metastases on fludeoxyglucose-18 positron emission tomography scan outside the primary tumor radiotherapy field) esophageal or gastroesophageal carcinoma, dysphagia, and Eastern Cooperative Oncology Group performance status 0-1. Treatment was with 2 weeks of concurrent hypofractionated radiotherapy (30 Gy/10#) to the primary tumor, weekly carboplatin AUC2, weekly paclitaxel 50 mg/m2, and q2weekly nivolumab 240 mg, followed by nivolumab 480 mg continuing q4weekly until disease progression or 24 months total. A single metastasis was treated with stereotactic radiotherapy (SBRT) (24 Gy/3#) in week 7. RESULTS: Five patients were recruited before trial closure to new participants for logistical reasons. Existing participants continued treatment per protocol as a pilot study at one center. All five patients completed chemoradioimmunotherapy and SBRT. All patients derived an improvement in their dysphagia. Two patients completed 24 months of nivolumab without disease progression. Grade 3 adverse events (AEs) occurred in 3 patients, however, there were no grade 4 AEs, AEs due to SBRT, or AEs of special interest as defined by the protocol. CONCLUSION: Pilot results from five patients at one center found that treatment was well tolerated and effective for dysphagia relief. The efficacy of hypofractionated chemoradiotherapy with concurrent checkpoint inhibition should be tested in a multicentre study.
OBJECTIVES: Hearing voices is associated with public stigma and this can influence readiness to identify as a voice hearer (VH) and psychological wellbeing. In this study, we investigated the relationships between a VH social identity, the integration of that identity with other important social identities and wellbeing. DESIGN: Cross-sectional study, with a subset of longitudinal data across three time points. METHODS: People who self-identified as voice hearers completed questionnaires (VH social identity, identity integration, wellbeing and perceptions of in-group and out-group empathy) at three time points, spaced at 3-monthly intervals. The final sample comprised 182 participants at T1, 91 at T2 and 75 at T3. Hierarchical linear multiple regression analyses were used to test all hypotheses. RESULTS: The integration of a VH social identity was strongly associated with better psychological wellbeing at T1. Identity integration was also associated with static wellbeing scores at 6 months. Effects on wellbeing were not accounted for by either severity of voice-hearing or paranoia. Whilst perceptions of in-group empathy were associated with VH social identification, perceptions of outgroup empathy were important for identity integration. CONCLUSIONS: Integrating a VH social identity with other important identities into a coherent sense of self is important for wellbeing in voice hearers; perceived in-group and outgroup empathy are important in this process.
BACKGROUND: There is wide variation in the problems prioritised by people with psychosis in cognitive behavioural therapy for psychosis (CBTp). While research trials and mental health services have often prioritised reduction in psychiatric symptoms, service users may prioritise issues not directly related to psychosis. This discrepancy suggests potential challenges in treatment outcome research. AIMS: The present study aimed to examine the types of problems that were recorded on problem lists generated in CBTp trials. METHOD: Problem and goals lists for 110 participants were extracted from CBTp therapy notes. Subsequently, problems were coded into 23 distinct categories by pooling together items that appeared thematically related. RESULTS: More than half of participants (59.62%) listed a non-psychosis-related priority problem, and 22.12% did not list any psychosis related problems. Chi-square tests indicated there was no difference between participants from early intervention (EI) and other services in terms of priority problem (χ2 = 0.06, p = .804), but that those from EI were more likely to include any psychosis-related problems in their lists (χ2 = 6.66, p = .010). CONCLUSIONS: The findings of this study suggest that psychiatric symptom reduction is not the primary goal of CBTp for most service users, particularly those who are not under the care of EI services. The implications for future research and clinical practice are discussed.
Cognitive Behavioral Therapy , Mental Health Services , Psychotic Disorders , Humans , Psychotic Disorders/psychology
BACKGROUND: Agoraphobic avoidance of everyday situations is a common feature in many mental health disorders. Avoidance can be due to a variety of fears, including concerns about negative social evaluation, panicking, and harm from others. The result is inactivity and isolation. Behavioural avoidance tasks (BATs) provide an objective assessment of avoidance and in situ anxiety but are challenging to administer and lack standardisation. Our aim was to draw on the principles of BATs to develop a self-report measure of agoraphobia symptoms. METHOD: The scale was developed with 194 patients with agoraphobia in the context of psychosis, 427 individuals in the general population with high levels of agoraphobia, and 1094 individuals with low levels of agoraphobia. Factor analysis, item response theory, and receiver operating characteristic analyses were used. Validity was assessed against a BAT, actigraphy data, and an existing agoraphobia measure. Test-retest reliability was assessed with 264 participants. RESULTS: An eight-item questionnaire with avoidance and distress response scales was developed. The avoidance and distress scales each had an excellent model fit and reliably assessed agoraphobic symptoms across the severity spectrum. All items were highly discriminative (avoidance: a = 1.24-5.43; distress: a = 1.60-5.48), indicating that small increases in agoraphobic symptoms led to a high probability of item endorsement. The scale demonstrated good internal reliability, test-retest reliability, and validity. CONCLUSIONS: The Oxford Agoraphobic Avoidance Scale has excellent psychometric properties. Clinical cut-offs and score ranges are provided. This precise assessment tool may help focus attention on the clinically important problem of agoraphobic avoidance.
Agoraphobia , Panic Disorder , Humans , Reproducibility of Results , Agoraphobia/diagnosis , Agoraphobia/epidemiology , Agoraphobia/psychology , Anxiety , Anxiety Disorders , Fear , Panic Disorder/epidemiology
Background: Onset of psychosis commonly occurs in adolescence, and long-term prognosis can be poor. There is growing evidence, largely from adult cohorts, that Cognitive Behavioural Therapy for Psychosis (CBTp) and Family Interventions (FI) can play a role in managing symptoms and difficulties associated with psychosis. However, adolescents have distinct developmental needs that likely impact their engagement and response to talking therapy. There is limited guidance on adapting CBTp to meet the clinical needs of under-eighteens experiencing psychosis. Method: This educational clinical practice article details learnings from therapists and supervisors working with young people (aged 14-18 years) with psychosis during the Managing Adolescent first-episode Psychosis: a feasibility Study (MAPS) randomised clinical treatment trial, supplemented by findings from nested qualitative interviews with young people receiving CBTp. Results: Suggested are given for tailoring CBTp assessment, formulation and interventions to meet the developmental and clinical needs of adolescents with psychosis. Developmentally appropriate techniques and resources described. Conclusions: Early indications from MAPS study indicate this developmentally tailored approach is an acceptable, safe and helpful treatment for young people with psychosis. Further research is needed to develop empirically grounded and evaluated CBTp for adolescents.
OBJECTIVE: To evaluate the relationship between hysterectomy with and without ovarian conservation and the onset of ovarian failure using anti-müllerian hormone (AMH) levels and imputed final menstrual period (FMP). METHODS: A total of 1,428 women with an observed FMP and 232 women who underwent hysterectomy (159 with bilateral salpingo-oophorectomy [BSO], 13 with one ovary conserved, and 60 with both ovaries conserved) and who had serial AMH measurements were included from SWAN (The Study of Women's Health Across the Nation), a multi-ethnic, multi-site, community-based study. Anti-müllerian hormone levels were sampled annually with at least one presurgery or pre-FMP measurement at least one postsurgery or post-FMP measurement. Surgery-related differences in patterns of AMH levels with respect to surgery date or FMP were estimated using piecewise linear mixed modeling; differences in age at first undetectable AMH level were estimated using survival analyses. RESULTS: Patients with conservation of one or both ovaries or natural menopause demonstrated similar patterns of decline in AMH levels when anchored to surgery or FMP. Patients with hysterectomy (all types) had a later counterfactual FMP (52.9±0.2 SEM) compared with the observed FMP in those with natural menopause (52.1±0.1 years, P =.002). Those undergoing BSO had an immediate reduction in AMH level to undetectable after surgery. CONCLUSION: Hysterectomy does not lead to a more rapid decline in AMH levels postoperatively compared with natural menopause. Patients undergoing BSO have a rapid loss of AMH, consistent with complete removal of the ovaries. These data suggest that hysterectomy as currently performed does not compromise ovarian reserve.
Anti-Mullerian Hormone , Menopause , Humans , Female , Ovariectomy , Hysterectomy/adverse effects , Hysterectomy/methods , Ovary
Adsorptive bubble separation techniques such as foam fractionation have recently been applied for the extraction of per- and polyfluoroalkyl substances (PFAS) from waters at both laboratory and operational scales. However, few authors have developed mathematical models of their removal of PFAS. This study presents a theoretical framework for the kinetics of PFAS removal from fresh and monovalent saline waters by a semi-batch foam fractionation process, by the mechanisms of adsorption, entrainment and volatilization, as a function of pertinent parameters including PFAS air-water adsorption, bubble radius, electrolyte concentration and ionic strength, PFAS volatility, and flow and geometric parameters. The freshwater model is validated for the removal of potassium perfluorooctane sulfonate (K-PFOS) using published experimental data (Meng, P. et al., Chemosphere, 2018, 203, 263-270). The proposed models provide quantitative tools for process design and the optimization of individual PFAS removal by semi-batch adsorptive bubble separation techniques such as foam fractionation.
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.
Psychotic Disorders , Virtual Reality Exposure Therapy , Virtual Reality , Humans , Anxiety , Patient Satisfaction , Psychotic Disorders/therapy , Psychotic Disorders/psychology
There is growing clinical interest in addressing relationship dynamics between service-users and their voices. The Talking With Voices (TwV) trial aimed to establish feasibility and acceptability of a novel dialogical intervention to reduce distress associated with voices amongst adults diagnosed with schizophrenia spectrum disorders. The single-site, single-blind (rater) randomised controlled trial recruited 50 participants who were allocated 1:1 to treatment as usual (TAU), or TAU plus up to 26 sessions of TwV therapy. Participants were assessed at baseline and again at end of treatment (six-months). The primary outcomes were quantitative and qualitative assessments of feasibility and acceptability. Secondary outcomes involved clinical measures, including targeted instruments for voice-hearing, dissociation, and emotional distress. The trial achieved 100 % of the target sample, 24 of whom were allocated to therapy and 26 to TAU. The trial had high retention (40/50 [80 %] participants at six-months) and high intervention adherence (21/24 [87.5 %] receiving ≥8 sessions). Signals of efficacy were shown in targeted measures of voice-hearing, dissociation, and perceptions of recovery. Analysis on the Positive and Negative Syndrome Scale indicated that there were no differences in means of general psychosis symptom scores in TwV compared to the control group. There were four serious adverse events in the therapy group and eight in TAU, none of which were related to study proceedings. The trial demonstrates the acceptability of the intervention and the feasibility of delivering it under controlled, randomised conditions. An adequately powered definitive trial is necessary to provide robust evidence regarding efficacy evaluation and cost-effectiveness. Trial registration: ISRCTN 45308981.
Psychosocial Intervention , Psychotic Disorders , Adult , Humans , Feasibility Studies , Single-Blind Method , Hallucinations/etiology , Hallucinations/therapy , Hallucinations/psychology , Psychotic Disorders/complications , Psychotic Disorders/therapy
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.
Cognitive Behavioral Therapy , Psychotic Disorders , Virtual Reality Exposure Therapy , Virtual Reality , Humans , Quality of Life , State Medicine , Psychotic Disorders/therapy , Psychotic Disorders/psychology
BACKGROUND: The social withdrawal of many patients with psychosis can be conceptualised as agoraphobic avoidance due to a range of long-standing fears. We hypothesised that greater severity of agoraphobic avoidance is associated with higher levels of psychiatric symptoms and lower levels of quality of life. We also hypothesised that patients with severe agoraphobic avoidance would experience a range of benefits from an automated virtual reality (VR) therapy that allows them to practise everyday anxiety-provoking situations in simulated environments. METHODS: 345 patients with psychosis in a randomised controlled trial were categorised into average, moderate, high, and severe avoidance groups using the Oxford Agoraphobic Avoidance Scale. Associations of agoraphobia severity with symptom and functioning variables, and response over six months to brief automated VR therapy (gameChange), were tested. RESULTS: Greater severity of agoraphobic avoidance was associated with higher levels of persecutory ideation, auditory hallucinations, depression, hopelessness, and threat cognitions, and lower levels of meaningful activity, quality of life, and perceptions of recovery. Patients with severe agoraphobia showed the greatest benefits with gameChange VR therapy, with significant improvements at end of treatment in agoraphobic avoidance, agoraphobic distress, ideas of reference, persecutory ideation, paranoia worries, recovering quality of life, and perceived recovery, but no significant improvements in depression, suicidal ideation, or health-related quality of life. CONCLUSIONS: Patients with psychosis with severe agoraphobic avoidance, such as being unable to leave the home, have high clinical need. Automated VR therapy can deliver clinical improvement in agoraphobia for these patients, leading to a number of wider benefits.
Cognitive Behavioral Therapy , Psychotic Disorders , Virtual Reality Exposure Therapy , Humans , Quality of Life , Agoraphobia/complications , Agoraphobia/therapy , Agoraphobia/psychology , Psychotic Disorders/complications , Psychotic Disorders/therapy , Psychotic Disorders/psychology
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.
BACKGROUND: People with psychosis have high rates of trauma, with a post-traumatic stress disorder (PTSD) prevalence rate of approximately 15%, which exacerbates psychotic symptoms such as delusions and hallucinations. Pilot studies have shown that trauma-focused (TF) psychological therapies can be safe and effective in such individuals. This trial, the largest to date, will evaluate the clinical effectiveness of a TF therapy integrated with cognitive behaviour therapy for psychosis (TF-CBTp) on post-traumatic stress symptoms in people with psychosis. The secondary aims are to compare groups on cost-effectiveness; ascertain whether TF-CBTp impacts on a range of other meaningful outcomes; determine whether therapy effects endure; and determine acceptability of the therapy in participants and therapists. METHODS: Rater-blind, parallel arm, pragmatic randomised controlled trial comparing TF-CBTp + treatment as usual (TAU) to TAU only. Adults (N = 300) with distressing post-traumatic stress and psychosis symptoms from five mental health Trusts (60 per site) will be randomised to the two groups. Therapy will be manualised, lasting 9 months (m) with trained therapists. We will assess PTSD symptom severity (primary outcome); percentage who show loss of PTSD diagnosis and clinically significant change; psychosis symptoms; emotional well-being; substance use; suicidal ideation; psychological recovery; social functioning; health-related quality of life; service use, a total of four times: before randomisation; 4 m (mid-therapy); 9 m (end of therapy; primary end point); 24 m (15 m after end of therapy) post-randomisation. Four 3-monthly phone calls will be made between 9 m and 24 m assessment points, to collect service use over the previous 3 months. Therapy acceptability will be assessed through qualitative interviews with participants (N = 35) and therapists (N = 5-10). An internal pilot will ensure integrity of trial recruitment and outcome data, as well as therapy protocol safety and adherence. Data will be analysed following intention-to-treat principles using generalised linear mixed models and reported according to Consolidated Standards of Reporting Trials-Social and Psychological Interventions Statement. DISCUSSION: The proposed intervention has the potential to provide significant patient benefit in terms of reductions in distressing symptoms of post-traumatic stress, psychosis, and emotional problems; enable clinicians to implement trauma-focused therapy confidently in this population; and be cost-effective compared to TAU through reduced service use. TRIAL REGISTRATION: ISRCTN93382525 (03/08/20).
Cognitive Behavioral Therapy , Psychotic Disorders , Stress Disorders, Post-Traumatic , Adult , Cognitive Behavioral Therapy/methods , Comorbidity , Humans , Multicenter Studies as Topic , Pragmatic Clinical Trials as Topic , Psychotic Disorders/diagnosis , Psychotic Disorders/etiology , Psychotic Disorders/psychology , Psychotic Disorders/therapy , Quality of Life , Randomized Controlled Trials as Topic , Stress Disorders, Post-Traumatic/diagnosis , Stress Disorders, Post-Traumatic/etiology , Stress Disorders, Post-Traumatic/psychology , Stress Disorders, Post-Traumatic/therapy
BACKGROUND: Automated delivery of psychological therapy using immersive technologies such as virtual reality (VR) might greatly increase the availability of effective help for patients. We aimed to evaluate the efficacy of an automated VR cognitive therapy (gameChange) to treat avoidance and distress in patients with psychosis, and to analyse how and in whom it might work. METHODS: We did a parallel-group, single-blind, randomised, controlled trial across nine National Health Service trusts in England. Eligible patients were aged 16 years or older, with a clinical diagnosis of a schizophrenia spectrum disorder or an affective diagnosis with psychotic symptoms, and had self-reported difficulties going outside due to anxiety. Patients were randomly assigned (1:1) to either gameChange VR therapy plus usual care or usual care alone, using a permuted blocks algorithm with randomly varying block size, stratified by study site and service type. gameChange VR therapy was provided in approximately six sessions over 6 weeks. Trial assessors were masked to group allocation. Outcomes were assessed at 0, 6 (primary endpoint), and 26 weeks after randomisation. The primary outcome was avoidance of, and distress in, everyday situations, assessed using the self-reported Oxford Agoraphobic Avoidance Scale (O-AS). Outcome analyses were done in the intention-to-treat population (ie, all participants who were assigned to a study group for whom data were available). We performed planned mediation and moderation analyses to test the effects of gameChange VR therapy when added to usual care. This trial is registered with the ISRCTN registry, 17308399. FINDINGS: Between July 25, 2019, and May 7, 2021 (with a pause in recruitment from March 16, 2020, to Sept 14, 2020, due to COVID-19 pandemic restrictions), 551 patients were assessed for eligibility and 346 were enrolled. 231 (67%) patients were men and 111 (32%) were women, 294 (85%) were White, and the mean age was 37·2 years (SD 12·5). 174 patients were randomly assigned to the gameChange VR therapy group and 172 to the usual care alone group. Compared with the usual care alone group, the gameChange VR therapy group had significant reductions in agoraphobic avoidance (O-AS adjusted mean difference -0·47, 95% CI -0·88 to -0·06; n=320; Cohen's d -0·18; p=0·026) and distress (-4·33, -7·78 to -0·87; n=322; -0·26; p=0·014) at 6 weeks. Reductions in threat cognitions and within-situation defence behaviours mediated treatment outcomes. The greater the severity of anxious fears and avoidance, the greater the treatment benefits. There was no significant difference in the occurrence of serious adverse events between the gameChange VR therapy group (12 events in nine patients) and the usual care alone group (eight events in seven patients; p=0·37). INTERPRETATION: Automated VR therapy led to significant reductions in anxious avoidance of, and distress in, everyday situations compared with usual care alone. The mediation analysis indicated that the VR therapy worked in accordance with the cognitive model by reducing anxious thoughts and associated protective behaviours. The moderation analysis indicated that the VR therapy particularly benefited patients with severe agoraphobic avoidance, such as not being able to leave the home unaccompanied. gameChange VR therapy has the potential to increase the provision of effective psychological therapy for psychosis, particularly for patients who find it difficult to leave their home, visit local amenities, or use public transport. FUNDING: National Institute of Health Research Invention for Innovation programme, National Institute of Health Research Oxford Health Biomedical Research Centre.
COVID-19 , Psychotic Disorders , Virtual Reality Exposure Therapy , Adult , England , Female , Humans , Male , Pandemics , Psychotic Disorders/psychology , Psychotic Disorders/therapy , Single-Blind Method , State Medicine , Treatment Outcome
The menopause transition in women is a period of significant bone loss, with rapid declines in bone mineral density (BMD) commencing a year before the final menstrual period (FMP). Changes in menstrual bleeding patterns cannot reliably tell us if this rapid bone loss has begun or is imminent. We hypothesized that low circulating levels of anti-Mullerian hormone (AMH), which decline as women approach the FMP, would be associated with future and ongoing rapid bone loss. We used data from The Study of Women's Health Across the Nation, a multisite, multi-ethnic, prospective cohort study of the menopause transition to test this hypothesis. Adjusted for age, body mass index, race/ethnicity, and study site, every 50% decrement in AMH level in premenopause and early perimenopause was associated with 0.14% per year faster decline over the following 3 to 4 years in lumbar spine BMD and 0.11% per year faster decline in femoral neck BMD (p < 0.001 for both). AMH in late perimenopause was not associated with the rate of future BMD decline. AMH was also associated with the magnitude of ongoing bone loss, measured as percent of peak BMD lost by the end of the next 2 to 3 years. Every 50% decrement in AMH level was associated with 0.22% additional loss in spine BMD in premenopause, 0.43% additional loss in early perimenopause, and 0.50% additional loss in late perimenopause (p < 0.001 for all three). If a woman will lose more of her peak BMD than the site-specific least significant change (LSC) at either the lumbar spine or femoral neck by the next 2 to 3 years, then AMH below 100 pg/mL will detect it with sensitivity of 50% in premenopause, 80% in early perimenopause, and 98% in late perimenopause. These findings suggest that AMH measurement can help flag women at the brink of significant bone loss for early intervention. © 2022 American Society for Bone and Mineral Research (ASBMR).
Anti-Mullerian Hormone , Bone Density , Bone Diseases, Metabolic , Menopause , Anti-Mullerian Hormone/blood , Bone Diseases, Metabolic/diagnosis , Female , Femur Neck , Humans , Lumbar Vertebrae , Premenopause , Prospective Studies
BACKGROUND: Many patients with mental health disorders become increasingly isolated at home due to anxiety about going outside. A cognitive perspective on this difficulty is that threat cognitions lead to the safety-seeking behavioural response of agoraphobic avoidance. AIMS: We sought to develop a brief questionnaire, suitable for research and clinical practice, to assess a wide range of cognitions likely to lead to agoraphobic avoidance. We also included two additional subscales assessing two types of safety-seeking defensive responses: anxious avoidance and within-situation safety behaviours. METHOD: 198 patients with psychosis and agoraphobic avoidance and 1947 non-clinical individuals completed the item pool and measures of agoraphobic avoidance, generalised anxiety, social anxiety, depression and paranoia. Factor analyses were used to derive the Oxford Cognitions and Defences Questionnaire (O-CDQ). RESULTS: The O-CDQ consists of three subscales: threat cognitions (14 items), anxious avoidance (11 items), and within-situation safety behaviours (8 items). Separate confirmatory factor analyses demonstrated a good model fit for all subscales. The cognitions subscale was significantly associated with agoraphobic avoidance (r = .672, p < .001), social anxiety (r = .617, p < .001), generalized anxiety (r = .746, p < .001), depression (r = .619, p < .001) and paranoia (r = .655, p < .001). Additionally, both the O-CDQ avoidance (r = .867, p < .001) and within-situation safety behaviours (r = .757, p < .001) subscales were highly correlated with agoraphobic avoidance. The O-CDQ demonstrated excellent internal consistency (cognitions Cronbach's alpha = .93, avoidance Cronbach's alpha = .94, within-situation Cronbach's alpha = .93) and test-re-test reliability (cognitions ICC = 0.88, avoidance ICC = 0.92, within-situation ICC = 0.89). CONCLUSIONS: The O-CDQ, consisting of three separate scales, has excellent psychometric properties and may prove a helpful tool for understanding agoraphobic avoidance across mental health disorders.
Trace metal exposure from environmental sources remains a persistent global problem, particularly in communities residing adjacent to metal extraction and processing industries. This study examines front yard soil and house dust from 62 residences throughout the Australian Ag-Pb-Zn mining city of Broken Hill to better understand spatial variability in metal distributions, compositions and exposures across an industrially polluted urban environment. X-ray fluorescence analysis of paired soil/dust samples indicated that geomean concentrations (mg/kg) of Cu (32/113), Zn (996/1852), As (24/34) and Pb (408/587) were higher in house dust while Ti (4239/3660) and Mn (1895/1101) were higher in outdoor soil. Ore associated metals and metalloids (Mn, Zn, As, Pb) in soil and house dust were positively correlated and declined in concentration away from mining areas, the primary source of metalliferous emissions in Broken Hill. The rate of decline was not equivalent between soil and house dust, with the indoor/outdoor concentration ratio increasing with distance from mining areas for Zn/Pb (geomean = 1.25/1.05 (<1 km); 2.14/1.52 (1-2 km); 2.54/2.04 (>2 km)). House dust and Broken Hill ore Pb isotopic compositions (206Pb/207Pb; 208Pb/207Pb) were more similar in homes nearest to mining areas than those further away (geomean apportioned ore Pb = 88% (<1 km); 76% (1-2 km); 66% (>2 km)), reflecting spatial shifts in the balance of sources contributing to indoor contamination. Incorporation of house dust Pb reduced overestimation of IEUBK modelled blood Pb concentrations compared to when only soil Pb was used. These findings demonstrate that even in contexts where the source and environmental burden of metals are relatively apparent, geochemical relationships and exposures between outdoor and indoor environments are not always predictable, nor easily disaggregated.
Metalloids , Metals, Heavy , Soil Pollutants , Australia , Dust/analysis , Environmental Monitoring , Humans , Metals, Heavy/analysis , Mining , Risk Assessment , Soil , Soil Pollutants/analysis
INTRODUCTION: Aggregate data meta-analyses have shown heterogeneous treatment effects for cognitive-behavioural therapy (CBT) for patients with schizophrenia spectrum diagnoses. This heterogeneity could stem from specific intervention or patient characteristics that could influence the clinical effectiveness of CBT, termed treatment effect modifiers. This individual participant data meta-analysis will investigate a range of potential treatment effect modifiers of the efficacy of CBT. METHODS AND ANALYSIS: We will perform a systematic review and meta-analysis of studies investigating CBT versus treatment as usual, or CBT versus other psychosocial interventions, for patients with schizophrenia spectrum diagnoses. The Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE and the online clinical trials registers of the US government, European Union, WHO and Current Controlled Trials will be searched. Two researchers will screen titles and abstracts identified by the search. Individual participant data will be requested for any eligible study, for the primary outcome (overall psychotic symptoms), secondary outcomes and treatment effect modifiers. Data will be checked and recoded according to an established statistical analysis plan. One-stage and two-stage random effects meta-analyses investigating potential treatment effect modifiers will be conducted. A list of potential treatment effect modifiers for CBT will be produced, motivating future research into particular modifiers. ETHICS AND DISSEMINATION: This study does not require ethical approval as it is based on data from existing studies, although best ethical practice for secondary analysis of clinical data will be followed. The findings will be submitted for publication in peer-reviewed journals, and promoted to relevant stakeholders. PROSPERO REGISTRATION NUMBER: CRD42017060068.
Cognitive Behavioral Therapy , Psychotic Disorders , Humans , Meta-Analysis as Topic , Psychosocial Intervention , Psychotic Disorders/therapy , Systematic Reviews as Topic , Treatment Outcome
PURPOSE: To present a treatment protocol for delivering Talking With Voices, a novel intervention for people with psychosis that involves dialogical engagement with auditory hallucinations. METHOD: This paper presents a manualized approach to therapy employed in the Talking With Voices trial, a feasibility and acceptability randomized control trial of 50 adult participants. A rationale for following a treatment manual is provided, followed by the theoretical underpinnings of the intervention and its principles and values, including the main tenet that voices can often be understood as dissociated parts of the self which serve a protective function by indicating social-emotional vulnerabilities. The four therapy phases for improving the relationship between the voice-hearer and their voices are outlined: (1) engagement and psychoeducation, (2) creating a formulation, (3) dialoguing with voices, and (4) consolidating outcomes, including key milestones at each phase. Implementation issues are discussed, as well as recommendations for best practice and future research. RESULTS: The Talking With Voices treatment protocol indicates that it is feasible to manualize a dissociation-based approach to support service users who are distressed by hearing voices. CONCLUSION: For some individuals, it is possible to engage in productive dialogue with even extremely hostile or distressing voices. Developing coping strategies, creating a formulation, and ultimately establishing a dialogue with voices has the potential to improve the relationship between voice(s) and voice-hearer. Further research is now required to evaluate feasibility, acceptability, and efficacy. PRACTITIONER POINTS: It is feasible to integrate a dissociation model of voice-hearing within a psychological intervention for people with psychosis. Combining psychosocial education, formulation and direct dialogue can be used to facilitate a more peaceful relationship between clients and their voices. Practitioners trained in other therapeutic modalities can draw on existing transferrable skills to dialogue with their clients' voices. The input of those with lived experience of mental health difficulties has an important role in guiding treatment design and delivery.
Psychotic Disorders , Voice , Adult , Clinical Protocols , Hallucinations/therapy , Humans , Pilot Projects , Psychotic Disorders/therapy , Randomized Controlled Trials as Topic
