Morita Therapy for depression (Morita Trial): a pilot randomised controlled trial

This is the final version of the article. Available from BMJ Publishing Group via the DOI in this record.Objective: To address uncertainties prior to conducting a fully powered randomised controlled trial of Morita Therapy plus treatment as usual (TAU) versus TAU alone, or to determine that such a trial is not appropriate and/or feasible. Design: Pilot parallel group randomised controlled feasibility trial. Setting and participants: Participants aged ≥18 years with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV major depressive disorder, with or without DSM-IV anxiety disorder(s), recruited from general practice record searches in Devon, UK. Interventions: We randomised participants on a 1:1 basis stratified by symptom severity, concealing allocation using a secure independent web-based system, to receive TAU (control) or 8–12 sessions of Morita Therapy, a Japanese psychological therapy, plus TAU (intervention). Outcomes: Rates of recruitment, retention and treatment adherence; variance and estimated between-group differences in follow-up scores (on the Patient Health Questionnaire 9 (PHQ-9) (depressive symptoms); Generalised Anxiety Disorder Questionnaire 7 (anxiety symptoms); Short Form 36 Health Survey Questionnaire/ Work and Social Adjustment Scale (quality of life); Morita Attitudinal Scale for Arugamama (attitudes)) and their correlation with baseline scores. Results: We recruited 68 participants, 5.1% (95% CI 3.4% to 6.6%) of those invited (34 control; 34 intervention); 64/68 (94%; 95% CI 88.3% to 99.7%) provided 4-month follow-up data. Participants had a mean age of 49 years and mean PHQ-9 score of 16.8; 61% were female. Twenty-four of 34 (70.6%) adhered to the minimum treatment dose. The follow-up PHQ-9 (future primary outcome measure) pooled SD was 6.4 (95% CI 5.5 to 7.8); the magnitude of correlation between baseline and follow-up PHQ-9 scores was 0.42 (95% CI 0.19 to 0.61). Of the participants, 66.7% and 30.0% recovered in the intervention and control groups, respectively; 66.7% and 13.3% responded to treatment in the intervention and control groups, respectively. Conclusions: A large-scale trial of Morita Therapy would require 133 participants per group and is feasible with minor modifications to the pilot trial protocol. Morita Therapy shows promise in treating depression and may provide patients with a distinct alternative to current treatments. Trial registration number: ISRCTN17544090; Pre-resultsThe first author (HVRS) had a PhD fellowship award from the University of Exeter Medical School; DAR and JF are also funded by the University of Exeter Medical School and DAR, as a National Institute for Health Research Senior Investigator, receives additional support from the UK National Institute for Health Research South West Peninsula Collaboration for Leadership in Applied Health Research and Care. The AccEPT Clinic is funded by the National Health Service Northern, Eastern and Western Devon Clinical Commissioning Group and hosted by the University of Exeter’s Mood Disorders Centre. The Morita Trial was sponsored by the University of Exeter (contact details available on request). The sponsor and funding sources have had no role in the design of this study, nor during its execution, analyses, interpretation of data, or submission of results

Morita Therapy for depression (Morita Trial): an embedded qualitative study of acceptability

This is the final version. Available on open access from BMJ Publishing Group via the DOI in this recordData sharing statement: The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.Objective To explore the views of UK-based recipients of Morita Therapy (MT) on the acceptability of MT. Design Qualitative study nested within a pilot randomised controlled trial of MT (a Japanese psychological therapy largely unknown in the UK) versus treatment as usual, using post-treatment semistructured interviews analysed with a framework approach. Setting and participants Participants who received MT as part of the Morita Trial, recruited for the trial from General Practice record searches in Devon, UK. Data from 16 participants were purposively sampled for analysis. Results We identified five themes which, together, form a model of how different participants viewed and experienced MT. Overall, MT was perceived as acceptable by many participants who emphasised the value of the approach, often in comparison to other treatments they had tried. These participants highlighted how accepting and allowing difficulties as natural phenomena and shifting attention from symptoms to external factors had facilitated symptom reduction and a sense of empowerment. We found that how participants understood and related to the principles of MT, in light of their expectations of treatment, was significantly tied to the extent to which MT was perceived as acceptable. Our findings also highlighted the distinction between MT in principle and practice, with participants noting challenges of engaging with the process of therapy such as fear and discomfort around rest, needing sufficient support from the therapist and others, and the commitment of treatment. Conclusions People in the UK can accept the premise of MT, and consider the approach beneficial and novel. Therefore, proceeding to a large-scale trial of MT is appropriate with minor modifications to our clinical protocol. Participants’ expectations and understandings of treatment play a key role in acceptability, and future research may investigate these potential moderators of acceptability in MT.University of ExeterNational Institute for Health Research (NIHR

Personalising psychotherapies for depression using a novel mixed methods approach: An example from Morita Therapy

This is the final version. Available on open access from BMC via the DOI in this recordBackground Current quantitative methods for personalising psychotherapies for depression are unlikely to be able to inform clinical decision-making for hundreds of years. Novel alternative methods to generate hypotheses for prospective testing are therefore required, and we showcase mixed methods as one such approach. By exploring patients’ perspectives in-depth, and integrating qualitative and quantitative data at the level of the individual, we may identify new potential psychosocial predictors of psychotherapy outcomes, potentially informing the personalisation of depression treatment in a shorter timeframe. Using Morita Therapy (a Japanese psychotherapy) as an exemplar, we thus explored how Morita Therapy recipients’ views on treatment acceptability explain their adherence and response to treatment. Methods The Morita Trial incorporated a pilot randomised controlled trial of Morita Therapy versus treatment as usual for depression, and post-treatment qualitative interviews. We recruited trial participants from General Practice record searches in Devon, UK, and purposively sampled data from 16 participants for our mixed methods analysis. We developed typologies of participants’ views from our qualitative themes, and integrated these with quantitative data on number of sessions attended and whether participants responded to treatment in a joint typologies and statistics display. We enriched our analysis using participant vignettes to demonstrate each typology. Results We demonstrate that (1) participants who could identify with the principles of Morita Therapy typically responded to treatment, regardless of how many sessions they attended, whilst those whose orientation towards treatment was incompatible with Morita Therapy did not respond to treatment, again regardless of treatment adherence; (2) participants whose personal circumstances impeded their opportunity to engage in Morita Therapy attended the fewest sessions, though still benefitted from treatment if the principles resonated with them. Conclusions We identified new potential relationships between ‘orientation’ and outcomes, and ‘opportunity’ and adherence, which could not have been identified using existing non-integrative methods. This mixed methods approach warrants replication in future trials and with other psychotherapies to generate hypotheses, based on typologies (or profiles) of patients for whom a treatment is more or less likely to be suitable, to be tested in prospective trials.National Institute for Health Research (NIHR)University of Exete

Evaluation of Intake Limiting Agents in a Self-fed Dried Distillers' Supplement

Response to range supplementation is in part driven by level of supplement consumed and amount of associated variation. In order to evaluate intake limiting agents in a self-fed dried distillers’ grain supplement (DDG), heifers (n=59) in Trial 1 were offered an ad libitum amount of sorghum × sudangrass hay as well as DDG containing either no limiter (CON), monensin (185 mg/kg; MON), or one of six additional limiters alone or in combination with monensin (185 mg/kg, +M). Evaluated treatments and initial rates consisted of sodium chloride (NACL, 10%), urea (UREA, 2%), sodium bicarbonate (LIME, 1.68%), DL-malic acid (MLAC, 3%), calcium propionate (CAPR, 3%), and sodium bicarbonate plus urea (LIUR, 1.68% + 2%). Supplement intake was recorded daily and limiters were evaluated over three rates of inclusion, each for a duration of 14 d, on the basis of intake level, intake variation (cumulative stability), and rate of intake change over time (temporal stability). Data was analyzed as a 7 × 2 factorial initial 7 days of each period were removed to avoid acclimation influence. A baseline period was observed to ensure no inherent differences were detected. Within the initial rate period, limiter affected OM intake (P = 0.02) as consumption was reduced by NACL (P < 0.01) and tended to be lower when limited by MLAC (P = 0.14) and LIUR (P = 0.11). Neither monensin (P = 0.86) nor a limiter × monensin interaction were present. Cumulative stability was indicated that heifers consuming NACL (P < 0.01) and CAPR (P < 0.01) consumed supplement with greater regularity than did CONT. Monensin (P = 0.75) and monensin × limiter (P = 0.76) did not influence intake stability. Temporal stability was unaffected by limiter (P = 0.43), monensin (P = 0.69), or monensin × limiter (P = 0.93). When rate of inclusion was 2 × initial rate, intake was affected by limiter (P < 0.01) with observations similar to the initial period. No monensin (P = 0.49) or interaction (P = 0.27) effect was present. Cumulative stability was unaffected by limiter (P = 022), monensin (P = 0.39), or interaction (P = 0.86). Temporal stability was increased with monensin (P 0.05) and an interaction resulted in an increased rate of supplement intake change in CONT when monensin was included. When supplement included limiters at 4 × the initial rate, Effects on intake and cumulative stability by limiter were the only significant responses. Intake of LIUR, NACL, and MLAC were reduced relative to CONT while NACL was consumed with greater regularity. Trial 2 was conducted to further compare sodium chloride and DL-malic acid as limiting agents. Each were included in a self-fed DDG supplement offered to steers (n=60, mean initial BW = 191 kg) at identical rates (8%, 16% 24%, and 32%) in addition to monensin (66 mg/kg). Within each rate, MLAC reduced supplement intake more effectively than NACL while cumulative stability and temporal stability measures were similar among limiter and only deviated from control levels at lower rates

What is Morita Therapy? The Nature, Origins, and Cross-cultural Application of a Unique Japanese Psychotherapy

This is the final version. Available on open access from Springer via the DOI in this recordMorita Therapy is a Japanese psychotherapy which contrasts with established Western approaches in teaching, through behavioural experience, that symptoms are part of the natural ecology of human experience. Morita Therapy has received increasing international interest over the decades, and the first randomized controlled trial of Morita Therapy to be published outside of China has recently demonstrated the promise of the approach in treating Western patients. To respond to the resulting interest in Morita Therapy from patients and practitioners, and facilitate further Morita Therapy research, it is necessary to provide the detailed explanation of Morita Therapy which is currently rare in the West. In this article, we fill this gap with a thorough description of Morita Therapy in terms of the key principles, objectives and processes of the approach; its basis in Eastern philosophy and naturalism; its sociohistorical context and development over a wide range of formats, patient conditions, and countries. To enable Western practitioners to appreciate and capitalize on the potential value of Morita Therapy as a distinct alternative for patients, we illustrate the approach’s unique method and objective compared to Western psychotherapies, and provide recommendations for practitioners applying Morita Therapy across cultures.University of Exete

ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer

PURPOSE: Enzalutamide, a potent androgen-receptor inhibitor, has demonstrated significant benefits in metastatic and nonmetastatic castration-resistant prostate cancer. We evaluated the efficacy and safety of enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC). METHODS: ARCHES (ClinicalTrials.gov identifier: NCT02677896) is a multinational, double-blind, phase III trial, wherein 1,150 men with mHSPC were randomly assigned 1:1 to enzalutamide (160 mg/day) or placebo, plus androgen deprivation therapy (ADT), stratified by disease volume and prior docetaxel chemotherapy. The primary end point was radiographic progression-free survival. RESULTS: As of October 14, 2018, the risk of radiographic progression or death was significantly reduced with enzalutamide plus ADT versus placebo plus ADT (hazard ratio, 0.39; 95% CI, 0.30 to 0.50; P < .001; median not reached v 19.0 months). Similar significant improvements in radiographic progression-free survival were reported in prespecified subgroups on the basis of disease volume and prior docetaxel therapy. Enzalutamide plus ADT significantly reduced the risk of prostate-specific antigen progression, initiation of new antineoplastic therapy, first symptomatic skeletal event, castration resistance, and reduced risk of pain progression. More men achieved an undetectable prostate-specific antigen level and/or an objective response with enzalutamide plus ADT (P < .001). Patients in both treatment groups reported a high baseline level of quality of life, which was maintained over time. Grade 3 or greater adverse events were reported in 24.3% of patients who received enzalutamide plus ADT versus 25.6% of patients who received placebo plus ADT, with no unexpected adverse events. CONCLUSION: Enzalutamide with ADT significantly reduced the risk of metastatic progression or death over time versus placebo plus ADT in men with mHSPC, including those with low-volume disease and/or prior docetaxel, with a safety analysis that seems consistent with the safety profile of enzalutamide in previous clinical trials in castration-resistant prostate cancer

Factors influencing identification of and response to intimate partner violence: a survey of physicians and nurses

BACKGROUND: Intimate partner violence against women (IPV) has been identified as a serious public health problem. Although the health care system is an important site for identification and intervention, there have been challenges in determining how health care professionals can best address this issue in practice. We surveyed nurses and physicians in 2004 regarding their attitudes and behaviours with respect to IPV, including whether they routinely inquire about IPV, as well as potentially relevant barriers, facilitators, experiential, and practice-related factors. METHODS: A modified Dillman Tailored Design approach was used to survey 1000 nurses and 1000 physicians by mail in Ontario, Canada. Respondents were randomly selected from professional directories and represented practice areas pre-identified from the literature as those most likely to care for women at the point of initial IPV disclosure: family practice, obstetrics and gynecology, emergency care, maternal/newborn care, and public health. The survey instrument had a case-based scenario followed by 43 questions asking about behaviours and resources specific to woman abuse. RESULTS: In total, 931 questionnaires were returned; 597 by nurses (59.7% response rate) and 328 by physicians (32.8% response rate). Overall, 32% of nurses and 42% of physicians reported routinely initiating the topic of IPV in practice. Principal components analysis identified eight constructs related to whether routine inquiry was conducted: preparedness, self-confidence, professional supports, abuse inquiry, practitioner consequences of asking, comfort following disclosure, practitioner lack of control, and practice pressures. Each construct was analyzed according to a number of related issues, including clinician training and experience with woman abuse, area of practice, and type of health care provider. Preparedness emerged as a key construct related to whether respondents routinely initiated the topic of IPV. CONCLUSION: The present study provides new insight into the factors that facilitate and impede clinicians' decisions to address the issue of IPV with their female patients. Inadequate preparation, both educational and experiential, emerged as a key barrier to routine inquiry, as did the importance of the "real world" pressures associated with the daily context of primary care practice

Population structure, connectivity, and demographic history of an apex marine predator, the bull shark <i>Carcharhinus leucas</i>

Knowledge of population structure, connectivity, and effective population size remains limited for many marine apex predators, including the bull shark Carcharhinus leucas. This large‐bodied coastal shark is distributed worldwide in warm temperate and tropical waters, and uses estuaries and rivers as nurseries. As an apex predator, the bull shark likely plays a vital ecological role within marine food webs, but is at risk due to inshore habitat degradation and various fishing pressures. We investigated the bull shark\u27s global population structure and demographic history by analyzing the genetic diversity of 370 individuals from 11 different locations using 25 microsatellite loci and three mitochondrial genes (CR, nd4, and cytb). Both types of markers revealed clustering between sharks from the Western Atlantic and those from the Western Pacific and the Western Indian Ocean, with no contemporary gene flow. Microsatellite data suggested low differentiation between the Western Indian Ocean and the Western Pacific, but substantial differentiation was found using mitochondrial DNA. Integrating information from both types of markers and using Bayesian computation with a random forest procedure (ABC‐RF), this discordance was found to be due to a complete lack of contemporary gene flow. High genetic connectivity was found both within the Western Indian Ocean and within the Western Pacific. In conclusion, these results suggest important structuring of bull shark populations globally with important gene flow occurring along coastlines, highlighting the need for management and conservation plans on regional scales rather than oceanic basin scale