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Background Clinical guidelines recommend antipsychotics for the treatment of delirium; however, there has been no confirmed recommendation regarding their administrating patterns. This study aims to investigate whether different dosing patterns of antipsychotics (single or multiple administrations) influence the outcomes of delirium treatment. Methods This is a secondary analysis of a prospective observational study involving patients with advanced cancer and delirium receiving antipsychotics. The Delirium Rating Scale Revised-98 was administered at baseline and after 72 h of starting pharmacotherapy. Patients were classified into single administration group (received a single dosage within 24 h before the assessment) and multiple administration group (received more than one dosage). Results A total of 555 patients (single administration 492 (88.6%); multiple administration 63 (11.4%)) were subjected to analyses. The patients in the multiple administration group were more likely to be male, in psycho-oncology consulting settings, with lower performance status, with hyperactive delirium and with severer delirium symptoms. In the multivariate analysis, single administration was significantly associated with better improvement of delirium (p Conclusions In this observational study sample, Delirium Rating Scale severity score improvement in single administration was higher than that seen in multiple administration. There was no difference in adverse events between the two groups.

Objectives This study aimed to adapt the meaning-centered psychotherapy (MCP) to treat post-bereavement grief in Japanese bereaved families who lost their loved ones to cancer and to examine the feasibility of the intervention using both quantitative and qualitative methods. Methods A modified version of MCP was developed with cultural consideration. Bereaved individuals aged ≥18 years who had lost their family members to cancer at least 6 months before and had severe or persistent grief with a score of ≥26 on the Inventory of Complicated Grief (ICG-19) were included in the study. The participants received the modified version of MCP, which was provided in a 5-session monthly format. The levels of grief (ICG-19), depression (Center for Epidemiologic Studies Depression Scale [CES-D]), general health (General Health Questionnaire-12), and post-traumatic growth (Post-traumatic Growth Inventory -Short Form) were compared before and after the intervention. Results Five bereaved individuals were enrolled, and all the participants completed the program. The mean scores of the ICG-19. The participants’ sense of regret, guilt, and being separated from the deceased person gradually shifted to the reappraisal of the experience, leading to a broadened view of the relationship with the deceased, and rediscovery of the core values, identity, and roles of the participants through the process of rediscovery of the meaning of life. Significance of results A modified version of the MCP was well accepted by Japanese bereaved families. The intervention appears to promote the rediscovery of the meaning of life and appears to have the potential to alleviate the bereaved individuals’ depression and grief-related symptoms and to facilitate their post-traumatic growth.

Depressive symptoms are prevalent in cancer patients and are one of the most distressing symptoms in this population. Although mental health professionals such as psychiatrists and psychologists are now engaged in cancer care, the management of depressive symptoms in cancer patients needs further improvement. Peer support interventions (PSIs) in cancer care have attracted substantial attention and have several advantages over support by medical professionals, potentially improving depressive symptoms in cancer patients. However, there may be some potential risks. Several strategies using PSIs have been developed to improve depressive symptoms and have been evaluated in randomized controlled trials. The strategies include education on stress management skills, promoting emotional support, counseling on specific topics that are difficult to discuss with others, helping patients navigate the use of resources, and promoting health-related behaviors to decrease depressive symptoms. In this paper, we present recent findings on PSIs in cancer, focusing on randomized controlled trials.

Background Strategies to implement early specialized palliative care have not yet been established. The present study investigated the feasibility of a nurse-led, screening-triggered early specialized palliative care intervention programme and obtained data to design a randomized controlled trial. Methods Patients with metastatic lung cancer undergoing first-line platinum-based chemotherapy were eligible. The intervention consisted of (1) a questionnaire-based screening programme and (2) advanced-level nurse counselling and care coordination with interdisciplinary team approach. The primary endpoint was the completion rate of the assessment questionnaire after the second course of first-line chemotherapy (T2). Secondary endpoints included changes in Functional Assessment of Cancer Therapy-Lung scores, depression and anxiety rates based on the Patient Health Questionnaire 9 and the Hospital Anxiety and Depression Scale, and the contents of specialized palliative care. Results A total of 50 patients were enrolled between August 2012 and March 2014. Median age was 66 years (range, 40–78 year) and 84% were male. A total of 38 patients had stage IV non-small cell lung carcinoma and 12 had extensive disease small-cell lung carcinoma. The completion rate was 70% (95% confidence interval 56.0–81.0). The median duration between baseline and T2 was 53 days. Improvement from baseline were observed at T2 in Functional Assessment of Cancer Therapy-Lung scores (86.0 ± 18.1 vs 94.9 ± 18.2, P = 0.057), depression (16.0 vs 5.7%; P = 0.26) and anxiety (32.0 vs 22.9%; P = 0.65); however, these results were not statistically significant. Conclusions This early specialized palliative care intervention is feasible and could be useful in improving patients’ quality of life. The present results justify the initiation of a randomized control trial.

Aim Pharmacotherapy is the primary treatment strategy in major depression. However, two-thirds of patients remain depressed after the initial antidepressant treatment. Augmented cognitive behavioral therapy (CBT) for pharmacotherapy-resistant depression in primary mental health care settings proved effective and cost-effective. Although we reported the clinical effectiveness of augmented CBT in secondary mental health care, its cost-effectiveness has not been evaluated. Therefore, we aimed to compare the cost-effectiveness of augmented CBT adjunctive to treatment as usual (TAU) and TAU alone for pharmacotherapy-resistant depression at secondary mental health care settings. Methods We performed a cost-effectiveness analysis at 64 weeks, alongside a randomized controlled trial involving 80 patients who sought depression treatment at a university hospital and psychiatric hospital (one each). The cost-effectiveness was assessed by the incremental cost-effectiveness ratio (ICER) that compared the difference in costs and quality-adjusted life years, and other clinical scales, between the groups. Results The ICERs were JPY -15,278,322 and 2,026,865 for pharmacotherapy-resistant depression for all samples and those with moderate/severe symptoms at baseline, respectively. The acceptability curve demonstrates a 0.221 and 0.701 probability of the augmented CBT being cost-effective for all samples and moderate/severe depression, respectively, at the threshold of JPY 4.57 million (GBP 30,000). The sensitivity analysis supported the robustness of our results restricting for moderate/severe depression. Conclusion Augmented CBT for pharmacotherapy-resistant depression is not cost-effective for all samples including mild depression. In contrast, it appeared to be cost-effective for the patients currently manifesting moderate/severe symptoms under secondary mental health care. This article is protected by copyright. All rights reserved.

Objective Comorbid psychiatric disorders negatively affect the survival rate of patients with some physical disorders. In liver transplant recipients, various psychiatric disorders have been identified as worsening prognosis. However, little is known about how the presence of any comorbid (overall) disorders affect the survival rate of transplant recipients. In this study, we examined the effect of overall comorbid psychiatric disorders on survival rate in liver transplant recipients. Methods A total of 1006 recipients who underwent liver transplantation between September 1997 and July 2017 across eight transplant facilities with a psychiatric consultation-liaison team were identified consecutively. Recipients were categorized into those with comorbid psychiatric disorders and those without comorbid psychiatric disorders. In the comorbid psychiatric disorder group, psychiatric disorder diagnosis and time of diagnosis were investigated retrospectively. Results Of the 1006 recipients, 294 (29.2%) had comorbid psychiatric disorders. Comorbid psychiatric disorders in the 1006 recipients were insomnia (N = 107, 10.6%), delirium (N = 103, 10.2%), major depressive disorder (N = 41, 4.1%), adjustment disorder (N = 19, 1.9%), anxiety disorder (N = 17, 1.7%), intellectual disability (N = 11, 1.1%), autism spectrum disorder (N = 7, 0.7%), somatic symptom disorder (N = 4, 0.4%) schizophrenia (N = 4, 0.4%), substance use disorder (N = 24, 2.4%) and personality disorder (N = 2, 0.2%). The most common time of psychiatric disorder diagnosis was within the first 3 months after liver transplantation (51.6%). The final mortality in patients with comorbid psychiatric disorder diagnosis during the five periods (pretransplant, transplant to 3 months, months to 1 year, 1 to 3 years, and over 3 years posttransplant) was 16.2%, 18.8%, 39.1%, 28.6%, and 16.2% respectively, and there were no significant differences between the five periods (χ2 = 8.05, df = 4, p = 0.09). Overall comorbid psychiatric disorders were significantly associated with shorter survival time (log-rank test: p = 0.01, hazard ratio: 1.59 [95% confidence interval: 1.14–2.21], survival rate at the endpoint [%]: 62.0 vs. 83.3). However, after adjusting for confounding variables using Cox proportional hazards regression, there was no significant effect of overall comorbid psychiatric disorders on prognosis. Conclusion Comorbid psychiatric disorders did not affect the survival rate of liver transplant recipients in this study.

Background: Both advanced cancer patients and their family caregivers experience distress and have a range of concerns after cancer diagnosis. However, longitudinal studies on this topic have been lacking. Aim: To investigate concerns in both patients with advanced lung cancer and their family caregivers longitudinally from diagnosis. Design: A multi-center prospective questionnaire-based study. Setting/participants: We recruited patients with newly diagnosed advanced lung cancer and their family caregivers at 16 hospitals in Japan. We prospectively assessed the prevalence of their concerns using the Concerns Checklist and investigated the associations between their concerns and mental status as well as quality of life until 24 months after diagnosis. Results: A total of 248 patients and their 232 family caregivers were enrolled. The prevalence of serious concerns was highest at diagnosis (patients: 68.3%, family caregivers: 65.3%). The most common serious concern was concern about the future in both groups at diagnosis (38.2% and 40.5%, respectively) and this remained high in prevalence over time, while the high prevalence of concern about lack of information improved 3 months after diagnosis in both groups. Approximately one-third of patient-family caregiver dyads had discrepant reports of serious concerns. The presence of serious concerns was significantly associated with anxiety and depression continuously in both groups. Conclusions: The majority of advanced lung cancer patients and their family caregivers have serious concerns from diagnosis, which is associated with their psychological distress. The spectrum of concerns alters over the disease trajectory, warranting efficient tailored care and support for both groups immediately after diagnosis.

Interoceptive awareness, the conscious perception of internal bodily states, is a key construct of mind-body interaction. Decreases in interoceptive awareness, as measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA), are found in chronic pain patients. In this study, we explored whether a specific aspect of interoceptive awareness is a risk for the onset and chronicity of pain. A longitudinal cohort study was conducted in 2018 and 2020 among a sample of full-time workers in an industrial manufacturing company in Japan. Participants completed a questionnaire on pain intensity, MAIA, exercise habits, kinesiophobia, psychological distress and work stress. Principal component analyses using the MAIA identified two principal components: self-control and emotional stability. Low emotional stability was associated with the prevalence of moderate to severe pain in 2020 among people with mild or no pain in 2018 (p < 0.01). Lack of exercise habits were associated with the prevalence of moderate to severe pain in 2020 among people with pain in 2018 (p < 0.01). Furthermore, exercise habits were associated with reduction in kinesiophobia among people with moderate to severe pain in 2018 (p = 0.047). Overall, these findings indicate that low emotional stability may be a risk for the onset of moderate to severe pain; lack of exercise habits may sustain kinesiophobia and be a risk for the chronicity of pain.

Background: Cancer incidence in the world is predicted to increase in the next decade. While progress has been in diagnosis and treatment, much still remains to be done to improve cancer pain therapy, mainly in underserved communities in low-income countries. Objective: To determine knowledge, beliefs, and barriers regarding pain management in both high- and low-income countries (according to the WHO classification); and to learn about ways to improve the current state of affairs. Design: Descriptive survey. Setting/Subjects: Fifty-six countries worldwide; convenience sample of 1639 consisted of 36.8% physicians; 45.1% nurses, and 4.5% pharmacists employed in varied settings. Results: Improved pain management services are key elements. Top barriers include religion factors, lack of appropriate education and training at all levels, nonadherence to guidelines, patients' reluctance to report on pains, over regulation associated with prescribing and access to opioid analgesics, fear of addiction to opioids, and lack of discussions around prognosis and treatment planning. Conclusion: The majority of patients with cancer in low-income countries are undertreated for their pain. Promoting cancer pain accredited program of training and education on pain management for physicians and nurses is crucial, as well as advocating policymakers and the public at large. Keywords: cancer; global; management; opioids; pain.

This study aimed to examine the prevalence and associated factors of perceived cancer-related stigma among Japanese cancer survivors. In this web-based survey involving 628 Japanese cancer survivors, perceived cancer-related stigma, quality of life (Quality of Life-Cancer Survivors Instrument), psychological distress (K6) and perceived social support (multidimensional scale of perceived social support) were evaluated. Perceived cancer-related stigma was endorsed by 61.2% of the participants. Perceived cancer-related stigma was significantly associated with quality of life (R = 0.35–0.37), psychological distress (R = 0.35) and perceived social support (R = 0.10). Logistic regression analysis demonstrated that cancer survivors at younger ages (odds ratio = 0.96), with low income (odds ratio = 2.49), with poorer performance status (odds ratio = 2.33), and with breast, urinary or gynecological cancers (odds ratio = 4.27, 4.01, 4.01, respectively) were at higher risk for perceived cancer-related stigma.

Background The Japanese Psycho-Oncology Society and Japanese Association of Supportive Care in Cancer recently launched the clinical practice guidelines for delirium in adult cancer patients. The aim of the guidelines was to provide evidence-based recommendations for the clinical assessment and management of delirium in cancer patients. This article reports the process of developing the guideline and summarizes the recommendations made. Methods The guidelines were developed in accordance with the Medical Information Network Distribution Service creation procedures. The guideline development group, consisting of multidisciplinary members, formulated nine clinical questions. A systematic literature search was conducted to identify relevant articles published prior to through 31 May 2016. Each article was reviewed by two independent reviewers. The level of evidence and the strength of the recommendations were graded using the grading system developed by the Medical Information Network Distribution Service, following the concept of The Grading of Recommendations Assessment, Development and Evaluation system. The modified Delphi method was used to validate the recommendation statements. Results This article provides a summary of the recommendations with rationales for each, as well as a short summary. Conclusions These guidelines will support the clinical assessment and management of delirium in cancer patients. However, additional clinical studies are warranted to further improve the management of delirium., The Japanese Psycho-Oncology Society and Japanese Association of Supportive Care in Cancer launched the guidelines for delirium. This article reports the process of developing the guideline and summarizes the recommendations.

IntroductionAn easy-to-access and effective psychotherapy for bereaved informal caregivers has not been established. People with higher self-compassion status tend to have lower bereavement related grief, psychotherapy focused on self-compassion can be promising for this population. This study aimed to examine the feasibility of online self-compassion focused psychotherapy for bereaved informal caregivers.Method and analysisA total of 60 study participants will undergo an intervention programme comprising online sessions of 2 hours per week for five consecutive weeks and undertake postsession work. The intervention personnel will comprise psychologists who have received more than 10 hours of structured training. The primary endpoint will be assessed on the intervention completion rate, with secondary endpoints consisting of the Complicated Grief Questionnaire, Patient Health Questionnaire-9, Generalised Anxiety Disorder-7, Brief Resilience Scale and Self-Compassion Scale. Evaluations will be conducted preintervention, immediately after intervention, and 4 and 12 weeks after intervention.Ethics and disseminationThis study has been reviewed and approved by the Ethics Committee of the Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital, Japan (Approved ID: C1565). The results of this study will be disseminated through publication in a peer-reviewed journal and conference presentations.Trial registration numberUMIN000048554.

ObjectivesTo deliver mindfulness-based cognitive therapy (MBCT) efficiently, the present study aimed (1) to identify predictors and moderators of patients who benefit from MBCT for psychological distress and (2) to explore the initial treatment reaction to identify the optimal number of sessions that produce a significant clinical effect.MethodsThis is the secondary analysis of a randomized controlled trial of MBCT for breast cancer patients (N = 74). We classified the participants into remitters vs. non-remitters, and responder vs. non-responders, according to the total score of the Hospital Anxiety and Depression Scale at the end of the intervention. We conducted multivariate analyses to explore for predictors of response and remission. We adopted generalized estimating equations to explore the optimal number of sessions.ResultsSociodemographic and clinical backgrounds did not have significant influence on the treatment outcomes of the MBCT. Better program adherence, which was represented as the participants’ better attendance to the MBCT program, was a significant predictor of both remission and response [odds ratio (OR) = 1.90, 95% confidence interval (CI) 1.25–2.89, p = 0.003, and OR = 1.72, 95% CI 1.12–2.65, p = 0.013, respectively]. It was not until seventh session that the remission rate exceeded 50% and the response rate showed significance.Significance of resultsSociodemographic and clinical characteristics did not significantly influence the treatment outcomes, while homework minutes and class attendance had significant effects on treatment outcomes. This implies that MBCT is recommended to any cancer patient, if he/she is motivated to the program, regardless of their sociodemographic and clinical characteristics. Patients are encouraged to attend a standard MBCT program (eight sessions) and do the assigned homework as intensely as possible. Further studies with larger sample and objective measurements are desired.

ObjectivesWork performance has been known to be influenced by both psychological stress (mind) and physical conditions (body). The aim of this study was to investigate the association between work performance and ‘body trusting’, which is a dimension of interoceptive awareness representing mind–body interactions.MethodsA cross-sectional study was conducted among a sample of workers in an industrial manufacturing company in Japan. Participants were assessed with a self-reported questionnaire including evaluations of work performance, body trusting, psychological distress, pain persistence, workplace and home stressors, and workaholism. Participants’ sociodemographic, health and lifestyle characteristics were collected from their annual health check data. The association between work performance and body trusting was examined using multivariable regression analyses in the overall sample and in a subsample of people with pain.ResultsA total of 349 workers participated in the study. A significant association between work performance and body trusting was observed, with higher body trusting representing higher work performance. The association was significant after controlling for psychological distress, workplace and home stress, workaholism and participants’ characteristics (pConclusionsWorkers with higher body trusting showed higher work performance, even after controlling for various influencing factors. Body trusting may be an important target to promote work performance and to prevent loss of performance induced by health problems.

Spitz nevus is an important differential diagnosis of malignant melanoma, especially in young adults. This case provides a significant information about unusual dermoscopic features of adult Spitz nevus, which may reflect changes over the years.

Suicide is a leading cause of death among Japanese college and university students. Our previous study showed that the gatekeeper training (GKT) program significantly improved competence and confidence in the management of suicidal students in university administrative staff. However, we could not determine which component of the program was effective, nor if this program was effective for university teachers as well. In the current study, 81 university teachers were recruited; 63 of them received a general mental health lecture (MHL) and 18 of them received a 2.5 -h GKT program based on the Mental Health First Aid program. Competence and confidence in managing suicide intervention and behavioral intention as a gatekeeper were assessed by a self-report questionnaire before and immediately after the intervention. As a result, we found a significant improvement in competence in the management of suicidal students in the GKT group compared to the MHL group. We also found significant improvements in confidence in the management of suicidal students and behavioral intention as gatekeepers in the GKT group, although the questionnaires for these outcomes were not validated. The program satisfaction score was significantly higher in the GKT group than in the MHL group. To our knowledge, this is the first study to evaluate a GKT program for university teachers in Japan. By comparing the two groups, we explicitly confirmed that active involvement of the participants is crucial for effective suicide prevention training.

Background Patient participation is a key foundation of advance care planning (ACP). However, a patient himself/herself may be left out from sensitive conversations such as end-of-life (EOL) care discussions. The objectives of this study were to investigate patients’ participation rate in the discussion of Cardiopulmonary Resuscitation (CPR) / Do-Not-Attempt-Resuscitation (DNAR) order, and in the discussion that the patient is at his/her EOL stage (EOL disclosure), and to explore their associated factors. Methods This is a retrospective chart review study. The participants were all the patients who were hospitalized and died in a university-affiliated teaching hospital (tertiary medical facility) in central Tokyo, Japan during the period from April 2018 to March 2019. The following patients were excluded: (1) cardiopulmonary arrest on arrival; (2) stillbirth; (3) under 18 years old at the time of death; and (4) refusal by their bereaved family. Presence or absence of CPR/DNAR discussion and EOL disclosure, patients’ involvement in those discussions, and their associated factors were investigated. Results CPR/DNAR discussions were observed in 336 out of the 358 patients (93.9%). However, 224 of these discussions were carried out without a patient (patient participation rate 33.3%). Male gender (odds ratio (OR) = 2.37 [95% confidence interval (CI) 1.32–4.25]), living alone (OR = 2.51 [1.34–4.71]), and 1 year or more from the date of diagnosis (OR = 1.78 [1.03–3.10]) were associated with higher patient’s participation in CPR/DNAR discussions. The EOL disclosure was observed in 341 out of the 358 patients (95.3%). However, 170 of the discussions were carried out without the patient (patient participation rate 50.1%). Patients who died of cancer (OR = 2.41[1.45–4.03]) and patients without mental illness (OR=2.41 [1.11–5.25]) were more likely to participate in EOL disclosure. Conclusions In this clinical sample, only up to half of the patients participated in CPR/DNAR discussions and EOL disclosure. Female, living with family, a shorter period from the diagnosis, non-cancer, and mental illness presence are risk factors for lack of patients’ participation in CPR/DNAR or EOL discussions. Further attempts to facilitate patients’ participation, based on their preference, are warranted.

Background Previous studies have indicated that higher subjective well-being works as a protective factor for health. Some studies have already shown the effects of mindfulness-based interventions on improving subjective well-being. However, these studies targeted specific populations rather than the general public. Furthermore, they assessed either life evaluation or affective aspects of subjective well-being rather than the concept as a whole, including the eudemonic aspect of well-being. Objective This study aims to investigate the effectiveness and cost-effectiveness of mindfulness-based cognitive therapy (MBCT) for improving the wholistic aspects of subjective well-being in healthy individuals. Methods This study was an 8-week, randomized, parallel-group, superiority trial with a 2-month follow-up. Healthy individuals aged 20-65 years with scores lower than 25 on the Satisfaction With Life Scale (SWLS) were eligible to participate and randomly allocated to the MBCT group or the wait-list control group. The intervention program was developed by modifying an MBCT program to improve the well-being of a nonclinical population. The primary outcome was the difference between the two groups in mean change scores from the baseline on the SWLS. The secondary outcomes included scores on the Flourishing Scale and the Scale of Positive and Negative Experience as well as the incremental cost-effectiveness ratio. Results This study began recruiting participants in July 2018 and recruitment was completed at the end of September 2019. Data collection and dataset construction was completed by the end of March 2020. Conclusions This study is unique in that it investigates MBCT’s effects on the three different aspects of subjective well-being: life evaluation, affect, and eudemonia. It is limited, as the specific effect attributable to MBCT cannot be detected because of the lack of an active control group. Trial Registration University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000031885; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036376 International Registered Report Identifier (IRRID) DERR1-10.2196/15892

Background Augmented mindfulness-based cognitive therapy (MBCT) with treatment as usual (mainly pharmacotherapy) is reported to be effective after treatment for anxiety disorders. However, whether its effectiveness persists in the long term is unclear. Objective This study aims to examine the feasibility, acceptability, and effectiveness of a follow-up program by conducting a feasibility randomized controlled trial (RCT) that compares augmented MBCT with follow-up sessions and that without follow-up sessions in preparation for a definitive RCT. Methods The study involves an 8-week MBCT with a 10-month follow-up. Patients aged 20 to 65 years who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for panic disorder, agoraphobia, or social anxiety disorder, which is not remitted with usual treatment for at least 4 weeks, will be included in the study and randomly allocated to receive augmented MBCT with follow-up sessions or augmented MBCT without follow-up sessions. For this feasibility RCT, the primary outcomes are (1) study inclusion rate, (2) dropout rate, (3) attendance rate, and (4) mean and standard deviation of several clinical measures at 8 weeks and 5, 8, and 12 months. Results We started recruiting participants in January 2020, and 43 participants have been enrolled up to January 2021. The study is ongoing, and data collection will be completed by May 2022. Conclusions This study is novel in terms of its design, which compares augmented MBCT with and without follow-up sessions. The limitations of the trial are as follows: (1) mixed participants in terms of the delivery mode of the intervention, and (2) lack of a pharmacotherapy-alone arm. Owing to its novelty and significance, this study will provide fruitful knowledge for future definitive RCTs. Trial Registration UMIN Clinical Trials Registry UMIN000038626; https://tinyurl.com/2p9dtxzh International Registered Report Identifier (IRRID) DERR1-10.2196/33776

While vast opportunities for using qualitative methods exist within palliative care research, few studies provide practical advice for researchers and clinicians as a roadmap to identify and utilize such opportunities.To provide palliative care clinicians and researchers descriptions of qualitative methodology applied to innovative research questions relative to palliative care research and define basic concepts in qualitative research. Body: We describe three qualitative projects as exemplars to describe major concepts in qualitative analysis of early palliative care: (1) a descriptive analysis of clinician documentation in the electronic health record, (2) a thematic content analysis of palliative care clinician focus groups, and (3) a framework analysis of audio-recorded encounters between patients and clinicians as part of a clinical trial.This study provides a foundation for undertaking qualitative research within palliative care and serves as a framework for use by other palliative care researchers interested in qualitative methodologies.

Background: To monitor quality of life (QOL) for patients with cancer in a large population-based survey, we developed a short QOL and quality-of-care (QOC) questionnaire. To determine the validity and reliability of this new questionnaire for evaluating QOL in patients with cancer. Methods: Outpatients and inpatients at National Cancer Center Hospital East were administered a questionnaire, including the following items—the short QOL and QOC questionnaire (physical distress, pain, emotional distress, walk burden, and need for help with self-care; perceived general health status; and satisfaction with medical care and treatment by doctor, communication with doctor, support by health-care staff other than doctor, care for physical symptoms such as pain, and psychological care), the Functional Assessment of Cancer Therapy—General (FACT-G), the Cancer Care Evaluation Scale (CCES) for patients, and demographic and medical data. We then readministered the short QOL and QOC questionnaire. Results: In total, 329 outpatients and 239 inpatients completed the survey (response rates: 80% and 90%, respectively). Total Cronbach α for the short QOL and QOC questionnaire was 0.83 for outpatients and 0.82 for inpatients. Items of the questionnaire correlated with cancer-specific measurements, FACT-G, and CCES. Intraclass correlation coefficients for all items of the questionnaire were 0.79 and 0.89 in each setting. Items of QOL and QOC did not correlate with each other. Conclusion: The validity and reliability of the short QOL and QOC questionnaire appear sufficient. This questionnaire enables continuous monitoring of patient QOL in large population-based surveys.

AIM The primary objective of this study was to examine the effectiveness of mindfulness-based cognitive therapy (MBCT) in secondary-care settings where the vast majority of the patients have already undergone pharmacotherapy but have not remitted. METHODS Eligible participants were aged between 20 and 75 years and met the criteria for panic disorder/agoraphobia or social anxiety disorder specified in the DSM-IV. They were randomly assigned to either the MBCT group (n = 20) or the wait-list control group (n = 20). The primary outcome was the difference in mean change scores between pre- and post-intervention assessments on the State-Trait Anxiety Inventory (STAI). The outcome was analyzed using an intent-to-treat approach and a mixed-effect model repeated measurement. RESULTS We observed significant differences in mean change scores for the STAI State Anxiety subscale (difference, -10.1; 95% confidence interval, -16.9 to -3.2; P

ObjectiveWearable devices such as a wrist actigraph may have a potential to objectively estimate patients’ functioning and may supplement performance status (PS). This proof-of-concept study aimed to evaluate whether actigraphy data are significantly associated with patients’ functioning and are predictive of their survival in patients with metastatic non-small cell lung cancer.MethodWe collected actigraphy data for a three-day period in ambulatory patients with stage IV non-small cell lung cancer. We computed correlations between actigraphy data (specifically, proportion of time spent immobile while awake) and clinician-rated PS, subjective report of physical activities, quality of life (the Functional Assessment of Cancer Therapy – Trial Outcome Index), and survival.ResultActigraphy data (the proportion of time awake spent immobile) were significantly correlated with Functional Assessment of Cancer Therapy – Trial Outcome Index (r= −0.53,p< 0.001) and with the Eastern Cooperative Oncology Group PS (ECOG PS) (r= 0.37,p< 0.001). The proportion of time awake spent immobile was significantly associated with worse survival. For each 10% increase in this measure, the hazard ratio (HR) was 1.48 (95% confidence interval [CI95%] = 1.06, 2.06) for overall mortality, and odds ratio was 2.99 (CI95%= 1.27, 7.05) for six-month mortality. ECOG PS was also associated with worse survival (HR = 2.80,CI95%= 1.34, 5.86). Among patients with ECOG PS 0-1, the percentage of time awake spent immobile was significantly associated with worse survival, HR = 1.93 (CI95%= 1.10, 3.42), whereas ECOG PS did not predict survival.Significance of ResultsActigraphy may have potential to predict important clinical outcomes, such as quality of life and survival, and may serve to supplement PS. Further validation study is warranted.

Objective Guidelines for supportive care in cancer patients have recommended routine psychological screening in clinical practice, and a Japanese national project has recommended screening for depression using the Distress and Impact Thermometer. However, a previous study advocating the validity of the Distress and Impact Thermometer may have overestimated its effectiveness, as the study included already-treated patients who were not screening targets. This study re-evaluated the performance and usefulness of the Distress and Impact Thermometer using an adequate sample size and appropriate study design. Methods Patients were consecutively recruited at two highly specialized hospitals and three university hospitals in Japan. Inclusion criteria were (i) undergoing aggressive anti-cancer treatment, (ii) the Eastern Cooperative Oncology Group performance status score 20 years. Patients who were receiving psychiatric treatment were excluded from the study. After completing the Distress and Impact Thermometer, patients were evaluated with the gold-standard Composite International Diagnostic Interview by researchers who were blinded to the patients' Distress and Impact Thermometer scores. Results Forty-four patients (9%) who were receiving psychiatric treatment were excluded. Of 468 subjects included in the final analysis, only 3 had current depression (0.6%). Using cutoff points recommended by the previous study, the positive and negative predictive values were 0.02 and 0.99, respectively. Conclusions Our data indicated that screening for untreated depression in cancer patients was not useful in the specific clinical settings that were studied, and such screening should be implemented in appropriate contexts. Since there are no evidence-based recommendations regarding contexts in which psychological screening is essential, further research is needed.

IntroductionIt has been suggested that palliative care integrated into standard cancer treatment from the early phase of the disease can improve the quality of life of patients with cancer. In this paper, we present the protocol for a multicentre randomised controlled trial to examine the effectiveness of a nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer.Methods and analysisA total of 206 patients will be randomised (1:1) to the intervention group or the control group (usual care). The intervention, triggered with a brief self-administered screening tool, comprises comprehensive need assessments, counselling and service coordination by advanced-level nurses. The primary outcome is the Trial Outcome Index of the Functional Assessment of Cancer Therapy (FACT) at 12 weeks. The secondary outcomes include participants’ quality of life (FACT-Lung), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), illness perception (Prognosis and Treatment Perceptions Questionnaire), medical service use and survival. A mixed-method approach is expected to provide an insight about how this intervention works.Ethics and disseminationThis study has been approved by the Institutional Review Board of the National Cancer Center Japan (approval number: 2016-235). The findings will be disseminated through peer-reviewed publications and conference presentations and will be reflected on to the national healthcare policy.Trial registration numberUMIN000025491.

AIM: Suicide has been a leading cause of death among Japanese college and university students. Gatekeeper-training programs have been shown to improve detection and referral of individuals who are at risk of suicide by training non-mental health professional persons, but no study have investigated effectiveness of such programs in university settings in Japan. The aim of this study is to investigate the effectiveness of gatekeeper-training program for administrative staff in Japanese universities. METHODS: We developed a 2.5 hours gatekeeper-training program based on the Mental Health First Aid program, which was originally developed for the general public. Seventy-six administrative staff in Hokkaido University participated in the program. Competence and confidence in managing suicide intervention, behavioral intention as a gatekeeper and attitude while handling suicidal students were measured by a self-reported questionnaire before, immediately after and a month after the program. RESULTS: We found a significant improvement in competence in the management of suicidal students. We also found improvements in confidence in management of suicidal students and behavioral intention as a gatekeeper after training, though questionnaires for those secondary outcomes were not validated. These improvements continued for a month. About 95% of the participants rated the program as useful or very useful and one-third of the participants had one or more chances to utilize their skill within a month. CONCLUSION: The current results suggest positive effects of the training program in university settings in Japan. Future evaluation that includes comparison with standard didactic trainings and an assessment of long-term effectiveness are warranted. Language: en

Depression is common among cancer patients and their families, and may lead to substantial clinical consequences. Clinicians should routinely screen cancer patients for comorbid depression and should provide appropriate care at both primary and specialized care levels. Good quality care is beneficial not only for cancer patients themselves but also for their family members. It includes good communication between patients and health providers, and addressing of unmet needs of cancer patients. Specialized care comprises pharmacotherapy and psychotherapy. The advancement of psychotherapy for cancer patients parallels the advancement of general psychotherapy. Among the many types of psychotherapies, mindfulness-based interventions have been attracting growing attention. Some relevant studies that have been conducted in Keio University Hospital are described herein.

Objectives Mindfulness-based intervention has been receiving growing attention in cancer care. This study aimed to examine feasibility and to preliminary explore effectiveness of mindfulness-based cognitive therapy (MBCT) in Japanese breast cancer patients, and to explore possible modification of the program so that it fits better with this population. Methods Twelve participants with diagnosis of Stage I-III breast cancer received an eight session, weekly MBCT intervention in a group therapy format. The participants were followed up until 3 months after the completion of the program. Results All the participants completed the program with high attendance rate (mean number of attended sessions = 7.7). Significant improvement in anxiety (Hospital Anxiety and Depression Scale (HADS) - anxiety subscale; effect size Cohen's d = 0.88, P < 0.05), trauma-related psychological symptoms (Impact of Event Scale-revised; d = 0.64, P < 0.01) and quality of life (Functional Assessment of Cancer Therapy-Breast Cancer: FACT-B; d = 0.72, P < 0.01), and trend-level improvement in depression (HADS - depression subscale; d = 0.53, P = 0.054) were observed. Qualitative analyses suggested the program may be beneficial for alleviating fear of cancer recurrence and for increasing spiritual well-being. Some recommended modification of the program was indicated from the post-intervention interviews. Conclusions Mindfulness-based cognitive therapy was well accepted by Japanese breast cancer patients and yielded favorable effect on their psychological status and quality of life. Further effectiveness study in a randomized-control design is warranted.

Little is known about the association between quality of end-of-life care of a patient and complicated grief among bereaved family members.This study aims to examine the impact of quality of end-of-life care on complicated grief among bereaved family members in a Japanese general population sample.A mail-based cross-sectional questionnaire survey was used. A total of 641 individuals aged 40 to 79 years in the general population who lost their loved one within the period between 6 months and 10 years were enrolled. Complicated grief was assessed using the Brief Grief Questionnaire, and the bereaved family members' perceptions on quality of end-of-life care were assessed using the Care Evaluation Scale and the Good Death Inventory. Logistic regression analysis was used to identify the variables that associated with possible complicated grief.Possible complicated grief was observed in 24.5% of the participants. Three components of quality of end-of-life care, namely, dissatisfaction with the explanation to the family about the patient's expected outcome, unreasonable cost of care, and family's perception that the deceased person had not achieved a sense of completion about his or her life, were significantly associated with possible complicated grief. Spousal relationship, primary caregiver, and high psychological distress also had significant association.Perceptions on quality of end-of-life care were significantly associated with complicated grief. Providing sufficient information to patients' family about expected outcome and enhancing patients' sense of completion about their life may prevent bereaved family members from developing complicated grief.

Patient suicide is a tragic occurrence, and it can be a demoralizing experience for medical residents. Few studies, however, have assessed suicide management skills among these front-line healthcare professionals. This study evaluated the self-assessed competence and confidence of medical residents with regard to the management of potentially suicidal patients and assessed the correlation with the residents' background characteristics.The authors conducted a multicenter, cross-sectional survey of 114 medical residents in Japan, using a modified version of the Suicide Intervention Response Inventory (SIRI-2), the Medical Outcomes Study 8-Item Short-Form Health Survey (SF-8), and a 5-point Likert scale to assess confidence in suicide management.A majority (89.5%) of the residents rated their confidence in managing suicidal patients as Not At All Confident or Rather Not Confident, although most were close to completing their psychiatric rotation. Results on the SIRI-2 suggested intermediate competence in managing suicidal behavior, as compared with that of other healthcare professionals. Competence as indicated by the SIRI-2 score was weakly and negatively correlated with the score for self-perceived Vitality on the SF-8 scale.Insufficient skills and lack of confidence in the management of suicidal patients was observed in this sample of Japanese medical residents, thus highlighting the need for improved suicide-management programs for junior medical residents in Japanese hospitals.

Objective:Physical and psychological symptoms in cancer patients are frequently overlooked by medical staff. However, little is known regarding the potential impacts of concurrent physical and psychological symptoms on the overlooking of other symptoms. The aim of this study was to examine the impact of concurrent symptoms on the overlooking of other symptoms in cancer inpatients.Method:A total of 255 cancer inpatients in the general wards of one university hospital, who were referred to the palliative care team, were included. On the day of referral, nurses and patients were independently assessed for the presence of the following eight symptoms: pain, fatigue, nausea and vomiting, shortness of breath, lack of appetite, dry mouth, sleep problems, and distressed feelings. The presence of delirium was also separately assessed by nurses and psychiatrists on the team. A total of nine symptoms detected by nurses and those reported by patients or psychiatrists were compared, and logistic regression analysis was performed to identify the variables associated with the overlooking of these symptoms.Results:The most frequently reported symptom was pain (76.5%), followed by distressed feelings (49.8%), sleep problems (34.1%), and delirium (25.1%). The proportion of those overlooked was more than one quarter (25.0–63.6%) for all symptoms except pain (12.8%). Significant associations were found between the overlooking of shortness of breath and concurrent delirium (odds ratio [OR] = 110.9); the overlooking of sleep problems and concurrent lack of appetite (OR = 9.1); and the overlooking of distressed feelings and concurrent dry mouth (OR = 27.7). No patient demographic characteristic was associated with the overlooking of any other symptoms.Significance of results:The presence of some specific concurrent symptoms is likely to lead to the overlooking of other symptoms in cancer inpatients by nurses. Comprehensive assessments of physical and psychological symptoms in daily clinical practice are needed.

Background: Chronic urticaria (CU) appears to be of autoimmune origin in about half of all patients, since several autoreactive immunoglobulin Gs (IgGs), such as anti-FcεRIα and anti-IgE, are detected in the sera of such patients. However, whether autoreactive IgE is associated with CU remains unclear. In this study, we attempted to identify autoreactive IgE antibodies in sera from patients with CU. Methods: Sera were collected from 67 normal subjects, 85 patients with CU and 28 patients with atopic dermatitis (AD). An autologous serum skin test (ASST) was performed on 27 of the CU patients. Autoreactive IgE and IgG levels against self-antigens were measured using enzyme-linked immunosorbent assays. The basophils were activated with dsDNA, and the CD63 expression level was examined using a fluorescence-activated cell sorter. Results: The anti-dsDNA IgE levels were significantly higher in patients with CU and AD than in normal subjects, but no differences in the anti-dsDNA IgG levels were seen. The levels of thioredoxin-, peroxiredoxin- and thyroglobulin-reactive IgE and IgG were not significantly higher in the CU patients than in the other 2 groups. There was no significant difference in the levels of anti-dsDNA IgE between ASST-positive and ASST-negative patients. The basophils from 2 out of 9 CU patients exhibited degranulation in response to dsDNA. Conclusions: Our data suggest that anti-dsDNA IgE is involved in the pathogenesis of some cases of CU.

Objective: Collaboration between psychiatry and palliative medicine has the potential to enhance the quality of medical practice. The integration between palliative care and psychiatry has been attempted only in discrete medical settings and is not yet firmly established as an institution. Our objective was to determine the availability and degree of integration between psychiatric consultation-liaison services and palliative care in Japan. Methods: A survey questionnaire was mailed to consultation-liaison psychiatrists at 375 government-designated cancer hospitals regarding their consultation-liaison services. Results: A total of 375 survey questionnaires were sent to consultation-liaison psychiatrists, with a response rate of 64.8%. Designated cancer hospitals with approved palliative care teams were significantly more likely to have a consultation-liaison psychiatrist in the palliative care team than those in non-approved palliative care teams [80/80 (100%) versus 110/153 (73%); P ¼ 0.008]. Approved palliative care teams had double the number of referrals, conducted rounds more frequently and held conferences more frequently. Psychiatrists of the approved palliative care teams spent more of their time on palliative care consultations, adhered more closely to consultation processes and contributed more actively to the integration of developmental perspectives in treatment plans. Conclusions: In Japan, most designated cancer hospitals with approved palliative care teams were more likely to integrate psychiatric consultation-liaison services into their palliative care programs. Systematic strategies for integration between palliative care and consultationliaison psychiatry would contribute to the provision of appropriate psychosocial care for cancer patients and families at all stages.

Cognitive therapy/cognitive behavior therapy was introduced into the field of psychiatry in the late 1980s in Japan, and the Japanese Association for Cognitive Therapy (JACT), founded in 2004, now has more than 1500 members. Along with such progress, awareness of the effectiveness of cognitive therapy/cognitive behavioral therapy has spread, not only among professionals and academics but also to the public. The Study Group of the Procedures and Effectiveness of Psychotherapy, funded by the Ministry of Health, Labor and Welfare, has conducted a series of studies on the effectiveness of cognitive therapy/cognitive behavior therapy since 2006 and shown that it is feasible for Japanese patients. As a result, in April 2010 cognitive therapy/cognitive behavior therapy for mood disorders was added to the national health insurance scheme in Japan. This marked a milestone in Japan's psychiatric care, where pharmacotherapy has historically been more common. In this article the authors review research on cognitive therapy/cognitive behavior therapy in Japan.

Aim: This study aimed to test reliability and validity of the Japanese-version Cognitive Therapy Awareness Scale, a self-rating scale that measures basic knowledge of cognitive behavioral therapy (CBT) concepts and methodology. Furthermore, we explored optimal cutoff score to demonstrate required standard of CBT competency. Methods: The reliability and validity of the scale was tested among 252 mental health professionals. The participants' number of readings relevant to CBT, as well as their experience in training and practice in CBT were used as external standards of competency. Results: The scale has good internal consistency (the Kuder-Richardson formula 20 = 0.76). The total score of the scale was significantly correlated with experience in training and practice in cognitive behavioral therapy, and the number of relevant readings (Spearman's rho = 0.27, 0.28 and 0.44, respectively, P

Psychiatry has been strongly influenced by culture, society, history and the prevailing public needs of the particular country.1–3 Accordingly, psychiatric training systems differ from country to country, which might be a mirror of the particular country's current situation and its future prospects toward mental health.4 A well-balanced view toward psychiatry, which is often described as a ‘biopsychosocial model of psychiatry’, has been proclaimed as ideal. However, recent increasing demand for biological factors of psychiatry presents a potential gap between expected and actually acquired skills in terms of psychosocial factors, leading younger psychiatrists to fall between mind–brain (or mind–body) dichotomy.5–8 How do young psychiatrists (in this article, ‘young psychiatrists’ are defined as psychiatric residents, trainees, and certified psychiatrists with clinical experience of 10 years or fewer) see themselves from biopsychosocial perspectives? Do they define themselves as doctors of the ‘brain’, doctors of the ‘mind’, or doctors who address sociocultural issues? The answer may be influenced by multiple factors, including their original motivation to become psychiatrists, their domains of interests, and the level of acquired skills and education/training undertaken. Facing recent sociocultural changes, such as aging society and high suicide rate, Japan implemented a new system of postgraduate medical education (PGME) in 2004. Until that time, psychiatric residents would start their psychiatric training immediately after graduating from medical school, join a specific clinical department of psychiatry in medical universities, known as ikyoku,9 and rotate through psychiatric hospitals.9–11 Therefore, under the pre-2004 PGME system, psychiatrists used to devote most of their time to psychiatry11 and have very little experience with medical approaches epitomized by evidence-based medicine and the systematic problem–solution approach. Since 2004, a two-year general residency has been required of medical graduates,12–14 in order to improve basic clinical skills of all medical doctors in primary care settings.15 In this new PGME system, first-year residents rotate in internal medicine, surgery, emergency medicine and anesthesiology, and second-year residents rotate in pediatrics, community medicine, obstetrics/gynecology and psychiatry for at least one month each. Thereafter, residents start their specialty training, including psychiatry, for up to 4 years.9 The balance among biological, psychological and sociocultural orientations may have been influenced by the implementation of the new PGME system. We hypothesized that psychiatrists trained in the new PGME system might lay more emphasis on biological factors because of their two-year rotation in medicine. Thus, the present study aimed to explore the balance among biological, psychological and sociocultural factors in young psychiatrists' attitudes – namely, to explore whether young psychiatrists consider themselves doctors of ‘brain’, doctors of ‘mind’, or doctors who address sociocultural issues. Changes in their attitudes before and after implementation of the new PGME system, as well as possible contributing factors, were also explored. The same questionnaire was distributed to both psychiatrists in and out of Japan, in order to highlight their differences.

Aim: Suicide is associated not only with primary psychiatric disorders but also with physical disorders. Physicians' education on suicide prevention contributes to reducing suicide. Therefore, medical residents, who contact patients daily and who eventually become primary physicians in each specialty, might be the most appropriate candidates for intervention. In this article, we introduce our newly developed suicide intervention program among medical residents. Methods: We developed a 2-hour suicide intervention program among medical residents, based on the Mental Health First Aid (MHFA), which had originally been developed for the public. The program contains a 1-hour lecture and a 1-hour role-play session. As the first pilot trial, we conducted the program among 44 first-year medical residents at a university hospital and evaluated its effectiveness. Changes in confidence, attitudes and behavior toward suicidal people were evaluated using self-reported questionnaires before, immediately after, and 6 months after the program. Results: Participants' confidence and attitudes significantly improved after the program. The total mean score (standard deviation) of the Suicide Intervention Response Inventory improved from 18.4 (2.0) before the intervention to 19.4 (2.0) immediately after the intervention. However, the effectiveness was limited after 6 months. In the course of 6 months, the participants learned to apply the MHFA principles in their daily clinical practice. Conclusion: Our newly developed brief suicide intervention program demonstrating its effectiveness among medical residents should be modified in order to be more effective in the long term. The next trial with a control group ought to be conducted to evaluate our developed program.

Objective: Major depression is expected to become the second leading contributor to disease burden worldwide by 2020. Only a few studies, however, have compared the cost-effectiveness of a combination of cognitive behavioural therapy and antidepressant therapy versus antidepressant therapy alone. The purpose of the present study was therefore to analyse cost-effectiveness, from the perspective of the health-care system and also from a social perspective, comparing combined cognitive behavioural therapy + antidepressant therapy and antidepressant therapy alone in the Japanese setting. Method: A formal decision analytical model was constructed. The analyses were performed from both the perspective of the health-care system and the societal perspective. The clinical outcomes were determined from published articles and reports of expert panels. Because no patient-level data were available, deterministic costing of the different treatment strategies was carried out. Cost-effectiveness was assessed first by determining the incremental cost-effectiveness ratio (ICER) per successfully treated patient, and then by the ICER per quality-adjusted life years (QALYs). Results: The combined therapy increased the rate of successfully treated patients, QALY of severe depression and QALY of moderate depression by 0.15, 0.08 and 0.04, respectively. The combined therapy proved to be more expensive from the health-care system perspective, but the incremental costs were completely offset by the considerable reduction of productivity loss from the social perspective. From the health-care perspective, the ICER per successfully treated patient, ICER per QALY of severe depression and ICER per QALY of moderate depression were JPY 140 418, JPY 268 550 and JPY 537 100, respectively. All the ICERs appeared to be negative from the social perspective. Conclusion: The combined therapy appeared to be cost-effective from the health-care system perspective and the dominant strategy from the social perspective.

Objective The authors compared early-career psychiatrists’ selection of psychological treatments for patients with mild to moderate major depressive disorder (MDD) in the US and Japan. Methods A total of 120 early-career psychiatrists from two residency programs in the US and Japan participated in web-based surveys. The psychiatrists selected first- and second-line psychological treatments in response to two case vignettes of patients with mild and moderate MDD. Results Eighty-one psychiatrists (68 %) returned the surveys, of whom 39 (48 %) were American and 42 (52 %) Japanese. In response to the mild MDD case, more US psychiatrists selected high-intensity psychological treatments (P

Although various factors thought to be correlated with anxiety in cancer patients, relative importance of each factors were unknown. We tested our hypothesis that personality traits and coping styles explain anxiety in lung cancer patients to a greater extent than other factors.A total of 1334 consecutively recruited lung cancer patients were selected, and data on cancer-related variables, demographic characteristics, health behaviors, physical symptoms and psychological factors consisting of personality traits and coping styles were obtained. The participants were divided into groups with or without a significant anxiety using the Hospital Anxiety and Depression Scale-Anxiety, and a binary logistic regression analysis was used to identify factors correlated with significant anxiety using a multivariate model.Among the recruited patients, 440 (33.0%) had significant anxiety. The binary logistic regression analysis revealed a coefficient of determination (overall R(2)) of 39.0%, and the explanation for psychological factors was much higher (30.7%) than those for cancer-related variables (1.1%), demographic characteristics (2.1%), health behaviors (0.8%) and physical symptoms (4.3%). Four specific factors remained significant in a multivariate model. A neurotic personality trait, a coping style of helplessness/hopelessness, and a female sex were positively correlated with significant anxiety, while a coping style of fatalism was negatively correlated.Our hypothesis was supported, and anxiety was strongly linked with personality trait and coping style. As a clinical implication, the use of screening instruments to identify these factors and intervention for psychological crisis may be needed.

IntroductionMajor depression is a serious mental disorder that causes substantial distress and impairment in individuals and places an enormous burden on society. Although antidepressant treatment is the most common therapy provided in routine practice, there is little evidence to guide second-line therapy for patients who have failed to respond to antidepressants. The aim of this paper is to describe the study protocol for a randomised controlled trial that measures the clinical effectiveness of cognitive behavioural therapy (CBT) as an augmentation strategy to treat patients with non-psychotic major depression identified as suboptimal responders to usual depression care.Methods and analysisThe current study is a 16-week assessor-blinded randomised, parallel-groups superiority trial with 12-month follow-up at an outpatient clinic as part of usual depression care. Patients aged 20–65 years with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Major Depressive Disorder who have experienced at least one failed trial of antidepressants as part of usual depression care, will be randomly assigned to receive CBT plus treatment as usual, or treatment as usual alone. The primary outcome is the change in clinician-rated 17-item GRID-Hamilton Depression Rating Scale (GRID-HAMD) score at 16 weeks, and secondary outcomes include severity and change in scores of subjective depression symptoms, proportion of responders and remitters, safety and quality of life. The primary population will be the intention-to-treat patients.Ethics and disseminationAll protocols and the informed consent form comply with the Ethics Guideline for Clinical Research (Japanese Ministry of Health, Labour and Welfare). Ethics review committees at the Keio University School of Medicine and the Sakuragaoka Memorial Hospital approved the study protocol. The results of the study will be disseminated at several research conferences and as published articles in peer-reviewed journals. The study will be implemented and reported in line with the CONSORT statement.Trial registration numberUMIN Clinical Trials Registry: UMIN000001218.

Background Empirical support for cognitive behavioral therapy (CBT) for treating Japanese patients with major depression is lacking, therefore, a feasibility study of CBT for depression in Japanese clinical settings is urgently required. Findings A culturally adapted, 16-week manualized individual CBT program for Japanese patients with major depressive disorder was developed. A total of 27 patients with major depression were enrolled in a single-group study with the purpose of testing the feasibility of the program. Twenty six patients (96%) completed the study. The mean total score on the Beck Depression Inventory-II (BDI-II) for all patients (Intention-to-treat sample) improved from 32.6 to 11.7, with a mean change of 20.8 (95% confidence interval: 17.0 to 24.8). Within-group effect size at the endpoint assessment was 2.64 (Cohen's d). Twenty-one patients (77.7%) showed treatment response and 17 patients (63.0%) achieved remission at the end of the program. Significant improvement was observed in measurement of subjective and objective depression severity (assessed by BDI-II, Quick Inventory of Depressive Symptomatology-Self Rated, and Hamilton Depression Rating Scale), dysfunctional attitude (assessed by Dysfunctional Attitude Scale), global functioning (assessed by Global Assessment of Functioning of DSM-IV) and subjective well-being (assessed by WHO Subjective Well-being Inventory) (all p values < 0.001). Conclusions Our manualized treatment comprised of a 16-week individual CBT program for major depression appears feasible and may achieve favorable treatment outcomes among Japanese patients with major depression. Further research involving a larger sample in a randomized, controlled trial design is warranted. Trial registration UMIN-CTR UMIN000002542.

Many anticoagulant proteins have been found from snake venoms. Recently, (L)-amino acid oxidase (LAO) from the venom of Gloydius blomhoffi, M-LAO, was reported to inhibit coagulation factor IX; however, the mechanism of its anticoagulant activity is still unclear. Here, we re-evaluated the anticoagulant activity of M-LAO. We first purified M-LAO from the venom of G. blomhoffi, and examined the effect of LAO inhibitors and the hydrogen peroxide scavenger, catalase, on the anticoagulant activity of M-LAO. We found that the isolated M-LAO fraction prolongs the APTT, PT and fibrinogen clotting time and cleaves the Aalpha-chain of fibrinogen. LAO inhibitors or catalase did not inhibit these effects. Detailed analysis revealed that the M-LAO fraction contained a small amount of 39-kDa metalloproteinase. The prolongation of clotting time and degradation of fibrinogen were inhibited by a metalloproteinase inhibitor. Therefore, we concluded that the anticoagulant activity of the M-LAO fraction was caused by the 39-kDa metalloproteinase.

The early detection of depression and suicidal ideation is essential for the prevention of suicide in the community. This study therefore aimed to develop a brief screen for depression and suicidal ideation that can be easily administered in primary-care settings. The Self-rating Depression Scale (SDS), the Hospital Anxiety and Depression Scale (HADS) and a modified version of the Composite International Diagnostic Interview (CIDI) were administered by 353 residents of a single community aged 64 years and over. A five-item screen was derived from SDS and HADS, using CIDI as the external criterion (study 1). The scale was modified so that it was more appropriate for our use, and was labeled the Depression and Suicide Screen (DSS). Its validity and reliability were examined among a further 382 residents of the same community aged 64 years and over, using the Short-Form Geriatric Depression Scale (GDS-S) as the external criterion (study 2). The DSS was internally consistent (Cronbach's alpha=0.62). Its reliability in detecting depression (defined as >or= 6 in GDS-S) and suicidal ideation (screened out by the inquiry by our trained staff) was 0.768 and 0.721, respectively. For depression, the sensitivity was 0.705; specificity, 0.729; positive predictive value (PPV), 0.446; negative predictive value (NPV), 0.888; and the overall diagnostic power, 0.723. For suicidal ideation, its sensitivity was 0.698; specificity, 0.693; PPV, 0.317; NPV, 0.926; and overall diagnostic power, 0.694. The DSS demonstrated a reasonable level of sensitivity and specificity in identifying both depression and suicidal ideation among the elderly within a community.