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Abstract 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.

Introduction: Anxiety disorder is one of the most prevalent mental disorders. Mindfulness-based cognitive therapy (MBCT) is effective for treating anxiety disorders. However, no studies have investigated the cost-effectiveness of MBCT for anxiety disorders. We aimed to conduct a cost-effectiveness analysis alongside a randomized controlled trial (RCT) to clarify the cost-effectiveness of MBCT for anxiety disorders. Methods: A cost-effectiveness analysis alongside an RCT was conducted for 8 weeks in 40 patients with anxiety disorders at a university hospital. Patients (1) aged 20–75 years; (2) who were diagnosed with panic disorder/agoraphobia or social anxiety disorder based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria; and (3) who provided written consent were analyzed. The participants were allocated randomly (1:1 ratio) to the augmented MBCT group (i.e., MBCT plus treatment as usual [TAU]) or TAU (waitlist control) group. The cost-effectiveness was assessed using the incremental cost-effectiveness ratio (ICER), which is the ratio of the incremental costs divided by the incremental state-trait anxiety inventory- state (STAI-S), state-trait anxiety inventory- trait (STAI-T), and quality-adjusted life years (QALYs). The QALYs were estimated using The Japanese version of EuroQoL five-dimensional 3-level questionnaire. The unit cost data were derived from the government-regulated fees. This study was conducted from a public healthcare insurance perspective. No discount rates were considered. Results: A total of 38 participants with complete data were included in the analysis. The MBCT was JPY 13,885 more than the cost of TAU and was associated with a STAI-S, STAI-T, and QALY increase of 10.13, 12.00, 0.009 respectively. The ICER were JPY 1,371 (USD13) per STAI-S, JPY 1,157 (USD 11) per STAI-T, and JPY 1,566,357 (USD 14,940) per QALY respectively. MBCT had an 77.5% probability of being cost-effective at a willingness to pay threshold in Japan (JPY 5,000,000 per QALY). The results of the four one-way sensitivity analyses supported the robustness of the base-case analysis findings. Discussion: Augmented MBCT for anxiety disorders is cost-effective compared with TAU post-treatment from a public healthcare insurance perspective. Future studies should include long-term observations, and analysis from a societal perspective. [ABSTRACT FROM AUTHOR]

Aim: Live two‐way video, easily accessible from home via smartphones and other devices, is becoming a new way of providing psychiatric treatment. However, lack of evidence for real‐world clinical setting effectiveness hampers its approval by medical insurance in some countries. Here, we conducted the first large‐scale pragmatic, randomized controlled trial to determine the effectiveness of long‐term treatment for multiple psychiatric disorders via two‐way video using smartphones and other devices, which are currently the primary means of telecommunication. Methods: This randomized controlled trial compared two‐way video versus face‐to‐face treatment for depressive disorder, anxiety disorder, and obsessive‐compulsive disorder in the subacute/maintenance phase during a 24‐week period. Adult patients with the above‐mentioned disorders were allocated to either a two‐way video group (≥50% video sessions) or a face‐to‐face group (100% in‐person sessions) and received standard treatment covered by public medical insurance. The primary outcome was the 36‐Item Short‐Form Health Survey Mental Component Summary (SF‐36 MCS) score. Secondary outcomes included all‐cause discontinuation, working alliance, adverse events, and the severity rating scales for each disorder. Results: A total of 199 patients participated in this study. After 24 weeks of treatment, two‐way video treatment was found to be noninferior to face‐to‐face treatment regarding SF‐36 MCS score (48.50 vs 46.68, respectively; p < 0.001). There were no significant differences between the groups regarding most secondary end points, including all‐cause discontinuation, treatment efficacy, and satisfaction. Conclusion: Two‐way video treatment using smartphones and other devices, was noninferior to face‐to‐face treatment in real‐world clinical settings. Modern telemedicine, easily accessible from home, can be used as a form of health care. [ABSTRACT FROM AUTHOR]

BackgroundPrevious 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. ObjectiveThis 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. MethodsThis 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. ResultsThis 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. ConclusionsThis 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 RegistrationUniversity 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

Purpose: This study aimed to conduct an economic evaluation of mindfulness-based cognitive therapy (MBCT) in healthy participants by performing cost-utility analysis (CUA) and cost-benefit analysis (CBA).Patients and Methods: CUA was carried out from a healthcare sector perspective and CBA was from the employer's perspective in parallel with a randomized controlled trial. Of the 90 healthy participants, 50 met the inclusion criteria and were randomized to the MBCT group (n = 25) or wait-list control group (n = 25). In the CUA, intervention costs and healthcare costs were included, while the mean difference in the change in quality-adjusted life years (QALYs) between the baseline and 16-week follow-up was used as an indicator of effect. Incremental cost-effectiveness ratio (ICER) was produced, and uncertainty was addressed using non-parametric bootstrapping with 5000 replications. In the CBA, the change in productivity losses was reflected as a benefit, while the costs included intervention and healthcare costs. The net monetary benefit was calculated, and uncertainty was handled with 5000 bootstrapping. Healthcare costs were measured with the self-report Health Service Use Inventory. The purchasing power parity in 2019 was used for currency conversion.Results: In the CUA, incremental costs and QALYs were estimated at JPY 19,700 (USD 189) and 0.011, respectively. The ICER then became JPY 1,799,435 (USD 17,252). The probability of MBCT being cost-effective was 92.2% at the threshold of 30,000 UK pounds per QALY. The CBA revealed that MBCT resulted in increased costs (JPY 24,180) and improved work productivity (JPY 130,640), with a net monetary benefit of JPY 106,460 (USD 1021). The probability of the net monetary benefit being positive was 69.6%.Conclusion: The results suggested that MBCT may be more cost-effective from a healthcare sector perspective and may be cost-beneficial from the employer's perspective. [ABSTRACT FROM AUTHOR]

Purpose: Cost-effective analysis is one of the most useful analyses for political decision-making in medicine under a limited budget. Although the data of the ICEpop CAPability measure for Adults (ICECAP-A) is sometimes essential for the measurement of cost effectiveness, such data are often lacking in most clinical trials. Therefore, a conversion formula (ie mapping) derived from the values of clinical assessment scales into utility is required. Patients and Methods: We used an internet survey where 500 general residents were asked to fill in four kinds of self-reported questionnaires [ICECAP-A, the Satisfaction with Life Scale (SWLS), Flourishing Scale (FS), and the Scale of Positive and Negative Experience (SPANE)]. A beta regression was conducted with the utility assessed by ICECAP-A as a dependent variable. Results: We developed several mapping formulae depending on available questionnaires. These mapping formulae were well-validated in our validation sample. The models using a greater number of questionnaires tended to show better mapping. Conclusion: The mapping function of our formula was within the range of other reported mapping studies. We believe this formula is useful for cost effective analyses of several trials where utility data are lacking. [ABSTRACT FROM AUTHOR]

BACKGROUND: There is a lack of studies that investigated the effect of a wide range of work environmental factors on stress and depression in Japan. OBJECTIVES: To examine the association of work environment factors with stress and depression among workers in Japan. METHODS: We conducted questionnaire surveys of workers that mainly engage in desk work in Japan. Stress was assessed through the Perceived Stress Scale (PSS), depression through the Patient Health Questionnaire-9 (PHQ-9), and work environment through physical and psychological workplace environment questionnaires. Workers were divided into low and high stress groups based on PSS score (median split), and divided into non-depressed and depressed groups based on their PHQ-9 score (< 5, and ≥5); these groups were then compared with their working environment. In addition, a multiple regression analysis was performed. RESULTS: Responses were obtained from 210 subjects. Multiple regression analysis showed that "Ability to work at one's own pace" and "Ability to apply personal viewpoint to work," etc., had effect on stress, while "Workplace harassment" and "Support from colleagues," etc., had effect on depression. CONCLUSIONS: The results suggest that stress and depression in Japanese workers are related to factors such as job demands, control of work, workplace harassment, and psychological safety. [ABSTRACT FROM AUTHOR]

Objectives: To 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.Methods: This 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.Results: Sociodemographic 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 Results: Sociodemographic 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. [ABSTRACT FROM AUTHOR]

Background: Although higher rates of burnout have been reported during the COVID-19 pandemic, the contribution of the modifiable factors is lesser-known. We investigated how the risk of emotional exhaustion was associated with mindfulness skills and social support in a single medical center in Japan. Methods: We conducted a cross-sectional web survey on mental health for all staff of a national medical hospital from February to March 2021. We examined the association between self-rated emotional exhaustion and levels of mindfulness and social support using multivariate logistic regression. Results: Of the 830 participants, signs of emotional exhaustion were observed in 261 (31%) individuals. Among those highly exposed to the virus at work, individuals with low levels of mindfulness and social support had significantly higher odds of emotional exhaustion [OR 3.46 (95% CI; 1.48–8.09), OR; 3.08 (95% CI; 1.33–7.13), respectively] compared to those with high levels. However, among those not highly exposed to the virus, individuals with both low and moderate levels of mindfulness had significantly higher odds of emotional exhaustion. [OR 3.33 (95% CI; 2.22–5.00), OR; 2.61 (95% CI; 1.73–3.94), respectively]. Conclusion: We found that factors associated with emotional exhaustion differed by exposure to SARS-CoV-2. Building mindfulness skills can help reduce the high burden placed on the staff. Additionally, increasing social support may be useful especially for workers highly exposed to SARS-CoV-2. [ABSTRACT FROM AUTHOR]

Background: Regular visit to psychiatric clinic is essential for successful treatment of any psychiatric condition including attention-deficit/hyperactivity disorder (AD/HD). However, cancellation of outpatient appointments in patients with AD/HD, which represents a significant medical loss, has not been systematically investigated to our knowledge. Methods: A systematic chart review was conducted for patients visiting the Shimada Ryoiku medical Center for Challenged Children in Japan at the age of ≤15 years from January to December 2013. The primary outcome measure was the cancellation rate, defined as the number of missed visits divided by the number of scheduled visits. The cancellation rates during 24 months after the first visit were compared between outpatients with AD/HD and other psychiatric disorders, including pervasive developmental disorders (PDD), and developmental coordination disorders and/or communication disorders (DCD-CD). A generalized linear model with binomial distribution was used to examine factors associated with cancellation rates exclusively in the AD/HD group. Results: We included 589 patients (mean ± SD age, 5.6 ± 3.4 years; 432 males) in the analysis. The cancellation rate in patients with AD/HD was 12.3% (95% confidence interval [CI]: 10.0–15.1), which was significantly higher than in those with PDD (5.6%, 95% CI: 3.8–8.3) and DCD-CD (5.3%, 95% CI: 3.6–7.8). Prescriptions of osmotic-release oral system-methylphenidate (OROS-MPH) and antipsychotics were associated with fewer cancellations in AD/HD patients (odds ratios: 0.61, 95% CI: 0.39–0.95 and 0.49, 95% CI: 0.25–0.95, respectively), although these significances did not find in the subgroup analysis including only patients with ≥ 6 years old. Conclusions: Patients with AD/HD were more likely to miss appointments compared to those with other psychiatric disorders. The impact of AD/HD medications as well as potential psychiatric symptoms of their parents or caregivers on appointment cancellations needs to be evaluated in more detail in future investigations. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose: Mindfulness-based cognitive therapy (MBCT) could be an intervention for improving subjective well-being among healthy individuals (HIs). However, MBCT studies for HIs to improve their subjective well-being are rare. The aim of this study was to report the feasibility, safety and effectiveness of MBCT for HIs in comparison with clinical samples. Patients and Methods: We conducted a single-arm, pre-post comparison pilot study offering MBCT to both HIs and people with common mental disorders. Twenty-four participants in total were included in the study. Eight weekly two-hour sessions with six monthly boosters were offered to all participants. Assessment was carried out at baseline, week 4, 8, and during follow-up. The 5-item World Health Organization Well-Being Index (WHO-5) was the primary clinical outcome measure. Results: The results showed the MBCT is sufficiently safe and would be more feasible in HIs compared to in clinical samples (attendance rate: 81.5% vs 61.3%, p=0.06). Although Satisfaction with Life Scale, the other scale of subjective well-being used, improved significantly at week 20 (p=0.01), no significant improvement was seen in WHO-5. The results of the sub-group analysis revealed WHO-5 improved significantly at week 8 and 32 among the subjects whose baseline scores began in the lower half. Conclusion: MBCT is sufficiently safe and would be more feasible with HIs compared to the clinical samples. In designing randomized controlled trials, selecting HIs with lower subjective well-being would be reasonable to minimize the "ceiling effect" on outcomes. [ABSTRACT FROM AUTHOR]

The importance of workers' well-being has been recognized in recent years. The assessment of well-being has been subjective, and few studies have sought potential biomarkers of well-being to date. This study examined the relationship between well-being and the LF/HF ratio, an index of heart rate variability that reflects sympathetic and parasympathetic nerve activity. Pulse waves were measured using photoplethysmography through a web camera attached to the computer used by each participant. The participants were asked to measure their pulse waves while working for 4 weeks, and well-being was assessed using self-reported measures such as the Satisfaction With Life Scale (SWLS), the Positive and Negative Affect Schedule (PANAS), and the Flourishing Scale (FS). Each of the well-being scores were split into two groups according to the median value, and the LF/HF ratio during work, as well as the number of times an LF/HF ratio threshold was either exceeded or subceeded, were compared between the high and low SWLS, positive emotion, negative emotion, and FS groups. Furthermore, to examine the effects of the LF/HF ratio and demographic characteristics on well-being, a multiple regression analysis was conducted. Data were obtained from 169 participants. The results showed that the low FS group had a higher mean LF/HF ratio during work than the high FS group. No significant differences were seen between the high and low SWLS groups, the high and low positive emotion groups, or the high and low negative emotion groups. The multiple regression analysis showed that the mean LF/HF ratio during work affected the FS and SWLS scores, and the number of times the mean LF/HF ratio exceeded +3 SD had an effect on the positive emotion. No effect of the LF/HF ratio on negative emotions was shown. The LF/HF ratio might be applicable as an objective measure of well-being. [ABSTRACT FROM AUTHOR]

Objectives: Better subjective and eudaimonic well-being fosters better health conditions. Several studies have confirmed that mindfulness-based interventions are effective for improving well-being; however, the samples examined in these studies have been limited to specific populations, and the studies only measured certain aspects of well-being rather than the entire construct. Additionally, few studies have examined the effect of mindfulness-based cognitive therapy on well-being. The present study examines the feasibility of mindfulness-based cognitive therapy and its effectiveness for improving subjective and eudaimonic well-being among community residents. Methods: The study design featured an 8-week randomized, waiting-list controlled, parallel-group study. 8 weekly mindfulness classes, followed by 2 monthly classes, were provided for healthy individuals aged 20–65 years who had a Satisfaction with Life Scale score of ≤ 24 indicating average to low cognitive aspect of subjective well-being. This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (ID: UMIN000031885, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr%5fe/ctr%5fview.cgi?recptno=R000036376). Results: The results showed that cognitive aspect of subjective well-being and mindfulness skills were significantly improved at 8 weeks, and this effect was enhanced up to the end of the follow-up period. Positive affective aspect of subjective and eudaimonic well-being were significantly improved at 16 weeks. Conclusions: Eight weeks of mindfulness-based cognitive therapy with a 2-month follow-up period improves cognitive and affective aspects of subjective and eudaimonic well-being in healthy individuals. The order of improvement was cognitive, positive affective, and eudaimonic well-being. To verify these findings, multi-center randomized controlled trials with active control groups and longer follow-up periods are warranted. [ABSTRACT FROM AUTHOR]

Objective: To assess the effectiveness of mindfulness-based interventions on people with dementia and mild cognitive impairment. Methods: We searched several electronic databases, namely Cochrane Library, EMBASE, and MEDLINE with no limitations for language or document type (last search: 1 February 2020). Randomized controlled trials of mindfulness-based interventions for people with dementia and mild cognitive impairment compared to active-control interventions, waiting lists, or treatment as usual were included. Predefined outcomes were anxiety symptoms, depressive symptoms, cognitive function, quality of life, mindfulness, ADL and attrition. We used the random effects model (DerSimonian-Laird method) for meta-analysis, reporting effect sizes as Standardized Mean Difference. Heterogeneity was assessed with the I2 statistics. Results: Eight randomized controlled trials, involving 276 patients, met the eligibility criteria and were included in the meta-analysis. We found no significant effects for mindfulness-based interventions in either the short-term or the medium- to long-term on any outcomes, when compared with control conditions. The number of included studies and sample sizes were too small. Additionally, the quality of evidence was low for each randomized controlled trial included in the analysis. This is primarily due to lack of intent-to-treat analysis, high risk of bias, and imprecise study results. The limited statistical power and weak body of evidence prevented us from reaching firm conclusions. Conclusions: We found no significant effects of mindfulness-based interventions on any of the outcomes when compared with control conditions. The evidence concerning the efficacy of mindfulness-based interventions in this population is scarce in terms of both quality and quantity. More well-designed, rigorous, and large-scale randomized controlled trials are needed. [ABSTRACT FROM AUTHOR]

Introduction: Mental disorders are a leading cause of disability worldwide. Depression has a significant impact in the field of occupational health because it is particularly prevalent during working age. On the other hand, there are a growing number of studies on the relationship between "well-being" and employee productivity. To promote healthy and productive workplaces, this study aims to develop a technique to quantify stress and well-being in a way that does not disturb the workplace. Methods and analysis: This is a single-arm prospective observational study. The target population is adult (>20 years old) workers at companies that often engage in desk work; specifically, a person who sits in front of a computer for at least half their work hours. The following data will be collected: (a) participants' background characteristics; (b) participants' biological data during the 4-week observation period using sensing devices such as a camera built into the computer (pulse wave data extracted from the facial video images), a microphone built into their work computer (voice data), and a wristband-type wearable device (electrodermal activity data, body motion data, and body temperature); (c) stress, well-being, and depression rating scale assessment data. The analysis workflow is as follows: (1) primary analysis, comprised of using software to digitalize participants' vital information; (2) secondary analysis, comprised of examining the relationship between the quantified vital data from (1), stress, well-being, and depression; (3) tertiary analysis, comprised of generating machine learning algorithms to estimate stress, well-being, and degree of depression in relation to each set of vital data as well as multimodal vital data. Discussion: This study will evaluate digital phenotype regarding stress and well-being of white-collar workers over a 4-week period using persistently obtainable biomarkers such as heart rate, acoustic characteristics, body motion, and electrodermal activity. Eventually, this study will lead to the development of a machine learning algorithm to determine people's optimal levels of stress and well-being. Ethics and dissemination: Collected data and study results will be disseminated widely through conference presentations, journal publications, and/or mass media. The summarized results of our overall analysis will be supplied to participants. Registration: UMIN000036814 [ABSTRACT FROM AUTHOR]

Background: Although the effects of various types of cognitive interventions have been evaluated, effectiveness and cost-saving effect of the combination of the different cognitive interventions is unknown.Objective: This study aimed to evaluate the feasibility of conducting a definitive trial to assess the effectiveness of combined cognitive intervention.Methods: A matched controlled trial of learning therapy (LT), a combination of cognitive training and stimulation, was conducted. The samples were recruited from the nursing homes. Inclusion criteria were as follows: age 65 years or older, clinical diagnosis of dementia, level of activities of daily living at II or above, Mini-Mental State Examination score between 10 and 26, receiving long-term-care services without history of LT, and provision of written consent. The primary outcomes were safety, validity of eligibility, retention rate, and effect on the functions of daily living represented by Criterion Time for Certification of Needed Long-Term-Care (CT for CNLTC) at 12 months. Cost-benefit analysis was also conducted to assess the cost saving effect of LT.Results: No serious adverse events were detected. The exclusion rate at the screening phase was 5% and the retention rate was 77% at 12 months. LT demonstrated statistically significant improvement in CT for CNLTC at 12 months (Δ=18.8, almost equivalent to "one" degree of the care needed level) and saved the long-term-care cost by JPY 200,000 (USD 1,618).Conclusions: LT is effective for improving care recipients' level of care needed and has a cost saving effect. A randomized controlled trial is required to verify these findings.Clinical Trial Registration: This study was approved by the ethics committee at Keio University School of Medicine (ID: 20150061). This trial was registered at University hospital Medical Information Network Clinical Trial Registry (UMIN-CTR ID: UMIN000018223). [ABSTRACT FROM AUTHOR]

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 < 0.005) and STAI Trait Anxiety subscale (difference, −11.7; 95% confidence interval, −17.0 to −6.4; P < 0.001) between the MBCT and control groups. Conclusion: MBCT is effective in patients with anxiety disorders in secondary‐care settings where the vast majority of patients are treatment‐resistant to pharmacotherapy. [ABSTRACT FROM AUTHOR]

Aim: Previous studies indicate that mirtazapine is unique in its quick responsiveness compared to other antidepressants. Although some other studies have evaluated its cost‐effectiveness, they have not considered its early stage remission rate. The aim of this study was to address this research gap by using precise clinical data to evaluate the cost‐effectiveness of mirtazapine in Japan. Methods: We developed a Markov model to reflect the week‐by‐week transition probabilities. The Markov cycle was set as 1 week. While our clinical parameters were obtained largely from existing meta‐analyses, cost data were derived from government reports. Cost‐effectiveness was evaluated by incremental cost‐effectiveness ratios (ICERs) per quality‐adjusted life year estimated based on the probability sensitivity analyses. The ICERs were estimated at 2, 8, 26, and 52 weeks. Results: In severe depression, the ICERs ranged between JPY 872 153 and 1 772 723. The probability of mirtazapine being cost‐effective ranged from 0.75 to 0.99 when the ICER threshold was JPY 5 000 000. In moderate depression, the ICERs ranged between JPY 2 356 499 and 4 770 145. The probability of mirtazapine being cost‐effective ranged from 0.55 to 0.83 when the ICER threshold was JPY 5 000 000. Conclusion: When considering the early stage efficacy of mirtazapine, it appeared to be cost‐effective compared to selective serotonin reuptake inhibitors, especially for severe depression and in the early stage treatment in the Japanese setting. However, our study has some limitations. First, mirtazapine is compared with batched selective serotonin reuptake inhibitors rather than individual ones. Second, we did not consider antidepressant combination therapy as treatment options. [ABSTRACT FROM AUTHOR]

Objective: Dementia has become a global critical issue. It is estimated that the global cost of dementia was 818 billion USD in 2015. The situation in Japan, which is the most aged country in the world, should be critical. However, the societal cost of dementia in Japan has not yet been estimated. This study was designed to estimate cost of dementia from societal perspective. Design: We estimated the cost from societal perspective with prevalence based approach. Setting, participants and measures: Main data sources for the parameters to estimate the costs are the National Data Base, a nationwide representative individual-level database for healthcare utilization, the Survey of Long-Term Care Benefit Expenditures, a nationwide survey based on individual-level secondary data for formal long-term care utilization, and the results of an informal care time survey for informal care cost. We conducted the analyses with ‘probabilistic modeling’ using the parameters obtained to estimate the costs of dementia. We also projected future costs. Results: The societal costs of dementia in Japan in 2014 were estimated at JPY 14.5 trillion (se 66.0 billion). Of these, the costs for healthcare, long-term care, and informal care are JPY 1.91 trillion (se 4.91 billion), JPY 6.44 trillion (se 63.2 billion), and JPY 6.16 trillion (se 12.5 billion) respectively. The cost per person with dementia appeared to be JPY5.95 million (se 27 thousand). The total costs would reach JPY 24.3 trillion by 2060, which is 1.6 times higher than that in 2014. Conclusions: The societal cost of dementia in Japan appeared to be considerable. Interventions to mitigate this impact should be considered. [ABSTRACT FROM AUTHOR]

ABSTRACTBackground:Caregivers of people with dementia are likely to have psychological distress that sometimes results in mental health problems, such as depression. The objective of this study was to examine some predictive factors that are thought to be associated with psychological distress of caregivers of people with dementia in Japan.Methods: Design: A cross-sectional study.Sample: As part of a study to estimate the cost of dementia in Japan, 1,437 people with dementia-caregiver dyads were enrolled in the current informal care time study. The measurements in the study included were the basic characteristics of the caregivers and the people with dementia, and the informal care time during a week.Analysis: Factors that predict caregivers' psychological distress, which was measured by Kessler's Psychological Distress scale (K6) score, were evaluated using univariate and multivariate regression analyses.Results: Approximately 69% of the caregivers recorded a K6 score higher than 4, while 18% scored higher than 12. According to the results of the logistic regression analysis (cut-off 4/5), the K6 score was associated with mental and comorbid diseases of people with dementia, informal care time, its lower number of caregivers, and the level of nursing care. According to the results of logistic regression analysis (cut-off 12/13), the K6 score was associated with mental symptoms and comorbid disease of people with dementia, sex of caregivers, informal care time, and its lower number of caregivers.Conclusion: Our findings indicated that the psychological distress of the caregivers is quite high and that informal care time and behavioral and psychological symptoms of dementia are associated with it. These results corroborate with previous findings. [ABSTRACT FROM AUTHOR]

The article presents the results of a literature review of the cost-effectiveness of implementing dementia-friendly designs (DFD). Topics discussed include the importance of the implementation of physical and cognitive DFD for ageing societies, discovery of the lack of research on the topics of cost-effectiveness analysis (CEA) of DFD, European Quality of Life 5 Dimensions (EQ5D) data and mapping strategy data, and significance of developing a new mapping approach for dementia.

Introduction: Schizophrenia is a disorder that produces considerable burdens due to its often relapsing/remitting or chronic longitudinal course. This burden is felt not only by patients themselves, but also by their families and health care systems. Although the societal burden caused by this disorder has been evaluated in several countries, the magnitude of the societal cost of schizophrenia in Japan has never been estimated. The aim of this study is to clarify the societal burden of schizophrenia by estimating the cost of schizophrenia in Japan in 2008. Methods: A human capital approach was adopted to estimate the cost of schizophrenia. The total cost of schizophrenia was calculated as the sum of the direct, morbidity, and mortality costs. Schizophrenia was defined as disorders coded as F20.0-F20.9 according to the International Classification of Diseases-10. The data required to estimate the total cost was collected from publicly available statistics or previously reported studies. Results: The total cost of schizophrenia in Japan in 2008 was JPY 2.77 trillion (USD 23.8 billion). While the direct cost was JPY 0.770 trillion (USD 6.59 billion), the morbidity and mortality costs were JPY 1.85 trillion (USD 15.8 billion) and JPY 0.155 trillion (USD 1.33 billion), respectively. Conclusion: The societal burden caused by schizophrenia is tremendous in Japan, similar to that in other developed countries where published data exist. Compared with other disorders, such as depression or anxiety disorders, the direct cost accounted for a relatively high proportion of the total cost. Furthermore, absolute costs arising from unemployment were larger, while the prevalence rate was smaller, than the corresponding results for depression or anxiety in Japan. [ABSTRACT FROM AUTHOR]

Background The societal burden caused by anxiety disorders has likely been underestimated, while those for schizophrenia and depression have received more attention. Anxiety disorders represent a significant illness category that occurs at a high prevalence and poses a considerable burden. However, the cost of anxiety disorders in Japan has not yet been well researched. The goal of the present study was to estimate the total cost of anxiety disorders in Japan and to clarify the characteristics of this burden. Method A prevalence-based approach was adopted to measure the total cost of anxiety disorders. Anxiety disorders were defined as diagnosis code F40.0-F41.9 according to the International Statistical Classification of Diseases and Related Health Problems, 10th Revision. The cost was comprised of the following components: medical treatment costs and social service costs as direct costs, and morbidity and mortality costs as indirect costs. Data were collected from publicly available statistics. Results The total cost of anxiety disorders in Japan in 2008 was JPY 2.4 trillion (US$ 29.2 billion at the current exchange rate of US$1 = \82). The direct cost was JPY 50 billion. The morbidity cost was JPY 2.1 trillion, while the mortality cost was JPY 0.24 trillion. Conclusions The social burden caused by anxiety disorders in Japan is tremendous and is similar to that of other mental disorders. Productivity loss in the workplace represents the largest portion of all the cost components. Because the medical examination rate is quite low, the improvement of healthcare access might contribute to cost mitigation. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: Mindfulness-based cognitive therapy (MBCT) could be a treatment option for anxiety disorders. Although its effectiveness under conditions of low pharmacotherapy rates has been demonstrated, its effectiveness under condition of high pharmacotherapy rate is still unknown. The aim of the study was to evaluate effectiveness of MBCT under the context of high pharmacotherapy rates. Results: A single arm with pre-post comparison design was adopted. Those who had any diagnosis of anxiety disorders, between the ages of 20 and 74, were included. Participants attended 8 weekly 2-hour-long sessions followed by 2 monthly boosters. Evaluation was conducted at baseline, in the middle, at end of the intervention, and at follow-up. The State-Trait Anxiety Inventory (STAI)-state was set as the primary outcome. Pre-post analyses with mixed-effect models repeated measures were conducted. Fourteen patients were involved. The mean age was 45.0, and 71.4% were female. The mean change in the STAI-state at every point showed statistically significant improvement. The STAI-trait also showed improvement at a high significance level from the very early stages. The participants showed significant improvement at least one point in some other secondary outcomes. Trial registration Retrospectively registered at the University Hospital Medical Information Network on 1st August 2013 (ID: UMIN000011347) [ABSTRACT FROM AUTHOR]