成澤 知美

Cognitive processing therapy (CPT) is one of the most widely tested evidence-based treatments for posttraumatic stress disorder (PTSD). However, most studies on CPT have been conducted in Western cultural settings. This open-label, single-arm trial investigated the feasibility, acceptability, and preliminary efficacy of CPT for treating Japanese patients with PTSD. A total of 25 outpatients underwent 12 CPT sessions. The primary outcome was the assessment of PTSD symptoms using the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV); secondary outcomes included the assessment of subjective PTSD severity, depressive and anxiety symptoms, trauma-related cognitions, and subjective quality of life. All outcomes were evaluated at pretreatment (i.e., baseline), posttreatment, and 6- and 12-month follow-ups. On average, participants attended 13 sessions of CPT (SD = 1.38), with a completion rate of 96.0%. One serious adverse event (hospitalization) occurred. Significant within-subjects standardized mean differences in CAPS-IV scores were found from baseline to treatment completion, g = -2.28, 95% CI [-3.00, -1.56]; 6-month follow-up, g = -2.95, 95% CI [-3.79, -2.12]; and 12-month follow-up, g = -2.15, 95% CI [-2.89, -1.41]. Moderate-to-large effects, gs = -0.77 to -2.45, were found on secondary outcomes. These findings support the feasibility, acceptability, and preliminary efficacy of CPT in a Japanese clinical setting.

OBJECTIVE: Insomnia is an increasingly recognized major symptom of breast cancer which can seriously disrupt the quality of life during and many years after treatment. Sleep problems have also been linked with survival in women with breast cancer. The aims of this study were to estimate the prevalence of insomnia in breast cancers survivors, clarify the clinical characteristics of their sleep difficulties and use machine learning techniques to explore clinical insights. METHODS: Our analysis of data, obtained in a nationwide questionnaire survey of breast cancer survivors in Japan, revealed a prevalence of suspected insomnia of 37.5%. With the clinical data obtained, we then used machine learning algorithms to develop a classifier that predicts comorbid insomnia. The performance of the prediction model was evaluated using 8-fold cross-validation. RESULTS: When using optimal hyperparameters, the L2 penalized logistic regression model and the XGBoost model provided predictive accuracy of 71.5 and 70.6% for the presence of suspected insomnia, with areas under the curve of 0.76 and 0.75, respectively. Population segments with high risk of insomnia were also extracted using the RuleFit algorithm. We found that cancer-related fatigue is a predictor of insomnia in breast cancer survivors. CONCLUSIONS: The high prevalence of sleep problems and its link with mortality warrants routine screening. Our novel predictive model using a machine learning approach offers clinically important insights for the early detection of comorbid insomnia and intervention in breast cancer survivors.

BACKGROUND: A strategy for maintaining and/or improving cardiorespiratory fitness (CRF) in the growing population of cancer survivors is of major clinical importance, especially in the COVID-19 era. The effect of unsupervised high-intensity interval training (HIIT) on increasing CRF in breast cancer survivors is unknown. PURPOSE: The purpose of this study was to determine whether the newly developed habit-B programme, which involves home-based smartphone-supported HIIT using body weight exercises, improves CRF in early-stage breast cancer survivors. METHODS: This single-centre, 12-week, parallel-group, single-blind, randomised controlled trial involved 50 women with stage I-IIa breast cancer, aged 20-59 years, who had completed initial treatment except for hormone therapy. Participants were randomised to either the exercise or control group. The primary outcome was the 12-week change in peak oxygen uptake [Formula: see text]. Other outcomes included muscle strength, 6 min walk test, resting heart rate, physical activity, fatigue, safety and quality of life. RESULTS: The change in [Formula: see text] and leg strength increased significantly in the exercise group compared with the control group (p<0.01). Changes in other outcomes were not significantly different between the groups. CONCLUSION: A home-based HIIT intervention can lead to improve CRF and muscle strength in early-stage breast cancer survivors.

Background: Posttraumatic stress disorder (PTSD) symptoms are known to occur after acute coronary syndrome (ACS). Peritraumatic distress has been indicated as a risk factor for PTSD and can be measured by the Peritraumatic Distress Inventory (PDI). However, no studies have yet measured peritraumatic distress after ACS using the PDI to predict PTSD. Objectives: This prospective cohort study examined the impact of peritraumatic distress on PTSD symptoms at 6 months after ACS. Methods: We used the PDI to assess peritraumatic distress in patients treated for ACS at a teaching hospital in Tokyo within 7 days after percutaneous coronary intervention. They were followed up over the next 6 months and were assessed for PTSD symptoms at 6 months using the Impact of Event Scale-Revised. The association between peritraumatic distress and PTSD symptoms was examined by multiple linear regression analysis. Results: The study enrolled 101 ACS patients, and 97 completed the follow-up assessment. PDI total score was an independent predictor of PTSD symptoms after adjustment for potential covariates (beta = 0.38; p < 0.01). Limitations: The results were obtained from a single teaching hospital and assessment of PTSD symptoms was questionnaire based. Conclusion: We provide the first evidence that PDI score can predict the development of PTSD symptoms in ACS patients. Assessing peritraumatic distress after ACS with the PDI may be useful for initiating early intervention against PTSD symptoms.

INTRODUCTION: A major concern is that few cancer survivors meet the guidelines for recommended levels of physical activity. No studies have investigated physical activity among breast cancer survivors nationwide in Japan. Therefore, the aims of this study are to identify the levels of physical activity among breast cancer survivors, to examine factors-related physical activity among breast cancer survivors and to identify breast cancer survivors' preferences for and interest in exercise programmes in order to inform the future programme development. METHODS AND ANALYSIS: We will administer a cross-sectional survey using a self-report questionnaire to breast cancer survivors. At each of 50 facilities selected to include a variety of institutional backgrounds according to the population distribution of different regions throughout Japan, we will consecutively distribute the questionnaire to 30 outpatients who have completed initial treatments, except for hormone therapy. The target sample size is 1500 survivors. We will calculate descriptive statistics for each measurement item and perform univariate and multivariate analyses using outcome measures (eg, physical activity and quality of life) related to physical, psychological, social and environmental factors. DISCUSSION: This is the first nationwide survey of physical activity levels among breast cancer survivors in Japan. Identifying the factors associated with physical activity will help us to develop, disseminate and implement programmes that encourage more survivors to adhere to physical activity guidelines. ETHICS AND DISSEMINATION: The protocol was approved by the Institutional Review Board (IRB) of the National Cancer Center on 11 January 2019 (ID: 2018-295). In addition, many of the participating facilities required ethical approval from their local IRBs, while others did not. Accordingly, approval from the local IRBs of individual facilities was obtained when required. The findings will be disseminated through peer-reviewed publications and conference presentations.

Background: Trauma-focused cognitive behavioural therapy (TF-CBT) is an efficacious treatment model for children and adolescents with trauma-related disorders. However, few studies have been conducted in community settings, and there have been no randomized controlled trials in Asian countries.Objective: To evaluate the effectiveness of TF-CBT in regular community settings in Japan through comparison with a waitlist with minimal services control condition.Method: Thirty Japanese children and adolescents with posttraumatic stress disorder symptoms (22 females, eight males, mean age = 13.90, range = 6-18) were randomly assigned to 12 sessions of TF-CBT or the waitlist control condition. The primary outcome measure was the Kiddie Schedule for Affective Disorders and Schizophrenia score assessed by blinded evaluators one month later.Results: The mean number of sessions was 12 (range: 11-13) in the TF-CBT group and 4.87 (range: 3-7) in the control group. Intention to treat analysis showed that the TF-CBT group achieved significantly greater symptom reduction than did the control group. The effect size (Cohen'sd) between the TF-CBT and control groups was 0.96 (p=.014) for posttraumatic symptoms and 1.15 (p=.004) for depressive symptoms. However, the TF-CBT group did not show better results than the control group with regard to improvements in anxiety symptoms, psychosocial functioning, and behavioural problems.Conclusions: The findings provided preliminary evidence of the effectiveness of TF-CBT for treating youth with trauma in community mental health facilities. TF-CBT in the Japanese context proved identical to the original, demonstrating that it is also suitable for use with children and adolescents in non-Western settings.

PURPOSE: To develop consensus-based components used in the first evidence-based cancer survivorship guidelines in Japan. METHODS: Purposive sampling was used to recruit a panel of experts in oncology clinical practice, nursing, health science, epidemiology, and patient advocacy. The panel engaged in a modified Delphi process to (1) generate consensus related to the definition of survivorship, (2) determine the aim and target users of the guideline, and (3) identify clinical issues for inclusion. A Web-based survey and panel meeting were conducted to obtain the panelists' feedback on the initial draft proposed by the secretariat. Multiple online votes were then completed until all elements of the proposed guidelines reached an approval rate of 80% or higher. Following each round, iterative refinements were made based on all panelists' feedback. RESULTS: Twenty-two experts were enrolled in the panel and participated in four rounds of online voting and two face-to-face meetings. Ultimately, the panel reached consensus on the definition of survivorship, the aim of the guidelines, and target users. Moreover, 11 of the original 17 clinical issues were retained. Finally, the panel selected two priority areas to implement immediately. CONCLUSION: The panel's consensus on the definition of survivorship, aim and target users of the guideline, and 11 clinical issues will serve as a compass for the development of comprehensive cancer survivorship guidelines in Japan. IMPLICATIONS FOR CANCER SURVIVORS: A culturally sensitive consensus approach was developed to improve the long term health and well- being of cancer survivors in Japan.

Cardiovascular disease is a known risk factor for the development of psychiatric disorder and about 20% of patients with acute coronary syndrome (ACS) develop depression. Our previous prospective study showed that serum linoleic acid (LA) level at baseline (admission) is a risk factor for the development of psychiatric disorder 3 months later. However, it was unclear whether serum LA could predict psychiatric disorders after 3 months. Thus, we examined the effects of polyunsaturated fatty acid (PUFA) levels at ACS onset on comorbid psychiatric disorders at 6 months. The study involved a follow-up investigation of the previous prospective cohort study of ACS patients. The sample with complete participant data at 6 months post-ACS comprised 100 patients. On admission, serum n-3 and n-6 PUFA levels were measured by gas chromatography and patients were interviewed to obtain medical information. Eight patients (8%) showed psychiatric disorder at 6 months. The association between psychiatric disorder and serum PUFA concentrations at ACS onset was examined by multivariable logistic regression analysis. Psychiatric disorders were predicted by baseline serum LA level (odds ratio = 7.27, 95% confidence interval = 1.11-47.76), indicating that it is a significant risk factor for the development of psychiatric disorder at 6 months. Thus, dietary education to reduce the intake of LA-containing foods might be useful for preventing psychiatric disorder in the population at high risk for ACS. However, the prevalence of psychiatric disorder, particularly depressive disorder, may have been too low to identify significant differences in PUFA analysis.

BACKGROUND: The efficacy of the mindfulness-based stress management program for maintaining a better mental state has not been examined among working populations. We aimed to explore the effectiveness of the brief mindfulness-based stress management program for hospital nurses. METHODS: In a multi-center randomized trial, 80 junior nurses working in hospitals were randomly allocated either to the brief mindfulness-based stress management program or psychoeducation using a leaflet. The program consisted of four 30 min individual sessions conducted by trained senior nurses using a detailed manual. The primary outcome was the total score of the Hospital Anxiety and Depression Scale (HADS) at week 26. Secondary outcomes included presence of a major depressive episode; severity of depression, anxiety, insomnia, burnout, and presenteeism; utility scores; and adverse events up to 52 weeks. RESULTS: The mean HADS score of all the participants at baseline was 7.2. At 26 weeks, adjusted mean scores on the HADS score were 7.2 (95% confidence intervals: 5.9, 8. 5) in the program group and 6.0 (4.8, 7.2) in the leaflet group, respectively. The coefficient of the group by time interaction was not statistically significant at -1.41 (-3.35, 0.54; P = 0.156). No significant superiority or inferiority was observed on the other outcomes. LIMITATIONS: We did not manage to recruit the number of participants we initially set out, although our post-hoc analyses showed that this did not lead to changes in our conclusions. CONCLUSIONS: The additive value of the brief mindfulness-based stress management program was not confirmed in mental state and self-evaluated work efficiency.

Background: The efficacy of the mindfulness-based stress management program for maintaining a better mental state has not been examined among working populations. We aimed to explore the effectiveness of the brief mindfulness-based stress management program for hospital nurses.Methods: In a multi-center randomized trial, 80 junior nurses working in hospitals were randomly allocated either to the brief mindfulness-based stress management program or psychoeducation using a leaflet. The program consisted of four 30 min individual sessions conducted by trained senior nurses using a detailed manual. The primary outcome was the total score of the Hospital Anxiety and Depression Scale (HADS) at week 26. Secondary outcomes included presence of a major depressive episode; severity of depression, anxiety, insomnia, burnout, and presenteeism; utility scores; and adverse events up to 52 weeks.Results: The mean HADS score of all the participants at baseline was 7.2. At 26 weeks, adjusted mean scores on the HADS score were 7.2 (95% confidence intervals: 5.9, 8. 5) in the program group and 6.0 (4.8, 7.2) in the leaflet group, respectively. The coefficient of the group by time interaction was not statistically significant at -1.41 (-3.35, 0.54; P=0.156). No significant superiority or inferiority was observed on the other outcomes.Limitations: We did not manage to recruit the number of participants we initially set out, although our post-hoc analyses showed that this did not lead to changes in our conclusions.Conclusions: The additive value of the brief mindfulness-based stress management program was not confirmed in mental state and self-evaluated work efficiency.

BACKGROUND: The pathophysiology of fear of cancer recurrence (FCR), the leading unmet psychological need of cancer survivors, may involve the dysfunctional processing of fear memory. n-3 polyunsaturated fatty acids (PUFAs) have beneficial effects on psychiatric disorders, including depressive disorder and anxiety disorders, and are involved in fear memory processing. We hypothesized that n-3 PUFA composition is associated with FCR in cancer survivors. METHODS: We conducted a cross-sectional study to examine the relationship between n-3 PUFAs and FCR among breast cancer survivors. Adults who had been diagnosed with invasive breast cancer and were not undergoing chemotherapy were asked to participate. Blood PUFA composition was evaluated by using capillary blood. We directly administered the Concerns About Recurrence Scale (CARS) to assess the grade of FCR. RESULTS: Among 126 participants used for the analysis, the mean age (SD) was 58 (11) years and 47% had stage I cancer. Multiple regression analysis controlling for possible confounders, depressive symptoms, and post-traumatic stress disorder (PTSD) symptoms revealed that the alpha-linolenic acid (ALA) level was significantly inversely associated with the average score on the CARS overall fear index (beta = -0.165, p = 0.04). No significant associations were found for other PUFAs. LIMITATIONS: Our findings were obtained from a cross-sectional study in a single institute. CONCLUSION: These findings provide the first evidence of a beneficial effect of ALA on FCR and indicate the need for prospective study of this association. FCR among breast cancer survivors might be controllable by prudent selection of ALA-containing cooking oil.

Background: Around 20% of patients with acute coronary syndrome (ACS) develop depression. Furthermore, some observational studies revealed baseline polyunsaturated fatty acids (PUFAs) may affect the prognosis of depression after ACS. This prospective cohort study examined the association between psychiatric disorder and PUFAs after ACS. Methods: Subjects were ACS patients admitted to a Tokyo teaching hospital. Psychiatric morbidity as a primary endpoint was measured using structured interview 3 months after admission. At admission, serum n-3 and n-6 PUFAs were measured by gas chromatography and patients were interviewed to evaluate medical information. Multiple logistic regression analysis was performed to calculate odds ratios (ORs) and 95% confidence intervals to examine the association between PUFAs at baseline and psychiatric disorder after ACS. Results: Between March 2014 and August 2016, 100 patients completed the follow-up assessment. Eleven patients (11%) showed some form of new-onset psychiatric disorder at 3 months, mainly depressive episode (major, 5; minor, 1) and PTSD (full, 1; partial, 2). Psychiatric disorder was predicted by serum linoleic acid level (OR= 3.96) and Hospital Anxiety and Depression Scale total score (OR = 1.34) at baseline. No significant associations were seen with other PUFAs. Limitations: The results were obtained from a single hospital and based on a small number of participants. There might be some patients with new-onset psychiatric disorder among the refused patients. Conclusions: Psychiatric disorder incidence in ACS patients might be lower in Japan than in Western countries. Reduced intake of linoleic acid-containing foods might prevent depression or PTSD after ACS.

Objective: We intended to build consensus on appropriate disaster mental health services among professionals working in the area affected by the Great East Japan Earthquake. Methods: We focused on the first 3 months after the disaster, divided into 3 phases: immediate aftermath, acute phase, and midphase. We adopted the Delphi process and asked our survey participants (n = 115) to rate the appropriateness of specific mental health services in each phase and comment on them. We repeated this process 3 times, giving participants feedback on the results of the previous round. Through this process, we determined the criterion for positive consensus for each item as having the agreement of more than 80% of the participants. Results: We found that the importance of acute psychiatric care and prescribing regular medication for psychiatric patients gained positive consensus in the immediate aftermath and acute phase. Counseling and psychoeducation after traumatic events or provision of information gained consensus in the acute phase and midphase, and screening of mental distress gained consensus in the midphase. Conclusions: Higher priority was given to continuous psychiatric services in the immediate aftermath and mental health activities in later phases.

Objectives: In this survey, we aimed to build consensus and gather opinions on ‘Kokoro-no care’ or mental health services and psychosocial support (MHSPSS) after a disaster, among mental health professionals who engaged in care after the Great East Japan Earthquake. Methods: We recruited mental health professionals who engaged in support activities after the Great East Japan Earthquake, which included local health professionals in the affected areas and members of mental health care teams dispatched from outside (n = 131). Adopting the Delphi process, we proposed a definition of ‘Kokoro-no care’, and asked the participants to rate the appropriateness on a 5-point Likert scale. We also solicited free comments based on the participants’ experiences during the disaster. After Round 1, we presented the summary statistics and comments, and asked the participants to re-rate the definition that had been modified based on their comments. This process was repeated twice, until the consensus criterion of ≥ 80% of the participants scoring ≥ 4 on the statement was fulfilled. Results: In Round 1, 68.7% of the respondents rated the proposed definition ≥ 4 for its appropriateness, and 88.4% did so in Round 2. The comments were grouped into categories (and subcategories) based on those related to the definition in general (Appropriate, Continuum of MHSPSS, Cautions in operation, Alternative categorisation of care components, Whether the care component should be categorised according to the professional involved, Ambiguous use of psychology, and Others), to mental health services (Appropriate, More specification within mental health services, More explicit remarks on mental health services, and Others), and to psychosocial support (Whether the care component should be categorised according to the professional involved, Raising concerns about the terms, and Others), and others. Conclusion: We achieved a consensus on the definition of ‘Kokoro-no care’, and systematically obtained suggestions on the concept, and practical advice on operation, based on the participants’ experiences from the Great East Japan Earthquake. This collective knowledge will serve as reference to prepare and respond to future disasters.

Background: It is reported that nursing is one of the most vulnerable jobs for developing depression. While they may not be clinically diagnosed as depressed, nurses often suffer from depression and anxiety symptoms, which can lead to a low level of patient care. However, there is no rigorous evidence base for determining an effective prevention strategy for these symptoms in nurses. After reviewing previous literature, we chose a strategy of treatment with omega-3 fatty acids and a mindfulness-based stress management program for this purpose. We aim to explore the effectiveness of these intervention options for junior nurses working in hospital wards in Japan. Methods/Design: A factorial-design multi-center randomized trial is currently being conducted. A total of 120 nurses without a managerial position, who work for general hospitals and gave informed consent, have been randomly allocated to a stress management program or psychoeducation using a leaflet, and to omega-3 fatty acids or identical placebo pills. The stress management program has been developed according to mindfulness cognitive therapy and consists of four 30-minute individual sessions conducted using a detailed manual. These sessions are conducted by nurses with a managerial position. Participants allocated to the omega-3 fatty acid groups are provided with 1,200 mg/day of eicosapentaenoic acid and 600 mg/day of docosahexaenoic acid for 90 days. The primary outcome is the change in the total score of the Hospital Anxiety and Depression Scale (HADS), determined by a blinded rater via the telephone at week 26. Secondary outcomes include the change in HADS score at 13 and 52 weeks; presence of a major depressive episode; severity of depression, anxiety, insomnia, burnout, and presenteeism; utility scores and adverse events at 13, 26 and 52 weeks. Discussion: An effective preventive intervention may not only lead to the maintenance of a healthy mental state in nurses, but also to better quality of care for inpatients. This paper outlines the background and methods of a randomized trial that evaluates the possible additive value of omega-3 fatty acids and a mindfulness-based stress management program for reducing depression in nurses.

We recently developed new disaster mental health guidelines in Japan through the Delphi process, a method for building consensus among experts, using as a reference the guidelines developed by The European Network for Traumatic Stress (TENTS) in Europe. We included in our survey 30 items used in the TENTS survey, 20 of which achieved positive consensus in that survey. Here we report on the extent of agreement of 95 Japanese experts on each of these 30 items and examine the reasons for disagreements with the TENTS survey results based on the comments obtained from the participants of our survey. Of the 20 items, 12 also gained consensus in our survey and 1 additional item achieved consensus that did not achieve it in the TENTS survey. Items that did not gain consensus in our survey, but did in the TENTS survey, were recommendations for close collaboration with the media, screening volunteers for their suitability, and withholding formal screening of the affected population. The need for specialist care for specific populations was endorsed in our survey, but not in the TENTS survey. Overall, the opinion of Japanese experts was congruent with that of Western experts, but some guideline amendments would be beneficial. © 2013 International Society for Traumatic Stress Studies.

Background: The mental health community in Japan had started reviewing the country's disaster mental health guidelines before the Great East Japan Earthquake, aiming to revise them based on evidence and experience accumulated in the last decade. Given the wealth of experience and knowledge acquired in the field by many Japanese mental health professionals, we decided to develop the guidelines through systematic consensus building and selected the Delphi method. Methods: After a thorough literature review and focus group interviews, 96 items regarding disaster mental health were included in Delphi Round 1. Of 100 mental health professionals experienced in disaster response who were invited to participate, 97 agreed. The appropriateness of each statement was assessed by the participants using a Likert scale (1: extremely inappropriate, 9: very appropriate) and providing free comments in three rounds. Consensus by experts was defined as an average score of &gt;= 7 for which &gt;= 70% of participants assigned this score, and items reaching consensus were included in the final guidelines. Results: Overall, of the 96 items (89 initially asked and 7 added items), 77 items were agreed on (46 items in Round 1, and 19 positive and 12 negative agreed on items in Round 2). In Round 2, three statements with which participants agreed most strongly were: 1) A protocol for emergency work structure and information flow should be prepared in normal times; 2) The mental health team should attend regular meetings on health and medicine to exchange information; and 3) Generally, it is recommended not to ask disaster survivors about psychological problems at the initial response but ask about their present worries and physical condition. Three statements with which the participants disagreed most strongly in this round were: 1) Individuals should be encouraged to provide detailed accounts of their experiences; 2) Individuals should be provided with education if they are interested in receiving it; and 3) Bad news should be withheld from distressed individuals for fear of causing more upset. Conclusions: Most items which achieved agreement in Round 1 were statements described in previous guidelines or publications, or statements regarding the basic attitude of human service providers. The revised guidelines were thus developed based on the collective wisdom drawn from Japanese practitioners' experience while also considering the similarities and differences from the international standards.