成澤 知美

IMPORTANCE: Cognitive processing therapy (CPT) is an evidence-based treatment for posttraumatic stress disorder (PTSD). However, there is little evidence on the efficacy of CPT in East Asia. OBJECTIVE: To evaluate whether CPT is effective in treating PTSD among outpatients in a Japanese medical setting. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial used a 16-week, single-center, assessor-blinded, parallel-group superiority design to examine the efficacy of CPT in conjunction with treatment as usual (CPT-TAU) vs waiting list with TAU (WL-TAU) from April 2016 through December 2022. The trial included adult patients with PTSD at a national psychiatric referral hospital in Tokyo, Japan. Analysis was based on intention to treat and per protocol and was performed from February 1 to April 30, 2024. INTERVENTIONS: Participants were randomized 1:1 to CPT-TAU (n = 29), which consisted of 12 weekly individual CPT sessions, or WL-TAU (n = 31), which consisted of clinical monitoring and/or pharmacotherapy. MAIN OUTCOMES AND MEASURES: The primary outcome was the Clinician-Administered PTSD Scale (CAPS-5) score for the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) at 17 weeks. Secondary outcomes included self-reported PTSD symptoms assessed by the PTSD Checklist-5 and responder status at 17 weeks. Adverse events were evaluated using the Japanese version of the Common Terminology Criteria for Adverse Events, version 4.0. RESULTS: Among 60 eligible participants (all included in the intention-to-treat analysis), mean (SD) age was 36.9 (9.9) years; 54 (90.0%) were women. The CPT-TAU group showed a mean (SE) reduction in CAPS-5 scores of 14.00 (1.92) points, with a low dropout rate (2 of 29 [6.9%]). Patients in the CPT-TAU group showed superiority in all secondary and other outcomes. The mean change difference was observed in depression (8.83; 95% CI, 6.00-11.66), suicidal ideation (6.73; 95% CI, 1.25-12.22), disability (8.16; 95% CI, 3.90-12.43), clinical global impression (0.84; 95% CI, 0.41-1.26), and loss of principal PTSD diagnosis (59.09; 95% CI, 37.19-81.00). There were no serious adverse events in the CPT-TAU group and 3 serious adverse events in the WL-TAU group during the intervention period. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of CPT-TAU vs WL-TAU, CPT was superior in reducing PTSD symptoms. These results strengthen the evidence for use of CPT in East Asian populations. TRIAL REGISTRATION: Umin.Uc.Jp/Ctr Identifier: UMIN000021670.

Background: Recent practice guidelines strongly recommend evidence-based psychotherapies (EBPs) as the first-line treatment for post-traumatic stress disorder (PTSD). However, previous studies found barriers to the implementation of EBPs and a relatively high dropout rate in clinical settings. After proving the efficacy of prolonged exposure (PE) in Japan [Asukai, N., Saito, A., Tsuruta, N., Kishimoto, J., & Nishikawa, T. (2010). Efficacy of exposure therapy for Japanese patients with posttraumatic stress disorder due to mixed traumatic events: A randomized controlled study. Journal of Traumatic Stress, 23(6), 744-750. https://doi.org/10.1002/jts.20589], we began implementing PE in a real-world clinical setting at the Victim Support Center of Tokyo (VSCT).Objective: We aimed to investigate the effectiveness and benefit of PE for crime-induced PTSD among VSCT clients and what causes dropout from treatment.Method: Of 311 adult clients who received counselling from clinical psychologists at VSCT due to violent or physical crime victimization from April 2008 through December 2019, 100 individuals received PE and participated in this study. Their PTSD symptoms were evaluated before and after treatment using the Impact of Event Scale-Revised and the Clinician-Administered PTSD Scale for DSM-IV.Results: A total of 93 participants completed PE and seven dropped out after six sessions or less. The completers group improved in PTSD symptoms with significant score differences between pre- and post-treatment in IES-R and CAPS-IV. Participants' symptoms did not exacerbate after treatment. Forty of 49 completers who left their workplace or college/school after victimization returned to work or study shortly after treatment. Compared to the completers, all dropout participants were women and younger. The majority were rape survivors, with significantly shorter intervals between victimization and treatment. The reasons for dropout were difficulty scheduling treatment between work/study schedules and manifestation of bipolar disorder or physical illness.Conclusions: PE can be implemented with significant effectiveness and a low dropout rate in a real-world clinical setting if advantages in the system and policies, local organizational context, fidelity support and patient engagement are fortified.

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.