Feasibility Study of Virtual Reality-Based Cognitive Behavioral Therapy for Patients With Depression: Protocol for an Open Trial and Therapeutic Intervention.

BACKGROUND: The clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, the longer time burden on health care providers associated with conducting CBT and the lack of a system for providing CBT lead to inadequate CBT provision to patients who wish to receive it. OBJECTIVE: We aim to evaluate the feasibility of introducing virtual reality (VR) into CBT for patients with depression. METHODS: This is a single-center, interventional, exploratory, single-arm, nonrandomized, open, pre-post-comparative feasibility study of an unapproved medical device program to evaluate the acceptability, preliminary efficacy, and safety of the study device. Eligible patients meet the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) for major depressive disorder, have a 17-item Hamilton Depression Rating Scale (HAMD-17) score of ≥12, and are aged 18-65 years. The sample will comprise 12 patients. VR-based CBT (CBT-VR) sessions will be conducted once a week in an outpatient setting. CBT-VR has been developed in accordance with 6 stages and 16 sessions in the current CBT therapist manual. VR contents and other components correspond to the themes of these 16 sessions. The flow of CBT-VR treatment is similar to that of normal CBT; however, this product replaces the in-person portion of CBT. The primary end point will be the change in the HAMD-17 score from baseline up to 16 sessions. Secondary end points will be treatment retention; psychiatrist consultation time; satisfaction with the equipment or program; ease of use; homework compliance; change in the HAMD-17 score from baseline up to 8 sessions; change in Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR), EQ-5D-5L, and Clinical Global Impressions (CGI) scores from baseline up to 8 and 16 sessions; and change in remission and response rates and HAMD-17, MADRS, QIDS-SR, and EQ-5D-5L scores from baseline to 3 and 6 months post intervention (or discontinuation). CBT-VR's feasibility will be assessed at baseline, after 8 sessions, after 16 sessions, or treatment discontinuation, by measuring the time required for testing and medical care during each session and with a patient questionnaire. After intervention discontinuation, a follow-up evaluation will be conducted unless the patient withdraws consent or otherwise discontinues participation in the study after 3 and 6 months. RESULTS: Participant recruitment started on November 30, 2022, and data collection is ongoing as of September 2023. CONCLUSIONS: This study is the first step in testing the acceptability, feasibility, and preliminary efficacy and safety of CBT-VR for patients with depression without controls in an open-label trial. If its feasibility for depression treatment is confirmed, we intend to proceed to a large-scale validation study. TRIAL REGISTRATION: Japan Registry of Clinical Trials jRCTs032220481; https://jrct.niph.go.jp/en-latest-detail/jRCTs032220481. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/49698.

Evaluation of the effect of a midwife-led online program using cognitive behavioral therapy for pregnant women at risk for anxiety disorder in Japan: A pilot randomized controlled trial.

AIM: This study aimed to conduct a pilot randomized controlled trial (RCT) to examine the appropriateness and feasibility of a midwife-led cognitive behavioral therapy (CBT)-based, three-session program delivered remotely to pregnant women at risk for anxiety disorders. METHODS: The study design was a pilot RCT. Outcome was the difference between the two groups in the change in generalized anxiety disorder-7 (GAD-7), Kessler6 (K6) and Edinberg Postnatal Depression Scale (EPDS) etc. Recruitment was conducted from August 2020 to July 2021 in clinics and web-based survey monitors in Japan, with follow-up through November 2021. RESULTS: This program involving 63 pregnant women were administered. Although the intervention was remote, a total of three sessions was completed during pregnancy. The change in GAD-7 scores from pre- to 1 month postpartum, was mean -1.77 in the intervention group and mean -0.97 in the control group, with a p-value of .521, indicating no significant difference between the two groups, although GAD-7 scores were lower in the intervention group. The change in K6 score from pre- to 1 month postpartum, was mean -3.55 in the intervention group and mean -1.62 in the control group, with a p-value of .168, indicating no significant difference between the two groups, although the intervention group showed a greater decrease. In particular, in primiparas, the change in GAD-7 scores in the intervention group was large, and some expressed a desire for a postpartum session, suggesting that a follow-up session after delivery may be effective. In multiparas, the control group showed an increase in both GAD-7 and K6 scores from late pregnancy to 1 month postpartum, while the intervention group showed a decrease in scores. CONCLUSION: The program was implemented using CBT conducted by midwife, anxiety decreased in primiparas. In future RCTs, it was suggested that additional postpartum sessions may be effective. TRIAL REGISTRATION: UMIN Clinical trial registry ID: UMIN000040304.

Feasibility, acceptability, and preliminary efficacy of cognitive processing therapy in Japanese patients with posttraumatic stress disorder.

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.

Adolescent Health Promotion Interventions Using Well-Care Visits and a Smartphone Cognitive Behavioral Therapy App: Randomized Controlled Trial.

BACKGROUND: Adolescent health promotion is important in preventing risk behaviors and improving mental health. Health promotion during adolescence has been shown to contribute to the prevention of late onset of the mental health disease. However, scalable interventions have not been established yet. OBJECTIVE: This study was designed to test the efficacy of two adolescent health promotion interventions: a well-care visit (WCV) with a risk assessment interview and counseling and self-monitoring with a smartphone cognitive behavioral therapy (CBT) app. Our hypothesis was that participants who had received both WCV and the CBT app would have better outcomes than those who had received only WCV or those who had not received any intervention. We conducted a prospective multi-institutional randomized controlled trial. METHODS: Participants were 217 adolescents aged 13-18 years. They were randomly divided into two intervention groups (WCV group and WCV with CBT app group) and a nonintervention group. WCV comprised a standardized physical examination along with a structured interview and counseling for youth risk assessment, which was designed with reference to the Guideline for Health Supervision of Adolescents of Bright Futures. A smartphone-based CBT program was developed based on the CBT approach. The CBT app comprised a 1-week psychoeducation component and a 1-week self-monitoring component. During the CBT program, participants created several self-monitoring sheets based on the CBT model with five window panels: event, thoughts, feelings, body response, and actions. The primary outcome was the change in scores for depressive symptoms. Secondary outcomes included changes in scores for self-esteem, quality of life, self-monitoring, and an adolescent health promotion scale. These outcomes were evaluated at baseline and at 1, 2, and 4 months after baseline. The exploratory outcome was the presence of suicidal ideation during the observation period. Intervention effects were estimated using mixed effect models. RESULTS: In total, 94% (204/217) of the participants completed the 4-month evaluation. Both intervention groups showed a significant effect in the form of reduced scores for depressive symptoms at 1 month in high school students; however, these effects were not observed at 2 and 4 months. The intervention effect was significantly more predominant in those scoring above cutoff for depressive symptoms. There was significantly less suicidal ideation in the intervention groups. As for secondary outcomes, there was significant increase in health promotion scale scores at the 4-month follow-up among junior high school students in the WCV group. Moreover, the CBT app was significantly effective in terms of obtaining self-monitoring skills and reducing depressive symptoms. CONCLUSIONS: Although adolescent health promotion interventions may have short-term benefits, the frequency of WCV and further revision of the CBT app should be considered to evaluate long-term effectiveness. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry UMIN 000036343; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041246.

Validating a Japanese Version of the Athlete Psychological Strain Questionnaire.

BACKGROUND: There is increasing international interest in clinical practice and research related to mental health in the international sports society. The athlete-specific psychological distress assessment tool that addresses potential mental health needs can help promote early detection and recovery of mental illness, as well as physical illnesses. Currently, little is known about the applicability of the useful assessment tool for Japanese elite athletes. The Athlete Psychological Strain Questionnaire (APSQ) is a brief, effective and reliable screening tool to identify early signs of athlete-specific distress and potential mental health symptoms. We examined the applicability and reliability of a Japanese version of the APSQ (APSQ-J) in a Japanese elite athlete context. Further, we examined the construct validity of the APSQ-J. METHODS: We collected web-based anonymous self-report data from 219 currently competing Japanese professional male rugby players. A two-stage process was conducted to validate the factor structure of the APSQ-J using exploratory factor analysis (EFA) in a randomly partitioned calibration sample and confirmatory factor analysis (CFA) in a separate validation sample. Cronbach's alpha is used to assess internal consistency. Pearson product-moment correlation coefficients were calculated to determine if the APSQ-J was significantly associated with measures of psychological distress and well-being using Kessler-6 (K6) and the WHO-5 Well-Being Index, respectively. RESULTS: We identified a one-factor structure for the APSQ-J. Confirmatory factor analysis supports this one-factor model, revealing good model fit indices. The standardized path coefficients for each of the items were ß = 0.41-0.83 (p < 0.001). A Cronbach's alpha of 0.84 was obtained for the APSQ-J. The APSQ-J demonstrated significant correlations with the K-6 (r = 0.80, p < 0.001) and WHO-5 (r = -0.58, p < 0.001). CONCLUSION: The APSQ-J can be an appropriate and psychometrically robust measure for identifying athlete-specific distress in elite athletes in Japan. Widely disseminating and utilizing this scale in Japanese sports society may support athletes' mental health via early detection of symptoms of psychological distress.

Association of mental health help-seeking with mental health-related knowledge and stigma in Japan Rugby Top League players.

BACKGROUND: Globally increasing clinical and research interests are driving a movement to promote understanding and practice of mental health in elite athletes. However, few studies have yet addressed this issue. This study aims to describe the association of the intention to seek help with mental health knowledge and stigma and the severity of depressive symptoms in Japan Rugby Top League players. METHODS: As a target population, we studied 233 Japan Rugby Top League male players (25-29 years = 123 [52.8%]), who were born in Japan, using a cross-sectional design. Surveys were conducted using anonymous, web-based self-administered questionnaires. Structural equation modelling was performed to evaluate the hypothesis of an interrelationship between mental health knowledge, stigma, and severity of depressive symptoms as factors influencing the intention to seek help. RESULTS: Players with more severe depressive symptoms were more reluctant to seek help from others (ß = - 0.20, p = 0.03). Players with greater knowledge about mental health tended to have less stigma toward others with mental health problems (ß = 0.13, p = 0.049), but tended not to seek help with their own mental health problems. CONCLUSIONS: Rugby players in need of mental health support, even with greater knowledge, tend not to seek help from others, while having less stigma toward people with mental health problems. Rugby players might require approaches other than a knowledge-based educational approach to encourage them to seek help.

Anxiety and Depression Symptoms and Suicidal Ideation in Japan Rugby Top League Players.

Clinical and research interest is growing in mental health support for elite athletes, based on findings from epidemiological surveys conducted in Australia, the United States, and European countries. However, little is known about the mental health status of elite athletes in Asia, including Japan. In the current study, we examine the prevalence of mental health problems and suicidal ideation and its risk factors in Japan Rugby Top League players. We analyze anonymous web-based self-reported data from 251 currently competing Japan Rugby Top League male players. During the off-season from December 2019 to January 2020, data on anxiety and depression symptoms were collected using the Japanese version of the 6-item Kessler-6. Suicidal ideation was assessed using the Baron Depression Screener for Athletes. Among the players, 81 players (32.3%) had experienced symptoms of mild anxiety and depression during the previous 30 days, while 12 (4.8%) and 13 (5.2%) had suffered from moderate and severe symptoms, respectively. Nineteen athletes (7.6%) reported that they had experienced suicidal ideation during the previous 2 weeks. Players with mental health problems experienced more events in competitions and daily life, including reduced subjective performance, missing opportunities to play during the last season, changes in health condition, and thinking about a career after retirement, compared with players without such problems. Mental health issues in Japan Rugby Top League players, as elite athletes, may be common, and research and practice development is expected in the near future.

Anxiety and Depressive Symptoms in the New Life With COVID-19: A Comparative Cross-Sectional Study in Japan Rugby Top League Players.

Objectives: The primary objective is to compare the prevalence of mental health problems, including psychological distress, anxiety and depressive symptoms in Japan Rugby Top League players in the new life with COVID-19 with those evaluated before COVID-19. Methods: An observational comparative web-based cross-sectional study was employed for Japan Rugby Top League players. We compared the data from 220 Japanese and 7 foreign players during the new life with COVID-19 with the data from before COVID-19, which was obtained from 233 Japanese and 18 foreign players. We measured anxiety and depression symptoms with the validated Kessler-6, which has been widely used in clinical and research settings among different populations. To investigate the distribution of K6 score and whether there are discrete clusters or not, we conducted the two-step cluster analysis. Results: In the new life with COVID-19, 15.0% of players reported mild symptoms, which was significantly lower than the 32.3% of players before COVID-19. The prevalence of moderate and severe symptoms was 6.7 and 3.5%, respectively, in the group during the new life with the COVID-19, and 4.8 and 5.2% in the pre-COVID-19 group, with no significant difference. A two-step cluster analysis supported the existence of these two qualitatively different clusters in both groups. Conclusions: With the spread of new lifestyles related to COVID-19, some rugby players may have improved mental health status due to changes in their daily living environment. Such environmental adjustments alone may not have been sufficient to change the mental health status of others. Rugby players or their teams may require mental health professionals and systems that ensure rest, adjust the environment, and sustainably provide more professional care.

Cognitive Behavioral Therapy Reduces Benzodiazepine Anxiolytics Use in Japanese Patients with Mood and Anxiety Disorders: A Retrospective Observational Study.

PURPOSE: Benzodiazepines (BZDs) are prescribed to treat psychiatric diseases. However, many guidelines recommend limiting the use of BZDs because of side effects and lack of evidence regarding long-term efficacy. Moreover, reducing BZDs' use is difficult because of dependency and the severity of withdrawal symptoms. The efficacy of cognitive behavioral therapy (CBT) for mood and anxiety disorders has been demonstrated. However, there is scant evidence that CBT has effectively reduced BZDs use, especially in Japan, where the BZDs prescription rate is high. Therefore, we sought to examine the impact of CBT on reducing BZDs use in a Japanese psychiatric setting. PATIENTS AND METHODS: Participants were outpatients with mood and anxiety disorders who were prescribed BZD anxiolytics. We retrospectively reviewed changes in BZD anxiolytics prescription dosages during CBT (66 patients; mean number of CBT sessions, 14.6) from our hospital record between April 2015 and September 2017. We checked prescriptions at four time points: at first interview for judging adaptation of CBT (baseline), at the first CBT session, at the last CBT session, and 3 months after the last CBT session. RESULTS: A total of 13 of 66 patients discontinued BZD anxiolytics during CBT, and 21 of 66 reduced their prescribed dosage by 50%. The association between discontinuation and dose-reduction and assessment period was modeled simultaneously using Bayesian hierarchical hurdle model. Results from the modeling showed a significant discontinuation at post-CBT and at 3 months post-CBT session compared to baseline (estimated median odds ratio [OR] post-CBT = 9.79 [95% CI: 4.65-20.45]; OR at 3 months post-CBT = 11.53 [95% CI: 6.06-22.33]). Moreover, a significant dose reduction was observed post-intervention (estimated median relative risk = 0.845 [95% CI: 0.729-0.982]), with a median reduction of 1.7 mg (diazepam conversion) in BZD use. CONCLUSION: Our results suggest that CBT possibly aids in reducing and discontinuing BZD anxiolytics use for Japanese patients.

Expressive suppression of emotion is a moderator of anxiety in a unified protocol for transdiagnostic treatment of anxiety and depressive disorders: A secondary analysis.

BACKGROUND: Expressive suppression (ES) of emotion is considered a moderator that reduces the efficacy of cognitive behavioural therapy (CBT); however, whether and how ES moderates the efficacy of the unified protocol for transdiagnostic treatment of emotional disorders (UP), a version of CBT targeting aversive/avoidant responses to emotions, including ES, remain unclear. We investigated whether and how emotion regulation, especially ES, moderates UP efficacy for anxiety symptoms in patients with anxiety and depressive disorders. METHODS: We conducted a secondary analysis of data from a previous trial. Seventeen patients with anxiety and/or depressive disorders were included. Changes (slope estimates) in the Structured Interview Guide for the Hamilton Anxiety Rating Scale from pre-treatment to post-treatment were measured using a latent growth curve model with empirical Bayesian estimation. Pre-treatment ES, cognitive reappraisal, and depressive symptoms were used as slope factor predictors. RESULTS: Only pre-treatment ES significantly predicted the slope in the latent growth curve model (estimate value = 0.45; standard deviation = 0.21; 95% credible interval = 0.03-0.87, one-tailed p-value = 0.004), and an inverse correlation between pre-treatment ES levels and improvement magnitude of anxiety symptoms was demonstrated. LIMITATIONS: Because the data were obtained from a single-arm trial, this study did not have controls, and most participants received pharmacotherapy in addition to UP. Therefore, generalisability of the present findings might be compromised. CONCLUSIONS: Low ES before UP was an effective predictor of greater improvement in anxiety symptoms after UP. The findings suggest that interventions intended to improve ES may improve UP efficacy.

Mental health crisis of Japanese health care workers under COVID-19.

During the COVID-19 outbreak, the mental health of health care workers has become a major public health concern. Particularly in Japan, women health care workers are experiencing a mental health crisis because of gender imbalance. In addition to honoring health care workers as heroes, we must promote efforts to compensate health care workers, strengthen infection prevention, and promote mental health. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Pseudo-continuous arterial spin labeling MRI study of patients with obsessive-compulsive disorder.

Arterial spin labeling (ASL) magnetic resonance imaging is a novel technique that can measure regional cerebral blood flow (rCBF). Here we used pseudo-continuous ASL (pCASL) to examine the structural and functional imaging data in patients with obsessive-compulsive disorder (OCD). We estimated the gray matter volume imaging and pCASL imaging data by means of a voxel-by-voxel statistical analysis. We evaluated the differences of rCBF and gray matter volume between the OCD patients and healthy subjects. We detected a significant rCBF reduction in OCD patients in the right posterior cingulate extending to the lingual gyrus, thalamus, and hippocampus, and a significant increase in the left temporal gyrus and left frontal white matter region, compared with healthy subjects. We also observed a significant reduction in gray matter volume of OCD patients in the right hippocampus. We also estimated the correlation between the clinical severity of OCD and the rCBF and gray matter volumes, and found significant negative correlations between the severity of illness and the regional gray matter volume in the bilateral anterior cingulate corti. Our study demonstrated significant changes of rCBF in the cortico-striato-thalamo-cortical pathway around the hippocampus in OCD patients. These findings may help to elucidate the pathogenesis of OCD.

Pilot study of a basic individualized cognitive behavioral therapy program for chronic pain in Japan.

BACKGROUND: Chronic pain is a major health problem, and cognitive behavioral therapy (CBT) is its recommended treatment; however, efforts to develop CBT programs for chronic pain and assess their feasibility are remarkably delayed in Asia. Therefore, we conducted this pilot study to develop a basic individualized CBT for chronic pain (CBT-CP) and assessed its feasibility for use in Japan. METHODS: Our study was an open-labeled before-after trial without a control group conducted cooperatively in five Japanese tertiary care hospitals. Of 24 outpatients, 15, age 20-80, who experienced chronic pain for at least three months were eligible. They underwent an eight-session CBT-CP consisting of relaxation via a breathing method and progressive muscle relaxation, behavioral modification via activity pacing, and cognitive modification via cognitive reconstruction. The EuroQol five-dimensional questionnaire five level (EQ5D-5 L) assessment as the primary outcome and quality of life (QOL), pain severity, disability, catastrophizing, self-efficacy, and depressive symptoms as secondary outcomes were measured using self-administered questionnaires at baseline, post-treatment, and 3-month follow-up. Intention-to-treat analyses were conducted. RESULTS: Effect size for EQ5D-5 L score was medium from baseline to post-treatment (Hedge's g = - 0.72, 90% confidence interval = - 1.38 to - 0.05) and up to the 3-month follow-up (g = - 0.60, CI = - 1.22 to 0.02). Effect sizes for mental and role/social QOL, disability, catastrophizing, self-efficacy, and depressive symptoms were medium to large, although those for pain severity and physical QOL were small. The dropout rate was acceptably low at 14%. No severe adverse events occurred. CONCLUSION: The findings suggest that CBT-CP warrants a randomized controlled trial in Japan. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), UMIN000020880. Registered on 04 February 2016.

The Feasibility and Efficacy of Social Cognition and Interaction Training for Outpatients With Schizophrenia in Japan: A Multicenter Randomized Clinical Trial.

Background: Schizophrenia is a disabling illness. Social cognition and interaction training (SCIT) seeks to improve patients' social functioning by alleviating deficits in social cognition. SCIT has shown promise in improving social cognition in patients with schizophrenia, but has not yet been studied in Japan. Design: An assessor-masked, randomized, parallel-group clinical trial was conducted to compare the feasibility and efficacy of SCIT with treatment as usual (TAU). Setting: Participants were recruited from outpatient clinics at the National Center of Neurology and Psychiatry and four other hospitals in Japan. Participants: Seventy-two patients diagnosed with schizophrenia or schizoaffective disorder consented to participate in the trial. Procedure: Participants were randomly allocated to either a SCIT subgroup or a TAU subgroup. SCIT is a manual-based group intervention that is delivered in 20-24-h-long weekly sessions. Groups include two to three clinicians and four to eight patients. Hypotheses: We hypothesized that SCIT would be found to be feasible and that patients who were randomized to receive SCIT would exhibit improvements in social cognition. Results: Data from 32 participants in each subgroup were entered into analyses. The persistence rate in the SCIT subgroup was 88.9%, and the average attendance rate was 87.0%. Intrinsic motivation was significantly higher in the SCIT subgroup than the TAU group during the first half of the program. Mixed effects modeling of various outcome measures revealed no significant interaction between measurement timepoint and group in any measures, including social cognition, neurocognition, symptom severity, and social functioning. In the case of the social cognition measure, significant change was observed only in the SCIT subgroup; however, the interaction between timepoint and group failed to reach significance. In an exploratory subgroup analysis, a shorter duration of illness was found to be associated with significantly better improvement on the social cognition measure in the SCIT subgroup compared with the TAU subgroup. Conclusions: In terms of the primary objective, the relatively low dropout rate observed in the present study suggests that SCIT is feasible and well tolerated by patients with schizophrenia in Japan. This view is also supported by participants' relatively high attendance and intrinsic motivation.

An Evaluation of Family-Based Treatment for OCD in Japan: A Pilot Randomized Controlled Trial.

Objective: Although family involvement in the treatment of obsessive-compulsive disorder (OCD) produces a reduction in OCD symptoms and has significant effects on global functioning, few studies have focused on family intervention as part of OCD treatment in Japan. This study aims to examine the feasibility and efficacy of the family-based exposure and response prevention (FERP) program for adult patients with OCD and their family members. Design: Randomized controlled pilot study. Methods: A total of 18 outpatients aged 18-65 years with a primary diagnosis of OCD and one family member of each patient were randomized to an intervention group or a control group (1:1). The intervention group received the FERP program, which consisted of 16 weekly face-to-face cognitive behavioral therapy (CBT) sessions, including eight joint sessions with family members, in addition to treatment-as-usual (TAU). The control group received TAU alone. The primary outcome was the alleviation of OCD symptoms, as measured by changes in the total Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score from baseline to posttreatment. Analyses were provided on an intention-to-treat basis, and linear mixed models were used to test for significant group differences. Results: After 16 weeks, patients allocated to the FERP program showed improvement in OCD symptom severity, as measured by the total change score of the Y-BOCS (Hedges' g = -1.58), as compared to the control group. Two patients (22.2%) in the FERP group reached remission, and five patients (55.6%) in the FERP group achieved treatment response. Clinical global improvement measured by the FAS-SR scores, K6 scores, and CGI-S scores was also observed (Hedges' g = -1.35, -1.25, and -1.26, respectively) in the FERP group as compared to the control group. The dropout rate from the study was low (n = 2, 11.8%), and no adverse events were reported in the FERP group. Conclusion: Our results suggest that FERP may be an effective program for reducing patients' OCD symptoms. Clinical Trial Registration: www.umin.ac.jp/ctr/, identifier UMIN000021763.

Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study.

INTRODUCTION: Cognitive processing therapy (CPT) is widely regarded as a safe and effective first-line treatment for individuals with post-traumatic stress disorder (PTSD); however, no comparative studies have been conducted to examine the treatment outcomes in an Asian population. The aim of the present trial is to investigate the efficacy of CPT (individual format) as a treatment for PTSD in a population of Japanese patients. METHODS AND ANALYSIS: A 16-week, single-centre, assessor-masked, randomised, parallel-group superiority trial has been designed to compare the efficacy of CPT in conjunction with treatment as usual (mostly pharmacotherapy and clinical monitoring) versus treatment as usual alone. The Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) will be our primary outcome measure of the post-traumatic stress symptoms at 17 weeks, whereas the PTSD Checklist for DSM-5 and determination of the operationally defined responder status will be used to assess the secondary outcomes. An estimated sample size of 29 participants in each group will be required to detect an expected effect size of 1.4 (95% CI 0.85 to 1.95). ETHICS AND DISSEMINATION: The institutional review board at the National Center of Neurology and Psychiatry in Japan approved this study. The results of this clinical trial will be presented at conferences and disseminated through publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: UMIN000021670 (registered on 1 April 2016).

Reliability and validity of the Japanese version of the Emotion Regulation Skills Questionnaire.

BACKGROUND: The Emotion Regulation Skills Questionnaire (ERSQ) comprehensively assesses nine aspects of emotion regulation skills: awareness, clarity, sensation, understanding, compassionate self-support, modification, acceptance, tolerance, and readiness to confront. However, it is unknown about the levels of emotion regulation skills in various mental disorders, and its cross-cultural validity. We developed a Japanese version of the ERSQ, then examined its validity and reliability in clinical and non-clinical populations. METHODS: In an Internet-based survey, 2684 participants (406 with MDD, 198 with PD, 116 with SAD, 66 with OCD, 636 with comorbid MDD and ≥1 anxiety disorder, and 99 with comorbid anxiety disorders; 1163 non-clinical sample) answered the ERSQ, diagnostic status, and measures of mindfulness, emotion regulation, behavioral activation, psychological distress, and life satisfaction. RESULTS: Confirmatory factor analysis (CFA) replicated the theoretical nine-factor structure of the original ERSQ. Higher-order factor analysis model assuming two second-order factors and nine first-order factors also showed adequate fit to the data, suggesting the factorial validity of the scale. Analyses of multi-group CFA indicated the equivalence of factor loadings across clinical and non-clinical subsamples. The levels of internal consistency and time stability were sufficient. Convergent validity of the scale was also confirmed for most of external criteria. Character on the emotion regulation skills for each diagnostic group was depicted. LIMITATIONS: Internet survey of samples with limited disorders, with self-reported diagnoses, may limit generalizability. CONCLUSIONS: The Japanese version of the ERSQ showed adequate reliability and validity.

Cognitive behavioral therapy for depression in Japanese Parkinson's disease patients: a pilot study.

OBJECTIVES: This study evaluated the feasibility of cognitive behavioral therapy (CBT) for Japanese Parkinson's disease (PD) patients with depression. To increase cultural acceptability, we developed the CBT program using manga, a type of Japanese comic novel. METHODS: Participants included 19 non-demented PD patients who had depressive symptoms (GRID-Hamilton Rating Scale for Depression score ≥8). A CBT program comprising six sessions was individually administered. We evaluated the feasibility and safety of the CBT program in terms of the dropout rate and occurrence of adverse events. The primary outcome was depressive symptom reduction in the GRID-Hamilton Rating Scale for Depression upon completion of CBT. Secondary outcomes included changes in the self-report measures of depression (Beck Depression Inventory-II, Hospital Anxiety and Depression Scale-Depression), anxiety (Hospital Anxiety and Depression Scale-Anxiety, State and Trait Anxiety Inventory, Overall Anxiety Severity and Impairment Scale), functional impairment, and quality of life (Medical Outcomes Study 36-Item Short-Form Health Survey). RESULTS: Of the 19 participants (mean age =63.8 years, standard deviation [SD] =9.9 years; mean Hohen-Yahr score =1.7, SD =0.8), one patient (5%) withdrew. No severe adverse event was observed. The patients reported significant improvements in depression (Hedges' g =-1.02, 95% confidence interval =-1.62 to -0.39). The effects were maintained over a 3-month follow-up period. Most of the secondary outcome measurements showed a small-to-moderate but nonsignificant effect size from baseline to post-intervention. CONCLUSION: This study provides preliminary evidence that CBT is feasible among Japanese PD patients with depression. Similar approaches may be effective for people with PD from other cultural backgrounds. The results warrant replication in a randomized controlled trial.

Transdiagnostic and Transcultural: Pilot Study of Unified Protocol for Depressive and Anxiety Disorders in Japan.

Unified protocol (UP) is a transdiagnostic cognitive behavior therapy for emotional disorders. It remains unknown whether UP is applicable for use in non-Western countries and for depressive disorders. We therefore examined its feasibility for a Japanese clinical population using this clinical trial design, which is multicentered, open-labeled, and single-armed (Clinical registry: UMIN000008322). The primary outcome was severity of anxiety symptoms, as assessed using Structured Interview Guide for the Hamilton Anxiety Rating Scale. Secondary outcomes were depressive symptoms, clinical global impression, functioning, quality of life, affectivity, emotion regulation, and adverse events. Of the 28 prospective participants, 17 were eligible and enrolled (depressive disorders=9, anxiety disorders=8). Severity of anxiety symptoms, which decreased significantly after the intervention, remained low for 3months (Hedges' g=1.29, 95% CI=0.56-2.06). Similar tendencies were observed for secondary outcome measures. No severe adverse event occurred. Two participants dropped out of the intervention. High treatment adherence and interrater reliability were confirmed. Results suggest the feasibility of UP in the Japanese context sufficient to warrant a larger clinical trial.

Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial.

BACKGROUND: The unified protocol for the transdiagnostic treatment of emotional disorders is a promising treatment approach that could be applicable to a broad range of mental disorders, including depressive, anxiety, trauma-related, and obsessive-compulsive disorders. However, no randomized controlled trial has been conducted to verify the efficacy of the unified protocol on the heterogeneous clinical population with depressive and anxiety disorders. METHODS/DESIGN: The trial was designed as a single-center, assessor-blinded, randomized, 20-week, parallel-group superiority study in order to compare the efficacy of the combination of unified protocol and treatment-as-usual versus waiting-list with treatment-as-usual for patients with depressive and/or anxiety disorders. The primary outcome was depression at 21 weeks, assessed by the 17-item version of the GRID-Hamilton Rating Scale for Depression. Estimated minimum sample size was 27 participants in each group. We will also examine the treatment mechanisms, treatment processes, and neuropsychological correlates. DISCUSSION: The results of this study will clarify the efficacy of the unified protocol for depressive and anxiety disorders, and the treatment mechanism, process, and neurological correlates for the effectiveness of the unified protocol. If its efficacy can be confirmed, the unified protocol may be of high clinical value for Japan, a country in which cognitive behavioral treatment has not yet been widely adopted. TRIAL REGISTRATION: ClinicalTrials.gov NCT02003261 (registered on December 2, 2013).