Masaru Horikoshi

Background Depression is a leading cause of global disability, and subthreshold cases contribute substantially to the burden. Cognitive behavioural therapy (CBT) is effective for depressive symptoms, but its impact on social functioning in subthreshold depression remains unclear. Objective This study evaluated the effects of smartphone-based CBT on social functioning and personal health records among individuals with subthreshold depression and examined whether a personalised and optimised therapy (POT) algorithm enhanced these outcomes. Methods We performed a secondary analysis of the RESiLIENT trial (n=5361). Participants were stratified by baseline Patient Health Questionnaire-9 (PHQ-9) scores (0–4 and 5–14) and randomised to nine CBT app groups or a self-check group. Outcomes included social functioning and health records. A mixed-effects model for repeated measures was used to analyse the outcomes. The POT algorithm selected CBT skills tailored to individual characteristics. Findings Depressive symptoms improved in both PHQ-9 groups compared with those of the self-check group, but gains in social functioning were modest, observed mainly in the PHQ-9 score ≤4 group. No consistent benefits were seen for health behaviours, job resignation, sick leave or healthcare costs. However, in a simulated randomised comparison using 10-fold cross-validated datasets, the POT algorithm had potentially beneficial effects for productivity (standardised mean difference (SMD)=0.16, 95% CI 0.03 to 0.29) and social adjustment (SMD=−0.13, 95% CI −0.26 to 0.00). Conclusions Smartphone CBT effectively reduced depressive symptoms but showed limited impact on social functioning and healthcare costs. Personalised optimisation may modestly improve productivity and adjustment, suggesting its promise for enhancing social outcomes. Clinical implications Personalised tailoring of CBT skills may strengthen the effects of digital interventions on social functioning. Trial registration number UMIN000047124.

BACKGROUND: Depression is a leading cause of global disability, and subthreshold cases contribute substantially to the burden. Cognitive behavioural therapy (CBT) is effective for depressive symptoms, but its impact on social functioning in subthreshold depression remains unclear. OBJECTIVE: This study evaluated the effects of smartphone-based CBT on social functioning and personal health records among individuals with subthreshold depression and examined whether a personalised and optimised therapy (POT) algorithm enhanced these outcomes. METHODS: We performed a secondary analysis of the RESiLIENT trial (n=5361). Participants were stratified by baseline Patient Health Questionnaire-9 (PHQ-9) scores (0-4 and 5-14) and randomised to nine CBT app groups or a self-check group. Outcomes included social functioning and health records. A mixed-effects model for repeated measures was used to analyse the outcomes. The POT algorithm selected CBT skills tailored to individual characteristics. FINDINGS: Depressive symptoms improved in both PHQ-9 groups compared with those of the self-check group, but gains in social functioning were modest, observed mainly in the PHQ-9 score ≤4 group. No consistent benefits were seen for health behaviours, job resignation, sick leave or healthcare costs. However, in a simulated randomised comparison using 10-fold cross-validated datasets, the POT algorithm had potentially beneficial effects for productivity (standardised mean difference (SMD)=0.16, 95% CI 0.03 to 0.29) and social adjustment (SMD=-0.13, 95% CI -0.26 to 0.00). CONCLUSIONS: Smartphone CBT effectively reduced depressive symptoms but showed limited impact on social functioning and healthcare costs. Personalised optimisation may modestly improve productivity and adjustment, suggesting its promise for enhancing social outcomes. CLINICAL IMPLICATIONS: Personalised tailoring of CBT skills may strengthen the effects of digital interventions on social functioning. TRIAL REGISTRATION NUMBER: UMIN000047124.

BACKGROUND: Marital satisfaction is a key determinant of maternal mental health during the perinatal period. Identifying psychosocial factors associated with changes in marital satisfaction can help inform early preventive interventions. METHODS: This longitudinal study examined associations between psychosocial factors measured during pregnancy and changes in marital satisfaction from pregnancy to 52 weeks postpartum. Participants were 752 pregnant women in Japan (mean age = 32.0 ± 4.3 years) who completed online surveys during pregnancy and at 52 weeks postpartum. Marital satisfaction was assessed using the Quality of Marriage Index (QMI), a validated measure of relationship satisfaction, and categorized into three groups based on QMI score differences: improved (≥ 1-point increase), unchanged (0-point difference), and worsened (≥ 1-point decrease). Psychosocial variables included depressive symptoms assessed by the Edinburgh Postnatal Depression Scale (EPDS), household income, perceived burden of household chores and childcare, parity, and perceived family support. Multinomial logistic regression was used to examine associations between these variables and changes in marital satisfaction. RESULTS: Higher levels of depressive symptoms during pregnancy, as measured by the EPDS, were significantly associated with worsening marital satisfaction after childbirth (RRR = 2.38, 95% CI: 1.30-4.37, p = 0.005). Lower household income also predicted a decline in satisfaction (RRR = 0.999, 95% CI: 0.999-1.00, p = 0.017). Participants who reported extremely long hours of household chores and childcare were less likely to experience improved satisfaction (RRR = 0.15, 95% CI: 0.04-0.65, p = 0.011). First-time childbirth was negatively associated with improvement (RRR = 0.41, 95% CI: 0.20-0.87, p = 0.019). Higher levels of perceived family support were also associated with less improvement in marital satisfaction (RRR = 0.89, 95% CI: 0.80-0.98, p = 0.017). CONCLUSION: Psychosocial factors during pregnancy, including depressive symptoms, economic hardship, and perceived domestic burden, were significantly associated with subsequent changes in marital satisfaction. These findings underscore the importance of early mental health screening and supportive interventions for expectant couples.

Abstract Background Chronic pain imposes a substantial burden on individuals and society. Cognitive behavioral therapy for chronic pain (CBT-CP) has proven effective internationally, but randomized evidence in Japan is scarce. The first Japanese trial was a single-center, 16-session videoconference program that prioritized pain intensity. In contrast, this multicenter trial tests a brief, face-to-face, individualized CBT-CP program with quality of life (QoL) as the primary outcome. Methods This open-label, randomized, parallel-group superiority trial enrolls 60 adults aged 20–80 years with chronic pain persisting ≥ 3 months and EQ-5D-5L scores ≤ 0.80, indicating reduced QoL. Participants are randomized 1:1 to treatment as usual (TAU) plus an eight-session CBT-CP program or to a waitlist control receiving TAU only. The manualized intervention includes psycho-education, relaxation, activity pacing, and cognitive restructuring, delivered weekly face-to-face, with the goal of completing eight sessions within 14 weeks. If necessary, sessions may extend beyond the 15th week; however, the post-assessment is always conducted at 15 ± 2 weeks irrespective of intervention timing. Therapists meet prespecified eligibility criteria and receive structured training, supervision, and fidelity monitoring. The primary outcome is QoL (EQ-5D-5L) at 15 ± 2 weeks. Secondary outcomes include pain intensity, disability, depressive symptoms, catastrophizing, fear of movement, pain self-efficacy, and health-related QoL assessed by the SF-12. These outcomes, together with prognostic risk and somatic symptom burden, will also be examined as potential mediators or moderators. The intervention group undergoes a 27 ± 2-week follow-up to explore mid-term durability in a single-arm pre/post analysis. Analyses follow the intent-to-treat principle using linear mixed models, with effect sizes and confidence intervals reported; multiplicity will be considered in interpreting secondary outcomes. Blinding of participants and therapists is not feasible. Discussion This trial will clarify the added value of a brief, fidelity-assured, face-to-face CBT-CP program in Japan, where implementation remains limited. Findings are expected to guide clinical adoption, workforce training, and dissemination, while also generating hypotheses about for whom and through which processes CBT-CP may confer benefit. Trial registration University Hospital Medical Information Network Clinical Trials Registry, UMIN000042798. Registered on 21 December 2020, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048858 .

BACKGROUND: The prevalence of mental health disorders among children in Japan has increased rapidly, and these children often show depressive symptoms and reduced quality of life (QOL). We previously developed a smartphone-based self-monitoring app to deliver cognitive behavioral therapy (CBT), implemented it in healthy children, and reported its effectiveness for health promotion. OBJECTIVE: This study aims to examine the usefulness of the CBT app for improvement in depressive symptoms and QOL in children with mental health disorders. METHODS: The participants were 115 children with mental health disorders (eg, school refusal, orthostatic hypotension, eating disorders, developmental disorders, among others) and aged 12-18 years. The CBT app-based program comprised 1 week of psychoeducation followed by 1 week of self-monitoring. After reading story-like scenarios, participants created a self-monitoring sheet with 5 panels: events, thoughts, feelings, body responses, and actions. All participants received regular mental health care from physicians in addition to the app-based program. To evaluate the participants' depressive symptoms and QOL, Patient Health Questionnaire for Adolescents (PHQ-9A), Depression Self-Rating Scale for Children (DSRS-C), and Pediatric Quality of Life Inventory (PedsQL) were measured at the beginning of the intervention, and at 2 and 6 months thereafter. Questionnaire for Triage and Assessment with 30 items (QTA30), and Rosenberg Self-Esteem Scale (RSES) were also used to measure their health and self-esteem. Participants were divided into 4 groups on the basis of the PHQ-9A score (above or below the cutoff; PHQ-9A≥5 or PHQ-9A<5) and completion or noncompletion of the CBT app-based program (app [+] or app [-]). The primary outcome was improvement in the DSRS-C score, and secondary outcomes were improvement in other psychometric scales including PedsQL, QTA30, and RSE. A paired-samples t test was used for statistical analysis. The Medical Ethics Committee of Fukuoka University Faculty of Medicine (approval U22-05-002) approved the study design. RESULTS: There were 48, 18, 18, and 7 participants in the PHQ-9A≥5 app (+), PHQ-9A≥5 app (-), PHQ-9A<5 app (+), and PHQ-9A<5 app (-) groups, respectively. A total of 24 participants dropped out. No improvement in the DSRS-C score was observed in all groups. However, PedsQL scores improved significantly at 2 and 6 months in the PHQ-9A<5 app (+) group (t17=6.62; P<.001 and t17=6.11; P<.001, respectively). There was a significant positive correlation between the PHQ-9A scores and the number of self-monitoring sheets completed. CONCLUSIONS: The CBT app was useful for improving PedsQL scores of children with mental health disorders. However, a higher-intensity CBT program is necessary for more severely depressed children.

Abstract Aim The association between alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) is well established. However, many studies in Japan have focused on trauma related to natural disasters, which differ from international studies that include several trauma types. We examined whether trauma exposure and PTSD are associated with AUD risk across diverse trauma types. Additionally, because gender differences in drinking patterns and AUD may vary by country, we explored whether findings from international research hold in a Japanese context. Methods An online survey of 6180 Japanese adults included 25 items from the World Health Organization's traumatic event list, the PTSD Checklist‐5, and the CAGE Questionnaire. Of these, 5150 reported exposure to traumatic events, and 1030 reported no exposure. Results Participants' mean age was 43.79 years, and 52.8% were women. The AUD group comprised more men (59.1%) than the non‐AUD group (44.1%). Logistic regression analyses showed that trauma exposure was associated with higher odds ratios (ORs) of AUD among individuals without PTSD (OR = 1.55, 95% confidence interval [CI]: 1.24–1.94) and among those with PTSD (OR = 2.02, 95% CI: 1.62–2.52) compared to those with no trauma exposure. Among women, several non‐natural‐disaster events showed a higher risk of AUD than that posed by natural disasters. In men, physical violence by a partner was associated with a higher risk. Conclusion These findings highlight the pertinence of assessing trauma characteristics and gender when addressing PTSD and AUD. They may inform gender‐sensitive interventions and culturally relevant policies targeting individuals at risk for comorbid PTSD and AUD.

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

Abstract Background Attention‐deficit/hyperactivity disorder (ADHD) symptoms, including executive function, emotional regulation, and motivation, can persist into adulthood and are often associated with mental illnesses. Cognitive behavioral therapy (CBT) may help ADHD adults in Japan, but the lack of studies and the variability in group CBT approaches make its effects unclear. Japan lacks unified CBT programs and adult ADHD guidelines, making it difficult to implement international individual CBT recommendations due to cultural differences. This study will assess the feasibility of a novel CBT program for Japanese adult ADHD patients. Methods This feasibility study will be open, nonrandomized, single‐arm, multicenter study. Twelve ADHD patients aged 20–65 years who are currently receiving treatment will be included based on Conners' Adult ADHD Rating Scale (CAARS) clinical severity threshold. An intervention phase of 12–16 weeks and a 12‐week follow‐up will total 24–28 weeks for all participants. The intervention will use a new CBT program tailored to individual assessments. Results The primary objective is to determine feasibility using dropout rates, adverse events, and CAARS score changes between Weeks 1 and 16. The secondary outcomes will assess long‐term effects of treatment beyond the intervention period and provide descriptive statistics on sex, depression, quality of life, and autistic scores in relation to the intervention outcomes. The full analysis set and per protocol set will be used for statistical analysis. Conclusions This study is essential for the development of CBT interventions in accordance with Japan's healthcare system that are tailored to the unique needs of its population.

AIM: Patients with cancer experience various forms of psychological distress, including depressive symptoms, which can impact quality of life, elevate morbidity risk, and increase medical costs. Psychotherapy and pharmacotherapy are effective for reducing depressive symptoms among patients with cancer, but most patients prefer psychotherapy. This study aimed to develop an efficient and effective smartphone psychotherapy component to address depressive symptom. METHODS: This was a decentralized, parallel-group, multicenter, open, individually randomized, fully factorial trial. Patients aged ≥20 years with cancer were randomized by the presence/absence of three cognitive-behavioral therapy (CBT) skills (behavioral activation [BA], assertiveness training [AT], and problem-solving [PS]) on a smartphone app. All participants received psychoeducation (PE). The primary outcome was change in the patient health questionnaire-9 (PHQ-9) total score between baseline and week 8. Secondary outcomes included anxiety. RESULTS: In total, 359 participants were randomized. Primary outcome data at week 8 were obtained for 355 participants (99%). The week 8 PHQ-9 total score was significantly reduced from baseline for all participants by -1.41 points (95% confidence interval [CI] -1.89, -0.92), but between-group differences in change scores were not significant (BA: -0.04, 95% CI -0.75, 0.67; AT: -0.16, 95% CI -0.87, 0.55; PS: -0.19, 95% CI -0.90, 0.52). CONCLUSION: As the presence of any of the three intervention components did not contribute to a significant additive reduction of depressive symptoms, we cannot make evidence-based recommendations regarding the use of specific smartphone psychotherapy.

Abstract Background Effective cognitive restructuring (CR) requires identification of automatic thoughts that underlie experienced emotions. However, accurate recording of thoughts and emotions is challenging when CR is provided in internet cognitive-behavior therapy (iCBT). This study investigated the potential use of the artificial intelligence (AI) including the natural language processing (NLP) to facilitate CR offered in iCBT. Methods We applied the Japanese Text-to-Text Transfer Transformer (T5), one of the most advanced Large Language Models for  the NLP,to records of thought-feeling pairs provided by participants in two randomized controlled trials of iCBT. We conducted threefold cross-validated prediction of self-reported feelings based on recorded thoughts. We examined the validity of the predictions by checking them against the human expert judgments and by the efficacy when the thought records were subjected to CR. Results 1626 participants provided 4369 though-feeling records. The overall prediction accuracy was 73.5%. The self-reported feelings matched the human expert judgments more frequently when they were correctly predicted by the T5 than not (90% vs 37.5%, 95%CI of difference: 34.8 to 70.2%). When subjected to CR, the correctly predicted thought-feeling pairs led to greater reductions in negative feelings than the incorrectly predicted pairs (− 1.54 vs − 1.43 on a scale of 0 to 5, 95%CI of difference: 0.03 to 0.19). Conclusions A new CR module of an iCBT application can incorporate this model and advise the users to revisit and revise their automatic thoughts to reflect their feelings more accurately. Whether such an iCBT application can ultimately lead to greater reductions in depression is to be examined in a future randomized trial.

BACKGROUND: Cancer patients experience various forms of psychological distress. Their distress, mainly in the form of depression and anxiety, leads to poor quality of life, increased medical spending due to frequent visits, and decrease in treatment adherence. It is estimated that 30-50% among them would require support from mental health professionals: in reality, much less actually receive such support partly due to a shortage of qualified professionals and also due to psychological barriers in seeking such help. The purpose of the present study is to develop the easily accessible and the most efficient and effective smartphone psychotherapy package to alleviate depression and anxiety in cancer patients. METHODS: Based on the multiphase optimization strategy (MOST) framework, the SMartphone Intervention to LEssen depression/Anxiety and GAIN resilience project (SMILE-AGAIN project) is a parallel-group, multicenter, open, stratified block randomized, fully factorial trial with four experimental components: psychosocial education (PE), behavioral activation (BA), assertion training (AT), and problem-solving therapy (PS). The allocation sequences are maintained centrally. All participants receive PE and then are randomized to the presence/absence of the remaining three components. The primary outcome of this study is the Patient Health Questionnaire-9 (PHQ-9) total score, which will be administered as an electronic patient-reported outcome on the patients' smartphones after 8 weeks. The protocol was approved by the Institutional Review Board of Nagoya City University on July 15, 2020 (ID: 46-20-0005). The randomized trial, which commenced in March 2021, is currently enrolling participants. The estimated end date for this study is March 2023. DISCUSSION: The highly efficient experimental design will allow for the identification of the most effective components and the most efficient combinations among the four components of the smartphone psychotherapy package for cancer patients. Given that many cancer patients face significant psychological hurdles in seeing mental health professionals, easily accessible therapeutic interventions without hospital visits may offer benefits. If an effective combination of psychotherapy is determined in this study, it can be provided using smartphones to patients who cannot easily access hospitals or clinics. TRIAL REGISTRATION: UMIN000041536, CTR. Registered on 1 November 2020  https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000047301 .

Introduction The health burden due to depression is ever increasing in the world. Prevention is a key to reducing this burden. Guided internet cognitive–behavioural therapies (iCBT) appear promising but there is room for improvement because we do not yet know which of various iCBT skills are more efficacious than others, and for whom. In addition, there has been no platform for iCBT that can accommodate ongoing evolution of internet technologies. Methods and analysis Based on our decade-long experiences in developing smartphone CBT apps and examining them in randomised controlled trials, we have developed the Resilience Training App Version 2. This app now covers five CBT skills: cognitive restructuring, behavioural activation, problem-solving, assertion training and behaviour therapy for insomnia. The current study is designed as a master protocol including four 2×2 factorial trials using this app (1) to elucidate specific efficacies of each CBT skill, (2) to identify participants’ characteristics that enable matching between skills and individuals, and (3) to allow future inclusion of new skills. We will recruit 3520 participants with subthreshold depression and ca 1700 participants without subthreshold depression, to examine the short-term efficacies of CBT skills to reduce depressive symptoms in the former and to explore the long-term efficacies in preventing depression in the total sample. The primary outcome for the short-term efficacies is the change in depressive symptoms as measured with the Patient Health Questionnaire-9 at week 6, and that for the long-term efficacies is the incidence of major depressive episodes as assessed by the computerised Composite International Diagnostic Interview by week 50. Ethics and dissemination The trial has been approved by the Ethics Committee of Kyoto University Graduate School of Medicine (C1556). Trial registration number UMIN000047124.

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.

BACKGROUND: Internet-cognitive behavioural therapy (iCBT) for depression can include multiple components. This study explored depressive symptom improvement prognostic factors (PFs) and effect modifiers (EMs) for five common iCBT components including behavioural activation, cognitive restructuring, problem solving, self-monitoring, and assertion training. METHODS: We used data from a factorial trial of iCBT for subthreshold depression among Japanese university students (N = 1093). The primary outcome was the change in PHQ-9 scores at 8 weeks from baseline. Interactions between each component and various baseline characteristics were estimated using a mixed-effects model for repeated measures. We calculated multiplicity-adjusted p-values at 5 % false discovery rate using the Benjamini-Hochberg procedure. RESULTS: After multiplicity adjustment, the baseline PHQ-9 total score emerged as a PF and exercise habits as an EM for self-monitoring (adjusted p-values <0.05). The higher the PHQ-9 total score at baseline (range: 5-14), the greater the decrease after 8 weeks. For each 5-point increase at baseline, the change from baseline to 8 weeks was bigger by 2.8 points. The more frequent the exercise habits (range: 0-2 points), the less effective the self-monitoring component. The difference in PHQ-9 change scores between presence or absence of self-monitoring was smaller by 0.94 points when the participant exercised one level more frequently. Additionally, the study suggested seven out of 36 PFs and 14 out of 160 EMs examined were candidates for future research. LIMITATIONS: Generalizability is limited to university students with subthreshold depression. CONCLUSIONS: These results provide some helpful information for the future development of individualized iCBT algorithms for depression.

PURPOSE: Fear of cancer recurrence (FCR) is a common distressing condition. We investigated the efficacy of smartphone problem-solving therapy and behavioral activation applications in breast cancer survivors. METHODS: This was a decentralized randomized trial. Participants were disease-free breast cancer survivors age 20-49 years who were randomly assigned to the smartphone-based intervention or waitlist control. Both groups received treatment as usual. The control group could access the smartphone apps during weeks 8-24. The intervention comprised smartphone problem-solving therapy and behavioral activation apps. The primary end point was the Concerns About Recurrence Scale at week 8. Secondary outcomes included the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF), the Hospital Anxiety and Depression Scale (HADS), the Short-form Supportive Care Needs Survey (SCNS-SF34), and the Posttraumatic Growth Inventory at weeks 8 and 24 (trial registration: UMIN-CTR: UMIN000031140). RESULTS: The intervention group included 223 participants, and the control group included 224 participants. Primary outcome data were obtained for 444 participants, and 213 participants in the intervention arm completed the week 24 assessment. The intervention group had statistically greater improvements than controls at week 8 on the Concerns About Recurrence Scale (difference -1.39; 95% CI, -1.93 to -0.85; P < .001), FCRI-SF (difference -1.65; 95% CI, -2.41 to -0.89; P < .001), HADS depression (difference -0.49; 95% CI, -0.98 to 0; P < .05), and SCNS-SF34 psychological domain (difference -1.49; 95% CI, -2.67 to -0.32; P < .05). These scores at week 24 were not statistically significant compared with week 8 although the HADS depression score at week 24 was significantly reduced (P = .03). CONCLUSION: Novel smartphone psychotherapy offers a promising way to reduce FCR given the large number of survivors and a limited number of therapists to competently conduct psychotherapy.

AIM: The aim of this pilot study is to evaluate a Japanese version of brief Cognitive Behavioral Therapy for Insomnia (CBT-I) and contribute to primary care which leads to prevention of a lifestyle-related disease or a psychiatric disorder. METHOD: A single-arm study in nine patients with chronic insomnia who were under the pharmacotherapy was executed. The Insomnia Severity Index (ISI), the Athens Insomnia Scale (AIS), and the European Quality of Life 5 Items (EQ-5D) were assessed at the beginning of intervention, at the end of intervention, and after 12 weeks. FINDINGS: There were no patient dropouts nor adverse events. The average change in ISI score was -7.33 (95% CI: -10.31 to -4.36) at post-treatment and -6.11 (95% CI: -8.20 to -4.03) at the 12-week follow-up point (Cohen's d = 2.25). The AIS score improved as well, and the EQ-5D score improved after 12 weeks. The safety and efficacy of the brief CBT-I were suggested.

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.

BACKGROUND: Internet-based cognitive-behavioural therapy (iCBT) is effective for subthreshold depression. However, which skills provided in iCBT packages are more effective than others is unclear. Such knowledge can inform construction of more effective and efficient iCBT programmes. OBJECTIVE: To examine the efficacy of five components of iCBT for subthreshold depression. METHODS: We conducted an factorial trial using a smartphone app, randomly allocating presence or absence of five iCBT skills including self-monitoring, behavioural activation (BA), cognitive restructuring (CR), assertiveness training (AT) and problem-solving. Participants were university students with subthreshold depression. The primary outcome was the change on the Patient Health Questionnaire-9 (PHQ-9) from baseline to week 8. Secondary outcomes included changes in CBT skills. FINDINGS: We randomised a total of 1093 participants. In all groups, participants had a significant PHQ-9 reduction from baseline to week 8. Depression reduction was not significantly different between presence or absence of any component, with corresponding standardised mean differences (negative values indicate specific efficacy in favour of the component) ranging between -0.04 (95% CI -0.16 to 0.08) for BA and 0.06 (95% CI -0.06 to 0.18) for AT. Specific CBT skill improvements were noted for CR and AT but not for the others. CONCLUSIONS: There was significant reduction in depression for all participants regardless of the presence and absence of the examined iCBT components. CLINICAL IMPLICATION: We cannot yet make evidence-based recommendations for specific iCBT components. We suggest that future iCBT optimisation research should scrutinise the amount and structure of components to examine. TRIAL REGISTRATION NUMBER: UMINCTR-000031307.

Remote cognitive and behavioral therapy (CBT) via videoconference has been garnering attention as a means of improving access to CBT for depression, in particular during the coronavirus disease 2019 pandemic. However, there is a lack of evidence supporting its implementation in Japanese clinical settings. This case series aimed to establish preliminary evidence of whether remote CBT can be an effective therapy for major depression in Japanese clinical settings. Five patients who met the diagnostic criteria for major depressive disorder were enrolled and underwent remote CBT via videoconference and face-to-face assessment interviews. The results showed that remote CBT via videoconference improved depressive symptoms, enabling a relatively high level of patient satisfaction and working alliance. Moreover, detailed feedback from our patients showed that continuous monitoring was preferable for increasing treatment engagement. Further research is warranted to test the efficacy and acceptability of remote CBT via videoconference for treating major depression.

INTRODUCTION: Few people can access psychotherapy for irritable bowel syndrome (IBS). Group cognitive-behavioral therapy (GCBT) may be efficient, but the evidence for its efficacy is weak and limited. We aimed to assess the efficacy and safety of GCBT with interoceptive exposure (GCBT-IE), a novel form of GCBT for drug-refractory IBS. METHODS: A single-center, open-label, randomized, controlled trial was conducted in Japan among people aged 18-75 years with moderate-to-severe drug-refractory IBS. Participants were stratified by IBS severity and allocated 1:1 to 10-week GCBT-IE or waiting list (WL) in a blockwise randomization by independent staff. Both arms practiced self-monitoring and received treatment as usual. Multiple primary outcomes were changes from baseline to week 13 in the IBS Symptom Severity Score and the IBS Quality of Life Measure (IBS-QOL), assessed in the intention-to-treat sample. RESULTS: A total of 114 people with drug-refractory IBS were randomized to GCBT-IE (n = 54) or WL (n = 60). Forty-nine participants (90.7%) in the GCBT-IE arm and 58 (96.7%) in the WL arm completed the week 13 assessment. Participants in the GCBT-IE arm reported greater improvements in both IBS symptom severity and quality of life compared with the WL arm, with -115.8 vs -29.7 on the IBS Symptom Severity Score (a difference of -86.1, 95% confidence interval -117.3 to -55.0), and 20.1 vs -0.2 on the IBS-QOL (a difference of 20.3, 95% confidence interval 15.2-25.3), respectively. Six unexpected serious adverse events were reported but were judged as unrelated to the interventions. DISCUSSION: GCBT-IE is an efficacious, safe, and efficient treatment option for people with drug-refractory IBS.

Affective styles are assumed to play an important role in maintaining negative affect, including anxiety and depression. However, little is known about the longitudinal relationship between affective styles and symptoms. Therefore, we conducted a longitudinal study to examine the influence of affective styles, assessed using the Affective Style Questionnaire, on anxiety and depression among clinical populations in Japan. Using an online survey, 1521 participants (406 with major depressive disorder; 479 with one or more anxiety disorders; and 636 with both) answered the Affective Style Questionnaire and measures of emotion regulation, anxiety and depression symptoms. Data were collected twice over 2 months. Confirmatory factor analyses replicated the same four-factor structure found in a previous sample of Japanese university students. Hierarchical regression analyses revealed that the affective styles had a slightly greater effect on anxiety symptoms but not on depression compared to other common emotion regulation strategies, such as suppression and reappraisal measured by the Emotion Regulation Questionnaire (ERQ). Limitations of this study were that it used online surveys, in which, participants' diagnostic statuses were based on unverifiable self-reports. In conclusion, the association of affective styles with anxiety and depression among the clinical populations was prospectively confirmed. Further study is needed to examine the association considering the combination or profiles of affective styles among different emotional disorders.

<title>Abstract</title> <sec id="S0033291721005067_sec_a1"> <title>Background</title> The efficacy of the unified protocol of the transdiagnostic treatment for emotional disorders (UP) has been poorly studied in patients with depressive disorders. This study aimed to examine the efficacy of UP for improving depressive symptoms in patients with depressive and/or anxiety-related disorders. </sec> <sec id="S0033291721005067_sec_a2" sec-type="methods"> <title>Methods</title> This assessor-blinded, randomized, 20-week, parallel-group, superiority study compared the efficacy of the UP with treatment-as-usual (UP-TAU) <italic>v.</italic> wait-list with treatment-as-usual (WL-TAU). Patients diagnosed with depressive and/or anxiety disorders and with depressive symptoms participated. The primary outcome was depressive symptoms assessed by GRID-Hamilton depression rating scale (GRID-HAMD) at 21 weeks. The secondary outcomes included assessor-rated anxiety symptoms, severity and improvement of clinical global impression, responder and remission status, and loss of principal diagnosis. </sec> <sec id="S0033291721005067_sec_a3" sec-type="results"> <title>Results</title> In total, 104 patients participated and were subjected to intention-to-treat analysis [mean age = 37.4, <sc>s.d.</sc> = 11.5, 63 female (61%), 54 (51.9%) with a principal diagnosis of depressive disorders]. The mean GRID-HAMD scores in the UP-TAU and WL-TAU groups were 16.15 (<sc>s.d.</sc> = 4.90) and 17.06 (<sc>s.d.</sc> = 6.46) at baseline and 12.14 (<sc>s.d.</sc> = 5.47) and 17.34 (<sc>s.d.</sc> = 5.78) at 21 weeks, with a significant adjusted mean change difference of −3.99 (95% CI −6.10 to −1.87). Patients in the UP-TAU group showed significant superiority in anxiety and clinical global impressions. The improvement in the UP-TAU group was maintained in all outcomes at 43 weeks. No serious adverse events were observed in the UP-TAU group. </sec> <sec id="S0033291721005067_sec_a4" sec-type="conclusions"> <title>Conclusions</title> The UP is an effective approach for patients with depressive and/or anxiety disorders. </sec>

OBJECTIVE: Several prognostic models of suicide risk have been published; however, few have been implemented in Japan using longitudinal cohort data. The aim of this study was to identify suicide risk factors for suicidal ideation in the Japanese population and to develop a machine-learning model to predict suicide risk in Japan. MATERIALS AND METHODS: Data was obtained from Wave1 Time 1 (November 2016) and Time 2 (March 2017) of the National Survey for Stress and Health in Japan, were incorporated into a suicide risk prediction machine-learning model, trained using 65 items related to trauma and stress. The study included 3,090 and 2,163 survey respondents >18 years old at Time 1 and Time 2, respectively. The mean (standard deviation, SD) age was 44.9 (10.9) years at Time 1 and 46.0 (10.7) years at Time 2. We analyzed the participants with increased suicide risk at Time 2 survey. Model performance, including the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity, were also analyzed. RESULTS: The model showed a good performance (AUC = 0.830, 95% confidence interval = 0.795-0.866). Overall, the model achieved an accuracy of 78.8%, sensitivity of 75.4%, specificity of 80.4%, positive predictive value of 63.4%, and negative predictive value of 87.9%. The most important risk factor for suicide risk was the participants' Suicidal Ideation Attributes Scale score, followed by the Sheehan Disability Scale score, Patient Health Questionnaire-9 scores, Cross-Cutting Symptom Measure (CCSM-suicidal ideation domain, Dissociation Experience Scale score, history of self-harm, Generalized Anxiety Disorder-7 score, Post-Traumatic Stress Disorder check list-5 score, CCSM-dissociation domain, and Impact of Event Scale-Revised scores at Time 1. CONCLUSIONS: This prognostic study suggests the ability to identify patients at a high risk of suicide using an online survey method. In addition to confirming several well-known risk factors of suicide, new risk measures related to trauma and trauma-related experiences were also identified, which may help guide future clinical assessments and early intervention approaches.