Optimizing smartphone psychotherapy for depressive symptoms in patients with cancer: Multiphase optimization strategy using a decentralized multicenter randomized clinical trial (J-SUPPORT 2001 Study).

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.

Three types of university students with subthreshold depression characterized by distinctive cognitive behavioral skills.

Subthreshold depression impairs young people's quality of life and places them at greater risk of developing major depression. Cognitive behavioral therapy (CBT) is an evidence-based approach for addressing such depressive states. This study identified subtypes of university students with subthreshold depression and revealed discrete profiles of five CBT skills: self-monitoring, cognitive restructuring, behavioral activation, assertive communication, and problem solving. Using data from the Healthy Campus Trial (registration number: UMINCTR-000031307), a hierarchical clustering analysis categorized 1,080 students into three clusters: Reflective Low-skilled, Non-reflective High-skilled, and Non-reflective Low-skilled students. Non-reflective Low-skilled students were significantly more depressed than other students (p < .001). The severity of depression seemed to be related to the combination of self-monitoring skills and other CBT skills. Considering the high prevalence of poor self-monitoring skills in persons with autism, the most severe depression was observed in the significant association between Non-reflective Low-skilled students and autistic traits (p = .008). These findings suggest that subthreshold depression can be categorized into three subtypes based on CBT skill profiles. The assessment of autistic traits is also suggested when we provide CBT interventions for Non-reflective Low-skilled students.

Efficacy of the unified protocol for transdiagnostic cognitive-behavioral treatment for depressive and anxiety disorders: a randomized controlled trial.

BACKGROUND: 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. METHODS: This assessor-blinded, randomized, 20-week, parallel-group, superiority study compared the efficacy of the UP with treatment-as-usual (UP-TAU) v. 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. RESULTS: In total, 104 patients participated and were subjected to intention-to-treat analysis [mean age = 37.4, s.d. = 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 (s.d. = 4.90) and 17.06 (s.d. = 6.46) at baseline and 12.14 (s.d. = 5.47) and 17.34 (s.d. = 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. CONCLUSIONS: The UP is an effective approach for patients with depressive and/or anxiety disorders.

Optimization of smartphone psychotherapy for depression and anxiety among patients with cancer using the multiphase optimization strategy (MOST) framework and decentralized clinical trial system (SMartphone Intervention to LEssen depression/Anxiety and GAIN resilience: SMILE AGAIN project): a protocol for a randomized controlled 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 .

Four 2×2 factorial trials of smartphone CBT to reduce subthreshold depression and to prevent new depressive episodes among adults in the community-RESiLIENT trial (Resilience Enhancement with Smartphone in LIving ENvironmenTs): a master protocol.

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.

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.

Prognostic factors and effect modifiers for personalisation of internet-based cognitive behavioural therapy among university students with subthreshold depression: A secondary analysis of a factorial trial.

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.

Smartphone Psychotherapy Reduces Fear of Cancer Recurrence Among Breast Cancer Survivors: A Fully Decentralized Randomized Controlled Clinical Trial (J-SUPPORT 1703 Study).

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.

Efficacy and Acceptability of Remote Cognitive Behavioral Therapy for Patients With Major Depressive Disorder in Japanese Clinical Settings: A Case Series.

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.

A machine-learning model to predict suicide risk in Japan based on national survey data.

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.

Evaluation of a Japanese brief CBT-I administered by a nurse: a pilot study.

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.

Components of smartphone cognitive-behavioural therapy for subthreshold depression among 1093 university students: a factorial trial.

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.

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.

Group Cognitive-Behavioral Therapy With Interoceptive Exposure for Drug-Refractory Irritable Bowel Syndrome: A Randomized Controlled Trial.

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 and their association with anxiety and depression in a Japanese clinical sample.

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.

Associations Between PTSD Symptom Custers and Longitudinal Changes in Suicidal Ideation: Comparison Between 4-Factor and 7-Factor Models of DSM-5 PTSD Symptoms.

Objective: The association between posttraumatic stress disorder (PTSD) and suicidal ideation (SI) is well-known. However, a few studies have investigated the associations between PTSD symptom clusters based on the fifth edition of the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) and changes in suicide risk longitudinally. Methods: We adopted a longitudinal study design using data from the National Survey for Stress and Health of 3,090 of the Japanese population. The first and second surveys were conducted on November 2016 and March 2017, respectively. The suicidal ideation attributes scale was applied to assess the severity of suicidal ideation at baseline and the follow-up period. A multivariate linear regression model was conducted to examine the associations between the 4- or 7-factor model of PTSD symptom clusters at baseline and longitudinal changes in SI. Results: Overall, 3,090 subjects were analyzed (mean age, 44.9 ± 10.9 years; 48.8% female) at Baseline, and 2,163 completed the second survey. In the 4-factor model, we found that the severity of negative alternations in cognition and mood were significantly associated with increased SI after 4 months. In the 7-factor model, we found that the severity of anhedonia and externalizing behavior at baseline was significantly associated with increased SI during the follow-up period. Conclusions: We found that the seven-factor model of DSM-5 PTSD symptoms may provide greater specificity in predicting longitudinal SI change in the general population. Closely monitoring specific PTSD core symptoms may be more effective in mitigating key clinical and functional outcomes.

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Among Japanese Children: A Pilot Study.

At present, there is no established cognitive behavioral therapy (CBT) for treating emotional disorders in Japanese children. Therefore, we introduced the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in Japan and adapted it to the Japanese context. We then examined its feasibility and preliminary efficacy using a single-arm pretest, posttest, follow-up design. Seventeen Japanese children aged between 8 and 12 years (female n = 11; male n = 6; M = 10.06 ± 0.97 years) with a principal diagnosis of anxiety, obsessive-compulsive, or depressive disorders, and their parents were enrolled in the study. The primary outcome was the overall severity of emotional disorders as assessed by psychiatrists using the Clinical Global Impression-Severity Scale. Secondary outcomes included child- and parent-reported anxiety symptoms, depressive symptoms, and functional status. No severe adverse events were observed. The feasibility was confirmed by the low dropout proportion (11.76%), high attendance proportion (children: 95.6%; parents: 94.6%), and sufficient participant satisfaction. Linear mixed models (LMMs) showed that the overall severity of emotional disorders and child- and parent-reported anxiety symptoms improved from pre-treatment to post-treatment, and that these treatment effects were maintained during the 3-month follow-up period. Additionally, child- and parent-reported functional status improved from pre-treatment to the 3-month follow-up. In contrast, child-reported depressive symptoms improved from pre-treatment to follow-up, but there was no significant change in parent-reported depressive symptoms between pre-treatment and other time points. These findings demonstrate the feasibility and preliminary efficacy of the Japanese version of the UP-C, suggesting that future randomized controlled trials (RCTs) are warranted (Clinical trial registration: UMIN000026911).

Application of the Unified Protocol for a Japanese Patient with Post-Traumatic Stress Disorder and Multiple Comorbidities: A Single-Case Study.

(1) Background: The efficacy of the Unified Protocol (UP), a transdiagnostic cognitive-behavioral therapy, with trauma-focused exposure has not been sufficiently demonstrated for post-traumatic stress disorder (PTSD) with multiple comorbidities. This study examined the effects of UP treatment with trauma-focused exposure on symptoms of PTSD and comorbidities in a client who was hesitant about exposure. (2) Methods: The client, who had comorbid dysthymia, social anxiety disorder, agoraphobia, and bulimia nervosa, participated in the UP for 20 sessions over 6 months. The principal diagnosis and symptoms of the comorbid disorders were assessed at baseline, post-intervention, and at the 3-month follow-up. This treatment was conducted as part of a clinical study (UMIN000008322). (3) Results: The client showed improvement in the principal diagnosis and symptoms of the comorbid disorders post-intervention compared with baseline and no longer met the diagnostic criteria for any of the disorders. Considerable symptom improvement was observed with imaginal exposure to trauma memories. (4) Conclusions: The UP was an effective alternative treatment for PTSD and symptoms of comorbidities in this client who was hesitant about exposure to traumatic memories, and that the inclusion of trauma-focused exposure provided sufficient therapeutic effects. Further research is needed to examine the generalizability of our findings.

Hybrid Cognitive Behavioral Therapy With Interoceptive Exposure for Irritable Bowel Syndrome: A Feasibility Study.

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder, which severely impairs the quality of life of patients. Treatment of refractory IBS patients is needed, but it is not yet widely available. Therefore, we previously developed a Japanese version of cognitive behavioral therapy with interoceptive exposure (CBT-IE) involving 10 face-to-face sessions to treat refractory IBS patients. To disseminate this treatment of IBS in places where therapists are limited, we further developed a hybrid CBT-IE program with complementary video materials that include psychoeducation and homework instructions so that patients can prepare for face-to-face sessions in advance at home and the session time can be shortened, thereby reducing the burden on both patient and therapist. In this study, we conducted a trial to evaluate the feasibility, efficacy, and safety of the hybrid CBT-IE program for Japanese IBS patients. The study was a single-arm, open-label pilot clinical trial. A total of 16 IBS patients were included in the study and 14 patients completed the intervention, which consisted of 10 weekly individual hybrid CBT-IE sessions. We performed an intention to treat analysis. The primary outcome measure for the efficacy of the intervention was a decrease in the severity of IBS symptoms. The feasibility and safety of the intervention were examined by the dropout rate and recording of adverse events, respectively. The dropout rate of the hybrid CBT-IE was comparable to that of our previous CBT-IE with only face-to-face sessions and no adverse events were recorded. The severity of IBS symptoms within-group was significantly decreased from the baseline to mid-treatment [Hedges' g = -0.98 (-1.54, -0.41)], post-treatment [Hedges' g = -1.48 (-2.09, -0.88)], 3-month follow-up [Hedges' g = -1.78 (-2.41, -1.14)], and 6-month follow-up [Hedges' g = -1.76 (-2.39, -1.13)]. Our results suggest that the hybrid CBT-IE is effective and could be conducted safely. To confirm the effectiveness of the hybrid CBT-IE, it is necessary to conduct a multicenter, parallel-design randomized control trial. Clinical Trial Registration: [https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041376], identifier [UMIN000036327].