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.

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.

Role of focusing on the positive side during COVID-19 outbreak: Mental health perspective from positive psychology.

This paper discusses how positive emotions can help maintain and improve mental health during the COVID-19 outbreak, taking into account examples of social interaction and positive psychology research efforts in Japanese context. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Augmentation of Positive Valence System-Focused Cognitive Behavioral Therapy by Inaudible High-Frequency Sounds for Anhedonia: A Trial Protocol for a Pilot Study.

Importance: Recent conceptualizations in Research Domain Criteria have indicated that anhedonia, 1 of 2 core symptoms of depression, which can be treatment resistant, is associated with deficits in the positive valence system, and inaudible high-frequency sound therapy has been shown to enhance reward-related brain circuitry. Hence, cognitive behavioral therapy focusing on the positive valence system enhanced with sound therapy could have a synergistic effect on anhedonia. Objective: To test the augmentation effect of inaudible high-frequency sounds on the efficacy of positive valence system-focused cognitive behavioral therapy to treat anhedonia. Design, Setting, and Participants: In this individual-level allocation, exploratory, single-center randomized superiority pilot trial, patients, therapists, and evaluators will be masked to intervention or placebo assignment. The trial will take place at a national psychiatric referral hospital in Tokyo, Japan, among 44 adult patients with clinically significant anhedonia and moderate to severe depression. Outcomes will be analyzed following the intent-to-treat principle using a repeated-measures mixed model. Intervention: The intervention group will participate in 8 weekly sessions of positive valence system-focused cognitive behavioral therapy with in-session exposure to an inaudible high-frequency sound; the comparison group will undergo cognitive behavioral therapy with in-session exposure to a placebo sound. Main Outcomes and Measures: The primary outcome is anhedonia assessed using the self-reported Snaith-Hamilton Pleasure Scale. The secondary outcome is anhedonia assessed using the clinician-administered version of the Snaith-Hamilton Pleasure Scale. Discussion: Recruitment for this study began in May 2018, and the projected date of final allocation is January 2020. A total of 21 eligible patients were registered for participation as of May 30, 2019. To date, treatments for depression do not guarantee clinically successful outcomes. This pilot trial will provide preliminary evidence of the augmentation effect of high-frequency inaudible sounds on cognitive behavioral therapy for anhedonia. Overall, exposure to an inaudible high-frequency sounds does not require attentional or cognitive effort from either patients or therapists; therefore, results from a future confirmative trial could indicate that cognitive behavioral therapy can be augmented in an effortless manner. Trial Registration: umin.ac.jp/ctr Identifier: UMIN000031948.

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.

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).

Assessing depression related severity and functional impairment: the Overall Depression Severity and Impairment Scale (ODSIS).

BACKGROUND: The Overall Depression Severity and Impairment Scale (ODSIS) is a brief, five-item measure for assessing the frequency and intensity of depressive symptoms, as well as functional impairments in pleasurable activities, work or school, and interpersonal relationships due to depression. Although this scale is expected to be useful in various psychiatric and mental health settings, the reliability, validity, and interpretability have not yet been fully examined. This study was designed to examine the reliability, factorial, convergent, and discriminant validity of a Japanese version of the ODSIS, as well as its ability to distinguish between individuals with and without a major depressive disorder diagnosis. METHODS: From a pool of registrants at an internet survey company, 2830 non-clinical and clinical participants were selected randomly (619 with major depressive disorder, 619 with panic disorder, 576 with social anxiety disorder, 645 with obsessive-compulsive disorder, and 371 non-clinical panelists). Participants were asked to respond to the ODSIS and conventional measures of depression, functional impairment, anxiety, neuroticism, satisfaction with life, and emotion regulation. RESULTS: Exploratory and confirmatory factor analysis of three split subsamples indicated the unidimensional factor structure of ODSIS. Multi-group confirmatory factor analysis showed invariance of factor loadings between non-clinical and clinical subsamples. The ODSIS also showed excellent internal consistency and test-retest intraclass correlation coefficients. Convergence and discriminance of the ODSIS with various measures were in line with our expectations. Receiver operating characteristic curve analyses showed that the ODSIS was able to detect a major depressive syndrome accurately. CONCLUSIONS: This study supports the reliability and validity of ODSIS in a non-western population, which can be interpreted as demonstrating cross-cultural validity.

Validity and clinical interpretability of Overall Anxiety Severity And Impairment Scale (OASIS).

BACKGROUND: The Overall Anxiety Severity and Impairment Scale is a brief generic measure for anxiety that encompasses frequency and intensity as well as behavioral and functional aspects of anxiety. This study was conducted to elucidate aspects of reliability, validity, and interpretability, such as equivalence of factor loadings across non-clinical and clinical populations, convergence and discriminance of related variables, and performance of detecting diagnostic and medical status of anxiety disorders. METHODS: Non-clinical and clinical Japanese populations were taken from a panelist pool registered with an internet survey company (total n=2830; 619 panic disorder, 576 for social anxiety disorder, 645 for obsessive-compulsive disorder, a 619 for major depressive disorder, and 371 for non-disorder panelists). Conventional measures of anxiety, depression, mental health and measures for discriminant validity were administered in addition to OASIS. RESULTS: Exploratory and confirmatory factor analyses indicated good fit to data for the one-factor model of OASIS. Multi-group confirmatory factor analysis showed the equivalence of the factor loadings between those of non-clinical and clinical subsamples. The OASIS reliability was confirmed by internal consistency and test-retest coefficients. Receiver operating characteristic curve analyses showed that OASIS and conventional anxiety measures have fair performance for detecting diagnostic and medical status as anxiety disorders. LIMITATIONS: Participants were limited to a Japanese population of people who had registered themselves at an internet survey company. CONCLUSIONS: Along with useful information to interpret OASIS, the results suggest the reliability and validity of OASIS in Japanese populations. These results also suggest cross-cultural validity.