14 research outputs found

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

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    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

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

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    Variation in target volume and centroid position due to breath holding during four-dimensional computed tomography scanning: A phantom study

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    This study investigated the effects of respiratory motion, including unwanted breath holding, on the target volume and centroid position on four‐dimensional computed tomography (4DCT) imaging. Cine 4DCT images were reconstructed based on a time‐based sorting algorithm, and helical 4DCT images were reconstructed based on both the time‐based sorting algorithm and an amplitude‐based sorting algorithm. A spherical object 20 mm in diameter was moved according to several simulated respiratory motions, with a motion period of 4.0 s and maximum amplitude of 5 mm. The object was extracted automatically, and the target volume and centroid position in the craniocaudal direction were measured using a treatment planning system. When the respiratory motion included unwanted breath‐holding times shorter than the breathing cycle, the root mean square errors (RSME) between the reference and imaged target volumes were 18.8%, 14.0%, and 5.5% in time‐based images in cine mode, time‐based images in helical mode, and amplitude‐based images in helical mode, respectively. In helical mode, the RSME between the reference and imaged centroid position was reduced from 1.42 to 0.50 mm by changing the reconstruction method from time‐ to amplitude‐based sorting. When the respiratory motion included unwanted breath‐holding times equal to the breathing cycle, the RSME between the reference and imaged target volumes were 19.1%, 24.3%, and 15.6% in time‐based images in cine mode, time‐based images in helical mode, and amplitude‐based images in helical mode, respectively. In helical mode, the RSME between the reference and imaged centroid position was reduced from 1.61 to 0.83 mm by changing the reconstruction method from time‐ to amplitude‐based sorting. With respiratory motion including breath holding of shorter duration than the breathing cycle, the accuracies of the target volume and centroid position were improved by amplitude‐based sorting, particularly in helical 4DCT

    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

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    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)

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

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    BackgroundThe 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.MethodsThis 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.ResultsIn 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.ConclusionsThe UP is an effective approach for patients with depressive and/or anxiety disorders

    Goodness of fit indices for four types of equivalence restriction on a one-factor model with error theory of the ODSIS.

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    <p>Model 1 imposed no equivalence restriction.</p><p>Model 2 had equivalence restriction on factor loadings.</p><p>Model 3 had equivalence restriction on factor loadings and variance of latent factor.</p><p>Model 4 included equivalence restriction on factor loadings, variance of latent factor, covariances and variances of error terms.</p><p>Goodness of fit indices for four types of equivalence restriction on a one-factor model with error theory of the ODSIS.</p
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