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

Ito, Masaya; Okumura, Yasuyuki; Horikoshi, Masaru; Kato, Noriko; Oe, Yuki; Miyamae, Mitsuhiro; Hirabayashi, Naotsugu; Kanie, Ayako; Nakagawa, Atsuo; Ono, Yutaka

doi:10.1186/s12888-016-0779-8

Cited by 8 publications

(8 citation statements)

References 109 publications

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“…Whether an AE was expected or not was seldom addressed. Some researchers restricted the assessment of AEs to mental health (Crawcour et al, 2012; Wiltink et al, 2011; Zwerenz et al, 2012), but others did not distinguish physical and mental health (Hofmann et al, 2015; Ito et al, 2016; Sloan et al, 2016). Changes in the social or professional environment were explicitly defined as potential AEs in one study protocol (Fuhr et al, 2017).…”

Section: Resultsmentioning

confidence: 99%

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review.

Klatte¹,

Strauß²,

Flückiger³

et al. 2023

Psychotherapy

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The assessment of safety data has become a standard across many clinical interventions. The aim of this systematic review is to investigate the extent to which harm is addressed within psychotherapy study protocols. The review includes study protocols of randomized controlled trials published between 2004 and 2017 investigating the effects of psychotherapy in adult patients with affective disorders, phobia, anxiety, obsessive-compulsive disorder, posttraumatic stress disorder, and/or personality disorders. We conducted a systematic search in the CENTRAL, Medline, PsycINFO, and Web of Science databases as well as in relevant journals. In total, 115 study protocols were included, examining 168 psychotherapy and 85 control conditions. These protocols differed considerably in the way they conceptualized harm: 77 explicitly addressed harm, 62 considered serious adverse events, and 39 considered adverse events. Although serious adverse events were defined somewhat consistently, adverse events were not. Our results imply that clinical researchers do not apply standardized approaches with regard to harm concepts, assessment, and management. To gather data on frequencies of harmful effects, we argue a higher degree of standardization would be useful. Feasible recommendations are provided based on examples Bernhard Strauss contributed equally to supervision and served as support for methodology, validation, original draft, and writing, review, and editing. Christoph Flückiger served as support for data curation and writing, review, and editing. Francesca Färber served as lead for methodology and project administration, contributed equally to conceptualization, funding acquisition, and supervision, and served as support for data curation, formal analysis, and investigation. Jenny Rosendahl served as editor.

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Section: Resultsmentioning

confidence: 99%

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review.

Klatte¹,

Strauß²,

Flückiger³

et al. 2023

Psychotherapy

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“…For ICECAP-A, the Japanese version of the ICECAP officially accepted by the University of Birmingham was used [ 63 ]. We adopted the Japanese version of the CEQ, which was translated by Ito et al [ 64 ] through a rigorous back-translation procedure with the permission and support of the original developer of the questionnaire. Regarding the TPS, we used the TPS questionnaire cited in the Japanese edition of The Fearless Organization: Creating Psychological Safety in the Workplace for Learning, Innovation, and Growth by Edmondson [ 65 ].…”

Section: Methodsmentioning

confidence: 99%

Effectiveness and Cost-effectiveness of Online Brief Mindfulness-based Cognitive Therapy for the Improvement of Productivity in the Workplace: Study Protocol for a Randomized Controlled Trial

Sado¹,

Yamada²,

Ninomiya³

et al. 2022

JMIR Res Protoc

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Background Numerous studies have demonstrated the effectiveness of mindfulness-based programs (MBPs) among both clinical and nonclinical populations. These data document positive impacts in the workplace, including reducing perceived stress and burnout and increasing well-being. However, the effectiveness for productivity, which is of most interest to managers and administrators, is still unclear. In addition, MBPs in the workplace tend to be modified by reducing the number of the program sessions or delivering content online to improve accessibility. To date, however, the impact of MBPs that feature these modifications on productivity in the workplace has not been investigated. Objective The study aims to investigate the effectiveness and cost-effectiveness of online-delivered brief mindfulness-based cognitive therapy (bMBCT) for improving productivity and other work-related outcomes among healthy workers compared to the waitlist control. Methods We will conduct a 4-week randomized controlled trial (RCT) with a 6-month follow-up. Employees are included in the study if they (1) are between the ages of 20 and 65 years and (2) work longer than 30 hours weekly. Employees are randomly allocated to either the bMBCT group or the waitlist control group. The primary outcome of the study is the mean difference of productivity measured by the World Health Organization Health and Work Performance Questionnaire (WHO-HPQ) between the groups at 4, 16, and 28 weeks. Secondary outcomes include several clinical outcomes and health economics evaluation. Results We started recruiting participants in August 2021, and the intervention began in October 2021. A total of 104 participants have been enrolled in the study as of October 2021. The intervention is scheduled to be completed in December 2023. Data collection will be completed by the end of January 2024. Conclusions The novelty of the study is that (1) it will investigate bMBCT’s effectiveness on productivity, which is still unclear, and (2) samples are recruited from 3 companies in different industries. The limitations of the study are that (1) all measures assessed are in self-report format and (2) we lack an active control group. This study has the potential to provide new data on the relationship between MBPs and occupational health and productivity. Trial Registration University Hospital Medical Information Network Clinical Trials Registry UMIN000044721; https://tinyurl.com/4e2fh873 International Registered Report Identifier (IRRID) DERR1-10.2196/36012

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“…Patients who are nonresponsive to primary care in their local clinic or hospital are commonly referred to the NCNP Hospital. A detailed description of the setting appears elsewhere …”

Section: Methodsmentioning

confidence: 99%

Augmentation of Positive Valence System–Focused Cognitive Behavioral Therapy by Inaudible High-Frequency Sounds for Anhedonia

et al. 2019

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Key PointsQuestionCan inaudible high-frequency sounds augment the efficacy of cognitive behavioral therapy for anhedonia?FindingsThis trial protocol describes a placebo-controlled, randomized clinical pilot study testing the augmentation effect of inaudible high-frequency sounds on positive valence system–focused cognitive behavioral therapy among patients with clinically significant anhedonia and depression. The sound presentation system is designed to optimize exposure to inaudible high-frequency sounds during face-to-face cognitive behavioral therapy sessions.MeaningThe preliminary results of this pilot study could contribute to the design of confirmatory randomized clinical trials that will examine the augmentation effect of inaudible high-frequency sounds on the treatment of anhedonia.

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

Cited by 8 publications

References 109 publications

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review.

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review.

Effectiveness and Cost-effectiveness of Online Brief Mindfulness-based Cognitive Therapy for the Improvement of Productivity in the Workplace: Study Protocol for a Randomized Controlled Trial

Augmentation of Positive Valence System–Focused Cognitive Behavioral Therapy by Inaudible High-Frequency Sounds for Anhedonia

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