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BMC Psychiatry
Published in: BMC Psychiatry 1/2016

Open Access 01-12-2016 | Study protocol

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

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

Published in: BMC Psychiatry | Issue 1/2016

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Abstract

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)
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Metadata
Title
Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial
Authors
Masaya Ito
Yasuyuki Okumura
Masaru Horikoshi
Noriko Kato
Yuki Oe
Mitsuhiro Miyamae
Naotsugu Hirabayashi
Ayako Kanie
Atsuo Nakagawa
Yutaka Ono
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2016
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-016-0779-8

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BMC Psychiatry 1/2016 Go to the issue

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Clinical correlates of vitamin D deficiency in established psychosis

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