title: Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02003261 (registered on December 2, 2013).
authors.affiliation: National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Ogawa Higashi 4-1-1, Kodaira, Tokyo, 187-8511, Japan. masayait@ncnp.go.jp.
authors.forename: Masaya
authors.initials: M
authors.lastname: Ito
authors.affiliation: Institute for Health Economics and Policy, Association for Health Economics Research and Social Insurance and Welfare, Tokyo, Japan.
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Okumura
authors.affiliation: National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Ogawa Higashi 4-1-1, Kodaira, Tokyo, 187-8511, Japan.
authors.forename: Masaru
authors.initials: M
authors.lastname: Horikoshi
authors.affiliation: National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Ogawa Higashi 4-1-1, Kodaira, Tokyo, 187-8511, Japan.
authors.forename: Noriko
authors.initials: N
authors.lastname: Kato
authors.affiliation: National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Ogawa Higashi 4-1-1, Kodaira, Tokyo, 187-8511, Japan.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Oe
authors.affiliation: National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Ogawa Higashi 4-1-1, Kodaira, Tokyo, 187-8511, Japan.
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Miyamae
authors.affiliation: National Center of Neurology and Psychiatry, Tokyo, Japan.
authors.forename: Naotsugu
authors.initials: N
authors.lastname: Hirabayashi
authors.affiliation: National Center of Neurology and Psychiatry, Tokyo, Japan.
authors.forename: Ayako
authors.initials: A
authors.lastname: Kanie
authors.affiliation: Center for Clinical Research, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Atsuo
authors.initials: A
authors.lastname: Nakagawa
authors.affiliation: Center for the Development of Cognitive Behavior Therapy Training, Tokyo, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Ono
mesh_terms: D000328:Adult; D000368:Aged; D001008:Anxiety Disorders / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003866:Depressive Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011615:Psychotherapy, Group; D012107:Research Design; D055815:Young Adult
keywords: Anxiety disorder; Depressive disorder; Emotion; Randomized controlled trial; Transdiagnostic; Unified protocol