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Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by National Center of Neurology and Psychiatry, Japan
Sponsor:
Information provided by (Responsible Party):
Masaya ITO, National Center of Neurology and Psychiatry, Japan
ClinicalTrials.gov Identifier:
NCT02003261
First received: December 2, 2013
Last updated: August 6, 2014
Last verified: August 2014

December 2, 2013
August 6, 2014
November 2013
December 2016   (final data collection date for primary outcome measure)
GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD) [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02003261 on ClinicalTrials.gov Archive Site
  • Hamilton Anxiety Rating Scale 14 item(HAM-A) [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression- Severity(CGI-S) [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Improvement(CGI-I) [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]
  • Responder Status assessed by GRID-HAMD [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]
    Reduction in GRID-HAMD score of at least 50% compared with baseline
  • Remission of symptoms assessed by GRID-HAMD [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]
    GRID-HAMD score of less than 8
  • Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID) [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]
Same as current
  • Global Assessment of Functioning(GAF) [ Time Frame: 10 weeks, 21 weeks, and 43 weeks ] [ Designated as safety issue: No ]
  • Disorder specific measures [ Time Frame: 10 weeks, 21 weeks, and 43 weeks ] [ Designated as safety issue: No ]
    Participants will be answered some of the following measures in accord with their diagnoses; Beck Depression Inventory-II for Depressive Disorders, Panic Disorder Severity Scale for Panic Disorder, Penn-State Worry Questionnaire for Generalized Anxiety Disorder, Impact of Event Scale-Revised for Post-Traumatic Stress Disorder, Yale-Brown Obsessive Compulsive Scale for Obsessive Compulsive Disorder and Fear Questionnaire for Agora Phobia.
  • Quality of Life(EQ-5D) [ Time Frame: 10 weeks, 21 weeks, and 43 weeks ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale(SDISS) [ Time Frame: 10 weeks, 21 weeks, and 43 weeks ] [ Designated as safety issue: No ]
  • Sense of Authenticity Scale(SOA) [ Time Frame: 10 weeks, 21 weeks, and 43 weeks ] [ Designated as safety issue: No ]
  • Overall Anxiety Severity and Impairment Scale(OASIS) [ Time Frame: 10 weeks, 21 weeks, 43 weeks and at every UP sessions ] [ Designated as safety issue: No ]
  • Overall Depression Severity and Impairment Scale(ODSIS) [ Time Frame: 10 weeks, 21 weeks, 43 weeks and at every UP sessions ] [ Designated as safety issue: No ]
  • Eysenck Personality Questionnaire- Revised Short version, Neuroticism(EPQR-S) [ Time Frame: 10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15 ] [ Designated as safety issue: No ]
  • Anxiety Sensitivity Index-III(ASI-III) [ Time Frame: 10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15 ] [ Designated as safety issue: No ]
  • Emotion Regulation Skills Questionnaire(ERSQ) [ Time Frame: 10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15 ] [ Designated as safety issue: No ]
  • Credibility/Expectancy Questionnaire(CEQ) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Session Rating Scale(SRS V.3.0) [ Time Frame: UP session at #1, 5, 10, and 15 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale(HCS) [ Time Frame: UP session at #1, 5, 10, and 15 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: From 1 week to 21 weeks ] [ Designated as safety issue: Yes ]
    Adverse Events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
  • GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD) [ Time Frame: 10 weeks, 43 weeks ] [ Designated as safety issue: No ]
  • Hamilton Anxiety Rating Scale 14 item(HAM-A) [ Time Frame: 10 weeks and 43 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression- Severity(CGI-S) [ Time Frame: 10 weeks, 43 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Improvement(CGI-I) [ Time Frame: 10 weeks, 43 weeks ] [ Designated as safety issue: No ]
  • Psychiatric diagnosis assessed by SCID [ Time Frame: 43 weeks ] [ Designated as safety issue: No ]
  • Emotion Exposure Scale (EES) [ Time Frame: 10 weeks, 21 weeks, 43 weeks ] [ Designated as safety issue: No ]
  • Understanding of Treatment Rational of Unified Protocol (TRUP) [ Time Frame: 10 weeks, 21 weeks, and 43 weeks ] [ Designated as safety issue: No ]
  • Magnetic Resonance Imaging(MRI) [ Time Frame: 21 weeks, 43 weeks ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning(GAF) [ Time Frame: 10 weeks, 21 weeks, and 43 weeks ] [ Designated as safety issue: No ]
  • Disorder specific measures [ Time Frame: 10 weeks, 21 weeks, and 43 weeks ] [ Designated as safety issue: No ]
    Participants will be answered some of the following measures in accord with their diagnoses; Beck Depression Inventory-II for Depressive Disorders, Panic Disorder Severity Scale for Panic Disorder, Penn-State Worry Questionnaire for Generalized Anxiety Disorder, Impact of Event Scale-Revised for Post-Traumatic Stress Disorder, Yale-Brown Obsessive Compulsive Scale for Obsessive Compulsive Disorder and Fear Questionnaire for Agora Phobia.
  • Quality of Life(EQ-5D) [ Time Frame: 10 weeks, 21 weeks, and 43 weeks ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale(SDISS) [ Time Frame: 10 weeks, 21 weeks, and 43 weeks ] [ Designated as safety issue: No ]
  • Sense of Authenticity Scale(SOA) [ Time Frame: 10 weeks, 21 weeks, and 43 weeks ] [ Designated as safety issue: No ]
  • Overall Anxiety Severity and Impairment Scale(OASIS) [ Time Frame: 10 weeks, 21 weeks, 43 weeks and at every UP sessions ] [ Designated as safety issue: No ]
  • Overall Depression Severity and Impairment Scale(ODSIS) [ Time Frame: 10 weeks, 21 weeks, 43 weeks and at every UP sessions ] [ Designated as safety issue: No ]
  • Eysenck Personality Questionnaire- Revised Short version, Neuroticism(EPQR-S) [ Time Frame: 10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15 ] [ Designated as safety issue: No ]
  • Anxiety Sensitivity Index-III(ASI-III) [ Time Frame: 10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15 ] [ Designated as safety issue: No ]
  • Emotion Regulation Skills Questionnaire(ERSQ) [ Time Frame: 10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15 ] [ Designated as safety issue: No ]
  • Credibility/Expectancy Questionnaire(CEQ) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Session Rating Scale(SRS V.3.0) [ Time Frame: UP session at #1, 5, 10, and 15 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale(HCS) [ Time Frame: UP session at #1, 5, 10, and 15 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: From 1 week to 21 weeks ] [ Designated as safety issue: Yes ]
    Adverse Events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
  • GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD) [ Time Frame: 10 weeks, 43 weeks ] [ Designated as safety issue: No ]
  • Hamilton Anxiety Rating Scale 14 item(HAM-A) [ Time Frame: 10 weeks and 43 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression- Severity(CGI-S) [ Time Frame: 10 weeks, 43 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Improvement(CGI-I) [ Time Frame: 10 weeks, 43 weeks ] [ Designated as safety issue: No ]
  • Psychiatric diagnosis assessed by SCID [ Time Frame: 43 weeks ] [ Designated as safety issue: No ]
 
Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP Study)
An Assessor-blinded, Randomized, 20-week, Parallel-group, Superiority Study to Compare the Efficacy of Transdiagnostic Cognitive Behavioral Therapy Versus Waiting-list in Depressive and Anxiety Symptoms of Depressive and Anxiety Disorders

This study is to examine the superiority of the combined treatments of transdiagnostic cognitive-behavior therapy (Unified Protocol; UP) and Treatment-As-Usual in comparison with the waiting-list with Treatment-As-Usual in the reduction of depressive and anxiety symptoms among depressive and anxiety disorders.

Participants with depressive or anxiety disorders will be randomized to either Unified Protocol with Treatment-As-Usual or Wail-list with Treatment-As-Usual. Intervention period will be 20-week and the follow-up period will be 43 week from registration.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Anxiety Disorders
  • Depressive Disorders
  • Behavioral: Unified Protocol with Treatment As Usual

    Unified Protocol(UP) is a transdiagnostic cognitive-behavioral therapy for depressive and anxiety disorders, which is developed by Dr. Barlow and his colleagues at Boston university.

    UP is weekly, face to face, individual psychotherapy consisting of 9 to 20 sessions. Average session number is 16 sessions. Contents of the treatment includes motivational enhancement, psychoeducation of treatment rationale and emotion, emotion awareness training, cognitive reappraisal, avoidance and emotion driven behaviors, interoceptive exposure and emotion exposure.

    Other Name: Cognitive Behavioral Therapy
  • Other: Treatment As Usual
    Most of the TAU will be drug therapy or nonsystematic supportive psychotherapy.
  • Experimental: Unified Protocol with Treatment As Usual
    Unified Protocol is designed to help patients learn how to confront and experience uncomfortable emotions and learn how to respond to their emotions in more adaptive ways. Individual treatment sessions will be conducted by experienced clinicians who will be trained in the administration of this protocol. A workbook will be provided to each patient as part of this manualized treatment. During this treatment period, the participants continue the Treatment As Usual.
    Interventions:
    • Behavioral: Unified Protocol with Treatment As Usual
    • Other: Treatment As Usual
  • Waitlist Control with Treatment As Usual
    Waitlist participants will not receive treatment during a 20-week waitlist period, but will receive the unified protocol immediately following the 20 week waiting period. During the waitlist period, the waitlist participants continue the treatment as usual.
    Intervention: Other: Treatment As Usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
54
Not Provided
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • DSM-IV diagnosis of Major Depressive Disorder, Dysthymia, Depressive Disorder Not Otherwise Specified, Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia, Agoraphobia Without History of Panic Disorder, Social Phobia(Social Anxiety Disorder), Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder Not Otherwise Specified assessed by SCID.
  • Depressive and anxiety symptoms is mild or more severe (GRID-HAMD >= 8).
  • Ages 20 years or older, and 65 years or younger at screening.
  • Subjects who give full consent in the participation of the study.

Exclusion Criteria:

  • No alcohol or substance use disorder in 6 months prior to the screening assessed by SCID
  • No current manic episode or current schizophrenia and other psychotic disorders at baseline assessed by SCID
  • No serious suicidal ideation at baseline (GRID-HAMD Item3 severity is 3 or higher.)
  • No life-threatening, severe or unstable physical disorders or major cognitive deficits at baseline.
  • Evidence of unable to participate half or more of the intervention phase.
  • No structured psychotherapy during at baseline.
  • Other relevant reason decided by the investigators.
Both
20 Years to 65 Years
No
Contact: Masaya Ito, Ph.D. +81-42-341-2712 ext 3605 masayait@ncnp.go.jp
Japan
 
NCT02003261
KAKENHI 25705018
No
Masaya ITO, National Center of Neurology and Psychiatry, Japan
National Center of Neurology and Psychiatry, Japan
Not Provided
Principal Investigator: Masaya Ito, Ph.D. National Center for Cognitive-Behavior Therapy and Research, National Center of Neurology and Psychiatry
National Center of Neurology and Psychiatry, Japan
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP