Back to resultsJapan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP Study)
Primary Purpose
Anxiety Disorders, Depressive Disorders
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Unified Protocol with Treatment As Usual
Treatment As Usual
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders
Eligibility Criteria
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.
Sites / Locations
- National Center of Neurology and Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Unified Protocol with Treatment As Usual
Waitlist Control with Treatment As Usual
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)
Secondary Outcome Measures
Hamilton Anxiety Rating Scale 14 item(HAM-A)
Clinical Global Impression- Severity(CGI-S)
Clinical Global Impression-Improvement(CGI-I)
Responder Status assessed by GRID-HAMD
Reduction in GRID-HAMD score of at least 50% compared with baseline
Remission of symptoms assessed by GRID-HAMD
GRID-HAMD score of less than 8
Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID)
Full Information
NCT ID
NCT02003261
First Posted
December 2, 2013
Last Updated
August 19, 2019
Sponsor
National Center of Neurology and Psychiatry, Japan
1. Study Identification
Unique Protocol Identification Number
NCT02003261
Brief Title
Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP Study)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 31, 2014 (Actual)
Primary Completion Date
November 2, 2018 (Actual)
Study Completion Date
April 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Center of Neurology and Psychiatry, Japan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depressive Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unified Protocol with Treatment As Usual
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control with Treatment As Usual
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
Unified Protocol with Treatment As Usual
Other Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment As Usual
Intervention Description
Most of the TAU will be drug therapy or nonsystematic supportive psychotherapy.
Primary Outcome Measure Information:
Title
GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)
Time Frame
21 weeks
Secondary Outcome Measure Information:
Title
Hamilton Anxiety Rating Scale 14 item(HAM-A)
Time Frame
21 weeks
Title
Clinical Global Impression- Severity(CGI-S)
Time Frame
21 weeks
Title
Clinical Global Impression-Improvement(CGI-I)
Time Frame
21 weeks
Title
Responder Status assessed by GRID-HAMD
Description
Reduction in GRID-HAMD score of at least 50% compared with baseline
Time Frame
21 weeks
Title
Remission of symptoms assessed by GRID-HAMD
Description
GRID-HAMD score of less than 8
Time Frame
21 weeks
Title
Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID)
Time Frame
21 weeks
Other Pre-specified Outcome Measures:
Title
Global Assessment of Functioning(GAF)
Time Frame
10 weeks, 21 weeks, and 43 weeks
Title
Disorder specific measures
Description
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.
Time Frame
10 weeks, 21 weeks, and 43 weeks
Title
Quality of Life(EQ-5D)
Time Frame
10 weeks, 21 weeks, and 43 weeks
Title
Sheehan Disability Scale(SDISS)
Time Frame
10 weeks, 21 weeks, and 43 weeks
Title
Sense of Authenticity Scale(SOA)
Time Frame
10 weeks, 21 weeks, and 43 weeks
Title
Overall Anxiety Severity and Impairment Scale(OASIS)
Time Frame
10 weeks, 21 weeks, 43 weeks and at every UP sessions
Title
Overall Depression Severity and Impairment Scale(ODSIS)
Time Frame
10 weeks, 21 weeks, 43 weeks and at every UP sessions
Title
Eysenck Personality Questionnaire- Revised Short version, Neuroticism(EPQR-S)
Time Frame
10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
Title
Anxiety Sensitivity Index-III(ASI-III)
Time Frame
10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
Title
Emotion Regulation Skills Questionnaire(ERSQ)
Time Frame
10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
Title
Credibility/Expectancy Questionnaire(CEQ)
Time Frame
2 weeks
Title
Session Rating Scale(SRS V.3.0)
Time Frame
UP session at #1, 5, 10, and 15
Title
Homework Compliance Scale(HCS)
Time Frame
UP session at #1, 5, 10, and 15
Title
Adverse Events
Description
Adverse Events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Time Frame
From 1 week to 21 weeks
Title
GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)
Time Frame
10 weeks, 43 weeks
Title
Hamilton Anxiety Rating Scale 14 item(HAM-A)
Time Frame
10 weeks and 43 weeks
Title
Clinical Global Impression- Severity(CGI-S)
Time Frame
10 weeks, 43 weeks
Title
Clinical Global Impression-Improvement(CGI-I)
Time Frame
10 weeks, 43 weeks
Title
Psychiatric diagnosis assessed by SCID
Time Frame
43 weeks
Title
Emotion Exposure Scale (EES)
Time Frame
10 weeks, 21 weeks, 43 weeks
Title
Understanding of Treatment Rational of Unified Protocol (TRUP)
Time Frame
10 weeks, 21 weeks, and 43 weeks
Title
Magnetic Resonance Imaging(MRI)
Time Frame
21 weeks, 43 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaya Ito, Ph.D.
Organizational Affiliation
National Center for Cognitive-Behavior Therapy and Research, National Center of Neurology and Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center of Neurology and Psychiatry
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26987315
Citation
Ito M, Okumura Y, Horikoshi M, Kato N, Oe Y, Miyamae M, Hirabayashi N, Kanie A, Nakagawa A, Ono Y. Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Mar 18;16:71. doi: 10.1186/s12888-016-0779-8.
Results Reference
derived
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