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

August 19, 2019 updated by: Masaya ITO, National Center of Neurology and Psychiatry, Japan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Kodaira, Tokyo, Japan, 187-8551
        • National Center of Neurology and Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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 Names:
  • Cognitive Behavioral Therapy
Other: Treatment As Usual
Most of the TAU will be drug therapy or nonsystematic supportive psychotherapy.
Other: 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.
Other: Treatment As Usual
Most of the TAU will be drug therapy or nonsystematic supportive psychotherapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)
Time Frame: 21 weeks
21 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hamilton Anxiety Rating Scale 14 item(HAM-A)
Time Frame: 21 weeks
21 weeks
Clinical Global Impression- Severity(CGI-S)
Time Frame: 21 weeks
21 weeks
Clinical Global Impression-Improvement(CGI-I)
Time Frame: 21 weeks
21 weeks
Responder Status assessed by GRID-HAMD
Time Frame: 21 weeks
Reduction in GRID-HAMD score of at least 50% compared with baseline
21 weeks
Remission of symptoms assessed by GRID-HAMD
Time Frame: 21 weeks
GRID-HAMD score of less than 8
21 weeks
Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID)
Time Frame: 21 weeks
21 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Global Assessment of Functioning(GAF)
Time Frame: 10 weeks, 21 weeks, and 43 weeks
10 weeks, 21 weeks, and 43 weeks
Disorder specific measures
Time Frame: 10 weeks, 21 weeks, and 43 weeks
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.
10 weeks, 21 weeks, and 43 weeks
Quality of Life(EQ-5D)
Time Frame: 10 weeks, 21 weeks, and 43 weeks
10 weeks, 21 weeks, and 43 weeks
Sheehan Disability Scale(SDISS)
Time Frame: 10 weeks, 21 weeks, and 43 weeks
10 weeks, 21 weeks, and 43 weeks
Sense of Authenticity Scale(SOA)
Time Frame: 10 weeks, 21 weeks, and 43 weeks
10 weeks, 21 weeks, and 43 weeks
Overall Anxiety Severity and Impairment Scale(OASIS)
Time Frame: 10 weeks, 21 weeks, 43 weeks and at every UP sessions
10 weeks, 21 weeks, 43 weeks and at every UP sessions
Overall Depression Severity and Impairment Scale(ODSIS)
Time Frame: 10 weeks, 21 weeks, 43 weeks and at every UP sessions
10 weeks, 21 weeks, 43 weeks and at every UP sessions
Eysenck Personality Questionnaire- Revised Short version, Neuroticism(EPQR-S)
Time Frame: 10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
Anxiety Sensitivity Index-III(ASI-III)
Time Frame: 10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
Emotion Regulation Skills Questionnaire(ERSQ)
Time Frame: 10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
Credibility/Expectancy Questionnaire(CEQ)
Time Frame: 2 weeks
2 weeks
Session Rating Scale(SRS V.3.0)
Time Frame: UP session at #1, 5, 10, and 15
UP session at #1, 5, 10, and 15
Homework Compliance Scale(HCS)
Time Frame: UP session at #1, 5, 10, and 15
UP session at #1, 5, 10, and 15
Adverse Events
Time Frame: From 1 week to 21 weeks
Adverse Events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
From 1 week to 21 weeks
GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)
Time Frame: 10 weeks, 43 weeks
10 weeks, 43 weeks
Hamilton Anxiety Rating Scale 14 item(HAM-A)
Time Frame: 10 weeks and 43 weeks
10 weeks and 43 weeks
Clinical Global Impression- Severity(CGI-S)
Time Frame: 10 weeks, 43 weeks
10 weeks, 43 weeks
Clinical Global Impression-Improvement(CGI-I)
Time Frame: 10 weeks, 43 weeks
10 weeks, 43 weeks
Psychiatric diagnosis assessed by SCID
Time Frame: 43 weeks
43 weeks
Emotion Exposure Scale (EES)
Time Frame: 10 weeks, 21 weeks, 43 weeks
10 weeks, 21 weeks, 43 weeks
Understanding of Treatment Rational of Unified Protocol (TRUP)
Time Frame: 10 weeks, 21 weeks, and 43 weeks
10 weeks, 21 weeks, and 43 weeks
Magnetic Resonance Imaging(MRI)
Time Frame: 21 weeks, 43 weeks
21 weeks, 43 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Center of Neurology and Psychiatry, Japan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Masaya Ito, Ph.D., National Center for Cognitive-Behavior Therapy and Research, National Center of Neurology and Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KAKENHI 25705018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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