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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders; Depressive Disorders
• Intervention / Treatment: Behavioral: Unified Protocol with Treatment As Usual; Other: Treatment As Usual

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: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)	21 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Anxiety Rating Scale 14 item(HAM-A)		21 weeks
Clinical Global Impression- Severity(CGI-S)		21 weeks
Clinical Global Impression-Improvement(CGI-I)		21 weeks
Responder Status assessed by GRID-HAMD	Reduction in GRID-HAMD score of at least 50% compared with baseline	21 weeks
Remission of symptoms assessed by GRID-HAMD	GRID-HAMD score of less than 8	21 weeks
Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID)		21 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Assessment of Functioning(GAF)		10 weeks, 21 weeks, and 43 weeks
Disorder specific measures	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)		10 weeks, 21 weeks, and 43 weeks
Sheehan Disability Scale(SDISS)		10 weeks, 21 weeks, and 43 weeks
Sense of Authenticity Scale(SOA)		10 weeks, 21 weeks, and 43 weeks
Overall Anxiety Severity and Impairment Scale(OASIS)		10 weeks, 21 weeks, 43 weeks and at every UP sessions
Overall Depression Severity and Impairment Scale(ODSIS)		10 weeks, 21 weeks, 43 weeks and at every UP sessions
Eysenck Personality Questionnaire- Revised Short version, Neuroticism(EPQR-S)		10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
Anxiety Sensitivity Index-III(ASI-III)		10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
Emotion Regulation Skills Questionnaire(ERSQ)		10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
Credibility/Expectancy Questionnaire(CEQ)		2 weeks
Session Rating Scale(SRS V.3.0)		UP session at #1, 5, 10, and 15
Homework Compliance Scale(HCS)		UP session at #1, 5, 10, and 15
Adverse Events	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)		10 weeks, 43 weeks
Hamilton Anxiety Rating Scale 14 item(HAM-A)		10 weeks and 43 weeks
Clinical Global Impression- Severity(CGI-S)		10 weeks, 43 weeks
Clinical Global Impression-Improvement(CGI-I)		10 weeks, 43 weeks
Psychiatric diagnosis assessed by SCID		43 weeks
Emotion Exposure Scale (EES)		10 weeks, 21 weeks, 43 weeks
Understanding of Treatment Rational of Unified Protocol (TRUP)		10 weeks, 21 weeks, and 43 weeks
Magnetic Resonance Imaging(MRI)		21 weeks, 43 weeks

Collaborators and Investigators

• Sponsor: National Center of Neurology and Psychiatry, Japan
• Investigators: Principal Investigator: Masaya Ito, Ph.D., National Center for Cognitive-Behavior Therapy and Research, National Center of Neurology and Psychiatry

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2014
• Primary Completion (Actual): November 2, 2018
• Study Completion (Actual): April 5, 2019

Study Registration Dates

• First Submitted: December 2, 2013
• First Submitted That Met QC Criteria: December 5, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Depressive Disorder; Disease; Anxiety Disorders
• Other Study ID Numbers: KAKENHI 25705018