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

NCT02003261 | Completed DMC

• 1 other identifier: KAKENHI 25705018
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Depressive Disorders

Outcome Measures

Primary Outcomes (1)

• GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)

  21 weeks

Secondary Outcomes (6)

• 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

  21 weeks

• Remission of symptoms assessed by GRID-HAMD

  21 weeks

Other Outcomes (22)

• Global Assessment of Functioning(GAF)

  10 weeks, 21 weeks, and 43 weeks

• Disorder specific measures

  10 weeks, 21 weeks, and 43 weeks

• Quality of Life(EQ-5D)

  10 weeks, 21 weeks, and 43 weeks

Study Arms (2)

Unified Protocol with Treatment As Usual

EXPERIMENTAL

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; Other: Treatment As Usual

Waitlist Control with Treatment As Usual

OTHER

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

Interventions

Unified Protocol with Treatment As Usual BEHAVIORAL

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.

Also known as: Cognitive Behavioral Therapy

Unified Protocol with Treatment As Usual

Treatment As Usual OTHER

Most of the TAU will be drug therapy or nonsystematic supportive psychotherapy.

Unified Protocol with Treatment As Usual; Waitlist Control with Treatment As Usual

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Center of Neurology and Psychiatry, Japan: lead

Study Sites (1)

National Center of Neurology and Psychiatry

Kodaira, Tokyo, 187-8551, Japan

Location

Related Publications (1)

• 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.

  PMID: 26987315 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder

Interventions

Therapeutics; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Masaya Ito, Ph.D.

  National Center for Cognitive-Behavior Therapy and Research, National Center of Neurology and Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of dissemination and training at National Center of Cognitive-Behavior Therapy and Research

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: January 31, 2014
• Primary Completion: November 2, 2018
• Study Completion: April 5, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

JP (1)