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

NCT ID: NCT02003261

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2019-04-05

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.

Conditions

Anxiety Disorders; Depressive Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Unified Protocol with Treatment As Usual

Intervention Type: 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.

Treatment As Usual

Intervention Type: OTHER

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

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.

Group Type: OTHER

Treatment As Usual

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment As Usual

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

Intervention Type: OTHER

Other Intervention Names

Cognitive Behavioral Therapy

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center of Neurology and Psychiatry, Japan

OTHER

Sponsor Role: lead

Responsible Party

Masaya ITO

Chief of dissemination and training at National Center of Cognitive-Behavior Therapy and Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Masaya Ito, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 26987315 (View on PubMed)

Other Identifiers

KAKENHI 25705018

Identifier Type: -

Identifier Source: org_study_id