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

Not Applicable

Completed

• Conditions: Anxiety Disorders; Depressive Disorders
• Interventions: Behavioral: Unified Protocol with Treatment As Usual; Other: Treatment As Usual

• Registration Number: NCT02003261
• Lead Sponsor: National Center of Neurology and Psychiatry, Japan

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.

Study Timeline

• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-06
• Study Start: 2014-01-31
• Primary Completion: 2018-11-02
• Study Completion: 2019-04-05
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unified Protocol with Treatment As Usual	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.
Waitlist Control with Treatment As Usual	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.
Unified Protocol with Treatment As Usual	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.

Primary Outcome Measures

Name	Time	Method
GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)	21 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Center of Neurology and Psychiatry; 🇯🇵 Kodaira, Tokyo, Japan