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

National Center of Neurology and Psychiatry, Japan1 site in 1 country104 target enrollmentJanuary 31, 2014

ConditionsAnxiety Disorders Depressive Disorders

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anxiety Disorders
Sponsor: National Center of Neurology and Psychiatry, Japan
Enrollment: 104
Locations: 1
Primary Endpoint: GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 31, 2014

End Date

April 5, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Center of Neurology and Psychiatry, Japan

Responsible Party

Principal Investigator

Masaya ITO

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

National Center of Neurology and Psychiatry, Japan

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.

Outcomes

Primary Outcomes

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

Time Frame: 21 weeks

Secondary Outcomes

Hamilton Anxiety Rating Scale 14 item(HAM-A)(21 weeks)
Clinical Global Impression-Improvement(CGI-I)(21 weeks)
Clinical Global Impression- Severity(CGI-S)(21 weeks)
Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID)(21 weeks)
Responder Status assessed by GRID-HAMD(21 weeks)
Remission of symptoms assessed by GRID-HAMD(21 weeks)