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

National Center of Neurology and Psychiatry, Japan

Status: Completed

Conditions: Depressive Disorders; Anxiety Disorders

Treatments: Other: Treatment As Usual; Behavioral: Unified Protocol with Treatment As Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT02003261

KAKENHI 25705018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Unified Protocol with Treatment As Usual

Experimental group

Description:

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.

Treatment:

Behavioral: Unified Protocol with Treatment As Usual

Other: Treatment As Usual

Waitlist Control with Treatment As Usual

Other group

Description:

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.

Treatment:

Other: Treatment As Usual