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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anxiety Disorders, Depressive Disorders

Intervention / Treatment
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* Behavioral: Unified Protocol with Treatment As Usual
* Other: Treatment As Usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unified Protocol with Treatment As Usual<br>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<br>* 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.<br>* Other names: Cognitive Behavioral Therapy;Other: Treatment As Usual<br>* Most of the TAU will be drug therapy or nonsystematic supportive psychotherapy.<br>|
| Other: Waitlist Control with Treatment As Usual<br>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<br>* Most of the TAU will be drug therapy or nonsystematic supportive psychotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD) |  | 21 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Reduction in GRID-HAMD score of at least 50% compared with baseline | 21 weeks | 
| Remission of symptoms assessed by GRID-HAMD | GRID-HAMD score of less than 8 | 21 weeks | 
| Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID) |  | 21 weeks |