NCT02003261

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: National Center of Neurology and Psychiatry, Japan · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
OTHER	Treatment As Usual	Most of the TAU will be drug therapy or nonsystematic supportive psychotherapy.

Timeline

• Start date: 2014-01-31
• Primary completion: 2018-11-02
• Completion: 2019-04-05
• First posted: 2013-12-06
• Last updated: 2019-08-21

Locations

1 site across 1 country: Japan