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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003261
• Other study ID #: KAKENHI 25705018
• Status: Completed
• Phase: N/A
• Start date: January 31, 2014
• Est. completion date: April 5, 2019

Study information

• Verified date: August 2019
• Source: National Center of Neurology and Psychiatry, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 5, 2019
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depressive Disorder
• Depressive Disorders
• Disease

Intervention

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.

Locations

Country	Name	City	State
Japan	National Center of Neurology and Psychiatry	Kodaira	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
National Center of Neurology and Psychiatry, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global Assessment of Functioning(GAF)		10 weeks, 21 weeks, and 43 weeks
Other	Disorder specific measures	Participants will be answered some of the following measures in accord with their diagnoses; Beck Depression Inventory-II for Depressive Disorders, Panic Disorder Severity Scale for Panic Disorder, Penn-State Worry Questionnaire for Generalized Anxiety Disorder, Impact of Event Scale-Revised for Post-Traumatic Stress Disorder, Yale-Brown Obsessive Compulsive Scale for Obsessive Compulsive Disorder and Fear Questionnaire for Agora Phobia.	10 weeks, 21 weeks, and 43 weeks
Other	Quality of Life(EQ-5D)		10 weeks, 21 weeks, and 43 weeks
Other	Sheehan Disability Scale(SDISS)		10 weeks, 21 weeks, and 43 weeks
Other	Sense of Authenticity Scale(SOA)		10 weeks, 21 weeks, and 43 weeks
Other	Overall Anxiety Severity and Impairment Scale(OASIS)		10 weeks, 21 weeks, 43 weeks and at every UP sessions
Other	Overall Depression Severity and Impairment Scale(ODSIS)		10 weeks, 21 weeks, 43 weeks and at every UP sessions
Other	Eysenck Personality Questionnaire- Revised Short version, Neuroticism(EPQR-S)		10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
Other	Anxiety Sensitivity Index-III(ASI-III)		10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
Other	Emotion Regulation Skills Questionnaire(ERSQ)		10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
Other	Credibility/Expectancy Questionnaire(CEQ)		2 weeks
Other	Session Rating Scale(SRS V.3.0)		UP session at #1, 5, 10, and 15
Other	Homework Compliance Scale(HCS)		UP session at #1, 5, 10, and 15
Other	Adverse Events	Adverse Events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.	From 1 week to 21 weeks
Other	GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)		10 weeks, 43 weeks
Other	Hamilton Anxiety Rating Scale 14 item(HAM-A)		10 weeks and 43 weeks
Other	Clinical Global Impression- Severity(CGI-S)		10 weeks, 43 weeks
Other	Clinical Global Impression-Improvement(CGI-I)		10 weeks, 43 weeks
Other	Psychiatric diagnosis assessed by SCID		43 weeks
Other	Emotion Exposure Scale (EES)		10 weeks, 21 weeks, 43 weeks
Other	Understanding of Treatment Rational of Unified Protocol (TRUP)		10 weeks, 21 weeks, and 43 weeks
Other	Magnetic Resonance Imaging(MRI)		21 weeks, 43 weeks
Primary	GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)		21 weeks
Secondary	Hamilton Anxiety Rating Scale 14 item(HAM-A)		21 weeks
Secondary	Clinical Global Impression- Severity(CGI-S)		21 weeks
Secondary	Clinical Global Impression-Improvement(CGI-I)		21 weeks
Secondary	Responder Status assessed by GRID-HAMD	Reduction in GRID-HAMD score of at least 50% compared with baseline	21 weeks
Secondary	Remission of symptoms assessed by GRID-HAMD	GRID-HAMD score of less than 8	21 weeks
Secondary	Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID)		21 weeks