Clinical trial NCT02003261: Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP Study)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Depressive Disorders
Lead sponsor: National Center of Neurology and Psychiatry, Japan
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)
timeFrame: 21 weeks
Secondary outcomes:
measure: Hamilton Anxiety Rating Scale 14 item(HAM-A)
timeFrame: 21 weeks
measure: Clinical Global Impression- Severity(CGI-S)
timeFrame: 21 weeks
measure: Clinical Global Impression-Improvement(CGI-I)
timeFrame: 21 weeks
measure: Responder Status assessed by GRID-HAMD
timeFrame: 21 weeks
measure: Remission of symptoms assessed by GRID-HAMD
timeFrame: 21 weeks
measure: Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID)
timeFrame: 21 weeks
Other outcomes:
measure: Global Assessment of Functioning(GAF)
timeFrame: 10 weeks, 21 weeks, and 43 weeks
measure: Disorder specific measures
timeFrame: 10 weeks, 21 weeks, and 43 weeks
measure: Quality of Life(EQ-5D)
timeFrame: 10 weeks, 21 weeks, and 43 weeks
measure: Sheehan Disability Scale(SDISS)
timeFrame: 10 weeks, 21 weeks, and 43 weeks
measure: Sense of Authenticity Scale(SOA)
timeFrame: 10 weeks, 21 weeks, and 43 weeks
measure: Overall Anxiety Severity and Impairment Scale(OASIS)
timeFrame: 10 weeks, 21 weeks, 43 weeks and at every UP sessions
measure: Overall Depression Severity and Impairment Scale(ODSIS)
timeFrame: 10 weeks, 21 weeks, 43 weeks and at every UP sessions
measure: Eysenck Personality Questionnaire- Revised Short version, Neuroticism(EPQR-S)
timeFrame: 10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
measure: Anxiety Sensitivity Index-III(ASI-III)
timeFrame: 10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
measure: Emotion Regulation Skills Questionnaire(ERSQ)
timeFrame: 10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15
measure: Credibility/Expectancy Questionnaire(CEQ)
timeFrame: 2 weeks
measure: Session Rating Scale(SRS V.3.0)
timeFrame: UP session at #1, 5, 10, and 15
measure: Homework Compliance Scale(HCS)
timeFrame: UP session at #1, 5, 10, and 15
measure: Adverse Events
timeFrame: From 1 week to 21 weeks
measure: GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)
timeFrame: 10 weeks, 43 weeks
measure: Hamilton Anxiety Rating Scale 14 item(HAM-A)
timeFrame: 10 weeks and 43 weeks
measure: Clinical Global Impression- Severity(CGI-S)
timeFrame: 10 weeks, 43 weeks
measure: Clinical Global Impression-Improvement(CGI-I)
timeFrame: 10 weeks, 43 weeks
measure: Psychiatric diagnosis assessed by SCID
timeFrame: 43 weeks
measure: Emotion Exposure Scale (EES)
timeFrame: 10 weeks, 21 weeks, 43 weeks
measure: Understanding of Treatment Rational of Unified Protocol (TRUP)
timeFrame: 10 weeks, 21 weeks, and 43 weeks
measure: Magnetic Resonance Imaging(MRI)
timeFrame: 21 weeks, 43 weeks
Locations:
city: Kodaira
country: Japan
facility: National Center of Neurology and Psychiatry
state: Tokyo
Study officials:
affiliation: National Center for Cognitive-Behavior Therapy and Research, National Center of Neurology and Psychiatry
name: Masaya Ito, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ito M, Okumura Y, Horikoshi M, Kato N, Oe Y, Miyamae M, Hirabayashi N, Kanie A, Nakagawa A, Ono Y. Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Mar 18;16:71. doi: 10.1186/s12888-016-0779-8.