UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility Study of Unified Protocol for Anxiety and Depressive Disorders
Acronym	Open label study of Unified Protocol for Emotional Disorders
Scientific Title	Feasibility Study of Unified Protocol for Anxiety and Depressive Disorders
Scientific Title:Acronym	Open label study of Unified Protocol for Emotional Disorders
Region	Japan

Condition
Condition	Anxiety Disorders, Depressive Disorders
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the feasibility of Unified Protocol for anxiety and depressive disorders in Japanese setting
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Severity of anxiety symptoms assessed by the SIGH-A (0 week vs 1 week after the completion of intervention)
Key secondary outcomes	1. Diagnoses assessed by the M.I.N.I. 2. Objective severity of depressive symptoms (GRID-HAM-D) 3. Subjective severity of depressive symptoms (BDI-II) 4. Quality of Life (EuroQol etc) 5. Subjective symptoms for primary diagnosis (self-report scale) 6. Emotion Regulation (ERQ) 7. Experienced Emotion (PANAS) 8. Drop Out rates 9. Adverse Events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	CBT (Unified Protocol)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Subjects with current DSM-IV Panic disorder with/without Agoraphobia, Agoraphobia without history of Panic Disorder, Specific Phobia, Social Phobia (Social Anxiety Disorder), Obsessive-Compulsive Disorder, Post-Traumatic Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder Not Otherwise Specified, Major Depressive Disorder, Depressive Disorder Not Otherwise Specified 2. HAM-D Anxiety Factor >= 7 3. Age 20 years or older, and 65 years or younger at screening. 4. Subjects who give full consent in the participation of the study
Key exclusion criteria	1. No alcohol or substance use disorder in 6 months prior to the screening. 2. No history or concurrent manic or psychotic episode. 3. No other primary DSM-IV Axis I Disorders in six months prior to the screening. 4. No comorbid of antisocial personality disorder. 5. No serious suicidal ideation at screening. 6. Evidence of unable to participate half or more of the intervention phase. 7. No past treatment of CBT. 8. No structured psychotherapy (except supportive therapy) during the intervention. 9. No major cognitive deficits at screening. 10. No life-threatening, severe or unstable physical disorders at screening. 11. Other relevant reason decided by the investigators.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masaya Ito, Ph.D.
Organization	National Center of Neurology and Psychiatry
Division name	National Center for Cognitive Behavior Therapy and Research, Department of Clinical Training
Zip code
Address	Ogawahigashi 4-1-1, Kodaira-shi, Tokyo, Japan
TEL	042-341-2712(3605)
Email	masayait@ncnp.go.jp

Public contact
Name of contact person	1st name Middle name Last name Noriko Kato
Organization	National Center of Neurology and Psychiatry
Division name	National Center for Cognitive Behavior Therapy and Research
Zip code
Address	Ogawahigashi 4-1-1, Kodaira-shi, Tokyo, Japan
TEL	042-341-2712(3605)
Homepage URL
Email	norikokato@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry, National Center for Cognitive Behavior Therapy and Research
Institute
Department

Funding Source
Organization	Intramural Research Grant (24-4) for Neurological and Psychiatric Disorders of NCNP
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Disaster Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立精神・神経医療研究センター(東京都) 国立病院機構 災害医療センター（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 12 Day

Related information
URL releasing protocol	not available
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1016/j.beth.2016.02.005
Number of participants that the trial has enrolled	17
Results	The severity of anxiety symptoms decreased significantly after the intervention and remained low for 3 months.
Results date posted	2022 Year 01 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2016 Year 02 Month 24 Day
Baseline Characteristics	10 female (59%) Mean age=35.18(SD=10.8)
Participant flow	Referred for study, baseline assessment, enrolled, intervention, post-assessment, 3-month follow-up assessment.
Adverse events	No severe adverse event occurred.
Outcome measures	Structured Interview Guide for the Hamilton Anxiety Rating Scale
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date	2014 Year 07 Month 31 Day
Date of closure to data entry	2014 Year 10 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 07 Month 03 Day
Last modified on	2022 Year 01 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009800