UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preliminary study of Mindfulness Class for anxiety disorders
Title of the study (Brief title)	Mindfulness Class for anxiety disorders
Region	Japan

Condition
Condition	Anxiety disorders
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To preliminarily investigate whether Mindfulness class for the patients with anxiety disorders (panic disorder, social anxiety disorder, generalized anxiety disorder, and obssessive compulsive disorder) is effective or not
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Difference of STAI score between pre and post treatment
Key secondary outcomes	Panic Disorder Severity Scale, Morbility Inventory for Agoraphobia, LSAS-J, Y-BOCS, PSWQ, CES-D, K-6, EQ-5D, SF-36, POMS,and Japanse version Five Facet Mindlfulness Questionnaire

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	Behavior,custom
Interventions/Control_1	Mindfulness Class
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	/Diagnosed as panic disorder, social anxiety disorder, generalized anxiety disorder, or obsessive compulsive disorder based on DSM-IV.
Key exclusion criteria	/Past history of substance related disorders /Impairment of cognitive function /Past history of manic or psychotic episode. /Anti social personality disorder /Severe suicidal ideation /Difficult to follow up for 14 months after start of intervention /Past history of mindfulness based intervention /Organic brain disorders /Other severe general medical conditions
Target sample size	20

Research contact person
Name of lead principal investigator	Mitsuhiro Sado
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	+81-(0)3-3353-1211
Email	mitsusado@keio.jp

Public contact
Name of contact person	Mitsuhiro Sado
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	+81-(0)3-3353-1211
Homepage URL
Email	mitsusado@z5.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	慶應義塾大学病院(東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 08 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 03 Month 15 Day
Anticipated trial start date	2013 Year 03 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 08 Month 01 Day
Last modified on	2018 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013297