UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness and Cost effectiveness of mindfulness class for anxiety disorders
Title of the study (Brief title)	Effectiveness and Cost effectiveness of 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 investigate whether Mindfulness class for the patients with anxiety disorders (panic disorder, agoraphobia, and social anxiety disorder) is effective and cost effective compared to the control group or not.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Difference of STAI score between both groups
Key secondary outcomes	Panic Disorder Severity Scale, Morbility Inventory for Agoraphobia, LSAS-J, CES-D, K-6, EQ-5D, SF-36, Japanse version Five Facet Mindlfulness Questionnaire, SAA, healthcare service use, and adherence to medication.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Mindfulness class
Interventions/Control_2	Treatment as usual
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	/Diagnosed as panic disorder, agoraphobia, or social anxiety disorder, based on SCID.
Key exclusion criteria	/Past history of substance related disorders /Alcohol dependence /Drug dependence /Anti social personality disorder /Severe suicidal ideation or self-harm behaviour /Difficult to follow up for 8 weeks after start of intervention /Dissent to the possibility of being allocated to the control group /Organic brain disorders /Other severe general medical conditions
Target sample size	40

Research contact person
Name of lead principal investigator	Joichiro Shirahase
Organization	Keio University
Division name	Center for Stress Research
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	+81-(0)3-3353-1211
Email	shirahase@z6.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	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 15 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 09 Month 01 Day
Anticipated trial start date	2014 Year 10 Month 15 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

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

Management information
Registered date	2014 Year 10 Month 11 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=R000017846