UMIN-CTR Clinical Trial

Basic information
Public title	Preliminary study on evaluating the effectiveness of outpatient Morita therapy for agoraphobia
Acronym	Preliminary study on outpatient Morita therapy for agoraphobia
Scientific Title	Preliminary study on evaluating the effectiveness of outpatient Morita therapy for agoraphobia
Scientific Title:Acronym	Preliminary study on outpatient Morita therapy for agoraphobia
Region	Japan

Condition
Condition	agoraphobia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of outpatient Morita therapy for agoraphobia. The expected outcome of this study is to clarify the effect size of the treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	PAS(Panic and Agoraphobia Scale)
Key secondary outcomes	anxiety: GAD-7 depression: QIDS or HAMD or MADRS resilience: Resilience scale quality of life: EQ-SD

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Structured Morita therapy (sMT) is performed outpatiently every 1-2 weeks for 30 minutes once (60 minutes only for the first time), for a total of 12 times.
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	18 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) 18 years old and over, under 60 years old 2) Meet the diagnostic criteria for agoraphobiafor of DSM-5 3) Meet Morita neurosis diagnostic criteria
Key exclusion criteria	1) Substance use disorder such as alcohol within 6 months 2) Comorbidity or history of manic episodes or psychotic disorders 3) Psychiatric disorders other than agoraphobia that should be prioritized for treatment 4) Antisocial personality disorder or menatl retardation 5) problems of suicide or self-harm 6) Cerebral organic lesions or cognitive dysfunction within 1 year 7) Physical illness, abuse, or violence interfere with continuation of the treatment
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Hidehito Middle name Last name Niimura
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	1608582
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL	03-5363-0187
Email	niimura-hide@keio.jp

Public contact
Name of contact person	1st name Hidehito Middle name Last name Niimura
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	1608582
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL	03-5363-0187
Homepage URL
Email	niimura-hide@keio.jp

Sponsor
Institute	Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Keio University School of Medicine Institutional Review Board
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo
Tel	03-5363-3503
Email	hikoukai

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）、東京歯科大学市川総合病院（千葉県）、横浜カメリアホスピタル（神奈川県）、医療法人社団形外会 三島森田病院（静岡県）、ひがメンタルクリニック（埼玉県）、医療法人社団泰明 銀座泰明クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2021 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 28 Day
Last modified on	2020 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048932

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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