UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042870
Receipt No. R000048932
Scientific Title Preliminary study on evaluating the effectiveness of outpatient Morita therapy for agoraphobia
Date of disclosure of the study information 2021/01/06
Last modified on 2020/12/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.