UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042870 |
|---|---|
| Receipt number | 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 | 2022/06/16 19:28:57 |
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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: PHQ-9
resilience: Resilience scale
quality of life: SF-36
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) 20 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
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
niimura-hide@keio.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department
Personal name
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
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）、医療法人社団泰明 銀座泰明クリニック（東京都）、浜田山メンタルクリニック(東京都）、下総精神医療センター（千葉県）
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | 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
| 2022 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048932
