UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006170 |
|---|---|
| Receipt number | R000007245 |
| Scientific Title | Intervention study of psychotherapy |
| Date of disclosure of the study information | 2011/08/14 |
| Last modified on | 2018/09/30 11:20:32 |
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Basic information
Public title
Intervention study of psychotherapy
Acronym
Psychotherapeutic intervention study(PIS)
Scientific Title
Intervention study of psychotherapy
Scientific Title:Acronym
Psychotherapeutic intervention study(PIS)
Region
| Japan |
Condition
Condition
mild PTSD caused by the disaster
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our aim is to investigate whether intervention using Horticultural therapy provide symptomatic relief of mild PTSD caused by the disaster.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain structure measured by MRI
Key secondary outcomes
Stress & mental health measurements, Salivary cortisol level, Natural killer cell activity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
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
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Studying gardening 15min/day everyday and taking a course once a week during 8 weeks.
Interventions/Control_2
Taking a course once a week during 8 weeks.
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
Female
Key inclusion criteria
1.Age:20-60
2.Right-handed person
3.Dwelling place:a maritime area of Miyagi pref.
Key exclusion criteria
1.Person whom has metal in the body(ex. a pacemaker, an aneurysm clip)
2.Person without medical history of the cerebral nerve disease
3.Person without medical history such as high blood pressure, the diabetes
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuka Kotozaki |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Smart Aging International Research Center
Zip code
Address
Seiryo-machi 4-1, Aoba-ku Sendai
TEL
022-717-7988
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Smart Aging International Research Center
Zip code
Address
TEL
022-717-7988
Homepage URL
Sponsor or person
Institute
Institute of Development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Address
Tel
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
| 2011 | Year | 08 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 13 | Day |
Last modified on
| 2018 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007245
