UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intervention study of psychotherapy
Title of the study (Brief title)	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	Yuka Kotozaki
Organization	Institute of Development, Aging and Cancer, Tohoku University
Division name	Smart Aging International Research Center
Address	Seiryo-machi 4-1, Aoba-ku Sendai
TEL	022-717-7988
Email

Public contact
Name of contact person
Organization	Institute of Development, Aging and Cancer, Tohoku University
Division name	Smart Aging International Research Center
Address
TEL	022-717-7988
Homepage URL
Email

Sponsor
Institute	Institute of Development, Aging and Cancer, Tohoku University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007245