UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of horticultural therapy on future perspective in patients with schizophrenia in chronic stage
Title of the study (Brief title)	Effects of horticultural therapy for patients with schizophrenia in chronic stage
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of horticultural therapy for patients with schizophrenia in chronic stage
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Beck Hopelessness Scale
Key secondary outcomes	Positive and Negative Syndrome Scale The Japanese version of the Schizophrenia Quality of Life Scale

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patient with Schizophrenia 2) Patient who stays more than 3 years in a hospital 3) Patient who has ability to establish verbal communication 4) Patient in stable condition 5) Patient who has ability to understand and respond the question 6) patient who has ability to determine whether participating the study or not
Key exclusion criteria	1) Patient with cognitive dysfunction
Target sample size	20

Research contact person
Name of lead principal investigator	Takuya Kenmochi
Organization	Hinaga general center for mental care
Division name	Department of Rehabilitation
Address	5039, Hinaga, Yokkaichi-shi, MIe
TEL	0593452356
Email	kenmochitakuya13@gmail.com

Public contact
Name of contact person	Takuya kenmochi
Organization	Hinaga general center for mental care
Division name	Department of Rehabilitation
Address	5039, Hinaga, Yokkaichi-shi, MIe
TEL	0593452356
Homepage URL
Email	kenmochitakuya13@gmail.com

Sponsor
Institute	Department of Rehabilitation, Hinaga general center for mental care
Institute
Department

Funding Source
Organization	Hinaga general center for mental care
Organization
Division
Category of Funding Organization	Other
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	2017 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 30 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Analyzing

Management information
Registered date	2017 Year 02 Month 26 Day
Last modified on	2017 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030221