UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Control Trial of Positive Psychotherapy.
Title of the study (Brief title)	Randomized Control Trial of positive psychotherapy.
Region	Japan

Condition
Condition	Healthy people
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The main objective of this study is to make people happy and reduce people's anxiety and depression.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Beck Depression Inventory 2 We will check immediately before and after the intervention which will be conducted monthly, five times. Also, check after three months from the final intervention.
Key secondary outcomes	Psychological well-being (especially self acceptance) The State-Trait Anxiety Inventory 1 The Satisfaction With Life Scale The Patient Health Questionnaire

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	We will perform intervention every four weeks five times. People in this group will do the self-help counseling paper worksheet by using worksheet manual. (about 50 min.) Evaluation point 1. before some days before first intervention session 2. Immediately before and after each session 3. 4,8,16,24 weeks after the final session.
Interventions/Control_2	We will perform intervention every four weeks five times. People in this group will be counseled by expert counselor one-on-one. (about 50 min.) Evaluation point 1. before some days before first intervention session 2. Immediately before and after each session 3. 4,8,16,24 weeks after the final session.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Nothing
Key exclusion criteria	Those who have mental illness.
Target sample size	100

Research contact person
Name of lead principal investigator	Ryosuke ISHII
Organization	Japan Institute of Cognitive Science, Graduate School of System Design and Management, Keio University
Division name	Board of directors. / researcher
Address	Collaboration Complex, 4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa 223-8526 Japan
TEL	050-5275-6601
Email	ryosuke-ishii@j-ics.org

Public contact
Name of contact person	Ryosuke ISHII
Organization	Japan Institute of Cognitive Science, Graduate School of System Design and Management, Keio Universi
Division name	Board of directors. / researcher
Address	Collaboration Complex, 4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa 223-8526 Japan
TEL	050-5275-6601
Homepage URL
Email	admin@j-ics.org

Sponsor
Institute	Graduate School of System Design and Management, Keio University
Institute
Department

Funding Source
Organization	Keio Advanced Research Centers, Center for Security Research
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Fringe81

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	東京都 六本木ヒルズ

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 26 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 05 Month 10 Day
Anticipated trial start date	2016 Year 05 Month 26 Day
Last follow-up date	2017 Year 07 Month 01 Day
Date of closure to data entry	2017 Year 07 Month 01 Day
Date trial data considered complete	2017 Year 08 Month 01 Day
Date analysis concluded	2017 Year 09 Month 01 Day

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

Management information
Registered date	2016 Year 05 Month 26 Day
Last modified on	2017 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025882