UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022468 |
|---|---|
| Receipt number | R000025882 |
| Scientific Title | Randomized Control Trial of Positive Psychotherapy. |
| Date of disclosure of the study information | 2016/05/26 |
| Last modified on | 2017/05/27 11:53:49 |
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Basic information
Public title
Randomized Control Trial of Positive Psychotherapy.
Acronym
Randomized Control Trial of positive psychotherapy.
Scientific Title
Randomized Control Trial of Positive Psychotherapy.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Ryosuke ISHII |
Organization
Japan Institute of Cognitive Science,
Graduate School of System Design and Management, Keio University
Division name
Board of directors. / researcher
Zip code
Address
Collaboration Complex, 4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa 223-8526 Japan
TEL
050-5275-6601
ryosuke-ishii@j-ics.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryosuke ISHII |
Organization
Japan Institute of Cognitive Science, Graduate School of System Design and Management, Keio Universi
Division name
Board of directors. / researcher
Zip code
Address
Collaboration Complex, 4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa 223-8526 Japan
TEL
050-5275-6601
Homepage URL
admin@j-ics.org
Sponsor or person
Institute
Graduate School of System Design and Management, Keio University
Institute
Department
Personal name
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
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
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 05 | Month | 10 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025882
