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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name