UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035191 |
|---|---|
| Receipt number | R000040111 |
| Scientific Title | A Study on Effectiveness of Rational Emotive Education among college students |
| Date of disclosure of the study information | 2018/12/11 |
| Last modified on | 2018/12/10 05:53:37 |
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Basic information
Public title
A Study on Effectiveness of Rational Emotive Education among college students
Acronym
A Study on Effectiveness of Rational Emotive Education among college students
Scientific Title
A Study on Effectiveness of Rational Emotive Education among college students
Scientific Title:Acronym
A Study on Effectiveness of Rational Emotive Education among college students
Region
| Japan |
Condition
Condition
non clinical depression
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a brief depression prevention program based on the principle of Cognitive Therapy (CT) and Rational Emotive Behavior Therapy (REBT) for college students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NIMH Center for Epidemiologic Studies - Depression Scale (CES-D)
Evaluation was made at 1 month and 2 months after group education program implementation.
Key secondary outcomes
1. The Kessler 6 scale (K6)
2. Automatic Thoughts Questionnare - Revised (ATQ-R)
3. Japan Irrational Belief Test-20 (JIBT-20)
Evaluation was made at 1 month and 2 months after group education program implementation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Group education based on cognitive therapy and REBT principle (1.5 hours).
Home work tackled by individuals based on the contents of group education (2 months).
Interventions/Control_2
Participants in the control group watched an educational DVD on psychology in groups, then wrote impressions(1.5 hours).
No home work was imposed.
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
| 18 | years-old | <= |
Age-upper limit
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students who take the relevant College lessons.
Key exclusion criteria
None.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsutoshi Tanaka |
Organization
Kitasato University
Division name
Graduate School of Medical Sciences
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0373, Japan
TEL
042-778-9305
k-tanaka@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hikaru Araki |
Organization
Kitasato University
Division name
Graduate School of Medical Sciences
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0373, Japan
TEL
042-778-9305
Homepage URL
dm15002z@st.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 11 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 10 | Day |
Last modified on
| 2018 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040111
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
