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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034985
Receipt No. R000039898
Scientific Title Development of Cognitive Behavior Therapy for University Students Experiencing Difficulty with Academic Adjustment
Date of disclosure of the study information 2018/11/24
Last modified on 2019/05/26

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Basic information
Public title Development of Cognitive Behavior Therapy for University Students Experiencing Difficulty with Academic Adjustment
Acronym Development of Cognitive Behavior Therapy for University Students Experiencing Difficulty with Academic Adjustment
Scientific Title Development of Cognitive Behavior Therapy for University Students Experiencing Difficulty with Academic Adjustment
Scientific Title:Acronym Development of Cognitive Behavior Therapy for University Students Experiencing Difficulty with Academic Adjustment
Region
Japan

Condition
Condition University Students
Experiencing Difficulty with Academic Adjustment
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to develop and then examine the effectiveness of a cognitive behavior therapy program designed to promote academic adjustment in university students.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes School Maladjustment
Key secondary outcomes (1)Mental health
(2)Profile of Mood States
(3)Social support
(4)Brief Core Schema Scales

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Cognitive Behavior Therapy
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
18 years-old <=
Age-upper limit
26 years-old >=
Gender Male and Female
Key inclusion criteria Japanese University students
Key exclusion criteria International students
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Sayaka
Middle name
Last name Ogawa
Organization Nagasaki University
Division name Center for Health and Community Medicine
Zip code 852-8521
Address 1-14, Bunkyo, Nagasaki, Japan
TEL 095-819-2214
Email ogawa-sa@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Sayaka
Middle name
Last name Ogawa
Organization Nagasaki University
Division name Center for Health and Community Medicine
Zip code 852-8521
Address 1-14, Bunkyo, Nagasaki, Japan
TEL 095-819-2214
Homepage URL
Email ogawa-sa@nagasaki-u.ac.jp

Sponsor
Institute Center for Health and Community
Medicine, Nagasaki University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nagasaki University Graduate School of Biomedical Sciences and Technology Cooperation Division
Address 1-12-4 Sakamoto Nagasaki, Japan
Tel 095-819-7195
Email gakujutu_gakuji@ml.nagasaki-u.ac.jp

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 長崎大学保健・医療推進センター

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 24 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
2018 Year 10 Month 31 Day
Date of IRB
2018 Year 05 Month 28 Day
Anticipated trial start date
2018 Year 11 Month 26 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 24 Day
Last modified on
2019 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039898

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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