UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034985 |
|---|---|
| Receipt number | 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 | 2022/11/28 20:18:08 |
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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
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
ogawa-sa@nagasaki-u.ac.jp
Sponsor or person
Institute
Center for Health and Community
Medicine, Nagasaki University
Institute
Department
Personal name
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
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
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000039898
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000039898
Number of participants that the trial has enrolled
35
Results
Cognitive-behavioral therapy was conducted with university students who experienced a sense of maladjustment in schooling. 22 of 34 students showed improvement in their sense of maladjustment in schooling. Depression (BDI-II) and mental health (GHQ-28) decreased significantly after one month compared to before the intervention.
Results date posted
| 2022 | Year | 11 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The academic status of university students is closely related to their mental health. Many students who take a leave of absence from school often feel maladjusted to their studies. In a few cases, the persistent feeling of maladjustment to study has led to the development of mood disorders.
Participant flow
In this study, those who felt maladjusted to school were invited to participate in cognitive-behavioral therapy. A total of six sessions of cognitive-behavioral therapy were conducted with those who gave informed consent.
Adverse events
None
Outcome measures
School Maladjustment
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
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
| 2021 | 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
| 2022 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039898
