UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039898