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

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 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

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

Value
https://center6.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