UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058274 |
|---|---|
| Receipt number | R000066197 |
| Scientific Title | Impact of Internet-Based Cognitive Behavioral Therapy on University Students Mental Health and Loneliness During COVID-19 Self-Isolation |
| Date of disclosure of the study information | 2025/06/25 |
| Last modified on | 2025/06/25 13:23:14 |
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Basic information
Public title
Impact of Internet-Based Cognitive Behavioral Therapy on University Students Mental Health and Loneliness During COVID-19 Self-Isolation
Acronym
Impact of Internet-Based Cognitive Behavioral Therapy on University Students Mental Health and Loneliness During COVID-19 Self-Isolation
Scientific Title
Impact of Internet-Based Cognitive Behavioral Therapy on University Students Mental Health and Loneliness During COVID-19 Self-Isolation
Scientific Title:Acronym
Impact of Internet-Based Cognitive Behavioral Therapy on University Students Mental Health and Loneliness During COVID-19 Self-Isolation
Region
| Japan |
Condition
Condition
Depression, anxiety, PTSD
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the present study aims to investigate the impact of iCBT on alleviating loneliness and psychological distress associated with self-isolation among university students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Participants demographic information
Evaluation of depression: Patient Health Questionnaire9:PHQ9 (Japanese version of PHQ 9)
Evaluation of anxiety: Generalized Anxiety Disorder 7:GAD7 (Japanese version of GAD 7)
Evaluation of traumatic experiences: Impact of Event Scale Revised:IES R (Japanese version of IES R)
Decreased motivation for schoolwork and class:Created by Shimoyama (1995)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Internet-Based Cognitive Behavioral Therapy
Interventions/Control_2
Control
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria
1) Participants were eligible for inclusion in the study if they met all the following criteria:
2) Enrollment Status: Currently enrolled as undergraduate or graduate students at a university.
3) Age: Aged 18 years or older.
4) Language Proficiency: Able to read and understand the language in which the intervention materials and assessments were provided.
5) Access to Technology: Had regular access to the internet and a compatible device (computer, tablet, or smartphone) for participating in the online iCBT program.
6) COVID-19 Self-Isolation: Currently experiencing or had experienced a period of self-isolation due to COVID-19 restrictions within the past 6 months.
7) Consent: Provided informed consent to participate in the study.
Key exclusion criteria
Exclusion Criteria
1) Participants were excluded from the study if they met any of the following criteria:
2) Severe Psychiatric Conditions: Current diagnosis of a severe mental disorder (e.g., schizophrenia, bipolar disorder) or active suicidal ideation requiring immediate clinical intervention.
3) Concurrent Psychological Treatment: Currently receiving psychotherapy or counseling for mental health issues.
4) Substance Abuse: Evidence of moderate to severe substance use disorder.
5) Inability to Commit: Unwilling or unable to complete the study assessments or the full duration of the iCBT program.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | OHUE |
| Middle name | |
| Last name | TAKASHI |
Organization
Okayama University
Division name
Graduate School of Health Sciences
Zip code
7008558
Address
Okayama City, Kita Ward, Shikata-cho 2-5-1
TEL
0862356841
t-ohue@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | OHUE |
| Middle name | |
| Last name | TAKASHI |
Organization
Okayama University
Division name
Graduate School of Health Sciences
Zip code
7008558
Address
Okayama City, Kita Ward, Shikata-cho 2-5-1
TEL
0862356841
Homepage URL
t-ohue@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Hyogo University Ethics Committee
Address
2301 Shinzaike, Hiraoka-cho, Kakogawa City, Hyogo Prefecture
Tel
079-427-5111
ohue@hyogo-dai.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 25 | 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
50
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
| 2025 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 25 | Day |
Last modified on
| 2025 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066197
