UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032736 |
|---|---|
| Receipt number | R000037334 |
| Scientific Title | Randomized Controlled Trial of Cognitive-Behavioral Therapy versus Mindfulness-Based Intervention for Depression in University Students |
| Date of disclosure of the study information | 2018/05/28 |
| Last modified on | 2023/12/01 19:20:37 |
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Basic information
Public title
Randomized Controlled Trial of Cognitive-Behavioral Therapy versus Mindfulness-Based Intervention for Depression in University Students
Acronym
CBT/MBI for Depression
Scientific Title
Randomized Controlled Trial of Cognitive-Behavioral Therapy versus Mindfulness-Based Intervention for Depression in University Students
Scientific Title:Acronym
CBT/MBI for Depression
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of cognitive-behavioral therapy and mindfulness-based intervention on depression in university students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Center for Epidemiological Studies Depression Scale (CES-D)
2) MINI
Key secondary outcomes
1) State Trait Anger Expression Inventory
2) Anger Rumination Scale
3) Five Facets of Mindfulness Questionnaire
4) Automatic Thoughts Questionnaire-Revised
5) The Experience Questionnaire
6) Ruminative Response Scale
7) State Trait Anxiety Inventory
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive-Behavioral Therapy
Interventions/Control_2
Mindfulness-Based Intervention
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
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Undergraduate students aged 18-24 years old
Key exclusion criteria
Participants with major depressive disorder, bipolar disorder, panic disorder, or serious suicidal risk
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sato |
Organization
Kwansei Gakuin University
Division name
School of Humanities
Zip code
6628501
Address
Uegahara 1-1-155, Nishinomiya, Hyogo
TEL
0798-54-6201
satokan@kwansei.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sato |
Organization
Kwansei Gakuin University
Division name
School of Humanities
Zip code
6628501
Address
Uegahara 1-1-155, Nishinomiya, Hyogo
TEL
0798-54-6201
Homepage URL
satokan@kwansei.ac.jp
Sponsor or person
Institute
Kwansei Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Kwansei Gakuin University Institutional Review Board for Medical and Biological Research Involving Human Subiects
Address
Organization for Research Development and Outreach, Kwansei Gakuin University, 1 Gakuen Uegahara, Sanda, Hyogo
Tel
079-565-7910
med-ethic@kwansei.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
| 2018 | Year | 05 | Month | 28 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | 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 | 05 | Month | 28 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037334
