UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040505 |
|---|---|
| Receipt number | R000046235 |
| Scientific Title | Preventive Effects of Group Cognitive Behavioral Therapy on University Students with High Risk for Depression from personality |
| Date of disclosure of the study information | 2020/05/24 |
| Last modified on | 2022/11/25 20:17:38 |
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Basic information
Public title
Preventive Effects of Group Cognitive Behavioral Therapy on University Students with High Risk for Depression from personality
Acronym
Preventive Effects of Group Cognitive Behavioral Therapy on University Students with High Risk for Depression from personality
Scientific Title
Preventive Effects of Group Cognitive Behavioral Therapy on University Students with High Risk for Depression from personality
Scientific Title:Acronym
Preventive Effects of Group Cognitive Behavioral Therapy on University Students with High Risk for Depression from personality
Region
| Japan |
Condition
Condition
University students with high garm avoidance
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study conduct to evaluate the effectiveness of group cognitive behavioral therapy interventions in preventing depression among first-year university students with high harm avoidance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Beck Depression Inventory-Second Edition
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Group cognitive behavioral therapy group
Interventions/Control_2
No treatment group
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
| 23 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Harm avoidance score of 77 or greater
Key exclusion criteria
23 years or older
University students with mood disorders by Mini International Neuropsychiatric Interview Japanese version
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Ogawa |
Organization
Nagasaki University
Division name
Health Center
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
Health Center
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
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
Ethics Committee of Nagasaki University Graduate School of Biomedical Sciences
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 24 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000046235
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000046235
Number of participants that the trial has enrolled
130
Results
Harm avoidance (HA) on Cloninger's Temperament and Character Inventory is a risk factor for depression. After group cognitive behavioral therapy was conducted with university students with high HA, the intervention group showed significantly lower BDI-II scores, a measure of depression, than the control group at 6 months after the intervention.
Results date posted
| 2022 | Year | 11 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants had a background of high harm avoidance, a risk factor for depression.
Participant flow
Japanese university students with a Harm Avoidance (HA) score of 77 or higher were invited to participate in group cognitive behavioral therapy for the prevention of depression. After obtaining written informed consent, 123 participants were randomly assigned to the intervention group (N = 62) or control group (N = 61).
Adverse events
None
Outcome measures
Beck Depression Inventory-Second Edition
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2010 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2010 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 24 | Day |
Last modified on
| 2022 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046235
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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