UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049265 |
|---|---|
| Receipt number | R000055948 |
| Scientific Title | A randomized controlled trial of cognitive behavioral group therapy for university students with borderline personality tendency |
| Date of disclosure of the study information | 2022/10/19 |
| Last modified on | 2022/10/19 18:14:37 |
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Basic information
Public title
A randomized controlled trial of cognitive behavioral group therapy for university students with borderline personality tendency
Acronym
A randomized controlled trial of cognitive behavioral group therapy for university students with borderline personality tendency
Scientific Title
A randomized controlled trial of cognitive behavioral group therapy for university students with borderline personality tendency
Scientific Title:Acronym
A randomized controlled trial of cognitive behavioral group therapy for university students with borderline personality tendency
Region
| Japan |
Condition
Condition
borderline personality tendency
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of STEPPS for university students with borderline personality tendency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Data will be collected by four times for both groups: Pre-intervention, Mid-intervention, Post-intervention, and three month later.Primary outcome was QuEST-J.
Key secondary outcomes
PRIME-J
QUIDS-J
PANAS
SWLS
ERQ
BIS/BAS
TIPI
DERS
JBCSS
ZAN-BPD
MSI-BPD
salivary amylase(only intervention group)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Behavior,custom |
Interventions/Control_1
STEPPS for 2 hours per session, 20 weeks
Interventions/Control_2
no 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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Have borderline personality tendency (28 points or more on QuEST-J)
2)Undergraduate and graduate students
Key exclusion criteria
1)Psychiatric symptoms requiring urgent treatment (severe depression, hallucinations, delusions, etc.) are observed.
2)Suicide attempt within 3 months
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Terashima |
Organization
Tokyo Keizai University
Division name
Center for General Education
Zip code
185-8502
Address
1-7-34, Minami-cho, Kokubunji, Tokyo 185-8502, Japan.
TEL
042-328-9217
hitera@tku.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Terashima |
Organization
Tokyo Keizai University
Division name
Center for General Education
Zip code
185-8502
Address
1-7-34, Minami-cho, Kokubunji, Tokyo 185-8502, Japan.
TEL
042-328-9217
Homepage URL
hitera@tku.ac.jp
Sponsor or person
Institute
Tokyo Keizai 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
Tokyo Keizai University
Address
1-7-34, Minami-cho, Kokubunji, Tokyo 185-8502, Japan.
Tel
042-328-7959
kenkyu@s.tku.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
| 2022 | Year | 10 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 10 | Month | 19 | Day |
Last modified on
| 2022 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055948
