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

Email

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


Email

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

Email

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