UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029784 |
|---|---|
| Receipt number | R000034033 |
| Scientific Title | Randomized Controlled Trial of Behavioral Activation Group Therapy for Depression in Undergraduate Students |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2019/04/02 14:13:28 |
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Basic information
Public title
Randomized Controlled Trial of Behavioral Activation Group Therapy for Depression in Undergraduate Students
Acronym
Behavioral Activation Group Therapy for Depression in Undergraduate Students
Scientific Title
Randomized Controlled Trial of Behavioral Activation Group Therapy for Depression in Undergraduate Students
Scientific Title:Acronym
Behavioral Activation Group Therapy for Depression in Undergraduate Students
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to examine the effect of behavioral activation group therapy for depression in undergraduate students .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient Health Questionnaire 9
Key secondary outcomes
1)Beck Depression Inventory Second Edition
2)Behavioral Activation for Depression Scale(Short Form)
3)Reward Probability Index
4)Social Adaptation Self evaluation Scale
5)Work and Social Adjustment Scale
6)World Health Organization Quality of Life 26
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In experimental group, we conduct behavioral activation group therapy.
Treatment of behavioral activation group therapy consists of 4 weekly 90-min sessions.
Interventions/Control_2
In control group, we do not conduct any 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
1)Undergraduate students in 18-24 years old in Chukyo University.
2) Undergraduate students who scored 5 or higher on the PHQ-9.
Key exclusion criteria
1)Undergraduate students with strong suicidal ideation.
2)Undergraduate students who currently receiving medication and psychotherapy for treatment
3)Undergraduate students who have met criteria for bipolar disorder.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Sakai |
Organization
Chukyo University
Division name
School of Psychology
Zip code
466-8666
Address
101-2 Yagoto Honmachi, Showa-ku Nagoya-City, Aichi Pref., Japan
TEL
052-835-7160
saka-ms@lets.chukyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yamamoto |
Organization
Chukyo University
Division name
School of Psychology
Zip code
466-8666
Address
101-2 Yagoto Honmachi, Showa-ku Nagoya-City, Aichi Pref., Japan
TEL
052-835-7160
Homepage URL
tatsuya@lets.chukyo-u.ac.jp
Sponsor or person
Institute
School of Psychology, Chukyo University
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Chukyo University
Address
101-2 Yagoto Honmachi, Showa-ku Nagoya-City, Aichi Pref., Japan
Tel
052-835-7111
kenkyurinri@mng.chukyo-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
| 2017 | Year | 11 | Month | 01 | 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
12
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 | 01 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 11 | Month | 01 | Day |
Last modified on
| 2019 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034033
