UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050111 |
|---|---|
| Receipt number | R000057088 |
| Scientific Title | The examination of the effective Acceptance and Commitment Therapy-based bibliotherapy of depressive symptoms for university students. |
| Date of disclosure of the study information | 2023/01/24 |
| Last modified on | 2023/01/23 16:03:20 |
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Basic information
Public title
The examination of the effective Acceptance and Commitment Therapy-based bibliotherapy of depressive symptoms for university students.
Acronym
The examination of the effectiveness of ACT-based bibliotherapy of deprresive symptoms for university students
Scientific Title
The examination of the effective Acceptance and Commitment Therapy-based bibliotherapy of depressive symptoms for university students.
Scientific Title:Acronym
The examination of the effectiveness of ACT-based bibliotherapy of deprresive symptom for university students
Region
| Japan |
Condition
Condition
depressive symptoms
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is whether Acceptance and Commitment Therapy-based bibliotherapy for university students could demonstrate significant decrease in depressive score.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A significant decrease in PHQ9 scores after 2 months of intervention using self-help books compared to PHQ9 scores measured before the intervention
Key secondary outcomes
Score change of the General Health Questionnaire
Score change of Acceptance and Action Questionnaire-II
Score change of Cognitive Fusion Questionnaire
Score change of Value Questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Acceptance and Commitment Therapy based bibliotherapy
Interventions/Control_2
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who are able to communicate in Japanese as necessary to explain interventions
Those who have a smartphone or PC
Those who are able to read books written in Japanese
Key exclusion criteria
1. Those attending psychiatry or psychosomatic medicine
2.Persons observed to have significant suicidal ideation
3.Any other person whom the principal investigator has determined to be unsuitable as a participant of the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Ito |
Organization
Biwako-Gakuin College
Division name
Deprtment of life design
Zip code
5278533
Address
29, Fusetyo, Higashiomi city, Shiga
TEL
0748223388
ito.mstka@gmail.com
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Ito |
Organization
Biwako-Gakuin College
Division name
Deprtment of life design
Zip code
5278533
Address
29, Fusetyo, Higashiomi city, Shiga
TEL
0748223388
Homepage URL
ito.mstka@gmail.com
Sponsor or person
Institute
Biwako-Gakuin College
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
Biwako-Gakuin university Ethical Review Committe
Address
29, Fusetyo, Higashiomi city, Shiga
Tel
0748-22-3388
ex-link@newton.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
| 2023 | Year | 01 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 24 | 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
| 2023 | Year | 01 | Month | 23 | Day |
Last modified on
| 2023 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057088
| 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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| Registered date | File name |
