UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056759 |
|---|---|
| Receipt number | R000064870 |
| Scientific Title | Examining the Effectiveness of Acceptance & Commitment Therapy bibliotherapy for undergraduates |
| Date of disclosure of the study information | 2025/01/22 |
| Last modified on | 2025/07/07 11:13:29 |
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Basic information
Public title
Examining the Effectiveness of Acceptance & Commitment Therapy bibliotherapy for undergraduates
Acronym
Examining the Effectiveness of Acceptance & Commitment Therapy bibliotherapy
Scientific Title
Examining the Effectiveness of Acceptance & Commitment Therapy bibliotherapy for undergraduates
Scientific Title:Acronym
Examining the Effectiveness of Acceptance & Commitment Therapy bibliotherapy
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The mental health of undergraduates is a critical factor influencing academic retention as well as various other domains of their lives. Cognitive behavioral therapies, including acceptance and commitment therapy (ACT), are transdiagnostic in nature and have been shown to contribute to the enhancement of overall mental health (e.g., A-Tjak et al., 2015). In this context, self-help interventions utilizing translated books have been implemented; however, the effectiveness of culturally adapted approaches tailored to the Japanese context has yet to be established. This study aims to investigate the effectiveness of self-help materials developed by Japanese authors for a Japanese population in improving mental health outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
GHQ12
Before intervention and one month after intervention began, and followup
Key secondary outcomes
CES-D
STAI
MFPI
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The Acceptance and Commitment Therapy Workbook, ACT Mental Exercise (Muto, 2023), will serve as the intervention material. Participants will engage in self-guided study of the workbook over a one-month period, supplemented by social reinforcement, such as verbal praise for their commitment to the program.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must be proficient in Japanese to effectively comprehend the intervention content and related explanations.
Participants must be capable of reading documents written in Japanese.
Participants must possess a smartphone or a similar communication device.
Key exclusion criteria
Participants must currently be receiving care at a psychiatry or psychosomatic medicine clinic.
Participants must have cultural roots outside of Japan.
Other cases where the program facilitator determines that participation may compromise the safe implementation of the program.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Ito |
Organization
Fukushima University
Division name
Faculty of Human Development and Culture
Zip code
9601296
Address
1 Kanayagawa, Fukushima-city, Fukushima
TEL
024-548-8103
masa-ito@educ.fukushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Ito |
Organization
Fukushima University
Division name
Faculty of Human Development and Culture
Zip code
9601296
Address
1 Kanayagawa, Fukushima-city, Fukushima
TEL
024-548-8103
Homepage URL
masa-ito@educ.fukushima-u.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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 Fukushima University
Address
1 Kanayagawa, Fukushima-city, Fukushima
Tel
024-548-5298
kyoudo@adb.fukushima-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
| 2025 | Year | 01 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 01 | Month | 20 | Day |
Last modified on
| 2025 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064870
