UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060480 |
|---|---|
| Receipt number | R000069189 |
| Scientific Title | Effectiveness of an Occupation-Based Individual Program Incorporating Self-Monitoring Elements for Patients with Alcohol Use Disorder in a Psychiatric Hospital |
| Date of disclosure of the study information | 2026/01/27 |
| Last modified on | 2026/01/27 09:52:05 |
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Basic information
Public title
Effectiveness of an Occupation-Based Individual Program Incorporating Self-Monitoring Elements for Patients with Alcohol Use Disorder in a Psychiatric Hospital
Acronym
Effectiveness of an Occupation-Based Individual Program Incorporating Self-Monitoring Elements for Patients with Alcohol Use Disorder in a Psychiatric Hospital
Scientific Title
Effectiveness of an Occupation-Based Individual Program Incorporating Self-Monitoring Elements for Patients with Alcohol Use Disorder in a Psychiatric Hospital
Scientific Title:Acronym
Effectiveness of an Occupation-Based Individual Program Incorporating Self-Monitoring Elements for Patients with Alcohol Use Disorder in a Psychiatric Hospital
Region
| Japan |
Condition
Condition
Alcohol Use Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the effectiveness of an occupation-based individual program incorporating self-monitoring elements for patients with Alcohol Use Disorder in a psychiatric hospital by clarifying its effects on relapse risk, occupational performance, subjective quality of life, and self-efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Alcohol Relapse Risk Scale
Key secondary outcomes
Canadian Occupational Performance Measure,WHO Quality of Life 26,General Self-Efficacy Scale
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In addition to the addiction treatment program routinely provided at the hospital where participants were hospitalized, an occupation-based individual program incorporating self-monitoring elements was delivered within a two-week period, consisting of approximately 60-minute sessions, with a maximum of 10 sessions.
Interventions/Control_2
Participants took part in the addiction treatment program implemented at the hospital where they were hospitalized.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants were inpatients at a psychiatric hospital specializing in addiction treatment and had been diagnosed with Alcohol Use Disorder according to the DSM-5 criteria by a psychiatrist at the study site.
Key exclusion criteria
Clients diagnosed with dementia were excluded.
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Imamoto |
Organization
Prefectural University of Hiroshima
Division name
Faculty of health and Welfare Department of Occupational Therapy
Zip code
723-0053
Address
Hiroshima Prefecture, Mihara City, Gakuen-cho 1-1, Japan
TEL
0848-60-1175
imamoto@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Imamoto |
Organization
Prefectural University of Hiroshima
Division name
Faculty of health and Welfare Department of Occupational Therapy
Zip code
723-0053
Address
Hiroshima Prefecture, Mihara City, Gakuen-cho 1-1, Japan
TEL
0848-60-1175
Homepage URL
imamoto@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Funding Source
Organization
Prefectural University of Hiroshima
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
Prefectural University of Hiroshima
Address
Hiroshima Prefecture, Mihara City, Gakuen-cho 1-1, Japan
Tel
0848-60-1175
imamoto@pu-hiroshima.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
| 2026 | Year | 01 | Month | 27 | 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
| 2026 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069189
