UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061384 |
|---|---|
| Receipt number | R000070233 |
| Scientific Title | A Yoga Therapy Intervention Study Using a Single-Case Experimental Design for Individuals with Alcohol Use Disorder |
| Date of disclosure of the study information | 2026/04/27 |
| Last modified on | 2026/04/27 10:34:38 |
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Basic information
Public title
Yoga Therapy Intervention for Individuals with Alcohol Use Disorder: A Single-Case Experimental Design Study
Acronym
SCED-Yoga-AUD
Scientific Title
A Yoga Therapy Intervention Study Using a Single-Case Experimental Design for Individuals with Alcohol Use Disorder
Scientific Title:Acronym
SCED-Yoga-AUD
Region
| Japan |
Condition
Condition
Alcohol Use Disorder (AUD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of yoga therapy (isometric asana, pranayama, and Vedic meditation) on drinking behavior, stress, anxiety, and self-efficacy in individuals with alcohol use disorder using a single-case experimental design (ABAB design).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Drinking behavior (daily alcohol consumption score on a 4-point scale and proportion of abstinent days), assessed daily via self-report (Google Form).
Key secondary outcomes
Craving (VAS 0-10), stress (PSS-10), anxiety (GAD-7), depression (PHQ-9), self-efficacy (GSES), yoga practice adherence, and subjective ratings of sleep, diet, and respiratory state (VAS 0-10), assessed weekly or daily via self-report (Google Form).
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Yoga therapy consisting of isometric asana, pranayama (breathing exercises), and Vedic meditation. ABAB design: A1 (baseline, 2 weeks), B1 (intervention, 4 weeks), A2 (withdrawal, 2 weeks), B2 (re-intervention, 4 weeks). During B phases: weekly individual session (in-person or online, 30 min) + daily home practice (video, approx. 20 min).
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults (>=20 years) diagnosed with alcohol use disorder (DSM-5), who are abstaining or motivated to recover, have obtained physician approval, and can provide written informed consent.
Key exclusion criteria
Individuals for whom yoga therapy is contraindicated due to physical illness or severe psychiatric disorder; those currently receiving other intensive psychotherapy; those lacking sufficient capacity to understand and consent to the study.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Chieko |
| Middle name | |
| Last name | Kato |
Organization
Toyo University
Division name
Faculty of Information Sciences and Arts, Department of Information Sciences and Arts
Zip code
350-8585
Address
2100 Kujirai, Kawagoe-shi, Saitama 350-8585, Japan
TEL
049-239-1675
kato-c@toyo.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Kezuka |
Organization
Toyo University
Division name
Graduate School of Information Sciences and Arts
Zip code
350-8585
Address
2100 Kujirai, Kawagoe-shi, Saitama 350-8585, Japan
TEL
090-5327-4982
Homepage URL
s4b101900014@toyo.jp
Sponsor or person
Institute
Toyo University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyo University Ethical Review Board for Medical and Biological Research Involving Human Subjects
Address
Kujirai, Kawagoe-shi, Saitama 350-8585, Japan
Tel
049-239-1440
mlkks@toyo.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 | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 04 | Month | 27 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070233
