UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057256 |
|---|---|
| Receipt number | R000065449 |
| Scientific Title | Examining the effectiveness and feasibility of online mindfulness yoga for adults with autism spectrum disorder |
| Date of disclosure of the study information | 2025/03/11 |
| Last modified on | 2026/03/12 09:32:23 |
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Basic information
Public title
Examining the effectiveness and feasibility of online mindfulness yoga for adults with autism spectrum disorder
Acronym
The efficacy of online mindfulness yoga for adults with autism spectrum disorder
Scientific Title
Examining the effectiveness and feasibility of online mindfulness yoga for adults with autism spectrum disorder
Scientific Title:Acronym
The efficacy and feasibility of online mindfulness yoga for adults with autism spectrum disorder
Region
| Japan |
Condition
Condition
autism spectrum disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an online mindfulness yoga program for autistic adults and test its feasibility and effectiveness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events
Key secondary outcomes
1.Satisfaction Survey
2.Retention rate
3.Rate of homework
4.Depression: Patient Health Questionnaire-9 (PHQ-9)
5.Anxiety: Generalized Anxiety Disorder-7 Japanese version (GAD-7)
6.Ruminating: Japanese version of the Ruminative Responses Scale (RRS)
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Online mindfulness yoga program for autistic adults
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed with ASD by the psychiatrist
2. Between the ages of 18 and 65
3. Not restricted from physical activity by the doctor
4. Medication has not been changed in the past 4 weeks
5. Not currently engaged in intensive mindfulness or yoga (participation in a program at least twice a week)
6. Depression or anxiety with at least a score of 5 (minor or mild) on the PHQ-9 or GAD-7)
7. No suicidal ideation that requires immediate attention (exclude if the last item on the PHQ-9 is a score of 3)
Key exclusion criteria
1. diagnosis of intellectual disability, schizophrenia, or substance abuse
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Murakami |
Organization
Niigata University of Health and Welfare
Division name
Department of Occupational Therapy
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata 950-3198, Japan
TEL
025-257-4455
tsukasa-murakami@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tsukasa |
| Middle name | |
| Last name | Murakami |
Organization
Niigata University of Health and Welfare
Division name
Department of Occupational Therapy
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata 950-3198, Japan
TEL
025-257-4455
Homepage URL
tsukasa-murakami@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata 950-3198, Japan
Tel
025-257-4455
rinri@nuhw.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 | 03 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | 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
| 2025 | Year | 03 | Month | 11 | Day |
Last modified on
| 2026 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065449
