UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063437 |
|---|---|
| Receipt number | R000072605 |
| Scientific Title | Evaluation of the Effects of a Polyvagal Theory-Based Surf Therapy Program for Trauma Recovery |
| Date of disclosure of the study information | 2026/10/27 |
| Last modified on | 2026/10/27 23:20:13 |
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Basic information
Public title
Changes in psychological health among adults participating in a trauma-informed surf therapy program
Acronym
Trauma-Informed Surf Therapy Study
Scientific Title
Evaluation of the Effects of a Polyvagal Theory-Based Surf Therapy Program for Trauma Recovery
Scientific Title:Acronym
PBST Study
Region
| Japan |
Condition
Condition
Psychological distress and trauma-related symptoms
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine changes in psychological outcomes before, immediately after, and one month after participation in a polyvagal theory-based surf therapy program among adults, and to explore its potential as an approach to supporting trauma recovery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the Japanese version of the Adult Resilience Measure (ARM-R) score from before to after the surf therapy program
Key secondary outcomes
Change in the ARM-R score from before the program to one month after the program; and changes in psychological distress assessed with the K6 and trauma-related symptoms assessed with the IES-R before, after, and one month after the program
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
A polyvagal theory-based surf therapy program provided by the nonprofit organization The SCC Surf Therapy Japan. The program consists of five approximately 90-minute sessions, held once a week. Each session includes orientation and warm-up, preparation before entering the sea, awareness of bodily sensations in shallow water, floating on a surfboard, surfing, and cool-down and reflection. Activities are adjusted or cancelled according to participants' condition and preferences and sea conditions.
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 18 years or older who participate in the surf therapy program provided by The SCC Surf Therapy Japan, are able to travel independently to the program site during the five weekly sessions, and provide written informed consent after receiving an explanation of the study. A history of trauma or a diagnosis of PTSD is not required. Participants receiving outpatient treatment for a medical condition must have permission from their treating physician to participate.
Key exclusion criteria
Individuals with a physician's instruction to restrict exercise; those currently hospitalized; those with severe cardiac or respiratory disease; those who are pregnant; and those unable to travel or communicate independently as required for safe participation. Individuals receiving outpatient treatment who cannot obtain permission to participate from their treating physician are also excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Tsuda |
Organization
Chubu University
Division name
College of Life and Health Sciences, Department of Occupational Therapy
Zip code
487-8501
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi, Japan
TEL
0568-51-1111
s-tsuda@fsc.chubu.ac.jp
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Kubota |
Organization
The University of Tokyo Hospital
Division name
Department of Healthcare Information Management
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358008685
Homepage URL
kkubota@m.u-tokyo.ac.jp
Sponsor or person
Institute
Chubu University
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chubu University Ethics Review Committee
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi
Tel
0568-51-1111
info-jinsoku@fsc.chubu.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 | 10 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | 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
| 2026 | Year | 10 | Month | 27 | Day |
Last modified on
| 2026 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072605
