UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057970 |
|---|---|
| Receipt number | R000044871 |
| Scientific Title | Investigating the degree of self-respect using mindfulness cognitive behavioral group therapy for somatic symptom disorder: a randomized controlled trial |
| Date of disclosure of the study information | 2025/05/26 |
| Last modified on | 2025/05/27 15:16:13 |
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Basic information
Public title
Investigating the degree of self-respect using mindfulness cognitive behavioral group therapy for somatic symptom disorder: a randomized controlled trial
Acronym
Investigating the degree of self-respect using mindfulness cognitive behavioral group therapy for somatic symptom disorder: a randomized controlled trial
Scientific Title
Investigating the degree of self-respect using mindfulness cognitive behavioral group therapy for somatic symptom disorder: a randomized controlled trial
Scientific Title:Acronym
SSD for MindfulnessCBGT
Region
| Japan |
Condition
Condition
Somatic Symptom Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cognitive Behavioral Therapy (CBT) incorporating Zen-like mindfulness for Somatic Symptom Disorder (SSD) will be administered in addition to usual treatment. The purpose of this randomized controlled trial is to determine whether the intervention group will increase subjective well-being scales (SWBS) compared to the usual treatment group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The subjective Well-being Scale Subjective Well-Being Scale after 8 weeks of treatment
Key secondary outcomes
SSD12, PHQ15, PHQ9, GAD7, VAS of Happiness, PCS, EQ5D5L, SHAI, SIUS, MAIA, Stroop Test, TAS20, DSM5, CGI, Stroop Color and Word Test and others
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Zen-based Cognitive Behavioral Therapy using Virtual Reality (VR)
Interventions/Control_2
Treat as usual
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
Main selection criteria
Individuals diagnosed with Somatic Symptom and Related Disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), at the Department of Psychiatry and Psychosomatic Medicine, Kyoto Prefectural University of Medicine Hospital
Individuals who are able to communicate, read, and write in Japanese
Individuals who understand the purpose and content of the study and provide written informed consent based on their own free will
Key exclusion criteria
Individuals with insufficient ability to communicate or comprehend in Japanese
Patients with psychotic disorders such as schizophrenia or organic mental disorders
Individuals currently undergoing other psychological therapies or participating in other clinical trials
Individuals deemed inappropriate for inclusion by the attending physician for any other reason
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Tominaga |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry, Graduate School of Medical Science
Zip code
6028566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
0752515612
totomi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Tominaga |
Organization
Kyoto Prefectural University of Medicine
Division name
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Zip code
6168186
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
0752515612
Homepage URL
totomi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Toshiyuki Tominaga
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board (IRB), Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel
075-251-5111
rinri@koto.kpu-m.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 | 05 | Month | 26 | 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
| 2025 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | 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 | 05 | Month | 26 | Day |
Last modified on
| 2025 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044871
