UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054190 |
|---|---|
| Receipt number | R000060425 |
| Scientific Title | Investigating well-being after applying the Zenological mindfulness approach to somatic symptom disorder: a randomized controlled trial. |
| Date of disclosure of the study information | 2024/04/18 |
| Last modified on | 2024/06/10 23:54:20 |
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Basic information
Public title
Investigating well-being after applying the Zen-based Cognitive Behavioral Therapy for somatic symptom disorder: a randomized controlled trial
Acronym
Zen-based CBT by RCT
Scientific Title
Investigating well-being after applying the Zenological mindfulness approach to somatic symptom disorder: a randomized controlled trial.
Scientific Title:Acronym
Zen-based CBT by RCT
Region
| Japan |
Condition
Condition
Somatic Symptom Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate group cognitive-behavioral therapy (CBT) incorporating Zen-based mindfulness for somatic symptom disorder (SSD). The superiority of the intervention group over the control group will be evaluated in a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
PHQ 15 (Patient Health Questionnaire 15), SSD 12 (The Somatic Symptom Disorder, B Criteria Scale)
Key secondary outcomes
PHQ-9 (Patient Health Questionnaire-9), GAD-7 (Generalized Anxiety Disorder-7), VAS (Visual analog Scale), PCS (Pain Catastrophe Scale), EQ-5D-5L, SHAI (Short Health Anxiety Inventory), SIUS (The Short Intolerance of Uncertainty Scale) 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
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive Behavioral Group Therapy
Interventions/Control_2
Treatment 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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects will be those who have been diagnosed with somatic and related symptoms using DSM5, who have given a written explanation of the purpose of the study and the benefits and disadvantages of participating in the study, and who have given their consent to the study. The subjects of this study must be at or above 18 years of age.
Key exclusion criteria
(1)Those who have insufficient ability to speak and understand Japanese.
(2)Persons undergoing other professional psychotherapy or clinical trials
(3)Other patients who are deemed inappropriate by the doctor in charge.
Target sample size
108
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Tominaga |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry, Graduate School of Medical Science
Zip code
602-8566
Address
465 Kajii-cho Kawaramachi Hirokoji Kamigyo-ku, Kyoto 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
Department of Psychiatry, Graduate School of Medical Science
Zip code
6168186
Address
465 Kajii-cho Kawaramachi Hirokoji Kamigyo-ku, Kyoto Japan
TEL
0752515612
Homepage URL
totomi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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
Medical Ethics Review Board, Kyoto Prefectural University of Medicine
Address
465 Kajii-cho Kawaramachi Hirokoji Kamigyo-ku, Kyoto Japan
Tel
0752515111
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
京都府立医科大学附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 18 | 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
| 2024 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 19 | 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
| 2024 | Year | 04 | Month | 18 | Day |
Last modified on
| 2024 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060425
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
