UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056408 |
|---|---|
| Receipt number | R000064447 |
| Scientific Title | Study of the effectiveness of a novel outpatient psychotherapy for patients with medically unexplained symptoms |
| Date of disclosure of the study information | 2024/12/09 |
| Last modified on | 2024/12/09 18:15:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of the effectiveness of a novel outpatient psychotherapy for patients with medically unexplained symptoms
Acronym
Study of the effectiveness of a novel psychotherapy for MUS
Scientific Title
Study of the effectiveness of a novel outpatient psychotherapy for patients with medically unexplained symptoms
Scientific Title:Acronym
Study of the effectiveness of a novel psychotherapy for MUS
Region
| Japan |
Condition
Condition
Patients diagnosed with "Somatic Symptoms Syndrome" or "Functional Neurological Symptoms Syndrome" following DSM-5-TR
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to verify the efficacy of a novel outpatient psychotherapy named "10 Minute Outpatient Morita Therapy for MUS (10-MT-MUS)", which is developed by the applicant.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Improvement in obsession with Physical Symptoms as measured by the Somatic Symptom Disorder-B Criteria (SSD-12)
Key secondary outcomes
Improvement in social maladjustment as measured by the Work and Social Adjustment Scale (WSAS)
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Outpatient Morita therapy in 10 minutes for Medically Unexplained Symptoms (10-MT-MUS)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who are willing to improve their physical symptoms and associated suffering.
2) Those who understand the content of this study and can indicate in writing that they agree to participate freely and voluntarily.
Key exclusion criteria
1) Those who have other physical or mental illnesses that should be treated as a priority
2) Those who need to change their medications before 10-MT-MUS is completed
3) Those who have difficulty interacting with therapists due to cognitive decline, personality issues, etc.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Tadokoro |
Organization
Sapporo Medical University Graduate School of Medicine
Division name
Department of Neuropsychiatry
Zip code
060-8556
Address
Minami 1-jo Nishi 17-chome, Chuo-ku, Sapporo-shi, Hokkaidou
TEL
(+81)11-611-2111
tadokoroshigenori@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Tadokoro |
Organization
Sapporo Medical University Graduate School of Medicine
Division name
Department of Neuropsychiatry
Zip code
060-8556
Address
Minami 1-jo Nishi 17-chome, Chuo-ku, Sapporo-shi, Hokkaidou
TEL
(+81)11-611-2111
Homepage URL
tadokoroshigenori@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Sapporo Medical University
Address
Minami 1-jo Nishi 17-chome, Chuo-ku, Sapporo-shi, Hokkaidou
Tel
(+81) 11-611-2111
ji-rskk@sapmed.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
| 2024 | Year | 12 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 09 | Day |
Last modified on
| 2024 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064447
