UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046138 |
|---|---|
| Receipt number | R000052664 |
| Scientific Title | A pilot single-arm study of the effects of remote cognitive behavioral therapy on somatic symptoms |
| Date of disclosure of the study information | 2021/11/25 |
| Last modified on | 2024/03/29 11:17:20 |
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Basic information
Public title
A pilot single-arm study of the effects of remote cognitive behavioral therapy on somatic symptoms
Acronym
A pilot single-arm study of the effects of remote cognitive behavioral therapy on somatic symptoms
Scientific Title
A pilot single-arm study of the effects of remote cognitive behavioral therapy on somatic symptoms
Scientific Title:Acronym
A pilot single-arm study of the effects of remote cognitive behavioral therapy on somatic symptoms
Region
| Japan |
Condition
Condition
somatic symptoms
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effectiveness of remote cognitive behavioral therapy using a video conferencing system for patients with somatic symptoms
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
MOS 36-Item Short-Form Health Survey Physical component summary
Pre vCBTp
Post vCBTp
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Video-conference based cognitive behavioral therapy for somatic symptoms (6weeks)
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Those who have received a diagnosis of somatic symptom disorder in DSM-5
(2) Patients who are between 20 and 65 years of age at the time of consent.
(3) Patients who have received a written consent of their own free will after receiving sufficient explanation and understanding to participate in this study.
(4) Those who understand cognitive-behavioral therapy and have the mental and physical condition to practice it continuously for at least two months.
(5) Those who have the ability and environment to use the Internet and computers to receive remote cognitive behavioral therapy (vCBT) using a web conference system.
Translated with www.DeepL.com/Translator (free version)
Key exclusion criteria
(1) Patients who are complicated by serious mental disorders such as DSM-5 neurocognitive disorder group, psychotic disorder, bipolar disorder, or substance-related disorder, and who are expected to discontinue cognitive behavioral therapy due to worsening of these symptoms.
(2) Patients with mental retardation (referring to assessment scores such as JART-25: Japanese Adult Reading Test-25) or autism spectrum disorder (referring to AQ: Autism Spectrum Index, etc.).
(3) Those who have a serious progressive physical disease that is expected to interrupt the study.
(4) Patients who are judged by the principal investigator or the study psychologist to be inappropriate for the safe conduct of the study.
(5) Persons whose physical symptoms involve litigation or compensation.
Translated with www.DeepL.com/Translator (free version)
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Graduate School of Medicine Chiba University
Division name
Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology
Zip code
260-8670
Address
1-8-1 Inohana,Chuouku,Chiba,Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Nakamura |
Organization
Graduate School of Medicine Chiba University
Division name
Department of Cognitive Behavioral Physiology
Zip code
260-8670
Address
1-8-1 Inohana,Chuouku,Chiba,Japan
TEL
043-226-2027
Homepage URL
cafa4942@chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine Chiba University
Department of Cognitive Behavioral Physiology
Institute
Department
Personal name
Funding Source
Organization
None
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
Chiba university certified clinical research board
Address
1-8-1 Inohana,Chuouku,Chiba,Japan
Tel
043-222-7171
hsp-chibacrc@chiba-u.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
| 2021 | Year | 11 | Month | 25 | 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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2021 | Year | 11 | Month | 22 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052664
