UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043689 |
|---|---|
| Receipt number | R000049560 |
| Scientific Title | Effect of Internet-Based Group Cognitive Behavioral Therapy on patients with Somatic Symptoms and Related Disorders |
| Date of disclosure of the study information | 2021/03/21 |
| Last modified on | 2025/03/27 15:37:45 |
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Basic information
Public title
Effect of Internet-Based Group Cognitive Behavioral Therapy on patients with Somatic Symptoms and Related Disorders
Acronym
Effect of Internet-Based Group Cognitive Behavioral Therapy on patients with Somatic Symptoms and Related Disorders
Scientific Title
Effect of Internet-Based Group Cognitive Behavioral Therapy on patients with Somatic Symptoms and Related Disorders
Scientific Title:Acronym
Effect of Internet-Based Group Cognitive Behavioral Therapy on patients with Somatic Symptoms and Related Disorders
Region
| Japan |
Condition
Condition
Somatic Symptom and Related Disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of Internet-Based Group Cognitive Behavioral Therapy on patients with Somatic Symptoms and Related Disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PHQ-15 Patient Health Questionnaire-15
Key secondary outcomes
Somatic Symptom Disorder B Criteria 12, Patient Health Questionnaire 9, Generalized Anxiety Disorder 7, Pain Catastrophe Scale, severity scales for SSD and social and psychological evaluation scales.
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
| Maneuver |
Interventions/Control_1
Internet-Based Cognitive Behavioral Group Therapy for patients with Somatic Symptom and Related Disorders, Eight sessions per group, From 90 to 120 minutes per session., two - four persons per group and online and internet CBT.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
20 years and over, Patients who can obtain written consent to participate in the study
Key exclusion criteria
Those who have insufficient conversation or comprehension in Japanese, those who the doctor in charge judges to be inappropriate
Target sample size
36
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
Zip code
6028566
Address
465 Kajiicho, Kamigyo Ward, Kyoto, 602-8566
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
Zip code
6028566
Address
465 Kajiicho, Kamigyo Ward, Kyoto, 602-8566
TEL
0752515612
Homepage URL
totomi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Graduate School of Medical Science, Kyoto Prefectural University of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science, 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
Kyoto Prefectural University of Medicine
Address
465 Kajiicho, Kamigyo Ward, Kyoto, 602-8566
Tel
0752515612
totomi@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
京都府立医科大学大学附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
36
Results
Results of the interim analysis for N=30 are shown. The mean age was 41.8 years (14.7). 73.3% were female. The PHQ-15 showed a significant main effect in the ANOVA (T0, T1, T2).In the post-hoc comparison with Bonferroni correction, T0 was higher than T2 (p<.05). The SSD-12 showed a significant main effect in the ANOVA. In post-hoc comparisons with Bonferroni correction, T0 and T1 were higher than T2 (p<.01 and p<.05). The intensity of physical symptoms was significantly reduced.
Results date posted
| 2024 | Year | 10 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
The results of the N=30 interim analysis are shown. The design of the protocol for this study is non-Randomized Controlled Trial.Participants are Somatic Symptom Disorders. Intervention i-SGCBT, Comparison Pre and post treatment effects Outcome The severe of SSD, depression and anxiety scales, physical condition score and disability in daily life. Measurement points T0 (At entry), T1 (Pre-intervention), T2 (Post-intervention), and T3 (at follow-up 6 months) Format; 8 weeks (90 minutes per session, 1 session per week) Number of people per group 3 subjects, psychologist and psychiatric. Period June 2021 present Medical Ethics Review Board ERB-C-1943. Analysis is to examine the within subject factor time (T0, T1, T2), we performed one-way repeated measure analysis of variance (ANOVA).
Adverse events
Not recognized.
Outcome measures
PHQ-15, SSD-12, PHQ-9, GAD-7, PCS, Good physical condition, Disability in daily life.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The test has started, and 34 cases have been conducted in units of several people per group.The final group is currently scheduled to be conducted. The study of the control group is ongoing.I presented my interim report at the International Conference. The progress report on the study of the efficacy of Internet-Based Small Group Cognitive Behavioral Therapy (i-SGCBT) in patients with Somatic Symptoms and Related Disorders. 10th World Congress of Cognitive and Beghabioral Therapies, 5, June, 2023. Korea.
Management information
Registered date
| 2021 | Year | 03 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049560
