UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045770 |
|---|---|
| Receipt number | R000052181 |
| Scientific Title | Safety and feasibility pilot study of community cooperation based online TFCBT for PTSD |
| Date of disclosure of the study information | 2021/10/20 |
| Last modified on | 2024/10/17 15:32:21 |
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Basic information
Public title
Safety and feasibility study of community cooperation based online TFCBT for PTSD
Acronym
Safety and feasibility study of online TFCBT for PTSD
Scientific Title
Safety and feasibility pilot study of community cooperation based online TFCBT for PTSD
Scientific Title:Acronym
Safety and feasibility pilot study of online TFCBT for PTSD
Region
| Japan |
Condition
Condition
Posttraumatic Stress Disorder (PTSD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety and efficacy of remotely delivered trauma-specific cognitive behavioral therapy to sexual assault victims suffering from PTSD
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Dropout rate
2.Occurrence of adverse event
Key secondary outcomes
1.PTSD Checklist for DSM-5(PCL-5)
2.Beck Depression Inventory -II(BDI -II)
3.Dissociative Experiences Scale(DES)
4.Posttraumatic Cognitions Inventory(JPTCI)
5. Clinician-Administered PTSD Scale for DSM-5(CAPS-5)
6. Mini International Neuropsychiatric Interview(M.I.N.I.)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Online TFCBT for sexual assault victims with PTSD
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The subject is consulting at the community rape crisis center, and the rape crisis center staff has agreed to cooperate with this study.
2. Diagnosed with PTSD by the community psychiatric medical institution.
3. The psychiatrist has approved the subject's participation in this study, and continuation of their once or if necessary, more than once a month consultation throughout the period of participation.
4. During the course of the psychotherapy, the subject and psychiatrist have agreed that the therapist, assessor, rape crisis center staff, etc., may inquiry them regarding the treatment, prescription, etc.
5. According to CAPS-5, the subject has been assessed with PTSD or a condition equivalent to PTSD (adjustment disorder, etc.) in relation to the concerned traumatic experience.
6. Is able to visit the community rape crisis center once a week.
7. Is able to use an online device and communicate in Japanese adequately.
8. Has no comorbid diagnosis of schizophrenia and other related disorders.
9. Has no comorbid physical disorder in which would interfere with the treatment.
10. During the assessment, there was no presence of psychological symptoms (manic state of bipolar disorder and extreme emotional instability, alcohol/substance abuse/dependence, severe depressive symptoms, self-harming behaviors, suicidal attempts, etc.) requiring other treatment/s which should be prioritized.
11. Has no clinical history of alcohol/substance dependence or abuse within the past 6 months.
12. Has no clinical history of suicidal attempt and serious self-harming behaviors (manipulative self-harm such as severe cut wounds, unconsciousness or overdose, etc.) within the past 6 months.
13. Has no changes in the prescription of antidepressants and antipsychotic medications for the past month, and currently has no plans in changing the prescription during the course of the treatment.
14. Not receiving any other psychotherapy other than supportive psychotherapy.
Key exclusion criteria
Other reasons in which the researchers determined the subject as inappropriate for this study
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Konishi |
Organization
Musashino University
Division name
Department of Human Sciences
Zip code
135-8181
Address
3-3-3, Ariake, Koto-Ku, Tokyo, Japan
TEL
03-5530-7333
takako_k@musashino-u.ac.jp
Public contact
Name of contact person
| 1st name | Rieko |
| Middle name | |
| Last name | Konno |
Organization
Musashino University
Division name
Department of Human Sciences
Zip code
135-8181
Address
3-3-3, Ariake, Koto-Ku, Tokyo, Japan
TEL
03-5530-7333
Homepage URL
rkonno@musashino-u.ac.jp
Sponsor or person
Institute
Musashino University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-aid for Scientific Research, JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE
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
Musashino University Human Sciences Department Ethics Committee
Address
3-3-3, Ariake, Koto-Ku, Tokyo, Japan
Tel
03-3350-7443
kenkyu@musashino-u.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
| 2021 | Year | 10 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 20 | 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
| 2021 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052181
