UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058527 |
|---|---|
| Receipt number | R000066927 |
| Scientific Title | A randomized controlled trial to verify the effectiveness of community-based Prolonged Exposure for victims of sexual violence |
| Date of disclosure of the study information | 2025/07/20 |
| Last modified on | 2025/07/20 16:26:05 |
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Basic information
Public title
A randomized controlled trial to verify the effectiveness of community-based Prolonged Exposure for victims of sexual violence
Acronym
RCT to verify the effectiveness of community-based PE for victims of sexual violence
Scientific Title
A randomized controlled trial to verify the effectiveness of community-based Prolonged Exposure for victims of sexual violence
Scientific Title:Acronym
RCT to verify the effectiveness of community-based PE for victims of sexual violence
Region
| Japan |
Condition
Condition
Posttraumatic Stress Disorder (PTSD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of the implementation of online PE in each remote location
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinician-Administered PTSD Scale for DSM-5(CAPS-5)
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.Emergence of adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Online PE for sexual assault victims with PTSD
Interventions/Control_2
Treatment-as-usual only
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
| 60 | years-old | > |
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 the study.
4. During the course of the PE, the subject and psychiatrist have agreed that the therapist, assessor, rape crisis center staff, etc., may inquiry them regarding the treatment, prescription, etc. of the subject.
5. Using CAPS-5, the subject has been assessed with PTSD or a condition equivalent to PTSD (adjustment disorder, etc.) in relation to the identified traumatic experience.
6. The subjects is able to visit the community rape crisis center once a week.
7. The subject is able to use an online device and communicate in Japanese adequately.
Key exclusion criteria
1. The subject has comorbid diagnosis of schizophrenia and other related disorders.
2. The subject has comorbid physical disorder in which would interfere with the treatment.
3. There is a 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.) for which other immediate treatment/s should be prioritized.
4. The subject has clinical history of alcohol/substance dependence or abuse within the past 6 months.
5. The subject has 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.
6. The subject has changes in the prescription of antidepressants and antipsychotic medications for the past month, and currently has plans in changing the prescription during the course of the treatment.
7. The subject is currently receiving any specific psychotherapeutic treatment/s other than supportive psychotherapy.
8. If the researcher determines that the subject is inappropriate
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Konisi |
Organization
Musashino University
Division name
Department of Human Sciences
Zip code
135-8181
Address
Ariake 3-3-3,Koto-Ku,Tokyo,Japan
TEL
03-5530-7333
takako_k@musashino-u.ac.jp
Public contact
Name of contact person
| 1st name | Riek |
| Middle name | |
| Last name | Konno |
Organization
Musashino University
Division name
Cognitive Behavioral Therapy and Research Institute
Zip code
135-8181
Address
Ariake 3-3-3,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
Ministry of Education, Culture, Sports, Science and Technology
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
Ethics Committee, Faculty of Human Sciences, Musashino University
Address
Ariake 3-3-3,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
| 2025 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | 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
| 2025 | Year | 07 | Month | 20 | Day |
Last modified on
| 2025 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066927
