UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051552 |
|---|---|
| Receipt number | R000058814 |
| Scientific Title | Evaluation of the usefulness of a web program for victims of acute sexual violence (support version of SARA) |
| Date of disclosure of the study information | 2023/07/25 |
| Last modified on | 2023/08/15 16:52:58 |
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Basic information
Public title
Evaluation of the usefulness of a web program for victims of acute sexual violence (support version of SARA)
Acronym
Validation of the effectiveness of the supported version of SARA
Scientific Title
Evaluation of the usefulness of a web program for victims of acute sexual violence (support version of SARA)
Scientific Title:Acronym
Validation of the effectiveness of the supported version of SARA
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 was to examine the safety and usefulness of a supportive version of SARA, which reduces anxiety and motivates victims of sexual violence who come to the One-Stop Support Center to continue their medical care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Status of implementation
2.Adverse events
3.Dropout rate, evaluation of usefulness through post-implementation questionnaires
Key secondary outcomes
1.PTSD Checklist for DSM-5(PCL-5)
2.SF8 Health Survey
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Psychological education through a web program for victims of sexual violence
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 a victim of sexual violence.
2. The subject is a native speaker of Japanese.
3. The subject is using a smart phone.
4. The subject is able to use the supported version of SARA for 2 months.
5.All of the following symptoms apply.
1) Unpleasant and distressing memories of sexual assault may come back suddenly, or nightmares may occur. They may also experience upset feelings or physical reactions such as palpitations or sweating.
2) The subject tries to avoid remembering or thinking about the sexual violence as much as possible, or tries to avoid people, things, situations, or conversations that remind of that sexual violence.
3)Blame themselves and distrust the world and others. They may also lose interest or concern, feel distant from their surroundings, and feel isolated.
4) Irritability, reckless or self-destructive behavior, excessive alertness, startle reactions such as being terribly surprised by the slightest stimulus, inability to concentrate on things, difficulty sleeping at night, and inability to sleep well apply.
Key exclusion criteria
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.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Rieko |
| Middle name | |
| Last name | Konno |
Organization
Musashino University
Division name
Department of Human Sciences
Zip code
135-8181
Address
Ariake 3-3-3, Koto-Ku, Tokyo, Japan
TEL
03-5530-7378
rkonno@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
Ariake 3-3-3, Koto-Ku, Tokyo, Japan
TEL
03-5530-7378
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
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, Department 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
| 2023 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 07 | Month | 07 | Day |
Last modified on
| 2023 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058814
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
