UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026518 |
|---|---|
| Receipt number | R000030454 |
| Scientific Title | Single arm no-randomized open trial on feasibility and efficacy of internet-based acute treatment / recovery program for sexual assaulted victims with PTSD |
| Date of disclosure of the study information | 2017/03/15 |
| Last modified on | 2020/03/18 11:00:21 |
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Basic information
Public title
Single arm no-randomized open trial on feasibility and efficacy of internet-based acute treatment / recovery program for sexual assaulted victims with PTSD
Acronym
Research on internet-based program for sexual assaulted victims with PTSD
Scientific Title
Single arm no-randomized open trial on feasibility and efficacy of internet-based acute treatment / recovery program for sexual assaulted victims with PTSD
Scientific Title:Acronym
Research on internet-based program for sexual assaulted victims with PTSD
Region
| Japan |
Condition
Condition
Posttraumatic Stress Disorder(PTSD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine feasibility and efficacy of internet-based program for sexual assaulted victims with PTSD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Impact of Event Scale Revised(IES-R)
Key secondary outcomes
1.Beck Depression Inventory -II (BDI -II)
2.Kessler10(K10)
3.Dissociative Experiences Scale(DES)
4.Posttraumatic Cognitions Inventory(JPTCI)
5.Satisfaction Survey
6.Dropout rate
7.Emergence of adverse event
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
Internet-based program for sexual assaulted 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
| 13 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Those who had their first psychiatric examination following rape
2.Native Japanese speaker
3.Those who own a mobile device capable of using the program
Key exclusion criteria
1.Those who cannot continue medical treatment due to psychiatric disorders (ex. schizophrenia, bipolar disorder, substance-related disorder, A cluster personality disorder, etc.) and psychiatric symptoms (severe psychotic symptoms, severe symptoms of depression, self-injury behavior, suicide attempt, etc.)
2. Those who have a physical disease in severe or unstable state
Target sample size
10
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 | Rieko |
| Middle name | |
| Last name | Konno |
Organization
Musashino University
Division name
Institution of Cognitive Behavioral Therapy and Research
Zip code
135-8181
Address
Ariake 3-3-3,Koto-Ku,Tokyo,Japan
TEL
03-5530-7695
Homepage URL
cbtinst@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
Musashino University
Address
Ariake 3-3-3,Koto-Ku,Tokyo,Japan
Tel
03-5530-7695
a_gakubu@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
| 2017 | Year | 03 | Month | 15 | 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
| 2017 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 03 | Month | 13 | Day |
Last modified on
| 2020 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030454
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
