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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026518
Receipt No. 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 2017/03/13

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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
Middle name
Last name Takako Konisi
Organization Musashino University
Division name Department of Human Sciences
Zip code
Address Ariake 3-3-3,Koto-Ku,Tokyo,Japan
TEL 03-5530-7333
Email takako_k@musashino-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rieko Konno
Organization Musashino University
Division name Graduate School of Human and Social Science
Zip code
Address Ariake 3-3-3,Koto-Ku,Tokyo,Japan
TEL 03-5530-7333
Homepage URL
Email g1477001@stu.musashino-u.ac.jp

Sponsor
Institute Musashino University
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2017 Year 03 Month 16 Day
Last follow-up date
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
2017 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.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


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