UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036200 |
|---|---|
| Receipt number | R000041033 |
| Scientific Title | An examination of the effect and adaptation of Narrative Exposure Therapy for complex PTSD |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/03/14 16:14:03 |
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Basic information
Public title
An examination of the effect and adaptation of Narrative Exposure Therapy for complex PTSD
Acronym
An examination of the effect and adaptation of Narrative Exposure Therapy for complex PTSD
Scientific Title
An examination of the effect and adaptation of Narrative Exposure Therapy for complex PTSD
Scientific Title:Acronym
An examination of the effect and adaptation of Narrative Exposure Therapy for complex PTSD
Region
| Japan |
Condition
Condition
post traumatic stress disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the effect and adaptation of Narrative Exposure Thrapy for complex PTSD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The PTSD symptoms reduction after NET measured by CAPS and IES-R was significant, and it gradually decreased for up to 12months after NET.Scales were administered at 5 time points: prior to therapy and 2weeks, 3months, 6months, 12months after therapy. PTSD symptoms did not worsen and they did not remain the same.
Key secondary outcomes
Accoding to data from 12months after NET, dissociative symptoms measured by DES were markedly reduced after NET.
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Narrative Exposure Therapy was administered once to twice a week, 80 to 120 minuits each during 2 to 12 months.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who were diagnosed with PTSD by a physician or based on the Clinician-Administered PTSD Scale(CAPS)
Key exclusion criteria
schizophrenia or a developmental disorder, and those who were pregnant, whose safety could not be assured, who lacked motivation, who had diminished consciousness or alterness(overly sadated by large doses of medications, substance abuse, etc.), who lacked the ability to converse(hallucinatory/elusional state, frequent dissociative symtoms, aphasia, mental retardation, etc), or who had such a vulnerable ego that they were unable to recount their life story
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Itsuko |
| Middle name | |
| Last name | DOMEN |
Organization
Sawa Hospital, Social medical corporation
Division name
Division of Clinical Psychology
Zip code
561-0803
Address
1-9-1 Shiroyamacho Toyonaka City, Osaka
TEL
06-6865-1211
Itsuko_Suzuki@j-hits.org
Public contact
Name of contact person
| 1st name | Itsuko |
| Middle name | |
| Last name | DOMEN |
Organization
Hyogo Institute for Traumatic Stress
Division name
Research Department
Zip code
651-0073
Address
1-3-2 Wkihamakaigandori, chuoku, Kobe, Hyogo
TEL
078-200-3010
Homepage URL
Itsuko_Suzuki@j-hits.org
Sponsor or person
Institute
Hyogo Institute for Traumatic Stress
Research Department
Institute
Department
Personal name
Funding Source
Organization
Hyogo Institute for Traumatic Stress
Research Department
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified review board, Social medical corporation Hokuto-kai
Address
1-9-1 Shiroyamacho Toyonaka City, Osaka
Tel
06-6865-1211
clin-res@hokuto-kai.com
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
| 2019 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
17
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
Completed
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 14 | Day |
Last modified on
| 2019 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041033
| Research Plan | |
|---|---|
| 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 |
