UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036200
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email Itsuko_Suzuki@j-hits.org

Sponsor
Institute Hyogo Institute for Traumatic Stress
Research Department
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041033

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.