UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030889 |
|---|---|
| Receipt number | R000035227 |
| Scientific Title | An open-label trial of cognitive behavioral therapy for complex posttraumatic stress disorder |
| Date of disclosure of the study information | 2018/01/20 |
| Last modified on | 2023/02/22 15:05:49 |
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Basic information
Public title
An open-label trial of cognitive behavioral therapy for complex posttraumatic stress disorder
Acronym
An open-label trial of cognitive behavioral therapy for complex PTSD
Scientific Title
An open-label trial of cognitive behavioral therapy for complex posttraumatic stress disorder
Scientific Title:Acronym
An open-label trial of cognitive behavioral therapy for complex PTSD
Region
| Japan |
Condition
Condition
Complex Posttraumatic Stress Disorder (Complex PTSD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility, safety, and efficacy of STAIR/NST for patients with complex PTSD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of complex PTSD assessed by PTSD & Complex PTSD Diagnostic Interview
Key secondary outcomes
Complex PTSD severity (ICD-TQ)
Emotion regulation (DERS, NMR)
Interpersonal problems (IIP)
PTSD severity (PDS)
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
| Behavior,custom |
Interventions/Control_1
STAIR/NST (Skills Training in Affective and Interpersonal Regulation followed by Narrative Story Telling)
STAIR/NST is psychotherapy for complex PTSD (Cloitre et al., 2011). The sixteen weekly sessions (60 minutes for each) will be conducted.
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Women between the ages of 18 and 65 years
2) Primary diagnosis of complex PTSD related to childhood sexual abuse and/or physical abuse before the age of 18 years
3) Native Japanese speaker
Key exclusion criteria
1) Substance use disorders has not been in remission at least for 3 months
2) Comorbidity of psychotic and related disorders, significant cognitive impairment, or untreated bipolar disorder
3) Presence of acute suicidality in the previous 3 months requiring hospitalization or referral to the emergency room
4) Ongoing court litigation in relation with PTSD
5) Other relevant reason decided by the investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Kim |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Department of Behavioral Medicine
Zip code
187-8553
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo, 187-8553, Japan
TEL
042-341-2711
kim@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Niwa |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Department of Behavioral Medicine
Zip code
187-8553
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo, 187-8553, Japan
TEL
042-341-2711
Homepage URL
m-niwa@umin.ac.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
KAKENHI Grants-in-aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry Ethics Committee
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo, 187-8553, Japan
Tel
042-341-2711
ml_rinrijimu@ncnp.go.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
| 2018 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
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
Main results already published
Date of protocol fixation
| 2017 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 19 | Day |
Last modified on
| 2023 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035227
