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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030889
Receipt No. 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 2019/07/24

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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
Email 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
Email m-niwa@umin.ac.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

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
Email 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 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 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 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
2018 Year 01 Month 19 Day
Last modified on
2019 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035227

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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