UMIN-CTR Clinical Trial

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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