UMIN-CTR Clinical Trial

Basic information
Public title	Research on feasibility and efficacy of Group Cognitive Processing Therapy for posttraumatic stress disorder in Japan
Acronym	Research on Group Cognitive Processing Therapy for PTSD in Japan
Scientific Title	Research on feasibility and efficacy of Group Cognitive Processing Therapy for posttraumatic stress disorder in Japan
Scientific Title:Acronym	Research on Group Cognitive Processing Therapy for PTSD in Japan
Region	Japan

Condition
Condition	Posttraumatic Stress Disorder (PTSD)
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine feasibility and efficacy of Group Cognitive Processing Therapy for posttraumatic stress disorder in Japan
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical Administered Scale for PTSD (CAPS)
Key secondary outcomes	1. Mini-International Neuropsychiatric Interview (M.I.N.I) 2.Impact of Event Scale Revised (IES-R) 3. Beck Depression Inventory-II (BDI-II) 4. Trauma Related Guilt Inventory (TRGI) 5. Trauma Related Guilt Inventory (TRGI) 6. Short Form 8 (SF-8) 7. Dissociative Experiences Scale (DES) 8. Overall Anxiety Severity and Impairment Scale (OASIS) 9. Dropout rate 10. Emergence of adverse event

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	Maneuver
Interventions/Control_1	The Group Cognitive Processing Therapy
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	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Those diagnosed as full or Partial PTSD by the CAPS with its score greater than 40 2.More than 6 months duration of PTSD 3.Those who live in the catchment area of the participating centers 4.Those who can spend 2 hours a day to do the homework assignment 5.Native Japanese speaker
Key exclusion criteria	1.Those who cannot continue the treatment due to concurrent psychiatric disorders (ex. schizophrenia, bipolar disorder alcohol /drug related disorder, A cluster personality disorder etc.)and severe self-destructive symptoms(self-injury or suicidal attempt) 2.Those who have a history of epilepsy and whose EEG has not been normalized 3.Those who have too severe cognitive dysfunctions to do CPT sessions 4.Physical disease that may interfere psychological treatment 5.Those who have already received cognitive behavioral treatment for traumatic symptoms, or currently receive it 6.Those who cannot go to the hospital regularly(the absence rate of treatment periods > 50%) 7.Those who are judged by the screening doctors due to other reasons, such as pregnant, difficulty in understanding the procedure of the study or treatment protocol due to illiteracy or intellectual problem, ongoing or scheduled court litigation for which PTSD works favorably (excluding arbitration or litigation for divorce), and etc. 8.Those who have long history of sexual abuse in their own family.
Target sample size	25

Research contact person
Last name of lead principal investigator	1st name Masaru Middle name Last name Horikoshi
Organization	National Center of Neurology and Psychiatry
Division name	National Center for Cognitive Behavior Therapy and Research
Zip code	187-6551
Address	Ogawahigashi 4-1-1, Kodaira-shi, Tokyo, Japan
TEL	042-341-2712
Email	cptmusashino@gmail.com

Public contact
1st name of contact person	1st name Tomoko Middle name Last name Masaki
Organization	Musashino University
Division name	Graduate School of Human and Social Science
Zip code	135-8181
Address	Ariake 3-3-3, Koto-ku, Tokyo, Japan
TEL	03-5530-7333
Homepage URL
Email	cptmusashino@gmail.com

Sponsor
Institute	Musashino University
Institute
Department

Funding Source
Organization	Grants-in-aid for Scientific Research, JAPAN SOCIETY FOR THE PROVOTION OF SCIENCE
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB, School of human science, Musasiho University
Address	3-3-3 Ariake, Koto-ku, Tokyo, Japan
Tel	03-5530-7312
Email	gakuji@musashino-u.ac.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	武蔵野大学心理臨床センター（東京都）/ Musashino University, Clinical Psychology Center (Tokyo)

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 23 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	No longer recruiting
Date of protocol fixation	2013 Year 10 Month 01 Day
Date of IRB	2013 Year 11 Month 13 Day
Anticipated trial start date	2014 Year 01 Month 25 Day
Last follow-up date	2019 Year 08 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	2014 Year 01 Month 22 Day
Last modified on	2019 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015106