UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012919 |
|---|---|
| Receipt number | R000015106 |
| Scientific Title | Research on feasibility and efficacy of Group Cognitive Processing Therapy for posttraumatic stress disorder in Japan |
| Date of disclosure of the study information | 2014/01/23 |
| Last modified on | 2019/05/24 02:55:47 |
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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
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
cptmusashino@gmail.com
Public contact
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
cptmusashino@gmail.com
Sponsor or person
Institute
Musashino University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015106
