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

Email

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


Email

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015106


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name