UMIN-CTR Clinical Trial

Public title

Randomized controlled trial on the efficacy of the prolonged exposure therapy for PTSD

Acronym

RCT of the PE for PTSD

Scientific Title

Randomized controlled trial on the efficacy of the prolonged exposure therapy for PTSD

Scientific Title:Acronym

RCT of the PE for PTSD

Region

Japan

Condition

Posttraumatic Stress Disorder (PTSD)

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the efficacy of the prolonged exposure therapy (PE) for PTSD by comparing the outcome of the groups of PE added to treatment as usual (TAU) and TAU alone, with the RCT design and masked assessment of the severity of PTSD symptoms pre and post treatment.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The severity of PTSD symptoms measured by the CAPS

Key secondary outcomes

1.PTSD diagnosis confirmed by the CAPS
2.Psychological symptoms other than PTSD, i.e., STAI, SCL-90R, DES, PTCI, WHOQOL
3.Autonomic nervous function at rest
4.Serum cortisol and stress related hormones

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

The prolonged exposure therapy added to the treatment as usual

Interventions/Control_2

treatment as usual

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

16

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Female

Key inclusion criteria

1.Diagnosed as PTSD by the CAPS with its score greater than 40
2.More than 6 months duration of PTSD
3.PTSD was caused by human violence, such as rape, intimate partner violence, assault etc.
4.Traumatized after the age 15
5.Those who live in the catchment area of the participating centers
6.Those who can spend two hours a day for the homework
7.Native Japanese speaker

Key exclusion criteria

1.Comorbidity of schizophrenia, bipolar disorder, alcohol or drug dependence, group A personality disorder.
2.Presence of psychopathology that needs acute treatment, such as severe depression, self-harm, severe suicidal attempt, etc.
3.Physical disease that may interfere psychological treatment
4.Those who have a history of epilepsy and whose EEG has not been normalized
5.Pregnant
6.Those who have difficulty in understanding the procedure of the study or treatment protocol, due to illiteracy or intellectual problem, etc.
7.Those who have already received psychological treatment based on exposure to trauma, including EMDR
8.Ongoing or scheduled court litigation for which PTSD works favorably (excluding arbitration or litigation for divorce)
9.Suicidal attempts of serious self harm within past six months(self mutilation that needs suture, overdose of drugs that caused loss of consciousness, manipulative self-harm in order to threat others, etc.)
10.Those who are participating in other clinical trial
11.Those who are judged by the screening doctors as inadequate, due to disturbed consciousness, poor treatment compliance, unstable family environment such as ongoing trauma, etc.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Yoshiharu Kim

Organization

National Institute of Mental Health, National Center of Neurology and Psychiatry

Division name

Division of Adult Mental Health

Zip code

Address

4-1-1 Ogawa Higashi Cho, Kodaira, Tokyo, JAPAN

TEL

042-346-1985

Email

Name of contact person

1st name
Middle name
Last name	Yoshiharu Kim

Organization

National Institute of Mental Health, National Center of Neurology and Psychiatry

Division name

Department of Adult Mental Health

Zip code

Address

4-1-1 Ogawa Higashi Cho, Kodaira, Tokyo, JAPAN

TEL

042-346-1985

Homepage URL

Email

Institute

National Institute of Mental Health, National Center of Neurology and Psychiatry

Institute

Department

Personal name

Organization

The Ministry of Health, Labor and Welfare, Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Institute of Women's Health, Tokyo Women's Medical University

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

06

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2008

Year

05

Month

07

Day

Date of IRB

Anticipated trial start date

2008

Year

05

Month

01

Day

Last follow-up date

2011

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

As is approved by the UMIN center, the protcol has been registered May, 2008, but due to inevitable technical reasons, appeared on the list 11 June, 2008.

Registered date

2008

Year

06

Month

11

Day

Last modified on

2011

Year

01

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001446