UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039341
Receipt number R000044870
Scientific Title Single arm preliminary trial of Cognitive Processing Therapy for adolescents with Post-traumatic Stress Symptoms: Cpt for Adolescents and Young Adult with Post-traumatic stress symptoms (CAYAP)
Date of disclosure of the study information 2020/02/01
Last modified on 2023/12/13 18:42:30

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Basic information

Public title

Single arm preliminary trial of Cognitive Processing Therapy for adolescents with Post-traumatic Stress Symptoms: Cpt for Adolescents and Young Adult with Post-traumatic stress symptoms (CAYAP)

Acronym

Research on Cognitive Processing Therapy for adolescents with Post -traumatic stress symptoms

Scientific Title

Single arm preliminary trial of Cognitive Processing Therapy for adolescents with Post-traumatic Stress Symptoms: Cpt for Adolescents and Young Adult with Post-traumatic stress symptoms (CAYAP)

Scientific Title:Acronym

Research on Cognitive Processing Therapy for adolescents with Post -traumatic stress symptoms

Region

Japan


Condition

Condition

Post-traumatic Stress Symptoms
Post-traumatic Stress Disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the feasibility and efficacy of Cognitive Processing Therapy for adolescents with Post -traumatic Stress Symptoms in Japan.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Post-traumatic stress symptoms assessed by a Clinician Administered PTSD Scale for DSM-5.

Key secondary outcomes

1. Post-traumatic stress symptoms assessed by PTSD Check List for DSM-5
2. Patient Health Questionnaire-9; PHQ-9
3. General Anxiety Disorder-7; GAD-7
4. Euro Quality of Life 5-dimensional 5-level; EQ-5D-5L
5. Sheehan Disability Scale; SDS
6. Dissociation symptoms (Items added to CAPS-5 and PCL-5)
7. Suicidal Ideation Attributes Scale; SIDAS


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

Cognitive Processing Therapy for Adolescents and Young Adults with Post-traumatic stress symptoms (CAYAP)

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

13 years-old <=

Age-upper limit

25 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Those aged 13 years or older, and 25 years or younger.
2) Patients who have been referred to NCNP Hospital or Aichi Psychiatric Medical Center by other institutions where they are either hospitalized or in ambulatory care.
3) The clinical presentation meets the B, C, D, E, F, H criteria of DSM-5 diagnosis of Post-traumatic Stress Disorder assessed by a Clinician-Administered PTSD Scale (CAPS-5). The Criteria A is not a prerequisite.

Key exclusion criteria

1) No severe substance use disorders at baseline as assessed by the Mini-International Neuropsychiatric Interview (MINI).
2) No current manic episode or current psychotic disorders at baseline assessed by MINI.
3) No serious suicidal ideation at baseline assessed by MINI.
4) No severe or unstable physical disorders or major cognitive deficits at baseline.
5) No structured psychotherapy at baseline.
6) Other relevant reasons determined by investigators.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Akiko
Middle name
Last name Katayanagi

Organization

National Center of Neurology and Psychiatry

Division name

National Center for Cognitive- Behavior Therapy

Zip code

187-8551

Address

Ogawahigashi 4-1-1, Kodaira, Tokyo,187-8551, Japan

TEL

+82-42-341-2711

Email

akatayanagi-ncnp@umin.ac.jp


Public contact

Name of contact person

1st name Akiko
Middle name
Last name Katayanagi

Organization

National Center of Neurology and Psychiatry

Division name

National Center for Cognitive- Behavior Therapy

Zip code

187-8551

Address

Ogawahigashi 4-1-1, Kodaira, Tokyo,187-8551, Japan

TEL

+82-42-341-2711

Homepage URL


Email

akatayanagi-ncnp@umin.ac.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



Funding Source

Organization

KAKENHI Grant-in-Aid(C)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Aichi Psychiatric Medical Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Center of Neurology and Psychiatry Ethics Committee

Address

Ogawahigashi 4-1-1, Kodaira, Tokyo,187-8551, Japan

Tel

042-341-2711

Email

rinri-jimu@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

国立精神・神経医療研究センター病院、愛知県精神医療センター


Other administrative information

Date of disclosure of the study information

2020 Year 02 Month 01 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

Open public recruiting

Date of protocol fixation

2019 Year 07 Month 17 Day

Date of IRB

2019 Year 08 Month 09 Day

Anticipated trial start date

2020 Year 01 Month 01 Day

Last follow-up date

2025 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

2020 Year 01 Month 31 Day

Last modified on

2023 Year 12 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044870


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name