UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043862
Receipt number R000050056
Scientific Title Secondary analysis of data from an online cognitive-behavioral therapy trial (G29036) (G30012) for panic disorder patients who remain symptomatic after pharmacotherapy to examine the effectiveness of a session dealing with " imagery rescripting for early traumatic memory.
Date of disclosure of the study information 2021/04/07
Last modified on 2021/11/26 18:20:40

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Basic information

Public title

Secondary analysis of data from an online cognitive-behavioral therapy trial (G29036) (G30012) for panic disorder patients who remain symptomatic after pharmacotherapy to examine the effectiveness of a session dealing with " imagery rescripting for early traumatic memory.

Acronym

Secondary analysis of data from an online cognitive-behavioral therapy trial for panic disorder patients who remain symptomatic after pharmacotherapy to examine the effectiveness of a session dealing with " imagery rescripting for early traumatic memory.

Scientific Title

Secondary analysis of data from an online cognitive-behavioral therapy trial (G29036) (G30012) for panic disorder patients who remain symptomatic after pharmacotherapy to examine the effectiveness of a session dealing with " imagery rescripting for early traumatic memory.

Scientific Title:Acronym

Secondary analysis of data from an online cognitive-behavioral therapy trial for panic disorder patients who remain symptomatic after pharmacotherapy to examine the effectiveness of a session dealing with " imagery rescripting for early traumatic memory.

Region

Japan


Condition

Condition

panic disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify the effectiveness of the "session dealing with the memory of past panic symptoms" that was additionally used by secondary analysis of data from remote cognitive behavioral therapy for patients with panic disorder.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Panic Disorder Severity Scale (PDSS)

Key secondary outcomes



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

Cognitive behavioral 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

18 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Primary diagnosis of Panic Disorder refractory to medicine(Taking antidepressant or anti-anxiety drugs treatment and had done so for at least 8 weeks at an adequate dose while remaining at least moderately ill(PDSS >=8)).

Key exclusion criteria

psychosis, major depression, bipolar, active suicidality, organic brain disorder, substance abuse or dependence, antisocial personality disorder, other severe mental / physical condition

Target sample size

26


Research contact person

Name of lead principal investigator

1st name Eiji
Middle name
Last name Shimizu

Organization

Graduate School of Medicine Chiba University,Chiba University Hospital

Division name

Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology,Cognitive Behavioral Therapy Center

Zip code

260-8677

Address

1-8-1 Inohana, Chuouku, Chiba, Japan

TEL

043-226-2027

Email

eiji@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Yoichi
Middle name
Last name Seki

Organization

Chiba University Hospital

Division name

Cognitive Behavioral Therapy Center

Zip code

260-8677

Address

1-8-1 Inohana, Chuouku, Chiba, Japan

TEL

043-226-2027

Homepage URL


Email

yoichi-seki@chiba-u.jp


Sponsor or person

Institute

Chiba University's Graduate School of Medicine and School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba University's Graduate School of Medicine and School of Medicine

Address

1-8-1 Inohana, Chuouku, Chiba, Japan

Tel

043-222-7171

Email

inohana-kyodo@chiba-u.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



Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 07 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

2021 Year 02 Month 08 Day

Date of IRB

2021 Year 02 Month 08 Day

Anticipated trial start date

2021 Year 02 Month 08 Day

Last follow-up date

2022 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

2021 Year 04 Month 07 Day

Last modified on

2021 Year 11 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050056


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name