UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029987
Receipt number R000034247
Scientific Title A randomized controlled trial of videoconference cognitive behavior therapy as an adjunct to usualcare for panic disorder refractory to medical treatment
Date of disclosure of the study information 2017/11/20
Last modified on 2020/09/23 18:35:31

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Basic information

Public title

A randomized controlled trial of videoconference cognitive behavior therapy as an adjunct to usualcare for panic disorder refractory to medical treatment

Acronym

RCT about the effectiveness of the vCBT for medical treatment-resistant panic disorder patients

Scientific Title

A randomized controlled trial of videoconference cognitive behavior therapy as an adjunct to usualcare for panic disorder refractory to medical treatment

Scientific Title:Acronym

RCT about the effectiveness of the vCBT for medical treatment-resistant panic disorder patients

Region

Japan


Condition

Condition

panic disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effectiveness of videoconference cognitive behavioral therapy as an adjunct to usual care when compared to usual care alone in patients with panic disorder refractory to medical treatment.

Basic objectives2

Others

Basic objectives -Others

To examine clinical and cost effectiveness of videoconference cognitive behavioral therapy as an adjunct to usual care 16weeks after.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Panic Disorder Severity Scale(PDSS)(assessor-rated)

Key secondary outcomes

PAS(Panic and Agoraphobia Scale)
PHQ-9(Patient Health Questionnare-9)
GHQ-7(Generalized anxiety disorder-7)
EQ-5D-5L(EuroQol5-Dimension-5Levels)


Base

Study type

Interventional


Study design

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


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

videoconference cognitive behavioral therapy(vCBT)and Treatment-As-Usual(TAU)(16weeks)

Interventions/Control_2

Treatment-As-Usual(TAU)(16weeks)

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

44


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 Hospital Clinical Research Center

Institute

Department

Personal name



Funding Source

Organization

Ministry of education

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

The Chiba University Clinical Research Center (CCRC)

Address

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

Tel

043-222-7171

Email

chibacrc@mac.com


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

2017 Year 11 Month 20 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

30

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

Completed

Date of protocol fixation

2017 Year 11 Month 20 Day

Date of IRB

2018 Year 07 Month 16 Day

Anticipated trial start date

2018 Year 07 Month 19 Day

Last follow-up date

2020 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

2017 Year 11 Month 15 Day

Last modified on

2020 Year 09 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034247


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name