UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026609
Receipt number R000030495
Scientific Title A single-arm pilot study of videoconference cognitive-behavioral therapy for obsessive-compulsive disorder, social anxiety, and panic disorder.
Date of disclosure of the study information 2017/03/21
Last modified on 2019/09/26 12:25:59

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Basic information

Public title

A single-arm pilot study of videoconference cognitive-behavioral therapy for obsessive-compulsive disorder, social anxiety, and panic disorder.

Acronym

Cognitive-Behavioral Therapy for obsessive-compulsive disorder and anxiety disorder; pilot study

Scientific Title

A single-arm pilot study of videoconference cognitive-behavioral therapy for obsessive-compulsive disorder, social anxiety, and panic disorder.

Scientific Title:Acronym

Cognitive-Behavioral Therapy for obsessive-compulsive disorder and anxiety disorder; pilot study

Region

Japan


Condition

Condition

Obsessive-compulsive disorder, social anxiety, and panic disorder.

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine effectiveness and feasibility of videoconference cognitive-behavioral therapy for obsessive-conpulsive disorder, social anxiety, and panic disorder.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

EQ-5D; Euro QOL 5-Dimension
Y-BOCS; Yale-Brown Obssesive-Compulsive Scale
LSAS; Liebowitz Social Anxiety Scale
PDSS; Panic Disorder Severity Scale
16 weeks after starting intervention

Key secondary outcomes

PHQ-9; Patient Health Questionnaire-9
GAD-7; Generalized Anxiety Disorder-7
Questionnaire for Remotal medical care
WAI-SF; Working Alliance Inventory-Short Form


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

Videoconference 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 Obsessive-Conpulsive Disorder, Social Anxiety, and Panic Disorder

Key exclusion criteria

psychotic disorder
active suicidal behavior
organic brain disorder
antisocial personality disorder
other severe mental/physical condition

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Eiji
Middle name
Last name Shimizu

Organization

Chiba University Hospital

Division name

Cognitive Behavioral Therapy Center

Zip code

260-8670

Address

1-8-1 Inohana, Chuoku, Chiba, Japan

TEL

043-222-7171

Email

eiji@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Kazuki
Middle name
Last name Kazuki

Organization

Chiba University

Division name

Research Center for Child Metnal Development

Zip code

260-8670

Address

1-8-1 Inohana, Chuoku, Chiba, Japan

TEL

043-226-2027

Homepage URL


Email

u287754g@ecs.osaka-u.ac.jp


Sponsor or person

Institute

Chiba University Hospital Clinical Research Center

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for research and Development

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

Clinical Research Center, Chiba University Hospital

Address

1-8-1 Inohana, Chuoku, Chiba, japan

Tel

043-226-2616

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 03 Month 21 Day


Related information

URL releasing protocol

https://www.jmir.org/2018/12/e12091/

Publication of results

Published


Result

URL related to results and publications

https://www.jmir.org/2018/12/e12091/

Number of participants that the trial has enrolled

30

Results

There were significant reductions for each symptoms of obsession-compulsion in Y-BOCS, panic in PDSS, and social anxiety in LSAS.

Results date posted

2019 Year 09 Month 26 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2018 Year 12 Month 14 Day

Baseline Characteristics

A total of 37 patients applied to participate through our website. After email or telephone screening, 6 patients were excluded; 1 did not meet one of the inclusion criteria due to epilepsy and 5 declined to participate because of long distance to our hospital. After the screening, 31 attended the face-to-face baseline assessment, and one did not meet one of the inclusion criteria due to high risk of suicide. Finally, 30 patients were enrolled to the study.

Participant flow

The participants entered a Web conference room by clicking a URL in an email sent from their therapists. The intervention was conducted at a 50-min session once a week for 16 weeks. The modules were derived from previous studies on in-person CBT for OCD, PD, and SAD in Japan and included psychoeducation, exposure exercises, behavioral experiments, and homework assignments.

Adverse events

Of the participants eligible to take part in the study, 1 SAD participant with major depressive disorder dropped out after 9 sessions because of worsening of his depressive state. The remaining 97% (29/30) completed the full course of videoconference-delivered CBT. All data at point each assessment (screening, session 1, session 8, and session 16) were statistically analyzed.

Outcome measures

Y-BOCS, PDSS, LSAS, EQ-5D, PHQ-9, GAD-7, WAI-SF

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2017 Year 02 Month 20 Day

Date of IRB

2017 Year 03 Month 21 Day

Anticipated trial start date

2017 Year 03 Month 21 Day

Last follow-up date

2018 Year 03 Month 20 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 03 Month 19 Day

Last modified on

2019 Year 09 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030495


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name