UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026609
Receipt No. 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 (Ver. 6)

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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
Institute Chiba University Hospital Clinical Research Center
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030495