UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000038118
Receipt No. R000043439
Scientific Title Guided Internet-based cognitive behavioral therapy for anxiety disorder (panic disorder and social anxiety disorder): a pilot feasibility study
Date of disclosure of the study information 2019/09/26
Last modified on 2020/07/01 (Ver. 5)

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Basic information
Public title Guided Internet-based cognitive behavioral therapy for anxiety disorder (panic disorder and social anxiety disorder): a pilot feasibility study
Acronym Guided ICBT for anxiety disorder: a pilot feasibility study
Scientific Title Guided Internet-based cognitive behavioral therapy for anxiety disorder (panic disorder and social anxiety disorder): a pilot feasibility study
Scientific Title:Acronym Guided ICBT for anxiety disorder: a pilot feasibility study
Region
Japan

Condition
Condition Anxiety disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine effectiveness and feasibility of Guided Internet-based cognitive behavioral therapy for patients with panic disorder and social anxiety disorder
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of STAI-trait between for pre- and post- 12 weeks-treatment
Key secondary outcomes Main diagnosis: panic disorder:
The Panic Disorder Severity Scale

Main diagnosis: social anxiety disorder:
Liebowitz Social Anxiety Scale

Beck Anxiety Inventory
Working Alliance Inventory Short Form
Patient Health Questionnaire-9
Generalized Anxiety Disorder -7

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 Guided Internet-Based 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
15 years-old <=
Age-upper limit
35 years-old >=
Gender Male and Female
Key inclusion criteria Primary diagnosis of panic disorder or social anxiety disorder by the Mini-International Neuropsychiatric Interview

Primary diagnosis of panic disorder:PDSS over 9
Primary diagnosis of social anxiety disorder:LSAS over 70
Key exclusion criteria Psychotic disorder
Highly likely to attempt suicide
Organic brain complications/disorders
Antisocial personality disorder
Mental retardation
Other severe mental / physical condition
Target sample size 6

Research contact person
Name of lead principal investigator
1st name Eiji
Middle name
Last name Shimizu
Organization Chiba University
Division name Research center for child mental development
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 Kazuki
Middle name
Last name Matsumoto
Organization Chiba University
Division name Research center for child mental development
Zip code 260-8677
Address 1-8-1, Inohana, Chuouku, Chiba, Japan
TEL 043-226-2027
Homepage URL
Email axpa0219@chiba-u.jp

Sponsor
Institute Chiba university
Institute
Department

Funding Source
Organization Japan society for the promotion of science
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 Chiba university
Address 1-8-1, Inohana, Chuouku, Chiba, Japan
Tel 0432262616
Email prc-jim@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
2019 Year 09 Month 26 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043439
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 6
Results 
The trial was completed with registration of 6 patients at the end of November 2019, and participants completed the trial process by March 2020. No adverse events were reported during the 12-week study period, suggesting that the study treatment is safe. Two of the three patients with panic disorder and one of the three patients with social anxiety have been remission after 12 weeks of this trial.
Results date posted
2020 Year 07 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Japanese with social anxiety disorder or panic disorder.
Participant flow 
After face-to-face consultation and consent, screening was performed. Participants who were qualified for the study inclusion criteria underwent a 12-week self-help program. After the trial treatment was completed, the post evaluation was performed by having participants answer the symptom rating scale.
Adverse events 
None.
Outcome measures 
The Stat-Trait Anxiety Inventory-Trait, STAI-T; the Beck Anxiety Scale, BAI; Liebowitz Social Anxiety Scale, LSAS; The Panic Disorder Severity Scale, PDSS; Working Alliance Inventory Short Form, WAI-SF; Patient Health Questionnaire-9, PHQ-9; Generalized Anxiety Disorder -7, GAD-7.
Plan to share IPD None.
IPD sharing Plan description None.

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 07 Month 16 Day
Date of IRB
2019 Year 07 Month 16 Day
Anticipated trial start date
2019 Year 07 Month 16 Day
Last follow-up date
2020 Year 02 Month 28 Day
Date of closure to data entry
2020 Year 02 Month 28 Day
Date trial data considered complete
2020 Year 02 Month 28 Day
Date analysis concluded
2020 Year 05 Month 27 Day

Other
Other related information As of July 1, 2020, I am submitting the manuscript summarizing results of this trial to an international academic journal.

Management information
Registered date
2019 Year 09 Month 26 Day
Last modified on
2020 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043439