UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038118 |
|---|---|
| Receipt number | 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 15:05:25 |
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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
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
axpa0219@chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043439
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
