UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001383 |
|---|---|
| Receipt number | R000001683 |
| Scientific Title | Treating social phobia via the Internet: Genetic influences on the response to Internet-delivered cognitive-behavior therapy |
| Date of disclosure of the study information | 2008/09/19 |
| Last modified on | 2009/03/19 19:49:44 |
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Basic information
Public title
Treating social phobia via the Internet: Genetic influences on the response to Internet-delivered cognitive-behavior therapy
Acronym
Genetic influences on the response to cognitive-behavior therapy
Scientific Title
Treating social phobia via the Internet: Genetic influences on the response to Internet-delivered cognitive-behavior therapy
Scientific Title:Acronym
Genetic influences on the response to cognitive-behavior therapy
Region
| Europe |
Condition
Condition
Social phobia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The primary objective is to evaluate genetic influences on the response to Internet-delivered cognitive-behavior therapy (ICBT) in individuals with social phobia. ICBT will be compared to a waiting-list control group having access to an online discussion forum. Genotyping from saliva will be performed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Liebowitz Social Anxiety Scale self-report (LSAS-SR), Social Phobia Scale (SPS), Social Interaction Anxiety Scale (SIAS), Social Phobia Screening Questionnaire (SPSQ)
Key secondary outcomes
Beck Anxiety Inventory (BAI), Montogmery-Asberg Depression Rating Scale (MADRS), Quality of Life Inventory (QOLI)
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Internet-delivered cognitive-behavioral treatment package
Interventions/Control_2
Waiting-list control group with access to an online discussion forum
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A main diagnosis of social phobia according to DSM-IV
Key exclusion criteria
Severe depression and/or suicidal
Target sample size
204
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomas Furmark |
Organization
Uppsala university
Division name
Dept. of Psychology
Zip code
Address
Box 1225, SE-751 42 Uppsala, Sweden
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Uppsala University
Division name
Dept. of Psychology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Uppsala university
Institute
Department
Personal name
Funding Source
Organization
Grants from the Swedish Research Council and the L.J. Boethius foundation
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Sweden
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2008 | Year | 09 | Month | 19 | 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
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
Terminated
Date of protocol fixation
| 2008 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 19 | Day |
Last modified on
| 2009 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001683
