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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001383
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Uppsala university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001683

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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