|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
7 November 2016 |
|
Main ID: |
NCT01463137 |
|
Date of registration:
|
27/10/2011 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder
SOFIE-11 |
|
Scientific title:
|
Computerized Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder |
|
Date of first enrolment:
|
October 2011 |
|
Target sample size:
|
129 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01463137 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Sweden
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Participants must meet criteria for social phobia using the International
classification system Diagnostic and Statistical Manual of Mental Disorders, 4th
edition (DSM-IV).
- Comorbidity is allowed, but social phobia must be the primary diagnosis.
Exclusion Criteria:
- Below 18 years old.
- Individuals who are suicide prone will be excluded from the study.
Age minimum:
18 Years
Age maximum:
100 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Social Phobia
|
|
Intervention(s)
|
|
Behavioral: Attention bias modification
|
|
Primary Outcome(s)
|
|
Change from baseline in Liebowitz Social Anxiety Scale self rated version
[Time Frame: pretreatment (week 0), post treatment (week 2), 4 month follow-up]
|
|
Secondary Outcome(s)
|
|
Change from baseline in Social Interaction Anxiety Scale (SIAS)
[Time Frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up]
|
|
Change from baseline in Quality of Life Inventory (QOLI)
[Time Frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up]
|
|
Change from baseline in Social Phobia Screening Questionnaire
[Time Frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up]
|
|
Change from baseline in Social Phobia Scale (SPS)
[Time Frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up]
|
|
Change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS-S)
[Time Frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|