Treatment of Social Phobia With Cognitive Bias Modification

Not Applicable

Completed

• Conditions: Social Phobia

• Registration Number: NCT01577303
• Lead Sponsor: Umeå University

Brief Summary

The purpose of this study is to determine whether different internet-based treatment programs, consisting of cognitive bias modification, reduce symptoms of social phobia among a population diagnosed with this disorder.

Detailed Description

Previous studies have shown that individuals with social phobia have attention biases, often focusing on aversive stimuli or avoiding aversive stimuli. Computerized training programs have been developed to implicitly direct the users attention towards a neutral, non-threatening stimuli. In this study, such a program will be provided to 128 participants that meet the diagnostic criteria for social phobia. It will be compared with a program that implicitly directs the users' attention towards threatening cues. Pre/post-measurements will be compared. Participants will be randomized to one of three groups, receiving one of the two variants of the cognitive bias modification program or a control training.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-13
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-29
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Written informed consent provided
• Diagnosed social phobia (according to DSM-IV criteria)
• Access to computer with internet connection, and printer

Exclusion Criteria

• Severe depression (and/or suicidal behavior)
• Addiction and/or abuse
• Suffer from other severe psychiatric condition (e.g. psychosis)
• Non-stable use of medication
• Undergoing other, parallel psychological treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)	4 months	The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Quality Of Life Inventory (QOLI)	4 months	The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	4 months	9-item depression rating scale.
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale	4 months	Self-rated measurements of social anxiety/phobia.

Trial Locations

Locations (1)

Department of Psychology, Umeå University; 🇸🇪 Umeå, Västerbotten, Sweden