Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT

Not Applicable

Completed

• Conditions: Social Phobia
• Interventions: Behavioral: Internet-administered cognitive behavioral therapy (iCBT); Behavioral: Cognitive bias modification training program variant 1; Behavioral: Cognitive bias modification training program variant 2

• Registration Number: NCT01570400
• Lead Sponsor: Umeå University

Brief Summary

The purpose of this study is to determine whether an internet-based treatment program, consisting of combined cognitive bias modification and cognitive behavioral therapy, reduces 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 or avoiding aversive stimuli (such as judging facial expressions) and thereby reinforcing the bias. Computerized training programs have been developed to implicitly direct the users attention. In this study, such a program -- combined with an established, well-researched and proven effective form of internet-based cognitive behavioral therapy (iCBT) -- will be provided to 128 participants that meet the diagnostic criteria for social phobia, and the pre/post-measurements will be compared. Participants will be randomized to one of two groups, receiving one of two variants of the cognitive bias modification program (both receive iCBT).

Study Timeline

• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-04-03
• Study First Posted: 2012-04-04
• Study Start: 2012-09
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-29
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

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

Exclusion Criteria

• Severe depression (and/or suicidal behavior)
• Suffer from other severe psychiatric condition (e.g. psychosis)
• Non-stable use of medication (3 months stable dosage)
• Undergoing other, parallel psychological treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBM training program variant 2 + iCBT	Internet-administered cognitive behavioral therapy (iCBT)	Cognitive bias modification training program variant 2 combined with iCBT
CBM training program variant 1 + iCBT	Cognitive bias modification training program variant 1	Cognitive bias modification training program variant 1 combined with iCBT
CBM training program variant 1 + iCBT	Internet-administered cognitive behavioral therapy (iCBT)	Cognitive bias modification training program variant 1 combined with iCBT
CBM training program variant 2 + iCBT	Cognitive bias modification training program variant 2	Cognitive bias modification training program variant 2 combined with iCBT

Primary Outcome Measures

Name	Time	Method
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)	Two weeks into treatment	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)	2 weeks into treatment	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 Social Phobia Scale + Social Interaction Anxiety Scale	2 weeks into treatment	Self-rated measurements of social anxiety/phobia.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	2 weeks into treatment	9-item depression rating scale.
Change from baseline in mini-SPIN	4 months	Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.

Trial Locations

Locations (1)

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