Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder

Not Applicable

Completed

• Conditions: Social Phobia
• Interventions: Behavioral: Attention bias modification

• Registration Number: NCT01463137
• Lead Sponsor: Umeå University

Brief Summary

A study investigating six different versions of a computerized attention bias modification internet program in the treatment of social phobia / social anxiety 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 compared with a program that implicitly directs the users' attention towards threatening cues. Pre/post-measurements will be compared in a sample of individuals that meet diagnostic criteria of Social Anxiety Disorder. Participants will be randomized to one of three groups, receiving one of the two variants of the attention bias modification program or a control training program.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-27
• Study First Submitted QC: 2011-10-31
• Study First Posted: 2011-11-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• 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

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control training with words	Attention bias modification	Computerized, internet-based control training program. Participant is exposed to a pair of words -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (\< or \>) in the previous position of ONE of these words and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe follows the more positive word and the more negative word with equal frequency.
Positive bias training with words	Attention bias modification	Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 1. Participant is exposed to two words -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (\< or \>) in the previous position of ONE of these words and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word pairs are shown during a session, of one third is the neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more positive word.
Control training with words + pictures	Attention bias modification	Computerized, internet-based control training program. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (\< or \>) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe follows the more positive stimulus and the more negative stimulus with equal frequency.
Positive bias training with words + pictures	Attention bias modification	Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 2. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (\< or \>) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more positive word or face.
Negative bias training with words	Attention bias modification	Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 3. Participant is exposed to two words -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (\< or \>) in the previous position of ONE of these words and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more negative word.
Negative bias training with words + pictures	Attention bias modification	Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 4. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (\< or \>) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more negative word or face.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Liebowitz Social Anxiety Scale self rated version	pretreatment (week 0), post treatment (week 2), 4 month follow-up	Change from baseline in social anxiety symptoms expected between time frames.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Social Phobia Screening Questionnaire	Pretreatment (week 0), post treatment (week 2), 4 month follow-up	Social Phobia Screening Questionnaire (SPSQ), diagnostic tool for social phobia.; Change from baseline in social anxiety symptoms expected between time frames.
Change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS-S)	Pretreatment (week 0), post treatment (week 2), 4 month follow-up	Measure depression.; Change from baseline in depressive symptoms expected between time frames.
Change from baseline in Social Interaction Anxiety Scale (SIAS)	Pretreatment (week 0), post treatment (week 2), 4 month follow-up	Change from baseline in social anxiety symptoms expected between time frames.
Change from baseline in Quality of Life Inventory (QOLI)	Pretreatment (week 0), post treatment (week 2), 4 month follow-up	Measure quality of life.; Change from baseline in quality of life expected between time frames.
Change from baseline in Social Phobia Scale (SPS)	Pretreatment (week 0), post treatment (week 2), 4 month follow-up	Change from baseline in social anxiety symptoms expected between time frames.

Trial Locations

Locations (1)

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