Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder (SOFIE-11)

Computerized Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder

A study investigating six different versions of a computerized attention bias modification internet program in the treatment of social phobia / social anxiety disorder.

Study Overview

• Status: Completed
• Conditions: Social Phobia
• Intervention / Treatment: Behavioral: Attention bias modification

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 Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västerbotten
    • Umeå, Västerbotten, Sweden, 901 87
      • Department of Psychology, Umeå University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control training with words; 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.	Behavioral: Attention bias modification; All arms will consist of 10 minutes of training in front of a computer screen (192 trials) once a day for 14 days.
Sham Comparator: Control training with words + pictures; 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.	Behavioral: Attention bias modification; All arms will consist of 10 minutes of training in front of a computer screen (192 trials) once a day for 14 days.
Active Comparator: Positive bias training with words; 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.	Behavioral: Attention bias modification; All arms will consist of 10 minutes of training in front of a computer screen (192 trials) once a day for 14 days.
Active Comparator: Positive bias training with words + pictures; 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.	Behavioral: Attention bias modification; All arms will consist of 10 minutes of training in front of a computer screen (192 trials) once a day for 14 days.
Active Comparator: Negative bias training with words; 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.	Behavioral: Attention bias modification; All arms will consist of 10 minutes of training in front of a computer screen (192 trials) once a day for 14 days.
Active Comparator: Negative bias training with words + pictures; 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.	Behavioral: Attention bias modification; All arms will consist of 10 minutes of training in front of a computer screen (192 trials) once a day for 14 days.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Umeå University

Publications and helpful links

General Publications

• Boettcher J, Leek L, Matson L, Holmes EA, Browning M, MacLeod C, Andersson G, Carlbring P. Internet-based attention bias modification for social anxiety: a randomised controlled comparison of training towards negative and training towards positive cues. PLoS One. 2013 Sep 30;8(9):e71760. doi: 10.1371/journal.pone.0071760. eCollection 2013.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 27, 2011
• First Submitted That Met QC Criteria: October 31, 2011
• First Posted (Estimate): November 1, 2011

Study Record Updates

• Last Update Posted (Estimate): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 29, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: anxiety; social phobia
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobia, Social; Phobic Disorders
• Other Study ID Numbers: SOFIE-11