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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Per Carlbring, PhD, Umeå University

ClinicalTrials.gov Identifier:

NCT01463137

First received: October 27, 2011

Last updated: January 18, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 27, 2011
Last Updated Date	January 18, 2013
Start Date ^ICMJE	October 2011
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 12, 2012)	Change from baseline in Liebowitz Social Anxiety Scale self rated version [ Time Frame: pretreatment (week 0), post treatment (week 2), 4 month follow-up ] [ Designated as safety issue: No ] Change from baseline in social anxiety symptoms expected between time frames.
Original Primary Outcome Measures ^ICMJE (submitted: October 31, 2011)	Liebowitz Social Anxiety Scale self rated version [ Time Frame: pretreatment (week 0), post treatment (week 2), 4 month follow-up ] [ Designated as safety issue: No ] Change from baseline in social anxiety symptoms expected between time frames.
Change History	Complete list of historical versions of study NCT01463137 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 12, 2012)	Change from baseline in Social Phobia Screening Questionnaire [ Time Frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up ] [ Designated as safety issue: No ] 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 Social Interaction Anxiety Scale (SIAS) [ Time Frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up ] [ Designated as safety issue: No ] Change from baseline in social anxiety symptoms expected between time frames. Change from baseline in Social Phobia Scale (SPS) [ Time Frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up ] [ Designated as safety issue: No ] Change from baseline in social anxiety symptoms expected between time frames. Change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS-S) [ Time Frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up ] [ Designated as safety issue: No ] Measure depression. Change from baseline in depressive symptoms expected between time frames. Change from baseline in Quality of Life Inventory (QOLI) [ Time Frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up ] [ Designated as safety issue: No ] Measure quality of life. Change from baseline in quality of life expected between time frames.
Original Secondary Outcome Measures ^ICMJE (submitted: October 31, 2011)	Social Phobia Screening Questionnaire [ Time Frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up ] [ Designated as safety issue: No ] Social Phobia Screening Questionnaire (SPSQ), diagnostic tool for social phobia. Change from baseline in social anxiety symptoms expected between time frames. Social Interaction Anxiety Scale (SIAS) [ Time Frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up ] [ Designated as safety issue: No ] Change from baseline in social anxiety symptoms expected between time frames. Social Interaction Anxiety Scale (SIAS) [ Time Frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up ] Change from baseline in social anxiety symptoms expected between time frames. Social Phobia Scale (SPS) [ Time Frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up ] Change from baseline in social anxiety symptoms expected between time frames. Montgomery Åsberg Depression Rating Scale (MADRS-S) [ Time Frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up ] Measure depression. Change from baseline in depressive symptoms expected between time frames. Quality of Life Inventory (QOLI) [ Time Frame: 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.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder
Official Title ^ICMJE	Computerized Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder
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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Social Phobia
Intervention ^ICMJE	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.
Study Arm (s)	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. Intervention: Behavioral: Attention bias modification 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. Intervention: Behavioral: Attention bias modification 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. Intervention: Behavioral: Attention bias modification 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. Intervention: Behavioral: Attention bias modification 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. Intervention: Behavioral: Attention bias modification 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. Intervention: Behavioral: Attention bias modification
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	129
Completion Date	January 2012
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Sweden

Administrative Information
NCT Number ^ICMJE	NCT01463137
Other Study ID Numbers ^ICMJE	SOFIE-11
Has Data Monitoring Committee	No
Responsible Party	Per Carlbring, PhD, Umeå University
Study Sponsor ^ICMJE	Umeå University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Umeå University
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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