Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder (SOFIE-11)
This study has been completed.
Sponsor:
Umeå University
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
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Purpose
A study investigating six different versions of a computerized attention bias modification internet program in the treatment of social phobia / social anxiety disorder.
| Condition | Intervention |
|---|---|
|
Social Phobia |
Behavioral: Attention bias modification |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Computerized Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder |
Resource links provided by NLM:
Further study details as provided by Umeå University:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 129 |
| Study Start Date: | October 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Per Carlbring, PhD, Professor, Umeå University |
| ClinicalTrials.gov Identifier: | NCT01463137 History of Changes |
| Other Study ID Numbers: | SOFIE-11 |
| Study First Received: | October 27, 2011 |
| Last Updated: | January 18, 2013 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Umeå University:
|
social phobia anxiety |
Additional relevant MeSH terms:
|
Anxiety Disorders Phobic Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013