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

Sponsor
Umeå University (Other)
Overall Status
Completed
CT.gov ID
NCT01463137
Collaborator
(none)
129
1
6
15
8.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Attention bias modification
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
129 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Computerized Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Department of Psychology, Umeå University Umeå Västerbotten Sweden 901 87

Sponsors and Collaborators

  • Umeå University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Per Carlbring, PhD, Professor, Umeå University
ClinicalTrials.gov Identifier:
NCT01463137
Other Study ID Numbers:
  • SOFIE-11
First Posted:
Nov 1, 2011
Last Update Posted:
Nov 1, 2016
Last Verified:
Oct 1, 2016
Keywords provided by Per Carlbring, PhD, Professor, Umeå University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2016