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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463137

Locations
Sweden
Department of Psychology, Umeå University
Umeå, Västerbotten, Sweden, 901 87
Sponsors and Collaborators
Umeå University
  More Information

No publications provided by Umeå University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 October 19, 2014