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

Primary Purpose

Social Phobia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Attention bias modification
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Phobia focused on measuring social phobia, anxiety

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Psychology, Umeå University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Sham Comparator

Sham Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control training with words

Control training with words + pictures

Positive bias training with words

Positive bias training with words + pictures

Negative bias training with words

Negative bias training with words + pictures

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in Liebowitz Social Anxiety Scale self rated version
Change from baseline in social anxiety symptoms expected between time frames.

Secondary Outcome Measures

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.
Change from baseline in Social Interaction Anxiety Scale (SIAS)
Change from baseline in social anxiety symptoms expected between time frames.
Change from baseline in Social Phobia Scale (SPS)
Change from baseline in social anxiety symptoms expected between time frames.
Change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS-S)
Measure depression. Change from baseline in depressive symptoms expected between time frames.
Change from baseline in Quality of Life Inventory (QOLI)
Measure quality of life. Change from baseline in quality of life expected between time frames.

Full Information

First Posted
October 27, 2011
Last Updated
October 29, 2016
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT01463137
Brief Title
Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder
Acronym
SOFIE-11
Official Title
Computerized Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
Keywords
social phobia, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control training with words
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Control training with words + pictures
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Positive bias training with words
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Positive bias training with words + pictures
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Negative bias training with words
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Negative bias training with words + pictures
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Attention bias modification
Intervention Description
All arms will consist of 10 minutes of training in front of a computer screen (192 trials) once a day for 14 days.
Primary Outcome Measure Information:
Title
Change from baseline in Liebowitz Social Anxiety Scale self rated version
Description
Change from baseline in social anxiety symptoms expected between time frames.
Time Frame
pretreatment (week 0), post treatment (week 2), 4 month follow-up
Secondary Outcome Measure Information:
Title
Change from baseline in Social Phobia Screening Questionnaire
Description
Social Phobia Screening Questionnaire (SPSQ), diagnostic tool for social phobia. Change from baseline in social anxiety symptoms expected between time frames.
Time Frame
Pretreatment (week 0), post treatment (week 2), 4 month follow-up
Title
Change from baseline in Social Interaction Anxiety Scale (SIAS)
Description
Change from baseline in social anxiety symptoms expected between time frames.
Time Frame
Pretreatment (week 0), post treatment (week 2), 4 month follow-up
Title
Change from baseline in Social Phobia Scale (SPS)
Description
Change from baseline in social anxiety symptoms expected between time frames.
Time Frame
Pretreatment (week 0), post treatment (week 2), 4 month follow-up
Title
Change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS-S)
Description
Measure depression. Change from baseline in depressive symptoms expected between time frames.
Time Frame
Pretreatment (week 0), post treatment (week 2), 4 month follow-up
Title
Change from baseline in Quality of Life Inventory (QOLI)
Description
Measure quality of life. Change from baseline in quality of life expected between time frames.
Time Frame
Pretreatment (week 0), post treatment (week 2), 4 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Department of Psychology, Umeå University
City
Umeå
State/Province
Västerbotten
ZIP/Postal Code
901 87
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24098630
Citation
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.
Results Reference
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Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder

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