Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder

NCT01463137 | Completed

• 1 other identifier: SOFIE-11
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Phobia

Keywords

social phobia; anxiety

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Liebowitz Social Anxiety Scale self rated version

  Change from baseline in social anxiety symptoms expected between time frames.

  pretreatment (week 0), post treatment (week 2), 4 month follow-up

Secondary Outcomes (5)

• Change from baseline in Social Phobia Screening Questionnaire

  Pretreatment (week 0), post treatment (week 2), 4 month follow-up

• 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 Phobia Scale (SPS)

  Pretreatment (week 0), post treatment (week 2), 4 month follow-up

• Change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS-S)

  Pretreatment (week 0), post treatment (week 2), 4 month follow-up

• Change from baseline in Quality of Life Inventory (QOLI)

  Pretreatment (week 0), post treatment (week 2), 4 month follow-up

Study Arms (6)

Control training with words

SHAM COMPARATOR

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

Control training with words + pictures

SHAM COMPARATOR

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

Positive bias training with words

ACTIVE COMPARATOR

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

Positive bias training with words + pictures

ACTIVE COMPARATOR

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

Negative bias training with words

ACTIVE COMPARATOR

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

Negative bias training with words + pictures

ACTIVE COMPARATOR

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

Interventions

Attention bias modification BEHAVIORAL

All arms will consist of 10 minutes of training in front of a computer screen (192 trials) once a day for 14 days.

Control training with words; Control training with words + pictures; Negative bias training with words; Negative bias training with words + pictures; Positive bias training with words; Positive bias training with words + pictures

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Below 18 years old.
• Individuals who are suicide prone will be excluded from the study.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Department of Psychology, Umeå University

Umeå, Västerbotten County, 901 87, Sweden

Location

Related Publications (1)

• 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.

  PMID: 24098630 RESULT

MeSH Terms

Conditions

Phobia, Social; Anxiety Disorders

Condition Hierarchy (Ancestors)

Phobic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 1, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

SE (1)