Treatment of Social Phobia With Cognitive Bias Modification

NCT01577303 | Completed

• 1 other identifier: Attention training
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether different internet-based treatment programs, consisting of cognitive bias modification, reduce symptoms of social phobia among a population diagnosed with this disorder.

Conditions

Social Phobia

Keywords

social phobia; social anxiety; cognitive bias modification

Outcome Measures

Primary Outcomes (3)

• Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)

  The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.

  24 hours

• Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)

  The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.

  14 days

• Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)

  The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.

  4 months

Secondary Outcomes (9)

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

  24 hours

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

  14 days

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

  4 months

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

  24 hours

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

  14 days

Study Arms (6)

CBM training program variant 1

EXPERIMENTAL

Attention training towards positive cues using words as stimuli

Behavioral: Cognitive bias modification training program variant 1

CBM training program variant 2

EXPERIMENTAL

Attention training towards positive cues using words and faces as stimuli

Behavioral: Cognitive bias modification training program variant 2

CBM training program variant 3

EXPERIMENTAL

Attention training towards negative using words as stimuli

Behavioral: CBM training program variant 3

CBM training program variant 4

EXPERIMENTAL

Attention training towards negative using words and faces

Behavioral: CBM training program variant 4

Control training variant 1

EXPERIMENTAL

Control training condition using words as stimuli

Behavioral: Control training variant 1

Control training variant 2

EXPERIMENTAL

Control training condition using words and faces as stimuli

Behavioral: Control training variant 2

Interventions

Cognitive bias modification training program variant 1 BEHAVIORAL

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.

CBM training program variant 1

Cognitive bias modification training program variant 2 BEHAVIORAL

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.

CBM training program variant 2

CBM training program variant 3 BEHAVIORAL

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.

CBM training program variant 3

CBM training program variant 4 BEHAVIORAL

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.

CBM training program variant 4

Control training variant 1 BEHAVIORAL

Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 1. 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..

Control training variant 1

Control training variant 2 BEHAVIORAL

Computerized, internet-based control training program, 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 follows the more positive stimulus and the more negative stimulus with equal frequency.

Control training variant 2

Eligibility Criteria

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

You may qualify if:

• Written informed consent provided
• Diagnosed social phobia (according to DSM-IV criteria)
• Access to computer with internet connection, and printer

You may not qualify if:

• Severe depression (and/or suicidal behavior)
• Addiction and/or abuse
• Suffer from other severe psychiatric condition (e.g. psychosis)
• Non-stable use of medication
• Undergoing other, parallel psychological treatment

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Department of Psychology, Umeå University

Umeå, Västerbotten County, 90187, 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

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Per Carlbring, Professor

  Department of Psychology, Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 13, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

SE (1)