Overview

This trial has been completed.

Condition social phobia
Treatments cognitive bias modification training program variant 1, cognitive bias modification training program variant 2, cbm training program variant 3, cbm training program variant 4, control training variant 1, control training variant 2
Sponsor Umeå University
Start date April 2012
End date September 2013
Trial size 129 participants
Trial identifier NCT01577303, Attention training

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Attention training towards positive cues using words as stimuli
cognitive bias modification training program variant 1
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.
(Experimental)
Attention training towards positive cues using words and faces as stimuli
cognitive bias modification training program variant 2
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.
(Experimental)
Attention training towards negative using words as stimuli
cbm training program variant 3
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.
(Experimental)
Attention training towards negative using words and faces
cbm training program variant 4
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.
(Experimental)
Control training condition using words as stimuli
control training variant 1
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..
(Experimental)
Control training condition using words and faces as stimuli
control training variant 2
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.

Primary Outcomes

Measure
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
time frame: 24 hours
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
time frame: 14 days
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
time frame: 4 months

Secondary Outcomes

Measure
Change from baseline in Quality Of Life Inventory (QOLI)
time frame: 24 hours
Change from baseline in Quality Of Life Inventory (QOLI)
time frame: 14 days
Change from baseline in Quality Of Life Inventory (QOLI)
time frame: 4 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
time frame: 24 hours
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
time frame: 14 days
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
time frame: 4 months
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
time frame: 24 hours
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
time frame: 14 days
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
time frame: 4 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Reduction of Social Phobia Symptoms With Internet-Based Cognitive Bias Modification
Principal investigator Per Carlbring, Professor
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 provided to 128 participants that meet the diagnostic criteria for social phobia. It will be compared with a program that implicitly directs the users' attention towards threatening cues. Pre/post-measurements will be compared. Participants will be randomized to one of three groups, receiving one of the two variants of the cognitive bias modification program or a control training.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Umeå University.