Clinical trial NCT01577303: Treatment of Social Phobia With Cognitive Bias Modification
Official title: Reduction of Social Phobia Symptoms With Internet-Based Cognitive Bias Modification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Phobia
Keywords: social phobia
social anxiety
cognitive bias modification
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2012-04-13
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
timeFrame: 24 hours
measure: Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
timeFrame: 14 days
measure: Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
timeFrame: 4 months
Secondary outcomes:
measure: Change from baseline in Quality Of Life Inventory (QOLI)
timeFrame: 24 hours
measure: Change from baseline in Quality Of Life Inventory (QOLI)
timeFrame: 14 days
measure: Change from baseline in Quality Of Life Inventory (QOLI)
timeFrame: 4 months
measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 24 hours
measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 14 days
measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 4 months
measure: Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
timeFrame: 24 hours
measure: Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
timeFrame: 14 days
measure: Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
timeFrame: 4 months
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Psychology, Umeå University
state: Västerbotten
Study officials:
affiliation: Department of Psychology, Umeå University
name: Per Carlbring, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.