Clinical trial NCT01570400: Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT
Official title: Reduction of Social Phobia Symptoms With Combined Internet-Based Cognitive Bias Modification and Cognitive Behavioral Therapy
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: 2012-04-04
Enrollment: 133
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 an internet-based treatment program, consisting of combined cognitive bias modification and cognitive behavioral therapy, reduces 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 or avoiding aversive stimuli (such as judging facial expressions) and thereby reinforcing the bias. Computerized training programs have been developed to implicitly direct the users attention. In this study, such a program -- combined with an established, well-researched and proven effective form of internet-based cognitive behavioral therapy (iCBT) -- will be provided to 128 participants that meet the diagnostic criteria for social phobia, and the pre/post-measurements will be compared. Participants will be randomized to one of two groups, receiving one of two variants of the cognitive bias modification program (both receive iCBT).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Severe depression (and/or suicidal behavior)
* Suffer from other severe psychiatric condition (e.g. psychosis)
* Non-stable use of medication (3 months stable dosage)
* 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: 11 weeks
measure: Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
timeFrame: 4 months
measure: Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
timeFrame: Two weeks into treatment
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: 11 weeks
measure: Change from baseline in Quality Of Life Inventory (QOLI)
timeFrame: 4 months
measure: Change from baseline in Quality Of Life Inventory (QOLI)
timeFrame: 2 weeks into treatment
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: 11 weeks
measure: Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
timeFrame: 4 months
measure: Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
timeFrame: 2 weeks into treatment
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: 11 weeks
measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 4 months
measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 2 weeks into treatment
measure: Change from baseline in mini-SPIN
timeFrame: Daily, 1-15 days into treatment
measure: Change from baseline in mini-SPIN
timeFrame: 11 weeks
measure: Change from baseline in mini-SPIN
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, Andersson G, Carlbring P; SOFIE-13 Research Group. Combining attention training with cognitive-behavior therapy in Internet-based self-help for social anxiety: study protocol for a randomized controlled trial. Trials. 2013 Mar 8;14:68. doi: 10.1186/1745-6215-14-68.
citation: Boettcher J, Hasselrot J, Sund E, Andersson G, Carlbring P. Combining attention training with internet-based cognitive-behavioural self-help for social anxiety: a randomised controlled trial. Cogn Behav Ther. 2014;43(1):34-48. doi: 10.1080/16506073.2013.809141. Epub 2013 Jul 30.