Overview

This trial has been completed.

Condition social phobia
Treatments internet-administered cognitive behavioral therapy (icbt), cognitive bias modification training program variant 1, cognitive bias modification training program variant 2
Sponsor Umeå University
Start date September 2012
End date September 2014
Trial size 133 participants
Trial identifier NCT01570400, SOFIE13a

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Cognitive bias modification training program variant 1 combined with iCBT
internet-administered cognitive behavioral therapy (icbt)
Established form of internet-administered cognitive behavioral therapy. Controlled progress, self-help modules with psychoeducative texts, assignments and homework. Therapist assisted.
cognitive bias modification training program variant 1
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. Duration: approx. 10 min. per session. Frequency: Once every day for 2 weeks.
(Experimental)
Cognitive bias modification training program variant 2 combined with iCBT
internet-administered cognitive behavioral therapy (icbt)
Established form of internet-administered cognitive behavioral therapy. Controlled progress, self-help modules with psychoeducative texts, assignments and homework. Therapist assisted.
cognitive bias modification training program 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. Duration: approx. 10 min. per session. Frequency: Once every day for 2 weeks.

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: 11 weeks
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
time frame: 4 months
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
time frame: Two weeks into treatment

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: 11 weeks
Change from baseline in Quality Of Life Inventory (QOLI)
time frame: 4 months
Change from baseline in Quality Of Life Inventory (QOLI)
time frame: 2 weeks into treatment
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: 11 weeks
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
time frame: 4 months
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
time frame: 2 weeks into treatment
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: 11 weeks
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
time frame: 4 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
time frame: 2 weeks into treatment
Change from baseline in mini-SPIN
time frame: Daily, 1-15 days into treatment
Change from baseline in mini-SPIN
time frame: 11 weeks
Change from baseline in mini-SPIN
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 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

Additional Information

Official title Reduction of Social Phobia Symptoms With Combined Internet-Based Cognitive Bias Modification and Cognitive Behavioral Therapy
Principal investigator Per Carlbring, Professor
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).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Umeå University.