Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT

Study Overview
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Brief Summary
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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
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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).

Official Title
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Reduction of Social Phobia Symptoms With Combined Internet-Based Cognitive Bias Modification and Cognitive Behavioral Therapy

Conditions
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Social Phobia

Intervention / Treatment
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* Behavioral: Internet-administered cognitive behavioral therapy (iCBT)
* Behavioral: Cognitive bias modification training program variant 1
* Behavioral: Cognitive bias modification training program variant 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBM training program variant 1 + iCBT<br>Cognitive bias modification training program variant 1 combined with iCBT | Behavioral: Internet-administered cognitive behavioral therapy (iCBT)<br>* Established form of internet-administered cognitive behavioral therapy. Controlled progress, self-help modules with psychoeducative texts, assignments and homework. Therapist assisted.<br>Behavioral: Cognitive bias modification training program variant 1<br>* 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.<br>|
| Experimental: CBM training program variant 2 + iCBT<br>Cognitive bias modification training program variant 2 combined with iCBT | Behavioral: Internet-administered cognitive behavioral therapy (iCBT)<br>* Established form of internet-administered cognitive behavioral therapy. Controlled progress, self-help modules with psychoeducative texts, assignments and homework. Therapist assisted.<br>Behavioral: Cognitive bias modification training program variant 2<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 11 weeks | 
| 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 | 
| 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. | Two weeks into treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Quality Of Life Inventory (QOLI) | The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health. | 24 hours | 
| Change from baseline in Quality Of Life Inventory (QOLI) | The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health. | 11 weeks | 
| Change from baseline in Quality Of Life Inventory (QOLI) | The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health. | 4 months | 
| Change from baseline in Quality Of Life Inventory (QOLI) | The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health. | 2 weeks into treatment | 
| Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale | Self-rated measurements of social anxiety/phobia. | 24 hours | 
| Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale | Self-rated measurements of social anxiety/phobia. | 11 weeks | 
| Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale | Self-rated measurements of social anxiety/phobia. | 4 months | 
| Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale | Self-rated measurements of social anxiety/phobia. | 2 weeks into treatment | 
| Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) | 9-item depression rating scale. | 24 hours | 
| Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) | 9-item depression rating scale. | 11 weeks | 
| Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) | 9-item depression rating scale. | 4 months | 
| Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) | 9-item depression rating scale. | 2 weeks into treatment | 
| Change from baseline in mini-SPIN | Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale. | Daily, 1-15 days into treatment | 
| Change from baseline in mini-SPIN | Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale. | 11 weeks | 
| Change from baseline in mini-SPIN | Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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social anxiety, cognitive bias modification, social phobia