Treatment of Social Phobia Over the Internet

Study Overview
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Brief Summary
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Forty-eight people diagnosed with social phobia in an experimental study that randomized into two treatment groups: 1) Internet-based Cognitive Behavioural Therapy (iCBT) (n = 24) or 2) computerized attention training (n = 24). After nine weeks we change the condition of the two groups of research participants, which should therefore be given both treatments. Pre-and post measurement of functional magnetic resonance imaging (fMRI) will take place in the first round of treatment. Genotyping based on saliva samples takes place before the start of treatment, at the first fMRI measurement, for those who voluntarily leave the sample. Study hypothesis How is the brain activity of emotional processing and anxiety affected after completing an Internet-based CBT compared with computerized attention training? Does the treatment response of an Internet based treatment affects by variations in serotonin-transporter-linked promoter region (5-HTTLPR) and tryptophan hydroxylase-3 (TPH3) genes? How is the genetic variations related to symptoms in social phobia (pre treatment)?

Official Title
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Functional Magnetic Resonance Imaging (fMRI) and Treatment of Social Phobia Over the Internet: Cognitive Behavioural Therapy (CBT) Versus Computerized Attention Training and the Possible Effect of Genetic Variation. (SOFIE-8)

Conditions
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Social Phobia

Intervention / Treatment
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* Behavioral: Internet-based cognitive behavioural therapy (iCBT)
* Behavioral: Internet-based computerized attention training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must meet criteria for social phobia using the International classification system Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). Exclusion Criteria: Individuals with current depression and/or is suicide prone will be excluded from the study. With fMRI the following criteria must not be filled: previous surgery in the heart or brain, metals implanted in the body, dental braces or bridge; piercings that can´t be taken out, tattoos (shoulders, arms and back is not so good, the legs are okay if it is not too large); trouble to lie still for about an hour, pregnancy or history of neurological diseases.

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive behavior therapy via the internet<br>Cognitive behavior therapy via the internet with therapist support. | Behavioral: Internet-based cognitive behavioural therapy (iCBT)<br>* The Internet-based cognitive behavioural therapy (iCBT) consists of our structured self-help program lasting a total of nine active treatment weeks. This treatment program has been well evaluated and involved in several research projects.<br>|
| Active Comparator: Attentional retraining<br>Attentional retraining as described by Nader Amir. | Behavioral: Internet-based computerized attention training<br>* The Internet-based computerized attention training program lasting a total of four active treatment weeks. The treatment is consist of two training sessions per week, about 10 minutes long.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in recruited brain regions measured using regional cerebral blood flow | Blood-oxygen-level dependence (BOLD) signal change as measured with 3.0 T fMRI Change from baseline in BOLD signal expected between time frames. | pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) | 
| Social Phobia Screening Questionnaire (SPSQ) | Social Phobia Screening Questionnaire (SPSQ), diagnostic tool for social phobia. Change from baseline in social anxiety symptoms expected between time frames. | pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) | 
| Liebowitz Social Anxiety Scale self rated version (LSAS-SR) | Measure social anxiety and social phobia. Change from baseline in social anxiety symptoms expected between time frames. | pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) | 
| Social Interaction Anxiety Scale (SIAS) | Measure social anxiety and social phobia. Change from baseline in social anxiety symptoms expected between time frames. | pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) | 
| Social Phobia Scale (SPS) | Measure social phobia. Change from baseline in social anxiety symptoms expected between time frames. | pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in genes that have been associated with emotional processing | We will study allelic variation in genes that have been associated with emotional processing e.g. monoaminergic gene polymorphisms such as the serotonin-transporter-linked promoter region (5-HTTLPR), tryptophan hydroxylase-2 (TPH2) G-703T, and Catechol-O-methyltransferase (COMT) 158Val/Met polymorphism | pretreatment (week 0). | 
| Montgomery Åsberg Depression Rating Scale (MADRS-S) | Measure depression. Change from baseline in depressive symptoms expected between time frames. | pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) | 
| Beck Anxiety Inventory (BAI) | Measure anxiety. Change from baseline in anxiety symptoms expected between time frames. | pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) | 
| Quality of Life Inventory (QOLI) | Measure quality of life. Change from baseline in quality of life expected between time frames. | pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) |