Treatment of Social Phobia Over the Internet

Not Applicable

Completed

• Conditions: Social Phobia
• Interventions: Behavioral: Internet-based cognitive behavioural therapy (iCBT); Behavioral: Internet-based computerized attention training

• Registration Number: NCT01312571
• Lead Sponsor: Umeå University

Brief Summary

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)?

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-31
• Study First Submitted QC: 2011-03-09
• Study First Posted: 2011-03-10
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-29
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cognitive behavior therapy via the internet	Internet-based cognitive behavioural therapy (iCBT)	Cognitive behavior therapy via the internet with therapist support.
Attentional retraining	Internet-based computerized attention training	Attentional retraining as described by Nader Amir.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Beck Anxiety Inventory (BAI)	pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)	Measure anxiety.; Change from baseline in anxiety symptoms expected between time frames.
Quality of Life Inventory (QOLI)	pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)	Measure quality of life.; Change from baseline in quality of life expected between time frames.
Variation in genes that have been associated with emotional processing	pretreatment (week 0).	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
Montgomery Åsberg Depression Rating Scale (MADRS-S)	pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)	Measure depression.; Change from baseline in depressive symptoms expected between time frames.

Trial Locations

Locations (1)

Department of Psychology, Umeå University; 🇸🇪 Umeå, Västerbotten, Sweden