Social Phobia
Conditions
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)?
Interventions
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.
BEHAVIORALInternet-based computerized attention training
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.
Sponsors
Uppsala University
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
Sweden
Outcome results
None listed