Clinical trial NCT01312571: Treatment of Social Phobia Over the Internet
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Phobia
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2011-03-10
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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)?


Eligibility criteria: 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.

Primary outcomes:
measure: Differences in recruited brain regions measured using regional cerebral blood flow
timeFrame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
measure: Social Phobia Screening Questionnaire (SPSQ)
timeFrame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
measure: Liebowitz Social Anxiety Scale self rated version (LSAS-SR)
timeFrame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
measure: Social Interaction Anxiety Scale (SIAS)
timeFrame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
measure: Social Phobia Scale (SPS)
timeFrame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Secondary outcomes:
measure: Variation in genes that have been associated with emotional processing
timeFrame: pretreatment (week 0).
measure: Montgomery Åsberg Depression Rating Scale (MADRS-S)
timeFrame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
measure: Beck Anxiety Inventory (BAI)
timeFrame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
measure: Quality of Life Inventory (QOLI)
timeFrame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Psychology, Umeå University
state: Västerbotten
Study officials:
affiliation: Umeå University
name: Per Carlbring, Professor
role: STUDY_DIRECTOR
affiliation: Linkoeping University
name: Gerhard Andersson, Professor
role: STUDY_CHAIR
affiliation: Uppsala University
name: Tomas Furmark, Ass. professor
role: STUDY_CHAIR
affiliation: Umeå center for Functional Brain Imaging
name: Carl-Johan Olsson, Post doc
role: STUDY_CHAIR
affiliation: NUS
name: Owe Bodlund, Ass. professor
role: STUDY_CHAIR
affiliation: Umeå University
name: Kristoffer NT Månsson, Student
role: STUDY_CHAIR
References:
citation: Mansson KN, Frick A, Boraxbekk CJ, Marquand AF, Williams SC, Carlbring P, Andersson G, Furmark T. Predicting long-term outcome of Internet-delivered cognitive behavior therapy for social anxiety disorder using fMRI and support vector machine learning. Transl Psychiatry. 2015 Mar 17;5(3):e530. doi: 10.1038/tp.2015.22.
citation: Mansson KN, Salami A, Frick A, Carlbring P, Andersson G, Furmark T, Boraxbekk CJ. Neuroplasticity in response to cognitive behavior therapy for social anxiety disorder. Transl Psychiatry. 2016 Feb 2;6(2):e727. doi: 10.1038/tp.2015.218.
citation: Mansson KN, Carlbring P, Frick A, Engman J, Olsson CJ, Bodlund O, Furmark T, Andersson G. Altered neural correlates of affective processing after internet-delivered cognitive behavior therapy for social anxiety disorder. Psychiatry Res. 2013 Dec 30;214(3):229-37. doi: 10.1016/j.pscychresns.2013.08.012. Epub 2013 Sep 21.