Treatment of Social Phobia Over the Internet

Social Phobia Clinical Trial

— SOFIE-8  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312571
• Other study ID #: 2010-185-31 M
• Status: Completed
• Phase: N/A
• First received: August 31, 2010
• Last updated: October 29, 2016
• Start date: August 2010
• Est. completion date: February 2016

Study information

• Verified date: October 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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)?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phobic Disorders
• Social Phobia

Intervention

Behavioral:
• Internet-based cognitive behavioural therapy (iCBT)
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.
• Internet-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.

Locations

Country	Name	City	State
Sweden	Department of Psychology, Umeå University	Umeå	Västerbotten

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Månsson 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) — View Citation

Månsson 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:e530. doi: 10.1038/tp.2015.22. — View Citation

Månsson 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:e727. doi: 10.1038/tp.2015.218. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	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).	Yes
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No