Treatment of Social Phobia Over the Internet (SOFIE-8)

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)

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)?

Study Overview

• Status: Completed
• Conditions: Social Phobia
• Intervention / Treatment: Behavioral: Internet-based cognitive behavioural therapy (iCBT); Behavioral: Internet-based computerized attention training

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västerbotten
    • Umeå, Västerbotten, Sweden, 901 87
      • Department of Psychology, Umeå University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cognitive behavior therapy via the internet; Cognitive behavior therapy via the internet with therapist support.	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.
Active Comparator: Attentional retraining; Attentional retraining as described by Nader Amir.	Behavioral: 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Uppsala University
• Investigators: Study Director: Per Carlbring, Professor, Umeå University; Study Chair: Gerhard Andersson, Professor, Linkoeping University; Study Chair: Tomas Furmark, Ass. professor, Uppsala University; Study Chair: Carl-Johan Olsson, Post doc, Umeå center for Functional Brain Imaging; Study Chair: Owe Bodlund, Ass. professor, NUS; Study Chair: Kristoffer NT Månsson, Student, Umeå University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: August 31, 2010
• First Submitted That Met QC Criteria: March 9, 2011
• First Posted (Estimate): March 10, 2011

Study Record Updates

• Last Update Posted (Estimate): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 29, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobia, Social; Phobic Disorders
• Other Study ID Numbers: 2010-185-31 M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No