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Completed

NCT Number: NCT01312571

Treatment of Social Phobia Over the Internet

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)?

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Key information

Conditions

Social Phobia Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychology, Umeå University

Umeå, Västerbotten County, 901 87, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internet-based Cognitive Behavioural Therapy (iCBT)

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Differences in recruited brain regions measured using regional cerebral blood flow

    Time frame: 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.

  2. Social Phobia Screening Questionnaire (SPSQ)

    Time frame: 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.

  3. Liebowitz Social Anxiety Scale self rated version (LSAS-SR)

    Time frame: 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.

  4. Social Interaction Anxiety Scale (SIAS)

    Time frame: 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.

  5. Social Phobia Scale (SPS)

    Time frame: 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.

Secondary outcomes

  1. Variation in genes that have been associated with emotional processing

    Time frame: 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

  2. Montgomery Åsberg Depression Rating Scale (MADRS-S)

    Time frame: 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.

  3. Beck Anxiety Inventory (BAI)

    Time frame: 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.

  4. Quality of Life Inventory (QOLI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Uppsala University

Registry information

Official study 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)

Acronym: SOFIE-8

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Mar 10, 2011
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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