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Completed

NCT Number: NCT01463137

Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder

A study investigating six different versions of a computerized attention bias modification internet program in the treatment of social phobia / social anxiety disorder.

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Key information

Conditions

Social Phobia Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychology, Umeå University

Umeå, Västerbotten County, 901 87, Sweden

About this study

Previous studies have shown that individuals with social phobia have attention biases, often focusing on aversive stimuli or avoiding aversive stimuli. Computerized training programs have been developed to implicitly direct the users attention towards a neutral, non-threatening stimuli. In this study, such a program will be compared with a program that implicitly directs the users' attention towards threatening cues. Pre/post-measurements will be compared in a sample of individuals that meet diagnostic criteria of Social Anxiety Disorder. Participants will be randomized to one of three groups, receiving one of the two variants of the attention bias modification program or a control training program.

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).
  • Comorbidity is allowed, but social phobia must be the primary diagnosis.

Exclusion criteria

  • Below 18 years old.
  • Individuals who are suicide prone will be excluded from the study.

Treatment and study plan

Attention Bias Modification

Behavioral

All arms will consist of 10 minutes of training in front of a computer screen (192 trials) once a day for 14 days.

Primary outcomes

  1. Change from baseline in Liebowitz Social Anxiety Scale self rated version

    Time frame: pretreatment (week 0), post treatment (week 2), 4 month follow-up

    Change from baseline in social anxiety symptoms expected between time frames.

Secondary outcomes

  1. Change from baseline in Social Phobia Screening Questionnaire

    Time frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up

    Social Phobia Screening Questionnaire (SPSQ), diagnostic tool for social phobia.

    Change from baseline in social anxiety symptoms expected between time frames.

  2. Change from baseline in Social Interaction Anxiety Scale (SIAS)

    Time frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up

    Change from baseline in social anxiety symptoms expected between time frames.

  3. Change from baseline in Social Phobia Scale (SPS)

    Time frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up

    Change from baseline in social anxiety symptoms expected between time frames.

  4. Change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS-S)

    Time frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up

    Measure depression.

    Change from baseline in depressive symptoms expected between time frames.

  5. Change from baseline in Quality of Life Inventory (QOLI)

    Time frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up

    Measure quality of life.

    Change from baseline in quality of life expected between time frames.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

Computerized Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder

Acronym: SOFIE-11

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 1, 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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