Skip to main content
OpenTrials
Completed

NCT Number: NCT01570400

Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT

The purpose of this study is to determine whether an internet-based treatment program, consisting of combined cognitive bias modification and cognitive behavioral therapy, reduces symptoms of social phobia among a population diagnosed with this disorder.

Completed

Looking for future studies?

Notify Me

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, 90187, Sweden

About this study

Previous studies have shown that individuals with social phobia have attention biases, often focusing on or avoiding aversive stimuli (such as judging facial expressions) and thereby reinforcing the bias. Computerized training programs have been developed to implicitly direct the users attention. In this study, such a program -- combined with an established, well-researched and proven effective form of internet-based cognitive behavioral therapy (iCBT) -- will be provided to 128 participants that meet the diagnostic criteria for social phobia, and the pre/post-measurements will be compared. Participants will be randomized to one of two groups, receiving one of two variants of the cognitive bias modification program (both receive iCBT).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent provided
  • Diagnosed social phobia (according to DSM-IV criteria)
  • Access to computer with internet connection

Exclusion criteria

  • Severe depression (and/or suicidal behavior)
  • Suffer from other severe psychiatric condition (e.g. psychosis)
  • Non-stable use of medication (3 months stable dosage)
  • Undergoing other, parallel psychological treatment

Treatment and study plan

Internet-administered cognitive behavioral therapy (iCBT)

Behavioral

Established form of internet-administered cognitive behavioral therapy. Controlled progress, self-help modules with psychoeducative texts, assignments and homework. Therapist assisted.

Cognitive bias modification training program variant 1

Behavioral

Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 4. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more negative word or face.

Duration: approx. 10 min. per session. Frequency: Once every day for 2 weeks.

Cognitive bias modification training program variant 2

Behavioral

Computerized, internet-based control training program, variant 2. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe follows the more positive stimulus and the more negative stimulus with equal frequency.

Duration: approx. 10 min. per session. Frequency: Once every day for 2 weeks.

Primary outcomes

  1. Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)

    Time frame: 24 hours

    The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.

  2. Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)

    Time frame: 11 weeks

    The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.

  3. Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)

    Time frame: 4 months

    The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.

  4. Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)

    Time frame: Two weeks into treatment

    The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.

Secondary outcomes

  1. Change from baseline in Quality Of Life Inventory (QOLI)

    Time frame: 24 hours

    The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.

  2. Change from baseline in Quality Of Life Inventory (QOLI)

    Time frame: 11 weeks

    The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.

  3. Change from baseline in Quality Of Life Inventory (QOLI)

    Time frame: 4 months

    The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.

  4. Change from baseline in Quality Of Life Inventory (QOLI)

    Time frame: 2 weeks into treatment

    The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.

  5. Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale

    Time frame: 24 hours

    Self-rated measurements of social anxiety/phobia.

  6. Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale

    Time frame: 11 weeks

    Self-rated measurements of social anxiety/phobia.

  7. Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale

    Time frame: 4 months

    Self-rated measurements of social anxiety/phobia.

  8. Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale

    Time frame: 2 weeks into treatment

    Self-rated measurements of social anxiety/phobia.

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

    Time frame: 24 hours

    9-item depression rating scale.

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

    Time frame: 11 weeks

    9-item depression rating scale.

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

    Time frame: 4 months

    9-item depression rating scale.

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

    Time frame: 2 weeks into treatment

    9-item depression rating scale.

  13. Change from baseline in mini-SPIN

    Time frame: Daily, 1-15 days into treatment

    Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.

  14. Change from baseline in mini-SPIN

    Time frame: 11 weeks

    Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.

  15. Change from baseline in mini-SPIN

    Time frame: 4 months

    Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

Reduction of Social Phobia Symptoms With Combined Internet-Based Cognitive Bias Modification and Cognitive Behavioral Therapy

Acronym: SOFIE13a

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2012
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.