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Completed

NCT Number: NCT01577303

Treatment of Social Phobia With Cognitive Bias Modification

The purpose of this study is to determine whether different internet-based treatment programs, consisting of cognitive bias modification, reduce symptoms of social phobia among a population diagnosed with this disorder.

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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, 90187, 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 provided to 128 participants that meet the diagnostic criteria for social phobia. It will be compared with a program that implicitly directs the users' attention towards threatening cues. Pre/post-measurements will be compared. Participants will be randomized to one of three groups, receiving one of the two variants of the cognitive bias modification program or a control training.

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, and printer

Exclusion criteria

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

Treatment and study plan

Cognitive bias modification training program variant 1

Behavioral

Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 1. Participant is exposed to two words -- 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 and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word pairs are shown during a session, of one third is the neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more positive word.

Cognitive bias modification training program variant 2

Behavioral

Computerized, internet-based training program for implicit modification of cognitive bias of attention, 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 always follows the more positive word or face.

CBM training program variant 3

Behavioral

Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 3. Participant is exposed to two words -- 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 and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word 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.

CBM training program variant 4

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.

Control training variant 1

Behavioral

Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 1. Participant is exposed to a pair of words -- 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 and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word 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 word and the more negative word with equal frequency..

Control training 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.

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: 14 days

    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.

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: 14 days

    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 Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: 24 hours

    9-item depression rating scale.

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

    Time frame: 14 days

    9-item depression rating scale.

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

    Time frame: 4 months

    9-item depression rating scale.

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

    Time frame: 24 hours

    Self-rated measurements of social anxiety/phobia.

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

    Time frame: 14 days

    Self-rated measurements of social anxiety/phobia.

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

    Time frame: 4 months

    Self-rated measurements of social anxiety/phobia.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

Reduction of Social Phobia Symptoms With Internet-Based Cognitive Bias Modification

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 13, 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.

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