Treatment of Social Phobia With Cognitive Bias Modification

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Per Carlbring, PhD, Umeå University
ClinicalTrials.gov Identifier:
NCT01577303
First received: April 11, 2012
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Social Phobia
Behavioral: Cognitive bias modification training program variant 1
Behavioral: Cognitive bias modification training program variant 2
Behavioral: CBM training program variant 3
Behavioral: CBM training program variant 4
Behavioral: Control training variant 1
Behavioral: Control training variant 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Reduction of Social Phobia Symptoms With Internet-Based Cognitive Bias Modification

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Self-rated measurements of social anxiety/phobia.

  • Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Self-rated measurements of social anxiety/phobia.

  • Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Self-rated measurements of social anxiety/phobia.


Estimated Enrollment: 128
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBM training program variant 1
Attention training towards positive cues using words as stimuli
Behavioral: Cognitive bias modification training program variant 1
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.
Experimental: CBM training program variant 2
Attention training towards positive cues using words and faces as stimuli
Behavioral: Cognitive bias modification training program variant 2
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.
Experimental: CBM training program variant 3
Attention training towards negative using words as stimuli
Behavioral: CBM training program variant 3
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.
Experimental: CBM training program variant 4
Attention training towards negative using words and faces
Behavioral: CBM training program variant 4
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.
Experimental: Control training variant 1
Control training condition using words as stimuli
Behavioral: Control training variant 1
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..
Experimental: Control training variant 2
Control training condition using words and faces as stimuli
Behavioral: Control training variant 2
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577303

Locations
Sweden
Department of Psychology, Umeå University
Umeå, Västerbotten, Sweden, 90187
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Per Carlbring, Professor Department of Psychology, Umeå University
  More Information

No publications provided

Responsible Party: Per Carlbring, PhD, Professor, Umeå University
ClinicalTrials.gov Identifier: NCT01577303     History of Changes
Other Study ID Numbers: Attention training
Study First Received: April 11, 2012
Last Updated: January 18, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
social phobia
social anxiety
cognitive bias modification

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 30, 2014