search
Back to results

Treatment of Social Phobia With Cognitive Bias Modification

Primary Purpose

Social Phobia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive bias modification training program variant 1
Cognitive bias modification training program variant 2
CBM training program variant 3
CBM training program variant 4
Control training variant 1
Control training variant 2
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Phobia focused on measuring social phobia, social anxiety, cognitive bias modification

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychology, Umeå University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

CBM training program variant 1

CBM training program variant 2

CBM training program variant 3

CBM training program variant 4

Control training variant 1

Control training variant 2

Arm Description

Attention training towards positive cues using words as stimuli

Attention training towards positive cues using words and faces as stimuli

Attention training towards negative using words as stimuli

Attention training towards negative using words and faces

Control training condition using words as stimuli

Control training condition using words and faces as stimuli

Outcomes

Primary Outcome Measures

Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
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)
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)
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)
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)
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)
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)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Self-rated measurements of social anxiety/phobia.
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Self-rated measurements of social anxiety/phobia.
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Self-rated measurements of social anxiety/phobia.

Full Information

First Posted
April 11, 2012
Last Updated
October 29, 2016
Sponsor
Umeå University
search

1. Study Identification

Unique Protocol Identification Number
NCT01577303
Brief Title
Treatment of Social Phobia With Cognitive Bias Modification
Official Title
Reduction of Social Phobia Symptoms With Internet-Based Cognitive Bias Modification
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
Keywords
social phobia, social anxiety, cognitive bias modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBM training program variant 1
Arm Type
Experimental
Arm Description
Attention training towards positive cues using words as stimuli
Arm Title
CBM training program variant 2
Arm Type
Experimental
Arm Description
Attention training towards positive cues using words and faces as stimuli
Arm Title
CBM training program variant 3
Arm Type
Experimental
Arm Description
Attention training towards negative using words as stimuli
Arm Title
CBM training program variant 4
Arm Type
Experimental
Arm Description
Attention training towards negative using words and faces
Arm Title
Control training variant 1
Arm Type
Experimental
Arm Description
Control training condition using words as stimuli
Arm Title
Control training variant 2
Arm Type
Experimental
Arm Description
Control training condition using words and faces as stimuli
Intervention Type
Behavioral
Intervention Name(s)
Cognitive bias modification training program variant 1
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive bias modification training program variant 2
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBM training program variant 3
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBM training program variant 4
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control training variant 1
Intervention Description
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..
Intervention Type
Behavioral
Intervention Name(s)
Control training variant 2
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
Description
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.
Time Frame
24 hours
Title
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
Description
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.
Time Frame
14 days
Title
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change from baseline in Quality Of Life Inventory (QOLI)
Description
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.
Time Frame
24 hours
Title
Change from baseline in Quality Of Life Inventory (QOLI)
Description
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.
Time Frame
14 days
Title
Change from baseline in Quality Of Life Inventory (QOLI)
Description
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.
Time Frame
4 months
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
24 hours
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
14 days
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
4 months
Title
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Description
Self-rated measurements of social anxiety/phobia.
Time Frame
24 hours
Title
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Description
Self-rated measurements of social anxiety/phobia.
Time Frame
14 days
Title
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Description
Self-rated measurements of social anxiety/phobia.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Carlbring, Professor
Organizational Affiliation
Department of Psychology, Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology, Umeå University
City
Umeå
State/Province
Västerbotten
ZIP/Postal Code
90187
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24098630
Citation
Boettcher J, Leek L, Matson L, Holmes EA, Browning M, MacLeod C, Andersson G, Carlbring P. Internet-based attention bias modification for social anxiety: a randomised controlled comparison of training towards negative and training towards positive cues. PLoS One. 2013 Sep 30;8(9):e71760. doi: 10.1371/journal.pone.0071760. eCollection 2013.
Results Reference
result

Learn more about this trial

Treatment of Social Phobia With Cognitive Bias Modification

We'll reach out to this number within 24 hrs