Augmentation Study of A Computerized Treatment for Social Anxiety Disorder
Primary Purpose
Social Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBM With Active Fear Reactivation
CBM With Inert Fear Reactivation
Inert CBM With Inert Fear Reactivation
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Social Anxiety Disorder, Social Phobia, Reconsolidation, Cognitive Bias Modification, Interpretation Bias
Eligibility Criteria
Inclusion Criteria:
- Ages 18-65
- Score of 30 or above on LSAS
- Score of 1.4 or greater on ASSIQ
Exclusion Criteria:
- Receiving any form of anxiety medication or psychotherapy for anxiety during the past 3 months
- Scoring above a "1" on item 9 of the BDI-II (presence of serious suicidal ideation)
Sites / Locations
- Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
CBM With Active Fear Reactivation
CBM With Inert Fear Reactivation
Inert CBM With Inert Fear Reactivation
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) at 24 Hours
The LSAS is a commonly used measure of social anxiety that measures fear as well as avoidance behaviors concerning social interactions. The study will use a computerized, self-report version of the LSAS, which has demonstrated little deviation from clinician-administered LSAS scores.
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) at 1 Week
The LSAS is a commonly used measure of social anxiety that measures fear as well as avoidance behaviors concerning social interactions. The study will use a computerized, self-report version of the LSAS, which has demonstrated little deviation from clinician-administered LSAS scores.
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) at 2 Weeks
The LSAS is a commonly used measure of social anxiety that measures fear as well as avoidance behaviors concerning social interactions. The study will use a computerized, self-report version of the LSAS, which has demonstrated little deviation from clinician-administered LSAS scores.
Change From Baseline in Brief Fear of Negative Evaluation Scale (BFNE) at 24 Hours
The 12-item, self-report Brief Fear of Negative Evaluation Scale measures fear of negative evaluation by others, which is a distinguishing characteristic of social anxiety. The scale is derived from the original 30-item Fear of Negative Evaluation measurement.
Change From Baseline in Brief Fear of Negative Evaluation Scale (BFNE) at 1 Week
The 12-item, self-report Brief Fear of Negative Evaluation Scale measures fear of negative evaluation by others, which is a distinguishing characteristic of social anxiety. The scale is derived from the original 30-item Fear of Negative Evaluation measurement.
Change From Baseline in Brief Fear of Negative Evaluation Scale (BFNE) at 2 Weeks
The 12-item, self-report Brief Fear of Negative Evaluation Scale measures fear of negative evaluation by others, which is a distinguishing characteristic of social anxiety. The scale is derived from the original 30-item Fear of Negative Evaluation measurement.
Change From Baseline in Appraisal of Social Concerns Scale (ASC) at 24 Hours
The ASC is a 20-item self-report questionnaire that focuses on cognitions present in socially anxious patients. It measures concerns about negative evaluation, observable symptoms, and perceived social helplessness.
Change From Baseline in Appraisal of Social Concerns Scale (ASC) at 1 Week
The ASC is a 20-item self-report questionnaire that focuses on cognitions present in socially anxious patients. It measures concerns about negative evaluation, observable symptoms, and perceived social helplessness.
Change From Baseline in Appraisal of Social Concerns Scale (ASC) at 2 Weeks
The ASC is a 20-item self-report questionnaire that focuses on cognitions present in socially anxious patients. It measures concerns about negative evaluation, observable symptoms, and perceived social helplessness.
Secondary Outcome Measures
Word Sentence Association Paradigm (WSAP)
This measure of interpretation bias involves a series of trials in which an ambiguous sentence describing a social situation is presented, followed by the presentation of a single word corresponding to either a threat interpretation or a benign interpretation of the sentence. The participant's task is to indicate whether the sentence and the word are related.
Ambiguous Social Scenarios Interpretation Questionnaire (ASSIQ)
The ASSIQ is an alternative measure of interpretation bias, involving the presentation of an ambiguous social scenario, and the subsequent listing of three possible explanations corresponding to positive, neutral, and negative interpretations. Participants rate these explanations based on their likelihood of explaining the scenario. Stimuli are to be developed by the authors of the current study. In contrast to the WSAP, the ASSIQ is being used to assess more reflective aspects of interpretation bias.
Brief State-Trait Anxiety Inventory- State (BSTAI)
The BSTAI is a self-report measure comprised of six items taken from the State-Trait Anxiety Inventory, which together measure state anxiety. The BSTAI is highly correlated (r=0.93) with the full 20-item STAI. The instrument measures current state anxiety levels, but will also be administered immediately after the speech tasks to assess peak anxiety during the speech itself. During these instances, the wording of the BSTAI questions will be adapted to reflect this timing.
Perception of Speech Performance Measure (PSP)
This adapted 17-item measure will ask subjects to predict how others would rate the subject's own speech performance. It includes questions about both specific (voice steadiness) and global (appearance of confidence) items.
Self-Beliefs Related To Social Anxiety Scale (SBSA)
The SBSA is a self-report measure that includes 15 items assessing the presence of three types of self-beliefs common in socially anxious individuals: (a) excessively high self-standards, (b) conditional self-beliefs, and (c) unconditional self-beliefs. Assessments from this scale will be examined as a potential moderator of social phobia and interpretation bias improvement.
Interpretation of Positive Events Scale (IPES)
The IPES is a 13-item self-report questionnaire assessing negative interpretations of positive social events. Assessments from this scale will be examined as a potential moderator of social phobia and interpretation bias improvement.
Beck Depression Inventory-II (BDI-II)
The BDI-II is a self-report scale that is among the most commonly used measures of depression. Assessments from this scale will be examined as a potential moderator of social phobia and interpretation bias improvement.
Dot Probe Task
The dot probe task will be used in the current study to determine whether attentional bias moderates change in interpretation bias. The computerized paradigm involves the repeated presentation of two stimuli simultaneously, with one stimulus representing threat and the other stimulus representing safety. 500ms after stimulus onset, both stimuli are removed and one is replaced with a probe (for example, a letter would appear behind the former location of the threat stimulus or the safety stimulus). The participant's task is to determine the location of the probe. Attentional deployment prior to probe onset is inferred by response time latencies to probe location. Assessments from this task will be examined as a potential moderator of social phobia and interpretation bias improvement.
Full Information
NCT ID
NCT02372019
First Posted
February 10, 2015
Last Updated
December 4, 2020
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT02372019
Brief Title
Augmentation Study of A Computerized Treatment for Social Anxiety Disorder
Official Title
Augmenting Interpretative Cognitive Bias Modification Using Memory Reconsolidation Updating
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether briefly reactivating a fear memory 10 minutes prior to administering a social anxiety treatment will enhance the durability of treatment effects.
Detailed Description
This study examines whether cognitive bias modification of interpretation (CBM-I) for socially anxious individuals can be augmented with the inclusion of a fear memory reactivation prior to administration of CBM. To date, CBM-I generally involves presenting participants with short vignettes that have ambiguous meaning. The ambiguity is resolved by having the subject complete a word stem at the conclusion of the paragraph, resolving the ambiguity in a positive/negative/neutral fashion. CBM attempts to retrain the tendency for socially phobic individuals to adopt negative interpretations of ambiguous events by repeatedly presenting trials resolving in a positive fashion. An inert control can be administered by having the majority of CBM trials resolve in a neutral fashion, without having the vignette end in either a positive or negative fashion.
Reactivating a fear memory, followed by a short break, purportedly opens a window of several hours during which the fear memory is rendered labile, and so CBM given during this time should show greater durability of effects. However, manipulations given outside of this timeframe will presumably have no increased effects. Individuals exhibiting clinical levels of social anxiety, as measured with the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, will be randomly assigned to one of three conditions: (1) fear reactivation administered 10 minutes prior to CBM, (2) fear reactivation administered 12-36 hours prior to CBM, and (3) fear reactivation administered 12-36 hours prior to an inert form of CBM. A variety of measures measuring anxiety, interpretation bias, and cognitions will be repeatedly assessed across the study, including at pretreatment, post treatment, and at one and two week follow up. Additionally, several potential moderators of treatment outcome will be assessed prior to engaging in treatment. At two week follow up, participants will also be given a speech stressor task to determine its effect on subsequent interpretation bias.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
Social Anxiety Disorder, Social Phobia, Reconsolidation, Cognitive Bias Modification, Interpretation Bias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBM With Active Fear Reactivation
Arm Type
Experimental
Arm Title
CBM With Inert Fear Reactivation
Arm Type
Active Comparator
Arm Title
Inert CBM With Inert Fear Reactivation
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
CBM With Active Fear Reactivation
Intervention Description
Participants will undergo a fear reactivation trial, which involves giving a one-minute impromptu speech after only 30 seconds of preparation time. 10 minutes afterwards, they will be given CBM for interpretation bias. Training will involve 84 social scenario vignettes, with 70 resolving positively, 7 resolving negatively, and 7 resolving neutrally. This training takes places during the "memory reconsolidation window" that opens after fear reactivation, during which time the fear memory is in a labile state and thus more amenable to rewriting.
Intervention Type
Behavioral
Intervention Name(s)
CBM With Inert Fear Reactivation
Intervention Description
Participants will undergo a fear reactivation trial, which involves giving a one-minute impromptu speech after only 30 seconds of preparation time. 12 to 36 hours afterwards, they will be given CBM for interpretation bias. Training will involve 84 social scenario vignettes, with 70 resolving positively, 7 resolving negatively, and 7 resolving neutrally. Because this training takes places well outside of the "memory reconsolidation window" that opens shortly after fear reactivation, the reactivation is not expected to have any effect, and only serves as a control.
Intervention Type
Behavioral
Intervention Name(s)
Inert CBM With Inert Fear Reactivation
Intervention Description
Participants will undergo a fear reactivation trial, which involves giving a one-minute impromptu speech after only 30 seconds of preparation time. 12 to 36 hours afterwards, they will be given an inert form of CBM, which should not influence the direction of interpretation bias. Training will involve 84 social scenario vignettes, with 70 resolving neutrally, 7 resolving positively, and 7 resolving negatively. Because the CBM training takes places well outside of the "memory reconsolidation window" that opens after fear reactivation, the reactivation is not expected to have any effect, and the inert CBM training is not expected to have any effect either. This condition only serves as a control for the other two conditions.
Primary Outcome Measure Information:
Title
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) at 24 Hours
Description
The LSAS is a commonly used measure of social anxiety that measures fear as well as avoidance behaviors concerning social interactions. The study will use a computerized, self-report version of the LSAS, which has demonstrated little deviation from clinician-administered LSAS scores.
Time Frame
pretreatment, 24-hour follow up
Title
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) at 1 Week
Description
The LSAS is a commonly used measure of social anxiety that measures fear as well as avoidance behaviors concerning social interactions. The study will use a computerized, self-report version of the LSAS, which has demonstrated little deviation from clinician-administered LSAS scores.
Time Frame
pre-treatment, 1-week follow up
Title
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) at 2 Weeks
Description
The LSAS is a commonly used measure of social anxiety that measures fear as well as avoidance behaviors concerning social interactions. The study will use a computerized, self-report version of the LSAS, which has demonstrated little deviation from clinician-administered LSAS scores.
Time Frame
pre-treatment, 2-week follow up
Title
Change From Baseline in Brief Fear of Negative Evaluation Scale (BFNE) at 24 Hours
Description
The 12-item, self-report Brief Fear of Negative Evaluation Scale measures fear of negative evaluation by others, which is a distinguishing characteristic of social anxiety. The scale is derived from the original 30-item Fear of Negative Evaluation measurement.
Time Frame
pretreatment, 24-hour follow up
Title
Change From Baseline in Brief Fear of Negative Evaluation Scale (BFNE) at 1 Week
Description
The 12-item, self-report Brief Fear of Negative Evaluation Scale measures fear of negative evaluation by others, which is a distinguishing characteristic of social anxiety. The scale is derived from the original 30-item Fear of Negative Evaluation measurement.
Time Frame
pretreatment, 1-week follow up
Title
Change From Baseline in Brief Fear of Negative Evaluation Scale (BFNE) at 2 Weeks
Description
The 12-item, self-report Brief Fear of Negative Evaluation Scale measures fear of negative evaluation by others, which is a distinguishing characteristic of social anxiety. The scale is derived from the original 30-item Fear of Negative Evaluation measurement.
Time Frame
pretreatment, 2-week follow up
Title
Change From Baseline in Appraisal of Social Concerns Scale (ASC) at 24 Hours
Description
The ASC is a 20-item self-report questionnaire that focuses on cognitions present in socially anxious patients. It measures concerns about negative evaluation, observable symptoms, and perceived social helplessness.
Time Frame
pretreatment, 24-hour follow up
Title
Change From Baseline in Appraisal of Social Concerns Scale (ASC) at 1 Week
Description
The ASC is a 20-item self-report questionnaire that focuses on cognitions present in socially anxious patients. It measures concerns about negative evaluation, observable symptoms, and perceived social helplessness.
Time Frame
pretreatment, 1-week follow up
Title
Change From Baseline in Appraisal of Social Concerns Scale (ASC) at 2 Weeks
Description
The ASC is a 20-item self-report questionnaire that focuses on cognitions present in socially anxious patients. It measures concerns about negative evaluation, observable symptoms, and perceived social helplessness.
Time Frame
pretreatment, 2-week follow up
Secondary Outcome Measure Information:
Title
Word Sentence Association Paradigm (WSAP)
Description
This measure of interpretation bias involves a series of trials in which an ambiguous sentence describing a social situation is presented, followed by the presentation of a single word corresponding to either a threat interpretation or a benign interpretation of the sentence. The participant's task is to indicate whether the sentence and the word are related.
Time Frame
pretreatment (assessed twice: before & after fear retrieval), post-treatment (within 30 minutes following CBM administration), 1-week follow up, 2-week follow up (assessed twice at 2-week follow up: before and after a speech task stressor)
Title
Ambiguous Social Scenarios Interpretation Questionnaire (ASSIQ)
Description
The ASSIQ is an alternative measure of interpretation bias, involving the presentation of an ambiguous social scenario, and the subsequent listing of three possible explanations corresponding to positive, neutral, and negative interpretations. Participants rate these explanations based on their likelihood of explaining the scenario. Stimuli are to be developed by the authors of the current study. In contrast to the WSAP, the ASSIQ is being used to assess more reflective aspects of interpretation bias.
Time Frame
pretreatment, post-treatment (within 30 minutes following CBM administration), 1-week follow up, 2-week follow up (assessed twice at 2-week follow up: before and after a speech task stressor)
Title
Brief State-Trait Anxiety Inventory- State (BSTAI)
Description
The BSTAI is a self-report measure comprised of six items taken from the State-Trait Anxiety Inventory, which together measure state anxiety. The BSTAI is highly correlated (r=0.93) with the full 20-item STAI. The instrument measures current state anxiety levels, but will also be administered immediately after the speech tasks to assess peak anxiety during the speech itself. During these instances, the wording of the BSTAI questions will be adapted to reflect this timing.
Time Frame
pretreatment (assessed 3x: before & after fear retrieval, & immediately before CBM), post treatment (within 30 minutes following CBM administration), 1-week follow up, 2-week follow up (assessed 2x at two-week follow up: before & after speech stressor)
Title
Perception of Speech Performance Measure (PSP)
Description
This adapted 17-item measure will ask subjects to predict how others would rate the subject's own speech performance. It includes questions about both specific (voice steadiness) and global (appearance of confidence) items.
Time Frame
2-week follow up (after speech stressor task)
Title
Self-Beliefs Related To Social Anxiety Scale (SBSA)
Description
The SBSA is a self-report measure that includes 15 items assessing the presence of three types of self-beliefs common in socially anxious individuals: (a) excessively high self-standards, (b) conditional self-beliefs, and (c) unconditional self-beliefs. Assessments from this scale will be examined as a potential moderator of social phobia and interpretation bias improvement.
Time Frame
pretreatment
Title
Interpretation of Positive Events Scale (IPES)
Description
The IPES is a 13-item self-report questionnaire assessing negative interpretations of positive social events. Assessments from this scale will be examined as a potential moderator of social phobia and interpretation bias improvement.
Time Frame
pretreatment
Title
Beck Depression Inventory-II (BDI-II)
Description
The BDI-II is a self-report scale that is among the most commonly used measures of depression. Assessments from this scale will be examined as a potential moderator of social phobia and interpretation bias improvement.
Time Frame
pretreatment
Title
Dot Probe Task
Description
The dot probe task will be used in the current study to determine whether attentional bias moderates change in interpretation bias. The computerized paradigm involves the repeated presentation of two stimuli simultaneously, with one stimulus representing threat and the other stimulus representing safety. 500ms after stimulus onset, both stimuli are removed and one is replaced with a probe (for example, a letter would appear behind the former location of the threat stimulus or the safety stimulus). The participant's task is to determine the location of the probe. Attentional deployment prior to probe onset is inferred by response time latencies to probe location. Assessments from this task will be examined as a potential moderator of social phobia and interpretation bias improvement.
Time Frame
pretreatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 18-65
Score of 30 or above on LSAS
Score of 1.4 or greater on ASSIQ
Exclusion Criteria:
Receiving any form of anxiety medication or psychotherapy for anxiety during the past 3 months
Scoring above a "1" on item 9 of the BDI-II (presence of serious suicidal ideation)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Telch, Ph.D.
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Augmentation Study of A Computerized Treatment for Social Anxiety Disorder
We'll reach out to this number within 24 hrs