Augmentation Study of A Computerized Treatment for Social Anxiety Disorder
- Conditions
- Social Anxiety Disorder
- Interventions
- Behavioral: CBM With Inert Fear ReactivationBehavioral: CBM With Active Fear ReactivationBehavioral: Inert CBM With Inert Fear Reactivation
- Registration Number
- NCT02372019
- Lead Sponsor
- University of Texas at Austin
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
- Ages 18-65
- Score of 30 or above on LSAS
- Score of 1.4 or greater on ASSIQ
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CBM With Inert Fear Reactivation CBM With Inert Fear Reactivation - CBM With Active Fear Reactivation CBM With Active Fear Reactivation - Inert CBM With Inert Fear Reactivation Inert CBM With Inert Fear Reactivation -
- Primary Outcome Measures
Name Time Method Change From Baseline in Brief Fear of Negative Evaluation Scale (BFNE) at 24 Hours pretreatment, 24-hour follow up 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 pretreatment, 24-hour follow up 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 pretreatment, 1-week follow up 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 pretreatment, 2-week follow up 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 Liebowitz Social Anxiety Scale (LSAS) at 24 Hours pretreatment, 24-hour follow up 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 pre-treatment, 1-week follow up 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 2 Weeks pretreatment, 2-week follow up 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 Liebowitz Social Anxiety Scale (LSAS) at 2 Weeks pre-treatment, 2-week follow up 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 1 Week pretreatment, 1-week follow up 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.
- Secondary Outcome Measures
Name Time Method Word Sentence Association Paradigm (WSAP) 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) 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) 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) 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.
Self-Beliefs Related To Social Anxiety Scale (SBSA) pretreatment 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) pretreatment 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) pretreatment 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.
Brief State-Trait Anxiety Inventory- State (BSTAI) 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) 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) 2-week follow up (after speech stressor task) 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.
Dot Probe Task pretreatment 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.
Trial Locations
- Locations (1)
Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
🇺🇸Austin, Texas, United States