Clinical trial NCT02372019: Augmentation Study of A Computerized Treatment for Social Anxiety Disorder
Official title: Augmenting Interpretative Cognitive Bias Modification Using Memory Reconsolidation Updating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: Social Anxiety Disorder
Social Phobia
Reconsolidation
Cognitive Bias Modification
Interpretation Bias
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) at 24 Hours
timeFrame: pretreatment, 24-hour follow up
measure: Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) at 1 Week
timeFrame: pre-treatment, 1-week follow up
measure: Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) at 2 Weeks
timeFrame: pre-treatment, 2-week follow up
measure: Change From Baseline in Brief Fear of Negative Evaluation Scale (BFNE) at 24 Hours
timeFrame: pretreatment, 24-hour follow up
measure: Change From Baseline in Brief Fear of Negative Evaluation Scale (BFNE) at 1 Week
timeFrame: pretreatment, 1-week follow up
measure: Change From Baseline in Brief Fear of Negative Evaluation Scale (BFNE) at 2 Weeks
timeFrame: pretreatment, 2-week follow up
measure: Change From Baseline in Appraisal of Social Concerns Scale (ASC) at 24 Hours
timeFrame: pretreatment, 24-hour follow up
measure: Change From Baseline in Appraisal of Social Concerns Scale (ASC) at 1 Week
timeFrame: pretreatment, 1-week follow up
measure: Change From Baseline in Appraisal of Social Concerns Scale (ASC) at 2 Weeks
timeFrame: pretreatment, 2-week follow up
Secondary outcomes:
measure: Word Sentence Association Paradigm (WSAP)
timeFrame: 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)
measure: Ambiguous Social Scenarios Interpretation Questionnaire (ASSIQ)
timeFrame: 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)
measure: Brief State-Trait Anxiety Inventory- State (BSTAI)
timeFrame: 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)
measure: Perception of Speech Performance Measure (PSP)
timeFrame: 2-week follow up (after speech stressor task)
measure: Self-Beliefs Related To Social Anxiety Scale (SBSA)
timeFrame: pretreatment
measure: Interpretation of Positive Events Scale (IPES)
timeFrame: pretreatment
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: pretreatment
measure: Dot Probe Task
timeFrame: pretreatment
Other outcomes:
Locations:
city: Austin
country: United States
facility: Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Michael J Telch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: