Augmentation Study of A Computerized Treatment for Social Anxiety Disorder

NCT02372019 | Completed

• 1 other identifier: 2014-11-0009
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder

Keywords

Social Anxiety Disorder; Social Phobia; Reconsolidation; Cognitive Bias Modification; Interpretation Bias

Outcome Measures

Primary Outcomes (9)

• 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.

  pretreatment, 24-hour follow up

• 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.

  pre-treatment, 1-week follow up

• 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.

  pre-treatment, 2-week follow up

• 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.

  pretreatment, 24-hour follow up

• 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.

  pretreatment, 1-week follow up

• 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.

  pretreatment, 2-week follow up

• 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.

  pretreatment, 24-hour follow up

• 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.

  pretreatment, 1-week follow up

• 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.

  pretreatment, 2-week follow up

Secondary Outcomes (8)

• 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)

• 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)

• 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)

• Perception of Speech Performance Measure (PSP)

  2-week follow up (after speech stressor task)

• Self-Beliefs Related To Social Anxiety Scale (SBSA)

  pretreatment

Study Arms (3)

CBM With Active Fear Reactivation

EXPERIMENTAL

Behavioral: CBM With Active Fear Reactivation

CBM With Inert Fear Reactivation

ACTIVE COMPARATOR

Behavioral: CBM With Inert Fear Reactivation

Inert CBM With Inert Fear Reactivation

PLACEBO COMPARATOR

Behavioral: Inert CBM With Inert Fear Reactivation

Interventions

CBM With Active Fear Reactivation BEHAVIORAL

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.

CBM With Active Fear Reactivation

CBM With Inert Fear Reactivation BEHAVIORAL

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.

CBM With Inert Fear Reactivation

Inert CBM With Inert Fear Reactivation BEHAVIORAL

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.

Inert CBM With Inert Fear Reactivation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-65
• Score of 30 or above on LSAS
• Score of 1.4 or greater on ASSIQ

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Laboratory for the Study of Anxiety Disorders, University of Texas at Austin

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Michael J Telch, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 26, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

US (1)