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Augmentation Study of A Computerized Treatment for Social Anxiety Disorder

NCT ID: NCT02372019

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Social Anxiety Disorder

Keywords

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Social Anxiety Disorder Social Phobia Reconsolidation Cognitive Bias Modification Interpretation Bias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CBM With Active Fear Reactivation

Group Type EXPERIMENTAL

CBM With Active Fear Reactivation

Intervention Type 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 Inert Fear Reactivation

Group Type ACTIVE_COMPARATOR

CBM With Inert Fear Reactivation

Intervention Type 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.

Inert CBM With Inert Fear Reactivation

Group Type PLACEBO_COMPARATOR

Inert CBM With Inert Fear Reactivation

Intervention Type 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.

Interventions

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CBM With Active Fear Reactivation

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

CBM With Inert Fear Reactivation

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

Inert CBM With Inert Fear Reactivation

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Michael J. Telch

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael J Telch, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2014-11-0009

Identifier Type: -

Identifier Source: org_study_id