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Augmentation Study of A Computerized Treatment for Social Anxiety Disorder

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Social Anxiety Disorder

Treatments

Behavioral: CBM With Inert Fear Reactivation
Behavioral: Inert CBM With Inert Fear Reactivation
Behavioral: CBM With Active Fear Reactivation

Study type

Interventional

Funder types

Other

Identifiers

NCT02372019
2014-11-0009

Details and patient eligibility

About

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.

Full 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.

Enrollment

74 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

74 participants in 3 patient groups, including a placebo group

CBM With Active Fear Reactivation
Experimental group
Treatment:
Behavioral: CBM With Active Fear Reactivation
CBM With Inert Fear Reactivation
Active Comparator group
Treatment:
Behavioral: CBM With Inert Fear Reactivation
Inert CBM With Inert Fear Reactivation
Placebo Comparator group
Treatment:
Behavioral: Inert CBM With Inert Fear Reactivation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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