Social Anxiety DisorderNCT02372019

Augmentation Study of A Computerized Treatment for Social Anxiety Disorder

A study testing CBM With Active Fear Reactivation, CBM With Inert Fear Reactivation and Inert CBM With Inert Fear Reactivation in people with Social Anxiety Disorder, run by University of Texas at Austin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Social Anxiety Disorder
What is being tested?: CBM With Active Fear Reactivation, CBM With Inert Fear Reactivation and Inert CBM With Inert Fear Reactivation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: 1 siteUnited States
Study dates: Feb 2015to May 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
Austin, Texas, 78705

Other trials in United States

About this study

Official title: Augmenting Interpretative Cognitive Bias Modification Using Memory Reconsolidation Updating

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.

Read the 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.

Conditions: Social Anxiety Disorder
Being tested: CBM With Active Fear Reactivation, CBM With Inert Fear Reactivation, Inert CBM With Inert Fear Reactivation
Keywords: Social Anxiety Disorder, Social Phobia, Reconsolidation, Cognitive Bias Modification, Interpretation Bias
Medical subject headings: Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBM With Active Fear ReactivationBehavioural
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 ReactivationBehavioural
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 ReactivationBehavioural
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.

Study groups in NCT02372019
Study group	Role	What they receive
CBM With Active Fear Reactivation	Experimental	Not described Receives: Behavioral: CBM With Active Fear Reactivation
CBM With Inert Fear Reactivation	Active comparator	Not described Receives: Behavioral: CBM With Inert Fear Reactivation
Inert CBM With Inert Fear Reactivation	Placebo comparator	Not described Receives: Behavioral: Inert CBM With Inert Fear Reactivation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pretreatment, 2-week follow up

Secondary outcomes (8)

Word Sentence Association Paradigm (WSAP)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 2-week follow up (after speech stressor task)
Self-Beliefs Related To Social Anxiety Scale (SBSA)
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.
Measured: pretreatment
Interpretation of Positive Events Scale (IPES)
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.
Measured: pretreatment
Beck Depression Inventory-II (BDI-II)
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.
Measured: pretreatment
Dot Probe Task
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.
Measured: pretreatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015May 2017

First posted26 Feb 2015 (estimated)
Study startFeb 2015
Primary completionMay 2017
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
More trials run by University of Texas at AustinThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02372019
Sponsor's protocol ID: 2014-11-0009
Status last verified: Dec 2020
First submitted: 10 Feb 2015
Last updated: 8 Dec 2020
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Social Anxiety Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Augmenting Interpretative Cognitive Bias Modification Using Memory Reconsolidation Updating
ClinicalTrials.gov ID: NCT02372019
Acronym / sponsor ID: 2014-11-0009
Conditions: Social Anxiety Disorder
Keywords: Social Anxiety Disorder, Social Phobia, Reconsolidation, Cognitive Bias Modification, Interpretation Bias
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: University of Texas at AustinUniversity, hospital or other
Study start: Feb 2015
Primary completion: May 2017 (actual)
Study completion: May 2017 (actual)
First posted: 26 Feb 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CBM With Active Fear ReactivationParticipants 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.	Behavioural	CBM With Active Fear Reactivation
CBM With Inert Fear ReactivationParticipants 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.	Behavioural	CBM With Inert Fear Reactivation
Inert CBM With Inert Fear ReactivationParticipants 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.	Behavioural	Inert CBM With Inert Fear Reactivation

Primary outcome

Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) at 24 Hours
Time frame: 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
Time frame: 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 Liebowitz Social Anxiety Scale (LSAS) at 2 Weeks
Time frame: 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 24 Hours
Time frame: 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 Brief Fear of Negative Evaluation Scale (BFNE) at 1 Week
Time frame: 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.
Change From Baseline in Brief Fear of Negative Evaluation Scale (BFNE) at 2 Weeks
Time frame: 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 Appraisal of Social Concerns Scale (ASC) at 24 Hours
Time frame: 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
Time frame: 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
Time frame: 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.

8 secondary outcomes

Word Sentence Association Paradigm (WSAP)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 2-week follow up (after speech stressor task)
Self-Beliefs Related To Social Anxiety Scale (SBSA)
Time frame: pretreatment
Interpretation of Positive Events Scale (IPES)
Time frame: pretreatment
Beck Depression Inventory-II (BDI-II)
Time frame: pretreatment
Dot Probe Task
Time frame: pretreatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael J Telch, Ph.D. principal investigator

University of Texas at Austin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) at 24 Hours (time frame: pretreatment, 24-hour follow up). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02372019.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.