Enhancing Exposure Therapy for Snake and Spider Phobias (Snake/Spider)

December 4, 2020 updated by: Michael J. Telch, University of Texas at Austin

Enhancing Exposure Therapy for Snake and Spider Phobias With Fear Retrieval and Compound Extinction

This study tests whether exposure therapy for fear of snakes or spiders is enhanced by the addition of a brief fear retrieval trial prior to treatment, and the use of compound extinction during treatment. The goal of the study is to determine whether these behavioral techniques enhance the efficacy of exposure therapy, one of the most empirically supported treatments for anxiety disorders.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study tests whether exposure therapy for fear of snakes or spiders is enhanced by the addition of a brief fear retrieval trial prior to treatment, and the use of compound extinction during treatment. The goal of the study is to determine whether these behavioral techniques enhance the efficacy of exposure therapy, one of the most empirically supported treatments for anxiety disorders. Individuals between the ages of 18-65 with elevated fear of spiders or fear of snakes are randomly assigned to one of four treatment conditions (1) standard exposure therapy, (2) exposure therapy with fear retrieval augmentation, (3) exposure therapy with compound extinction augmentation, and (4) exposure therapy with fear retrieval and compound extinction augmentations. All participants undergo an online prescreen and a face-to-face screening assessment to determine eligibility and baseline (pre-treatment) symptom severity. Participants additionally complete assessments directly after treatment (post-treatment), and approximately one week after treatment (follow-up). The pre-treatment assessment occurs 1-14 days prior to treatment, the post-treatment assessment occurs during the treatment visit as soon as the treatment procedure is complete, and the follow-up assessment occurs within a window of 6-14 days after the completion of treatment. Participants complete two behavioral approach tests (in the treatment context and in the generalization context) at pre-treatment, post-treatment, and follow-up. Participants complete a battery of self-report questionnaires at pre-treatment and follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • University of Texas at Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 to 65.
  2. Speaks English fluently.
  3. A score of 70 or higher on the Fear of Snakes/Spiders Questionnaire.
  4. Demonstrates avoidance during behavioral approach tests (defined as inability to put palm flat on the bottom of a tank containing a snake/spider, and inability to touch a snake/spider with a bare finger).

Exclusion Criteria:

  1. Unstable dose of psychotropic medications during the 4 weeks prior to baseline assessment.
  2. Currently receiving exposure-based treatment for snake/spider phobia.
  3. Currently at risk for suicide.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exposure with Retrieval
Exposure Therapy with Retrieval
Behavioral: Exposure Therapy with Retrieval
Participants will receive one-session exposure therapy (up to 92 minutes) for fear of spiders or fear of snakes. Thirty minutes prior to exposure therapy, participants will receive a fear retrieval trial, which is a brief exposure to the feared stimulus (snake or spider). Based on recent basic science research, the fear retrieval trial is expected to enhance the efficacy of exposure therapy.
Experimental: Exposure with Compounding
Exposure Therapy with Compound Extinction
Behavioral: Exposure Therapy with Compound Extinction
Participants will receive one-session exposure therapy (up to 92 minutes) for fear of spiders or fear of snakes. As a component of therapy, participants will receive compound extinction, which consists of exposure to two feared stimuli simultaneously (two spiders or two snakes). Based on recent basic science research, compound extinction is expected to enhance the efficacy of exposure therapy.
Experimental: Exposure with Retrieval and Compounding
Exposure Therapy with Retrieval and Compound Extinction
Behavioral: Exposure Therapy with Retrieval and Compound Extinction
Participants will receive one-session exposure therapy (up to 92 minutes) for fear of spiders or fear of snakes. Thirty minutes prior to exposure therapy, participants will receive a brief fear retrieval trial. As a component of therapy, participants will also receive compound extinction.
Active Comparator: Therapist-Guided Exposure Therapy
Therapist-guided Exposure Therapy
Behavioral: Therapist-guided Exposure Therapy
Participants will receive one-session exposure therapy (up to 92 minutes) for fear of spiders or fear of snakes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in peak subjective fear (0 - 100), behavioral approach (0 - 4), and heart rate reactivity to a live snake/spider not used during treatment (generalization context) from pre-treatment to follow-up
Time Frame: pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in peak subjective fear (0 - 100), behavioral approach (0 - 4), and heart rate reactivity to a live snake/spider not used during treatment (generalization context) from pre-treatment to post-treatment.
Time Frame: pre-treatment (window of 1-14 days prior to treatment); post-treatment (directly after the treatment procedure is completed)
pre-treatment (window of 1-14 days prior to treatment); post-treatment (directly after the treatment procedure is completed)
Change in peak subjective fear (0 - 100), behavioral approach (1 - 8), and heart rate reactivity to a live snake/spider used during treatment (treatment context) from pre-treatment to follow-up
Time Frame: pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
Change in peak subjective fear (0 - 100), behavioral approach (1 - 8), and heart rate reactivity to a live snake/spider used during treatment (treatment context) from pre-treatment to post-treatment
Time Frame: pre-treatment (window of 1-14 days prior to treatment); post-treatment (directly after the treatment procedure is completed)
pre-treatment (window of 1-14 days prior to treatment); post-treatment (directly after the treatment procedure is completed)
Change in Fear of Snakes/Spiders Questionnaire from pre-treatment to follow-up
Time Frame: pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
Change in Snake/Spider Belief Questionnaire from pre-treatment to follow-up
Time Frame: pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
Change in Agoraphobic Cognitions Questionnaire for Snake/Spider Phobia from pre-treatment to follow-up
Time Frame: pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
Change in Self-Efficacy Questionnaire for Spider/Snake Phobia from pre-treatment to follow-up
Time Frame: pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
Change in Armfield and Mattiske Disgust Questionnaire from pre-treatment to follow-up
Time Frame: pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
Change in Lab for the Study of Anxiety Disorders Specific Phobia Diagnostic Questionnaire from pre-treatment to follow-up
Time Frame: pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
change from pre-treatment in current phobic diagnostic status and in level of phobic-related distress and impairment
pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas at Austin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael J Telch, PhD, University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011-10-0012
  • 1F31MH100760-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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