- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02160470
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
Completed
Conditions
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
Interventional
Enrollment (Anticipated)
120
Phase
- 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
-
-
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
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 to 65.
- Speaks English fluently.
- A score of 70 or higher on the Fear of Snakes/Spiders Questionnaire.
- 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:
- Unstable dose of psychotropic medications during the 4 weeks prior to baseline assessment.
- Currently receiving exposure-based treatment for snake/spider phobia.
- 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 |
Intervention / Treatment |
|---|---|
|
Experimental: Exposure with Retrieval
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
|
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
|
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
|
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
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
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
Collaborators
Investigators
- 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.
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)
August 1, 2012
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
January 22, 2014
First Submitted That Met QC Criteria
June 6, 2014
First Posted (Estimate)
June 10, 2014
Study Record Updates
Last Update Posted (Actual)
December 8, 2020
Last Update Submitted That Met QC Criteria
December 4, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Specific Phobia
-
Johns Hopkins UniversityCompletedSpecific Phobia | Specific Phobia, Animal | Specific Phobia, Situational | Specific Phobia, Natural Environment | Childhood Anxiety DisorderUnited States
-
University of South FloridaNational Institute of Mental Health (NIMH)Not yet recruitingSpecific Phobia, AnimalUnited States
-
Columbia UniversityWithdrawn
-
Ruhr University of BochumCompletedFear of Heights | Specific Phobia, SituationalGermany
-
University of Nevada, RenoCompletedSpecific Phobia | Arachnophobia | Spider PhobiaUnited States
-
University of CyprusYouth Board of CyprusCompleted
-
Norwegian University of Science and TechnologySt. Olavs HospitalWithdrawnSpecific Phobia
-
University of GroningenZonMw: The Netherlands Organisation for Health Research and DevelopmentCompleted
-
Universitat Jaume IRecruitingSpecific Phobia, AnimalSpain
-
University of OtagooVRcomeCompleted
Clinical Trials on Exposure Therapy with Retrieval
-
University of California, Los AngelesCompleted
-
Philipps University MarburgCompletedArachnophobia | Spider FearGermany
-
Universitätsklinikum Hamburg-EppendorfUnknownObsessive-compulsive Disorder (OCD)Germany
-
Karolinska InstitutetCompletedIrritable Bowel Syndrome
-
EugoniaAristotle University Of ThessalonikiCompleted
-
Region of Southern DenmarkUniversite du Quebec en OutaouaisCompleted
-
Universitat Jaume IRecruitingAnxiety Disorders | Social Anxiety Disorder | Panic Disorder | Specific Phobia | AgoraphobiaSpain
-
University of Texas at AustinTerminated
-
Region of Southern DenmarkOdense University Hospital; University of Southern Denmark; Universite du Quebec... and other collaboratorsCompletedSocial Anxiety | Social PhobiaDenmark
-
University of Texas at AustinUniversity of PennsylvaniaTerminatedChronic Posttraumatic Stress DisorderUnited States