Specific PhobiaPhase 1/2Snake/SpiderNCT02160470
Enhancing Exposure Therapy for Snake and Spider Phobias
A Phase 1/2 study testing Exposure Therapy with Retrieval, Exposure Therapy with Compound Extinction and Exposure Therapy with Retrieval and Compound Extinction in people with Specific Phobia, run by University of Texas at Austin at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Specific Phobia
- What is being tested?
- Exposure Therapy with Retrieval, Exposure Therapy with Compound Extinction and Exposure Therapy with Retrieval and Compound Extinction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2019
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Specific Phobia
- Being tested
- Exposure Therapy with Retrieval, Exposure Therapy with Compound Extinction, Exposure Therapy with Retrieval and Compound Extinction, Therapist-guided Exposure Therapy
- Medical subject headings
- Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure Therapy with RetrievalBehavioural
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.
Exposure Therapy with Compound ExtinctionBehavioural
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.
Exposure Therapy with Retrieval and Compound ExtinctionBehavioural
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.
Therapist-guided Exposure TherapyBehavioural
Participants will receive one-session exposure therapy (up to 92 minutes) for fear of spiders or fear of snakes.
| Study group | Role | What they receive |
|---|---|---|
| Exposure with Retrieval | Experimental | Exposure Therapy with Retrieval Receives: Behavioral: Exposure Therapy with Retrieval |
| Exposure with Compounding | Experimental | Exposure Therapy with Compound Extinction Receives: Behavioral: Exposure Therapy with Compound Extinction |
| Exposure with Retrieval and Compounding | Experimental | Exposure Therapy with Retrieval and Compound Extinction Receives: Behavioral: Exposure Therapy with Retrieval and Compound Extinction |
| Therapist-Guided Exposure Therapy | Active comparator | Therapist-guided Exposure Therapy Receives: Behavioral: Therapist-guided Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
Secondary outcomes (9)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
change from pre-treatment in current phobic diagnostic status and in level of phobic-related distress and impairment
Measured: pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startAug 2012
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Specific PhobiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michael J. Telch, University of Texas at Austin
- Investigators
- Michael J Telch, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160470
- Sponsor's protocol ID
- 2011-10-0012
- Other IDs
- 1F31MH100760-01
- Acronym
- Snake/Spider
- Status last verified
- Dec 2020
- First submitted
- 22 Jan 2014
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lancaster CL, Monfils MH, Telch MJ. Augmenting exposure therapy with pre-extinction fear memory reactivation and deepened extinction: A randomized controlled trial. Behav Res Ther. 2020 Dec;135:103730. doi: 10.1016/j.brat.2020.103730. Epub 2020 Sep 19.
PubMed 33096291
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
- Enhancing Exposure Therapy for Snake and Spider Phobias With Fear Retrieval and Compound Extinction
- ClinicalTrials.gov ID
- NCT02160470
- Acronym / sponsor ID
- Snake/Spider / 2011-10-0012
- Conditions
- Specific Phobia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2012 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 10 Jun 2014 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exposure with Retrieval | Experimental | Behavioral: Exposure Therapy with RetrievalExposure Therapy with Retrieval |
| Exposure with Compounding | Experimental | Behavioral: Exposure Therapy with Compound ExtinctionExposure Therapy with Compound Extinction |
| Exposure with Retrieval and Compounding | Experimental | Behavioral: Exposure Therapy with Retrieval and Compound ExtinctionExposure Therapy with Retrieval and Compound Extinction |
| Therapist-Guided Exposure Therapy | Active comparator | Behavioral: Therapist-guided Exposure TherapyTherapist-guided Exposure Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Exposure Therapy with RetrievalParticipants 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. | Behavioural | Exposure with Retrieval |
| Exposure Therapy with Compound ExtinctionParticipants 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. | Behavioural | Exposure with Compounding |
| Exposure Therapy with Retrieval and Compound ExtinctionParticipants 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. | Behavioural | Exposure with Retrieval and Compounding |
| Therapist-guided Exposure TherapyParticipants will receive one-session exposure therapy (up to 92 minutes) for fear of spiders or fear of snakes. | Behavioural | Therapist-Guided Exposure Therapy |
Primary outcome
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)
9 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- Derived from this study: PubMed 33096291Lancaster CL, Monfils MH, Telch MJ. Augmenting exposure therapy with pre-extinction fear memory reactivation and deepened extinction: A randomized controlled trial. Behav Res Ther. 2020 Dec;135:103730. doi: 10.1016/j.brat.2020.103730. Epub 2020 Sep 19.
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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, PhD 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?
A Phase 1/2 study testing Exposure Therapy with Retrieval, Exposure Therapy with Compound Extinction and Exposure Therapy with Retrieval and Compound Extinction in people with Specific Phobia, run by University of Texas at Austin at 1 site in United States.
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 4 inclusion and 3 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 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)). 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 NCT02160470, which also lists 1 linked publication.
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.