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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02160470
Other study ID # 2011-10-0012
Secondary ID 1F31MH100760-01
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date August 2012
Est. completion date December 2019

Study information

Verified date December 2020
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.
Therapist-guided Exposure Therapy
Participants will receive one-session exposure therapy (up to 92 minutes) for fear of spiders or fear of snakes.

Locations

Country Name City State
United States University of Texas at Austin Austin Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas at Austin National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
Secondary 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. pre-treatment (window of 1-14 days prior to treatment); post-treatment (directly after the treatment procedure is completed)
Secondary 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 pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
Secondary 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 pre-treatment (window of 1-14 days prior to treatment); post-treatment (directly after the treatment procedure is completed)
Secondary Change in Fear of Snakes/Spiders Questionnaire from pre-treatment to follow-up pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
Secondary Change in Snake/Spider Belief Questionnaire from pre-treatment to follow-up pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
Secondary Change in Agoraphobic Cognitions Questionnaire for Snake/Spider Phobia from pre-treatment to follow-up pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
Secondary Change in Self-Efficacy Questionnaire for Spider/Snake Phobia from pre-treatment to follow-up pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
Secondary Change in Armfield and Mattiske Disgust Questionnaire from pre-treatment to follow-up pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
Secondary 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 pre-treatment (window of 1-14 days prior to treatment); follow-up (window of 6-14 days after treatment)
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