- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02905279
Spider Phobia Opposite Action Treatment Study
Enhancing Exposure Therapy for Spider Phobia With the Use of Threat-Relevant and Threat-Irrelevant Opposite Actions
Study Overview
Status
Conditions
Detailed Description
This study tests whether exposure therapy for fear of spiders can be enhanced with the use of opposite actions, which are actions opposite to fear-related action tendencies. The investigators will test two sub-types of opposite actions (a) threat-relevant opposite actions, which are actions antagonistic to specific threats associated with spider phobia, and (b) threat-irrelevant opposite actions, which are actions antagonistic to the fear response, but unrelated to specific threats associated with spider phobia. This exposure therapy enhanced with opposite actions will be compared with two control groups: standard exposure therapy and non-specific anxiety treatment (biofeedback relaxation training).
Individuals between the ages of 18-65 with elevated fear of spiders are randomly assigned to one of four treatment conditions (1) biofeedback relaxation training, (2) standard exposure therapy, (3) exposure therapy with threat-relevant opposite actions, and (4) exposure therapy with threat-irrelevant opposite actions. 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 two weeks after treatment (follow-up). The pre-treatment assessment occurs on the same day as 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 14-21 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
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Austin, Texas, United States, 78712
- Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
At Prescreen:
- Total score of greater than or equal to 70 on the Fear of Spiders - Questionnaire (with higher scores indicating higher fear levels).
- Indicates ongoing fear of spiders and inability to complete close approach towards spiders on brief questionnaire.
- At Screening visit: inability to complete close approach toward spiders as determined by the treatment context and generalization context Behavioral Approach Tests
Exclusion Criteria:
- Currently receiving psychotherapy for spider phobia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Biofeedback
Biofeedback Relaxation Training
|
Participants will receive one-session biofeedback relaxation training (24 minutes) for anxiety reduction.
Prior to biofeedback, participants will receive education about spiders and the development and maintenance of spider phobia.
|
Active Comparator: Standard Exposure
Exposure Therapy
|
Participants will receive one-session exposure therapy (24 minutes) for fear of spiders.
Prior to exposure therapy, participants will receive education about spiders and the development and the development and maintenance of spider phobia.
|
Experimental: Exposure with Threat-Relevant OAs.
Exposure with Threat-Relevant Opposite Actions
|
Participants will receive one-session exposure therapy (24 minutes) for fear of spiders.
During exposure, participants will engage in actions opposite to the tendencies associated with threat avoidance.
Prior to exposure therapy, participants will receive education about spiders and the development and maintenance of spider phobia.
|
Experimental: Exposure with Threat-Irrelevant OAs
Exposure with Threat-Irrelevant Opposite Actions
|
Participants will receive one-session exposure therapy (24 minutes) for fear of spiders.
During exposure therapy, participants will engage in actions opposite of the action tendencies associated with the fear, but unrelated to the specific threats associated with spider phobia.
Prior to exposure therapy, participants will receive education about spiders and the development and maintenance of spider phobia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Performance on a Behavioral Approach Test in a Generalization Context (Pre-treatment to 2-week Follow-Up)
Time Frame: Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
|
Change in peak subjective fear (0 - 100 scale), behavioral approach (0 - 13 scale), and physiological reactivity (heart rate and skin conductance) to a live spider not used during treatment (generalization context) from pre-treatment to follow-up
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Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Performance on a Behavioral Approach Test in a Generalization Context (Pre-treatment to Post-treatment)
Time Frame: Change from pre-treatment (same day as treatment) to post-treatment (within 30 minutes of completion of the treatment procedure)
|
Change in peak subjective fear (0 - 100 scale), behavioral approach (0 - 13 scale), and physiological reactivity (heart rate and skin conductance) to a live spider not used during treatment (generalization context) from pre-treatment to post-treatment.
|
Change from pre-treatment (same day as treatment) to post-treatment (within 30 minutes of completion of the treatment procedure)
|
Change in Performance on a Behavioral Approach Test in the Treatment Context (Pre-treatment to 2-week Follow-Up)
Time Frame: Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
|
Change in peak subjective fear (0 - 100), behavioral approach (0 - 10), and physiological reactivity (heart rate and skin conductance) to a live spider used during treatment (treatment context) from pre-treatment to follow-up
|
Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
|
Change in Performance on a Behavioral Approach Test in the Treatment Context (Pre-treatment to Post-treatment)
Time Frame: Change from pre-treatment (same day as treatment) to post-treatment (within 30 minutes of completion of the treatment procedure)
|
Change in peak subjective fear (0 - 100), behavioral approach (0 - 10), and physiological reactivity (heart rate and skin conductance) to a live spider used during treatment (treatment context) from pre-treatment to post-treatment.
|
Change from pre-treatment (same day as treatment) to post-treatment (within 30 minutes of completion of the treatment procedure)
|
Change in Fear of Spiders Questionnaire (Pre-treatment to 2-week Follow-Up)
Time Frame: Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
|
Change in psychometrically validated questionnaire assessing spider phobia severity from pre-treatment to follow-up.
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Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
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Change in Armfield and Mattiske Disgust Questionnaire (Pre-treatment to 2-week Follow-Up)
Time Frame: Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
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Change in psychometrically validated questionnaire assessing severity of disgust response related to spider phobia from pre-treatment to follow-up.
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Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
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Change in Spider Belief Questionnaire from pre-treatment to follow-up (Pre-treatment to 2-Week Follow-Up)
Time Frame: Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
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Change in psychometrically validated questionnaire assessing cognitions related to spider phobia from pre-treatment to follow-up.
|
Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Michael J Telch, PhD, The University of Texas at Austin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-07-0020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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