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Spider Phobia Opposite Action Treatment Study

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ClinicalTrials.gov Identifier: NCT02905279
Recruitment Status : Unknown
Verified September 2016 by University of Texas at Austin.
Recruitment status was:  Recruiting
First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
University of Texas at Austin

Brief Summary:
This study tests the effectiveness of exposure therapy for fear of spiders as enhanced by the use of antagonistic or opposite actions during treatment. The goal of the study is to compare the efficacy threat-relevant opposite actions and threat-irrelevant opposite actions in extinguishing fear.

Condition or disease Intervention/treatment Phase
Specific Phobia Behavioral: Biofeedback Relaxation Training Behavioral: Exposure Therapy Behavioral: Exposure with Threat-Relevant Opposite Actions Behavioral: Exposure with Threat-Irrelevant Opposite Actions Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing Exposure Therapy for Spider Phobia With the Use of Threat-Relevant and Threat-Irrelevant Opposite Actions
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Phobias

Arm Intervention/treatment
Active Comparator: Biofeedback
Biofeedback Relaxation Training
Behavioral: 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
Behavioral: 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
Behavioral: 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
Behavioral: 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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) ]
    Change in psychometrically validated questionnaire assessing severity of disgust response related to spider phobia from pre-treatment to follow-up.

  6. 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) ]
    Change in psychometrically validated questionnaire assessing cognitions related to spider phobia from pre-treatment to follow-up.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905279


Contacts
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Contact: Cynthia L Lancaster 512-404-9118 spiderstudy.lsad@gmail.com

Locations
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United States, Texas
Laboratory for the Study of Anxiety Disorders, University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Michael J Telch, Ph.D.    512-404-9118    Telch@austin.utexas.edu   
Contact: Cynthia L Lancaster    512-404-9118    cindy.lancaster@utexas.edu   
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Study Director: Michael J Telch, PhD The University of Texas at Austin

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Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT02905279     History of Changes
Other Study ID Numbers: 2015-07-0020
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Texas at Austin:
spider phobia
animal phobia
exposure therapy
biofeedback
relaxation training
Additional relevant MeSH terms:
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Phobic Disorders
Anxiety Disorders
Mental Disorders