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Spider Phobia Opposite Action Treatment Study

Primary Purpose

Specific Phobia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biofeedback Relaxation Training
Exposure Therapy
Exposure with Threat-Relevant Opposite Actions
Exposure with Threat-Irrelevant Opposite Actions
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Specific Phobia focused on measuring spider phobia, animal phobia, exposure therapy, biofeedback, relaxation training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Laboratory for the Study of Anxiety Disorders, University of Texas at Austin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Biofeedback

Standard Exposure

Exposure with Threat-Relevant OAs.

Exposure with Threat-Irrelevant OAs

Arm Description

Biofeedback Relaxation Training

Exposure Therapy

Exposure with Threat-Relevant Opposite Actions

Exposure with Threat-Irrelevant Opposite Actions

Outcomes

Primary Outcome Measures

Change in Performance on a Behavioral Approach Test in a Generalization Context (Pre-treatment to 2-week Follow-Up)
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

Change in Performance on a Behavioral Approach Test in a Generalization Context (Pre-treatment to Post-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 post-treatment.
Change in Performance on a Behavioral Approach Test in the Treatment Context (Pre-treatment to 2-week Follow-Up)
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 in Performance on a Behavioral Approach Test in the Treatment Context (Pre-treatment to Post-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 post-treatment.
Change in Fear of Spiders Questionnaire (Pre-treatment to 2-week Follow-Up)
Change in psychometrically validated questionnaire assessing spider phobia severity from pre-treatment to follow-up.
Change in Armfield and Mattiske Disgust Questionnaire (Pre-treatment to 2-week Follow-Up)
Change in psychometrically validated questionnaire assessing severity of disgust response related to spider phobia from pre-treatment to follow-up.
Change in Spider Belief Questionnaire from pre-treatment to follow-up (Pre-treatment to 2-Week Follow-Up)
Change in psychometrically validated questionnaire assessing cognitions related to spider phobia from pre-treatment to follow-up.

Full Information

First Posted
August 23, 2016
Last Updated
December 4, 2020
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT02905279
Brief Title
Spider Phobia Opposite Action Treatment Study
Official Title
Enhancing Exposure Therapy for Spider Phobia With the Use of Threat-Relevant and Threat-Irrelevant Opposite Actions
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Doctoral student running the study left for internship and did not finish the study
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 3, 2017 (Actual)
Study Completion Date
December 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Phobia
Keywords
spider phobia, animal phobia, exposure therapy, biofeedback, relaxation training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback
Arm Type
Active Comparator
Arm Description
Biofeedback Relaxation Training
Arm Title
Standard Exposure
Arm Type
Active Comparator
Arm Description
Exposure Therapy
Arm Title
Exposure with Threat-Relevant OAs.
Arm Type
Experimental
Arm Description
Exposure with Threat-Relevant Opposite Actions
Arm Title
Exposure with Threat-Irrelevant OAs
Arm Type
Experimental
Arm Description
Exposure with Threat-Irrelevant Opposite Actions
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback Relaxation Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure with Threat-Relevant Opposite Actions
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure with Threat-Irrelevant Opposite Actions
Intervention Description
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 Measure Information:
Title
Change in Performance on a Behavioral Approach Test in a Generalization Context (Pre-treatment to 2-week Follow-Up)
Description
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
Time Frame
Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
Secondary Outcome Measure Information:
Title
Change in Performance on a Behavioral Approach Test in a Generalization Context (Pre-treatment to Post-treatment)
Description
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.
Time Frame
Change from pre-treatment (same day as treatment) to post-treatment (within 30 minutes of completion of the treatment procedure)
Title
Change in Performance on a Behavioral Approach Test in the Treatment Context (Pre-treatment to 2-week Follow-Up)
Description
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
Time Frame
Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
Title
Change in Performance on a Behavioral Approach Test in the Treatment Context (Pre-treatment to Post-treatment)
Description
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.
Time Frame
Change from pre-treatment (same day as treatment) to post-treatment (within 30 minutes of completion of the treatment procedure)
Title
Change in Fear of Spiders Questionnaire (Pre-treatment to 2-week Follow-Up)
Description
Change in psychometrically validated questionnaire assessing spider phobia severity from pre-treatment to follow-up.
Time Frame
Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
Title
Change in Armfield and Mattiske Disgust Questionnaire (Pre-treatment to 2-week Follow-Up)
Description
Change in psychometrically validated questionnaire assessing severity of disgust response related to spider phobia from pre-treatment to follow-up.
Time Frame
Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
Title
Change in Spider Belief Questionnaire from pre-treatment to follow-up (Pre-treatment to 2-Week Follow-Up)
Description
Change in psychometrically validated questionnaire assessing cognitions related to spider phobia from pre-treatment to follow-up.
Time Frame
Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Telch, PhD
Organizational Affiliation
The University of Texas at Austin
Official's Role
Study Director
Facility Information:
Facility Name
Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Spider Phobia Opposite Action Treatment Study

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