Spider Phobia Opposite Action Treatment Study

Not Applicable

Terminated

• Conditions: Specific Phobia
• Interventions: Behavioral: Biofeedback Relaxation Training; Behavioral: Exposure Therapy; Behavioral: Exposure with Threat-Irrelevant Opposite Actions; Behavioral: Exposure with Threat-Relevant Opposite Actions

• Registration Number: NCT02905279
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Primary Completion: 2017-12-03
• Study Completion: 2017-12-12
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback	Biofeedback Relaxation Training	Biofeedback Relaxation Training
Standard Exposure	Exposure Therapy	Exposure Therapy
Exposure with Threat-Irrelevant OAs	Exposure with Threat-Irrelevant Opposite Actions	Exposure with Threat-Irrelevant Opposite Actions
Exposure with Threat-Relevant OAs.	Exposure with Threat-Relevant Opposite Actions	Exposure with Threat-Relevant Opposite Actions

Primary Outcome Measures

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

Name	Time	Method
Change in Performance on a Behavioral Approach Test in the Treatment Context (Pre-treatment to 2-week Follow-Up)	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 in Spider Belief Questionnaire from pre-treatment to follow-up (Pre-treatment to 2-Week Follow-Up)	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.
Change in Performance on a Behavioral Approach Test in a Generalization Context (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 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 Post-treatment)	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 in Fear of Spiders Questionnaire (Pre-treatment to 2-week Follow-Up)	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.
Change in Armfield and Mattiske Disgust Questionnaire (Pre-treatment to 2-week Follow-Up)	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.

Trial Locations

Locations (1)

Laboratory for the Study of Anxiety Disorders, University of Texas at Austin; 🇺🇸 Austin, Texas, United States