An interventional study of Biofeedback Relaxation Training and Exposure Therapy in Specific Phobia, sponsored by University of Texas at Austin. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-08.
Sponsored by University of Texas at Austin · Not applicable, Interventional, and Treatment
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.
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.
135 studies on the registry are indexed under Phobic Disorders; 16 are open to participants now.
This study's enrollment of 44 is below the median of 68 across 122 interventional studies indexed under Phobic Disorders.
Browse Phobic Disorders studies →University of Texas at Austin is the lead sponsor of 319 studies on the registry; 78 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
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At Prescreen:
Exclusion Criteria:
Biofeedback Relaxation Training
Behavioral: Biofeedback Relaxation Training
Exposure Therapy
Behavioral: Exposure Therapy
Exposure with Threat-Relevant Opposite Actions
Behavioral: Exposure with Threat-Relevant Opposite Actions
Exposure with Threat-Irrelevant Opposite Actions
Behavioral: Exposure with Threat-Irrelevant Opposite Actions
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.
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.
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.
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.
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
Time frame: 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 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.
Time frame: 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)
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)
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.
Time frame: 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)
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)
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.
Time frame: Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
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.
Time frame: Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)
Plan to share: No
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University of Texas at Austin