Use of Safety Behaviors in Exposure Therapy for Arachnophobia

Study Overview
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Brief Summary
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This study examines the impact of safety behaviors (i.e., unnecessary protective actions) on outcomes of exposure therapy for spider phobia. Researchers will compare exposure therapy with (a) no safety behaviors, (b) safety behaviors faded toward the end of treatment, and (c) unfaded safety behaviors.

Detailed Description
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Some studies suggest that safety behaviors might undermine the efficacy of exposure therapy (Powers et al., 2010), whereas other studies suggest that there is no difference in exposure therapy outcomes whether or not safety behaviors are used (Deacon et al., 2010). Mixed findings could be explained by the parameters of safety behaviors use, such as whether they are used throughout the full course of therapy or faded toward the end of therapy. This will be the first study to directly compare the impact of faded and unfaded safety behaviors on exposure therapy outcomes. Specifically, researchers will randomize participants with a fear of spiders to receive exposure therapy (a) without safety behavior use, (b) with faded safety behavior use, and (c) with un-faded safety behavior use. Researchers will compare each condition's impact on fear reduction and on the tolerability/acceptability of treatment.

Official Title
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Use of Safety Behaviors in Exposure Therapy for Arachnophobia

Conditions
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Arachnophobia, Specific Phobia, Spider Phobia

Intervention / Treatment
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* Behavioral: Exposure with faded safety behaviors
* Behavioral: Exposure without safety behaviors
* Behavioral: Exposure with unfaded safety behaviors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fluent in English Displays sufficiently high fear of spiders, as indicated by responses on (a) a self report questionnaire (the Fear of Spiders Questionnaire) at prescreening, and (b) Behavioral Avoidance Tests at baseline Exclusion Criteria: younger than 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposure with faded safety behaviors<br>Exposure therapy will involve three, 10-minute trials in which participants encounter a spider. Participants in this group will wear protective gear during the first two trials, and will remove the protective gear during the last trial. | Behavioral: Exposure with faded safety behaviors<br>* Exposure therapy will involve three, 10-minute trials in which participants encounter a spider. Participants in this group will wear protective gear during the first two trials, and will remove the protective gear during the last trial.<br>|
| Active Comparator: Exposure without safety behaviors<br>Exposure therapy will involve three, 10-minute trials in which participants encounter a spider. Participants in this group will not wear protective gear during any of the exposure therapy trials. | Behavioral: Exposure without safety behaviors<br>* Exposure therapy will involve three, 10-minute trials in which participants encounter a spider. Participants in this group will not wear protective gear during any of the exposure therapy trials.<br>|
| Experimental: Exposure with unfaded safety behaviors<br>Exposure therapy will involve three, 10-minute trials in which participants encounter a spider. Participants in this group will wear protective gear during all three exposure therapy trials. | Behavioral: Exposure with unfaded safety behaviors<br>* Exposure therapy will involve three, 10-minute trials in which participants encounter a spider. Participants in this group will wear protective gear during all three exposure therapy trials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral approach test (treatment context) - behavioral outcome | Participants will approach a live, non-poisonous tarantula, placed on the floor, at the opposite end of the room. The participant will walk toward the spider during this test. The test is over when the participant has reached the hardest step that they can complete at that time. During this BAT, investigators will assess fear response behaviorally by recording the most challenging step completed (range, steps 0 -12). | Change from baseline up to 4 weeks later (through follow up assessment) | 
| Behavioral approach test (treatment context) - subjective outcome | Participants will approach a live, non-poisonous tarantula, placed on the floor, at the opposite end of the room. The participant will walk toward the spider during this test. The test is over when the participant has reached the hardest step that they can complete at that time. During this BAT, investigators will assess fear response subjectively by having participants self report their peak fear level (on a 0 to 100 scale). | Change from baseline up to 4 weeks later (through follow up assessment) | 
| Behavioral approach test (treatment context) - physiological outcome | Participants will approach a live, non-poisonous tarantula, placed on the floor, at the opposite end of the room. The participant will walk toward the spider during this test. The test is over when the participant has reached the hardest step that they can complete at that time. During this BAT, investigators will assess fear response physiologically by assessing heart rate variability. | Change from baseline up to 4 weeks later (through follow up assessment) | 
| Behavioral approach test (generalization context) - behavioral outcome | Participants will approach a live, non-poisonous tarantula, placed in a clear tank on a table, at the opposite end of the room. The test is over when the participant has reached the hardest step that they can complete at that time. Steps include walking toward the spider and lowering one hand into the tank. During this BAT, investigators will assess fear response behaviorally by recording the most challenging step completed (range, steps 0-21). | Change from baseline up to 4 weeks later (through follow up assessment) | 
| Behavioral approach test (generalization context) - subjective outcome | Participants will approach a live, non-poisonous tarantula, placed in a clear tank on a table, at the opposite end of the room. The test is over when the participant has reached the hardest step that they can complete at that time. Steps include walking toward the spider and lowering one hand into the tank. During this BAT, investigators will assess fear response subjectively by having participants self report their peak fear level (on a 0 to 100 scale). | Change from baseline up to 4 weeks later (through follow up assessment) | 
| Behavioral approach test (generalization context) - physiological outcome | Participants will approach a live, non-poisonous tarantula, placed in a clear tank on a table, at the opposite end of the room. The test is over when the participant has reached the hardest step that they can complete at that time. Steps include walking toward the spider and lowering one hand into the tank. During this BAT, investigators will assess fear response physiologically by assessing heart rate variability. | Change from baseline up to 4 weeks later (through follow up assessment) | 
| Fear of Spiders Questionnaire (FSQ) | Self-report rating scale in which participants rate the extent that they agree with a number of statements that are representative of having a fear of spiders. Sum total scores will be calculated (range 0-108). Higher scores indicate more severe symptom levels. | Change from baseline up to 4 weeks later (through follow up assessment) | 
| Spider Phobia Beliefs Questionnaire (SBQ) | Self-report rating scale assessing the level to which the participant believes a number of cognitions/thoughts commonly associated with spider phobia. An overall average rating will be calculated (range 0-100). Higher average scores indicate greater belief in spider phobic cognitions. | Change from baseline up to 4 weeks later (through follow up assessment) | 
| Armfield and Mattiske Disgust Questionnaire (AMDQ) | Self-report questionnaire assessing feelings of disgust associated with spiders. Sum total scores will be calculated (range 0-48). Higher scores indicate more severe spider-related disgust. | Change from baseline up to 4 weeks later (through follow up assessment) | 
| Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5) | Participants will be given a structured interview to identify whether they meet diagnostic criteria for specific phobia. Responses will be coded dichotomously (yes = has diagnosis; no = no diagnosis). | Change from baseline up to 4 weeks later (through follow up assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Acceptability/Adherence Scale (Modified version) | Self-report questionnaire assessing the participant's perceptions regarding treatment acceptability and willingness to adhere to treatment procedures. Sum total scores will be calculated (range 10-70). Higher scores indicate greater acceptability/adherence. | Measured just prior to beginning a one-session treatment | 
| Treatment Acceptability/Adherence Scale (Modified version) | Self-report questionnaire assessing the participant's perceptions regarding treatment acceptability and willingness to adhere to treatment procedures. Sum total scores will be calculated (range 10-70). Higher scores indicate greater acceptability/adherence. | Measured immediately after completing a one-session treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exposure therapy, Safety behaviors, Arachnophobia, Spider phobia, Specific phobia