- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04470882
Use of Safety Behaviors in Exposure Therapy for Arachnophobia
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nevada
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Reno, Nevada, United States, 89557
- University of Nevada, Reno
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exposure with faded safety behaviors
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.
|
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.
|
Active Comparator: Exposure without safety behaviors
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.
|
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.
|
Experimental: Exposure with unfaded safety behaviors
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral approach test (treatment context) - behavioral outcome
Time Frame: Change from baseline up to 4 weeks later (through follow up assessment)
|
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
Time Frame: Change from baseline up to 4 weeks later (through follow up assessment)
|
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
Time Frame: Change from baseline up to 4 weeks later (through follow up assessment)
|
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
Time Frame: Change from baseline up to 4 weeks later (through follow up assessment)
|
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
Time Frame: Change from baseline up to 4 weeks later (through follow up assessment)
|
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
Time Frame: Change from baseline up to 4 weeks later (through follow up assessment)
|
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)
Time Frame: Change from baseline up to 4 weeks later (through follow up assessment)
|
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)
Time Frame: Change from baseline up to 4 weeks later (through follow up assessment)
|
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)
Time Frame: Change from baseline up to 4 weeks later (through follow up assessment)
|
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)
Time Frame: Change from baseline up to 4 weeks later (through follow up assessment)
|
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)
Time Frame: Measured just prior to beginning a one-session treatment
|
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)
Time Frame: Measured immediately after completing a one-session treatment
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Deacon BJ, Sy JT, Lickel JJ, Nelson EA. Does the judicious use of safety behaviors improve the efficacy and acceptability of exposure therapy for claustrophobic fear? J Behav Ther Exp Psychiatry. 2010 Mar;41(1):71-80. doi: 10.1016/j.jbtep.2009.10.004. Epub 2009 Oct 24.
- Powers MB, Smits JA, Telch MJ. Disentangling the effects of safety-behavior utilization and safety-behavior availability during exposure-based treatment: a placebo-controlled trial. J Consult Clin Psychol. 2004 Jun;72(3):448-54. doi: 10.1037/0022-006X.72.3.448.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1330971-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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