Use of Safety Behaviors in Exposure Therapy for Arachnophobia

Specific Phobia Clinical Trial

Official title:

Use of Safety Behaviors in Exposure Therapy for Arachnophobia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04470882
• Other study ID #: 1330971-1
• Status: Completed
• Phase: N/A
• Start date: February 28, 2019
• Est. completion date: April 6, 2020

Study information

• Verified date: October 2021
• Source: University of Nevada, Reno
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 6, 2020
• Est. primary completion date: April 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arachnophobia
• Phobic Disorders
• Specific Phobia
• Spider Phobia

Intervention

Behavioral:
• 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 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 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.

Locations

Country	Name	City	State
United States	University of Nevada, Reno	Reno	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Reno

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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
Secondary	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