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CompletedNCT04470882Updated Oct 18, 2021

Use of Safety Behaviors in Exposure Therapy for Arachnophobia

An interventional study of Exposure with faded safety behaviors and Exposure without safety behaviors in Specific Phobia, Arachnophobia and Spider Phobia, sponsored by University of Nevada, Reno. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-18.

Sponsored by University of Nevada, Reno · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Specific Phobia
  • Arachnophobia
  • Spider Phobia

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Keywords

  • Exposure therapy
  • Safety behaviors
  • Arachnophobia
  • Spider phobia
  • Specific phobia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • younger than 18 years old
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • 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.

    Behavioral: Exposure with faded safety behaviors

  • 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.

    Behavioral: Exposure without safety behaviors

  • 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.

    Behavioral: Exposure with unfaded safety behaviors

Interventions

  • BehavioralExposure 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.

  • BehavioralExposure 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.

  • BehavioralExposure 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.

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Change from baseline up to 4 weeks later (through follow up assessment)

  2. 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).

    Time frame: Change from baseline up to 4 weeks later (through follow up assessment)

  3. 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.

    Time frame: Change from baseline up to 4 weeks later (through follow up assessment)

  4. 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).

    Time frame: Change from baseline up to 4 weeks later (through follow up assessment)

  5. 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).

    Time frame: Change from baseline up to 4 weeks later (through follow up assessment)

  6. 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.

    Time frame: Change from baseline up to 4 weeks later (through follow up assessment)

  7. 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.

    Time frame: Change from baseline up to 4 weeks later (through follow up assessment)

  8. 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.

    Time frame: Change from baseline up to 4 weeks later (through follow up assessment)

  9. 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.

    Time frame: Change from baseline up to 4 weeks later (through follow up assessment)

  10. 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).

    Time frame: Change from baseline up to 4 weeks later (through follow up assessment)

Secondary outcomes

  1. 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.

    Time frame: Measured just prior to beginning a one-session treatment

  2. 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.

    Time frame: Measured immediately after completing a one-session treatment

06

Study locations

1 site
  • University of Nevada, Reno
    Reno, Nevada 89557, United States
07

References and documents

Publications

  • 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. PubMed 15279528 ↗
  • 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. PubMed 19892318 ↗
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Registry details

Key details

Study ID
NCT04470882
Lead sponsor
University of Nevada, Reno
Responsible party
Cynthia Lancaster (Assistant Professor, Clinical Psychology, University of Nevada, Reno) — Principal investigator
First posted
Jul 14, 2020
Start date
Feb 28, 2019
Primary completion
Apr 6, 2020
Completion
Apr 6, 2020
Last update
Oct 18, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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