Use of Safety Behaviors in Exposure Therapy for Arachnophobia

Sponsor
University of Nevada, Reno (Other)
Overall Status
Completed
CT.gov ID
NCT04470882
Collaborator
(none)
59
1
3
13.2
4.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exposure with faded safety behaviors
  • Behavioral: Exposure without safety behaviors
  • Behavioral: Exposure with unfaded safety behaviors
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of Safety Behaviors in Exposure Therapy for Arachnophobia
Actual Study Start Date :
Feb 28, 2019
Actual Primary Completion Date :
Apr 6, 2020
Actual Study Completion Date :
Apr 6, 2020

Arms and Interventions

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.

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.

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
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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Behavioral approach test (treatment context) - behavioral outcome [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).

  2. Behavioral approach test (treatment context) - subjective outcome [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).

  3. Behavioral approach test (treatment context) - physiological outcome [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.

  4. Behavioral approach test (generalization context) - behavioral outcome [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).

  5. Behavioral approach test (generalization context) - subjective outcome [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).

  6. Behavioral approach test (generalization context) - physiological outcome [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.

  7. Fear of Spiders Questionnaire (FSQ) [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.

  8. Spider Phobia Beliefs Questionnaire (SBQ) [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.

  9. Armfield and Mattiske Disgust Questionnaire (AMDQ) [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.

  10. Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5) [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).

Secondary Outcome Measures

  1. Treatment Acceptability/Adherence Scale (Modified version) [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.

  2. Treatment Acceptability/Adherence Scale (Modified version) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  • younger than 18 years old

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Nevada, Reno Reno Nevada United States 89557

Sponsors and Collaborators

  • University of Nevada, Reno

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Cynthia Lancaster, Assistant Professor, Clinical Psychology, University of Nevada, Reno
ClinicalTrials.gov Identifier:
NCT04470882
Other Study ID Numbers:
  • 1330971-1
First Posted:
Jul 14, 2020
Last Update Posted:
Oct 18, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cynthia Lancaster, Assistant Professor, Clinical Psychology, University of Nevada, Reno
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2021