Use of Safety Behaviors in Exposure Therapy for Arachnophobia

October 8, 2021 updated by: Cynthia Lancaster, University of Nevada, Reno
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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nevada
      • Reno, Nevada, United States, 89557
        • University of Nevada, Reno

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2019

Primary Completion (Actual)

April 6, 2020

Study Completion (Actual)

April 6, 2020

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

July 9, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Actual)

October 18, 2021

Last Update Submitted That Met QC Criteria

October 8, 2021

Last Verified

October 1, 2021

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

No

Studies a U.S. FDA-regulated device product

No

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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