<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04470882</url>
  </required_header>
  <id_info>
    <org_study_id>1330971-1</org_study_id>
    <nct_id>NCT04470882</nct_id>
  </id_info>
  <brief_title>Use of Safety Behaviors in Exposure Therapy for Arachnophobia</brief_title>
  <official_title>Use of Safety Behaviors in Exposure Therapy for Arachnophobia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nevada, Reno</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nevada, Reno</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examines the impact of safety behaviors (i.e., unnecessary protective actions) on&#xD;
      outcomes of exposure therapy for spider phobia. Researchers will compare exposure therapy&#xD;
      with (a) no safety behaviors, (b) safety behaviors faded toward the end of treatment, and (c)&#xD;
      unfaded safety behaviors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Some studies suggest that safety behaviors might undermine the efficacy of exposure therapy&#xD;
      (Powers et al., 2010), whereas other studies suggest that there is no difference in exposure&#xD;
      therapy outcomes whether or not safety behaviors are used (Deacon et al., 2010). Mixed&#xD;
      findings could be explained by the parameters of safety behaviors use, such as whether they&#xD;
      are used throughout the full course of therapy or faded toward the end of therapy. This will&#xD;
      be the first study to directly compare the impact of faded and unfaded safety behaviors on&#xD;
      exposure therapy outcomes. Specifically, researchers will randomize participants with a fear&#xD;
      of spiders to receive exposure therapy (a) without safety behavior use, (b) with faded safety&#xD;
      behavior use, and (c) with un-faded safety behavior use. Researchers will compare each&#xD;
      condition's impact on fear reduction and on the tolerability/acceptability of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2019</start_date>
  <completion_date type="Actual">April 6, 2020</completion_date>
  <primary_completion_date type="Actual">April 6, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Behavioral approach test (treatment context) - behavioral outcome</measure>
    <time_frame>Change from baseline up to 4 weeks later (through follow up assessment)</time_frame>
    <description>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.&#xD;
During this BAT, investigators will assess fear response behaviorally by recording the most challenging step completed (range, steps 0 -12).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Behavioral approach test (treatment context) - subjective outcome</measure>
    <time_frame>Change from baseline up to 4 weeks later (through follow up assessment)</time_frame>
    <description>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.&#xD;
During this BAT, investigators will assess fear response subjectively by having participants self report their peak fear level (on a 0 to 100 scale).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Behavioral approach test (treatment context) - physiological outcome</measure>
    <time_frame>Change from baseline up to 4 weeks later (through follow up assessment)</time_frame>
    <description>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.&#xD;
During this BAT, investigators will assess fear response physiologically by assessing heart rate variability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Behavioral approach test (generalization context) - behavioral outcome</measure>
    <time_frame>Change from baseline up to 4 weeks later (through follow up assessment)</time_frame>
    <description>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.&#xD;
During this BAT, investigators will assess fear response behaviorally by recording the most challenging step completed (range, steps 0-21).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Behavioral approach test (generalization context) - subjective outcome</measure>
    <time_frame>Change from baseline up to 4 weeks later (through follow up assessment)</time_frame>
    <description>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.&#xD;
During this BAT, investigators will assess fear response subjectively by having participants self report their peak fear level (on a 0 to 100 scale).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Behavioral approach test (generalization context) - physiological outcome</measure>
    <time_frame>Change from baseline up to 4 weeks later (through follow up assessment)</time_frame>
    <description>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.&#xD;
During this BAT, investigators will assess fear response physiologically by assessing heart rate variability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fear of Spiders Questionnaire (FSQ)</measure>
    <time_frame>Change from baseline up to 4 weeks later (through follow up assessment)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spider Phobia Beliefs Questionnaire (SBQ)</measure>
    <time_frame>Change from baseline up to 4 weeks later (through follow up assessment)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Armfield and Mattiske Disgust Questionnaire (AMDQ)</measure>
    <time_frame>Change from baseline up to 4 weeks later (through follow up assessment)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5)</measure>
    <time_frame>Change from baseline up to 4 weeks later (through follow up assessment)</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment Acceptability/Adherence Scale (Modified version)</measure>
    <time_frame>Measured just prior to beginning a one-session treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Acceptability/Adherence Scale (Modified version)</measure>
    <time_frame>Measured immediately after completing a one-session treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Specific Phobia</condition>
  <condition>Arachnophobia</condition>
  <condition>Spider Phobia</condition>
  <arm_group>
    <arm_group_label>Exposure with faded safety behaviors</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exposure without safety behaviors</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exposure with unfaded safety behaviors</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure with faded safety behaviors</intervention_name>
    <description>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.</description>
    <arm_group_label>Exposure with faded safety behaviors</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure without safety behaviors</intervention_name>
    <description>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.</description>
    <arm_group_label>Exposure without safety behaviors</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure with unfaded safety behaviors</intervention_name>
    <description>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.</description>
    <arm_group_label>Exposure with unfaded safety behaviors</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
          -  Displays sufficiently high fear of spiders, as indicated by responses on (a) a self&#xD;
             report questionnaire (the Fear of Spiders Questionnaire) at prescreening, and (b)&#xD;
             Behavioral Avoidance Tests at baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 18 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Nevada, Reno</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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. doi: 10.1037/0022-006X.72.3.448.</citation>
    <PMID>15279528</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19892318</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>April 11, 2019</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>October 8, 2021</last_update_submitted>
  <last_update_submitted_qc>October 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nevada, Reno</investigator_affiliation>
    <investigator_full_name>Cynthia Lancaster</investigator_full_name>
    <investigator_title>Assistant Professor, Clinical Psychology</investigator_title>
  </responsible_party>
  <keyword>Exposure therapy</keyword>
  <keyword>Safety behaviors</keyword>
  <keyword>Arachnophobia</keyword>
  <keyword>Spider phobia</keyword>
  <keyword>Specific phobia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phobic Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04470882
org study id: 1330971-1
nct id: NCT04470882
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Behavioral approach test (treatment context) - behavioral outcome
time frame: Change from baseline up to 4 weeks later (through follow up assessment)
description: 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).
measure: Behavioral approach test (treatment context) - subjective outcome
time frame: Change from baseline up to 4 weeks later (through follow up assessment)
description: 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).
measure: Behavioral approach test (treatment context) - physiological outcome
time frame: Change from baseline up to 4 weeks later (through follow up assessment)
description: 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.
measure: Behavioral approach test (generalization context) - behavioral outcome
time frame: Change from baseline up to 4 weeks later (through follow up assessment)
description: 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).
measure: Behavioral approach test (generalization context) - subjective outcome
time frame: Change from baseline up to 4 weeks later (through follow up assessment)
description: 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).
measure: Behavioral approach test (generalization context) - physiological outcome
time frame: Change from baseline up to 4 weeks later (through follow up assessment)
description: 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.
measure: Fear of Spiders Questionnaire (FSQ)
time frame: Change from baseline up to 4 weeks later (through follow up assessment)
description: 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.
measure: Spider Phobia Beliefs Questionnaire (SBQ)
time frame: Change from baseline up to 4 weeks later (through follow up assessment)
description: 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.
measure: Armfield and Mattiske Disgust Questionnaire (AMDQ)
time frame: Change from baseline up to 4 weeks later (through follow up assessment)
description: 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.
measure: Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5)
time frame: Change from baseline up to 4 weeks later (through follow up assessment)
description: 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).
measure: Treatment Acceptability/Adherence Scale (Modified version)
time frame: Measured just prior to beginning a one-session treatment
description: 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.
measure: Treatment Acceptability/Adherence Scale (Modified version)
time frame: Measured immediately after completing a one-session treatment
description: 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.
arm group label: Exposure with faded safety behaviors
arm group type: Experimental
description: 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.
arm group label: Exposure without safety behaviors
arm group type: Active Comparator
description: 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.
arm group label: Exposure with unfaded safety behaviors
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Exposure with faded safety behaviors
description: 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.
arm group label: Exposure with faded safety behaviors
intervention type: Behavioral
intervention name: Exposure without safety behaviors
description: 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.
arm group label: Exposure without safety behaviors
intervention type: Behavioral
intervention name: Exposure with unfaded safety behaviors
description: 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.
arm group label: Exposure with unfaded safety behaviors
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
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. doi: 10.1037/0022-006X.72.3.448.
PMID: 15279528
citation: 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.
PMID: 19892318
responsible party type: Principal Investigator
investigator affiliation: University of Nevada, Reno
investigator full name: Cynthia Lancaster
investigator title: Assistant Professor, Clinical Psychology
mesh term: Phobic Disorders