NCT04470882

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

April 11, 2019

Last Update Submit

October 8, 2021

Conditions

Keywords

Exposure therapySafety behaviorsArachnophobiaSpider phobiaSpecific phobia

Outcome Measures

Primary Outcomes (10)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (2)

  • Treatment Acceptability/Adherence Scale (Modified version)

    Measured just prior to beginning a one-session treatment

  • Treatment Acceptability/Adherence Scale (Modified version)

    Measured immediately after completing a one-session treatment

Study Arms (3)

Exposure with faded safety behaviors

EXPERIMENTAL

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 without safety behaviors

ACTIVE COMPARATOR

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 with unfaded safety behaviors

EXPERIMENTAL

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

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 with faded 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 without 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 with unfaded safety behaviors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • younger than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada, Reno

Reno, Nevada, 89557, United States

Location

Related Publications (2)

  • 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: 15279528BACKGROUND
  • 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: 19892318BACKGROUND

MeSH Terms

Conditions

Phobia, SpecificArachnophobia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Clinical Psychology

Study Record Dates

First Submitted

April 11, 2019

First Posted

July 14, 2020

Study Start

February 28, 2019

Primary Completion

April 6, 2020

Study Completion

April 6, 2020

Last Updated

October 18, 2021

Record last verified: 2021-10

Locations