Specific PhobiaNCT04470882
Use of Safety Behaviors in Exposure Therapy for Arachnophobia
A study testing Exposure with faded safety behaviors, Exposure without safety behaviors and Exposure with unfaded safety behaviors in people with Specific Phobia and Arachnophobia, run by University of Nevada, Reno at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Specific Phobia, Arachnophobia, Spider Phobia
- What is being tested?
- Exposure with faded safety behaviors, Exposure without safety behaviors and Exposure with unfaded safety behaviors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2019to 6 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- younger than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Specific Phobia, Arachnophobia, Spider Phobia
- Being tested
- Exposure with faded safety behaviors, Exposure without safety behaviors, Exposure with unfaded safety behaviors
- Keywords
- Exposure therapy, Safety behaviors, Arachnophobia, Spider phobia, Specific phobia
- Medical subject headings
- Phobia, Specific, Arachnophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure with faded safety behaviorsBehavioural
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 without safety behaviorsBehavioural
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 with unfaded safety behaviorsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Exposure with unfaded safety behaviors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Change from baseline up to 4 weeks later (through follow up assessment)
Secondary outcomes (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.
Measured: Measured just prior to beginning a one-session treatment
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.
Measured: Measured immediately after completing a one-session treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start28 Feb 2019
- Primary completion6 Apr 2020
- Study completion6 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Specific PhobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Lancaster, University of Nevada, Reno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470882
- Sponsor's protocol ID
- 1330971-1
- Status last verified
- Oct 2021
- First submitted
- 11 Apr 2019
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 15279528Deacon 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 19892318Meckes SJ, Cole AC, Gee K, Lancaster CL. Testing Judicious Use of Safety Behaviors During Exposure: A Randomized Controlled Trial Examining When and For Whom Safety Behaviors Improve Fear Reduction. Cognit Ther Res. 2025 Oct 17;50(2):341-359. doi: 10.1007/s10608-025-10667-1.
PubMed 42267056
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Safety Behaviors in Exposure Therapy for Arachnophobia
- ClinicalTrials.gov ID
- NCT04470882
- Acronym / sponsor ID
- 1330971-1
- Conditions
- Specific Phobia, Arachnophobia, Spider Phobia
- Keywords
- Exposure therapy, Safety behaviors, Arachnophobia, Spider phobia, Specific phobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exposure with faded safety behaviors | Experimental | Behavioral: Exposure with faded safety behaviorsExposure 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 without safety behaviors | Active comparator | Behavioral: Exposure without safety behaviorsExposure 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 with unfaded safety behaviors | Experimental | Behavioral: Exposure with unfaded safety behaviorsExposure 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- younger than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure with faded safety behaviorsExposure 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. | Behavioural | Exposure with faded safety behaviors |
| Exposure without safety behaviorsExposure 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. | Behavioural | Exposure without safety behaviors |
| Exposure with unfaded safety behaviorsExposure 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. | Behavioural | Exposure with unfaded safety behaviors |
Primary outcome
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).
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).
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.
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).
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).
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.
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.
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.
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.
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).
2 secondary outcomes
Treatment Acceptability/Adherence Scale (Modified version)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Background: PubMed 15279528Powers 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.
- Background: PubMed 19892318Deacon 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.
- Derived from this study: PubMed 42267056Meckes SJ, Cole AC, Gee K, Lancaster CL. Testing Judicious Use of Safety Behaviors During Exposure: A Randomized Controlled Trial Examining When and For Whom Safety Behaviors Improve Fear Reduction. Cognit Ther Res. 2025 Oct 17;50(2):341-359. doi: 10.1007/s10608-025-10667-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure with faded safety behaviors, Exposure without safety behaviors and Exposure with unfaded safety behaviors in people with Specific Phobia and Arachnophobia, run by University of Nevada, Reno at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral approach test (treatment context) - behavioral outcome (time frame: Change from baseline up to 4 weeks later (through follow up assessment)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04470882, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.