Spider PhobiaNCT03410264
One-session Treatment for Spider Fears
A study testing CR-EXP, EXP-CR and Stress Management in people with Spider Phobia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Despite the efficacy of exposure and response prevention (ERP) for anxiety and phobias, recent theoretical research on fear extinction via inhibitory learning suggests that cognitive restructuring (CR)--the explicit challenging of maladaptive beliefs (e.g,. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spider Phobia
- What is being tested?
- CR-EXP, EXP-CR and Stress Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2018to 8 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
- Participants must
- be 18 years or older,
- be fluent in English, and
- meet DSM-5 criteria for specific (spider) phobia to be considered eligible
Who cannot join
- Participants will be deemed ineligible if they do not meet the above inclusion criteria or
- are allergic to spiders or bee stings,
- are experiencing current psychosis, mania, or substance abuse, or
- successfully complete 10 of 13 possible BAT steps in the pretreatment appointment (to ensure that participants are indeed spider phobic at pretreatment).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Despite the efficacy of exposure and response prevention (ERP) for anxiety and phobias, recent theoretical research on fear extinction via inhibitory learning suggests that cognitive restructuring (CR)--the explicit challenging of maladaptive beliefs (e.g,. overestimation of threat)--may actually attenuate exposure outcomes during an exposure trial. That is, by verbally disputing certain beliefs (e.g., "the spider will jump on me and attack me and I will faint from the anxiety") before an exposure task (e.g., gradually approaching a non-venomous spider), anxious individuals may experience less "surprise" from the non-occurrence of feared outcomes, and consequently experience less inhibitory learning (e.g., learning that spiders are not inherently dangerous). Thus, the investigators aim to empirically test the conventional (yet recently challenged) assumption that cognitive restructuring is a necessary component for psychosocial interventions for phobias.
90 participants recruited from the Psychology Department Participant Pool and the community will participate in this study. All participants will meet DSM-5 criteria for spider phobia. Following consent, participants will complete a pre-test assessment of various aspects of spider phobia. Participants will then receive education about the nature of anxiety/spider phobia and be randomly assigned to one of three 45-min intervention conditions: (a) CR before EXP, (b) EXP before CR, and (c) stress management (a control condition that involves neither CR nor EXP). Following the intervention, participants will complete a 10-minute post-test assessment and be scheduled to return for a follow-up assessment a month later.
Read the detailed description
Recent conceptualizations of the mechanisms by which exposure therapy (EXP; i.e., confronting one's fear in a systematic and therapeutic way) works in the treatment of phobias focus on the importance of extinction learning). This "inhibitory learning model" proposes that EXP helps the phobic individual learn that phobic stimuli are not dangerous; yet older danger-related learning is not "erased", and so must be inhibited by the new "safety learning." Research indicates that incorporating surprise into EXP (e.g., the patient is surprised that the spider didn't bite) maximizes this type of inhibitory learning and would correspond to better outcomes for phobias then when there is no surprise at the outcome of EXP.
Traditionally, EXP is used with the addition of cognitive restructuring (CR), which involves discussing and disputing exaggerated beliefs that underlie one's fears (e.g., "spiders are very dangerous"). CR encourages phobic individuals to re-evaluate their expectations of danger when encountering phobic stimuli, and therefore might rob the individual of the opportunity to be surprised when actually facing their fear.
Despite the theoretical plausibility of the importance of surprise during EXP, this question has yet to be investigated empirically. The aim of the present study is to test the hypothesis that incorporating surprise into EXP (by postponing CR until after EXP) will enhance immediate and long-term outcome of EXP for spider phobia.
- Conditions
- Spider Phobia
- Being tested
- CR-EXP, EXP-CR, Stress Management
- Medical subject headings
- Arachnophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CR-EXPBehavioural
See arm/group descriptions
EXP-CRBehavioural
See arm/group descriptions
Stress ManagementBehavioural
See arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| CR-EXP | Experimental | Cognitive restructuring before exposure with response prevention (45 minute intervention). Receives: Behavioral: CR-EXP |
| EXP-CR | Experimental | Exposure with response prevention before cognitive restructuring (45 minute intervention). Receives: Behavioral: EXP-CR |
| Stress Management | Active comparator | Stress management skills. Receives: Behavioral: Stress Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Behavioral Approach Task (BAT) at 1-month follow-up
The Behavioral Approach Task (BAT) includes 13 rank-ordered steps ranging from standing at the opposite end of a room containing a tarantula enclosed in a closed terrarium covered with a sheet to allowing the tarantula to crawl up one's bare arm. A participant must perform a BAT step for 10 consecutive seconds for the step to count as completed. BAT scores are recorded as the number of the highest step completed. Immediately after completing each step of the BAT (at the baseline and post-treatment assessments), participants are asked to verbally report their (a) anxiety and (b) disgust, using a scale of 0 (not at all) to 10 (maximum).
Measured: Baseline, 1-month follow-up
Change from baseline Spider Beliefs Questionnaire (SBQ) at 1-month follow-up
The SBQ is a 78-item scale measuring one's concerns related to encounters with spiders. Items are rated on a 0-100 scale (0= I do not believe it at all (0%); 100= I absolutely believe it (100%)). Total scores range from 0-7800. Higher scores indicate more negative beliefs about spiders.
Measured: Baseline, 1-month follow-up
Change from baseline Spider Self-Efficacy Scale (SSES) at 1-month follow-up
The Spider Self-Efficacy Scale (SSES) is a self-report measure of the strength of self-efficacy about performing behaviors related to spiders. The scale consists of 26 items describing approach behaviors towards spiders, on which respondents rate the strength of their self-efficacy about performing that behavior on an 11-point scale ranging from 0 (no confidence/highly uncertain) to 10 (total confidence/complete certainty). Total scores range from 0 to 260. Higher scores indicate higher self-efficacy.
Measured: Baseline, 1-month follow-up
Secondary outcomes (12)
Change from baseline Distress Tolerance Scale (DTS) at 1-month follow-up
The DTS is a 15-item self-report measure of one's ability to tolerate psychological distress. Items are rated on a 5-point scale ranging from 1 (strongly agree) to 5 (strongly disagree). Total scores range from 15 to 75. High scores on the DTS indicate that an individual can tolerate high levels of distress. Low scores reflect low DT (i.e., distress intolerance).
Measured: Baseline, 1-month follow-up
Change from baseline Distress Tolerance Scale (DTS) at 0-5 hours post-treatment
The DTS is a 15-item self-report measure of one's ability to tolerate psychological distress. Items are rated on a 5-point scale ranging from 1 (strongly agree) to 5 (strongly disagree). Total scores range from 15 to 75. High scores on the DTS indicate that an individual can tolerate high levels of distress. Low scores reflect low DT (i.e., distress intolerance).
Measured: Baseline, 0-5 hours post-treatment
Change from baseline Anxiety Sensitivity Index-3 (ASI-3) at 1-month follow-up
The ASI is a 16-item self-report measure of beliefs regarding the dangerousness of anxious arousal (e.g., "It scares me when my heart beats rapidly"). Participants rate their agreement with each statement on a 0 (very little) to 4 (very much) scale; higher scores indicate greater anxiety sensitivity. Total scores range from 0 to 64.
Measured: Baseline, 1-month follow-up
Change from baseline Anxiety Sensitivity Index-3 (ASI-3) at 0-5 hours post-treatment
The ASI is a 16-item self-report measure of beliefs regarding the dangerousness of anxious arousal (e.g., "It scares me when my heart beats rapidly"). Participants rate their agreement with each statement on a 0 (very little) to 4 (very much) scale; higher scores indicate greater anxiety sensitivity. Total scores range from 0 to 64.
Measured: Baseline, 0-5 hours post-treatment
Change from baseline Depression Anxiety Stress Scales-21 (DASS-21) at 1-month follow-up
The DASS-21 is a 21-item self-report measure of general psychological distress. Participants rate items on a four-point Likert scale ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much, or most of the time). Total scores range from 0 to 63, and higher scores indicate more distress.
Measured: Baseline, 1-month follow-up
Change from baseline Depression Anxiety Stress Scales-21 (DASS-21) at 0-5 hours post-treatment
The DASS-21 is a 21-item self-report measure of general psychological distress. Participants rate items on a four-point Likert scale ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much, or most of the time). Total scores range from 0 to 63, and higher scores indicate more distress.
Measured: Baseline, 0-5 hours post-treatment
Change from baseline Disgust Scale-Revised (DS-R) at 1-month follow-up
The DS-R is a 25-item measure of respondents' propensity to experience disgust across multiple domains. Participants rate the degree to which they might find a number of scenarios (e.g., ''you see maggots on a piece of meat in an outdoor garbage pail'') disgusting on a scale of 0 (strongly disagree) to 4 (strongly agree). Total scores range from 0 to 100, and higher scores indicate more disgust sensitivity.
Measured: Baseline, 1-month follow-up
Change from baseline Disgust Scale-Revised (DS-R) at 0-5 hours post-treatment
The DS-R is a 25-item measure of respondents' propensity to experience disgust across multiple domains. Participants rate the degree to which they might find a number of scenarios (e.g., ''you see maggots on a piece of meat in an outdoor garbage pail'') disgusting on a scale of 0 (strongly disagree) to 4 (strongly agree). Total scores range from 0 to 100, and higher scores indicate more disgust sensitivity.
Measured: Baseline, 0-5 hours post-treatment
Change from baseline Anxiety Control Questionnaire (ACQ) at 1-month follow-up
The Anxiety Control Questionnaire (ACQ) comprises 30 items and assesses the perception of control over emotional reactions (e.g., "My emotions seem to have a life of their own") and external threats (e.g., "I am usually able to avoid threat quite easily"). This self-report instrument attributes lower scores to individuals with lower perceptions of control and provides. Participants respond on a 0-5 scale, and total scores range from 0 to 150.
Measured: Baseline, 1-month follow-up
Change from baseline Anxiety Control Questionnaire (ACQ) at 0-5 hours post-treatment
The Anxiety Control Questionnaire (ACQ) comprises 30 items and assesses the perception of control over emotional reactions (e.g., "My emotions seem to have a life of their own") and external threats (e.g., "I am usually able to avoid threat quite easily"). This self-report instrument attributes lower scores to individuals with lower perceptions of control and provides. Participants respond on a 0-5 scale, and total scores range from 0 to 150.
Measured: Baseline, 0-5 hours post-treatment
Change from baseline Acceptance and Action Questionnaire-II (AAQ-II) at 1-month follow-up
The Acceptance and Action Questionnaire-II (AAQ-II) is a 10-item revision of the original 9-item AAQ. Each item is rated from 1 (never true) to 7 (always true) and total scores range from 10 to 70. The scale assesses experiential avoidance, also known as ''psychological flexibility,'' which is a core construct of the acceptance and commitment therapy model of psychopathology. Higher scores on the AAQ-II indicate greater psychological flexibility (less pathology).
Measured: Baseline, 1-month follow-up
Change from baseline Acceptance and Action Questionnaire-II (AAQ-II) at 0-5 hours post-treatment
The Acceptance and Action Questionnaire-II (AAQ-II) is a 10-item revision of the original 9-item AAQ. Each item is rated from 1 (never true) to 7 (always true) and total scores range from 10 to 70. The scale assesses experiential avoidance, also known as ''psychological flexibility,'' which is a core construct of the acceptance and commitment therapy model of psychopathology. Higher scores on the AAQ-II indicate greater psychological flexibility (less pathology).
Measured: Baseline, 0-5 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start20 Jan 2018
- Primary completion8 Apr 2020
- Study completion8 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spider 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
- Model description
- Randomized controlled trial with three treatment conditions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon Abramowitz, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410264
- Sponsor's protocol ID
- 15-1609
- Status last verified
- Feb 2020
- First submitted
- 11 Jan 2018
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-session Treatment for Spider Fears
- ClinicalTrials.gov ID
- NCT03410264
- Acronym / sponsor ID
- 15-1609
- Conditions
- Spider Phobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 25 Jan 2018 (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.
Despite the efficacy of exposure and response prevention (ERP) for anxiety and phobias, recent theoretical research on fear extinction via inhibitory learning suggests that cognitive restructuring (CR)--the explicit challenging of maladaptive beliefs (e.g,. overestimation of threat)--may actually attenuate exposure outcomes during an exposure trial. That is, by verbally disputing certain beliefs (e.g., "the spider will jump on me and attack me and I will faint from the anxiety") before an exposure task (e.g., gradually approaching a non-venomous spider), anxious individuals may experience less "surprise" from the non-occurrence of feared outcomes, and consequently experience less inhibitory learning (e.g., learning that spiders are not inherently dangerous). Thus, the investigators aim to empirically test the conventional (yet recently challenged) assumption that cognitive restructuring is a necessary component for psychosocial interventions for phobias.
90 participants recruited from the Psychology Department Participant Pool and the community will participate in this study. All participants will meet DSM-5 criteria for spider phobia. Following consent, participants will complete a pre-test assessment of various aspects of spider phobia. Participants will then receive education about the nature of anxiety/spider phobia and be randomly assigned to one of three 45-min intervention conditions: (a) CR before EXP, (b) EXP before CR, and (c) stress management (a control condition that involves neither CR nor EXP). Following the intervention, participants will complete a 10-minute post-test assessment and be scheduled to return for a follow-up assessment a month later.
Detailed description
Recent conceptualizations of the mechanisms by which exposure therapy (EXP; i.e., confronting one's fear in a systematic and therapeutic way) works in the treatment of phobias focus on the importance of extinction learning). This "inhibitory learning model" proposes that EXP helps the phobic individual learn that phobic stimuli are not dangerous; yet older danger-related learning is not "erased", and so must be inhibited by the new "safety learning." Research indicates that incorporating surprise into EXP (e.g., the patient is surprised that the spider didn't bite) maximizes this type of inhibitory learning and would correspond to better outcomes for phobias then when there is no surprise at the outcome of EXP.
Traditionally, EXP is used with the addition of cognitive restructuring (CR), which involves discussing and disputing exaggerated beliefs that underlie one's fears (e.g., "spiders are very dangerous"). CR encourages phobic individuals to re-evaluate their expectations of danger when encountering phobic stimuli, and therefore might rob the individual of the opportunity to be surprised when actually facing their fear.
Despite the theoretical plausibility of the importance of surprise during EXP, this question has yet to be investigated empirically. The aim of the present study is to test the hypothesis that incorporating surprise into EXP (by postponing CR until after EXP) will enhance immediate and long-term outcome of EXP for spider phobia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial with three treatment conditions.
| Arm | Type | Receives |
|---|---|---|
| CR-EXP | Experimental | Behavioral: CR-EXPCognitive restructuring before exposure with response prevention (45 minute intervention). |
| EXP-CR | Experimental | Behavioral: EXP-CRExposure with response prevention before cognitive restructuring (45 minute intervention). |
| Stress Management | Active comparator | Behavioral: Stress ManagementStress management skills. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must
Key exclusion criteria (4 listed)
- Participants will be deemed ineligible if they do not meet the above inclusion criteria or
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 |
|---|---|---|
| CR-EXPSee arm/group descriptions | Behavioural | CR-EXP |
| EXP-CRSee arm/group descriptions | Behavioural | EXP-CR |
| Stress ManagementSee arm/group descriptions | Behavioural | Stress Management |
Primary outcome
Change from baseline Behavioral Approach Task (BAT) at 1-month follow-up
Time frame: Baseline, 1-month follow-up
The Behavioral Approach Task (BAT) includes 13 rank-ordered steps ranging from standing at the opposite end of a room containing a tarantula enclosed in a closed terrarium covered with a sheet to allowing the tarantula to crawl up one's bare arm. A participant must perform a BAT step for 10 consecutive seconds for the step to count as completed. BAT scores are recorded as the number of the highest step completed. Immediately after completing each step of the BAT (at the baseline and post-treatment assessments), participants are asked to verbally report their (a) anxiety and (b) disgust, using a scale of 0 (not at all) to 10 (maximum).
Change from baseline Spider Beliefs Questionnaire (SBQ) at 1-month follow-up
Time frame: Baseline, 1-month follow-up
The SBQ is a 78-item scale measuring one's concerns related to encounters with spiders. Items are rated on a 0-100 scale (0= I do not believe it at all (0%); 100= I absolutely believe it (100%)). Total scores range from 0-7800. Higher scores indicate more negative beliefs about spiders.
Change from baseline Spider Self-Efficacy Scale (SSES) at 1-month follow-up
Time frame: Baseline, 1-month follow-up
The Spider Self-Efficacy Scale (SSES) is a self-report measure of the strength of self-efficacy about performing behaviors related to spiders. The scale consists of 26 items describing approach behaviors towards spiders, on which respondents rate the strength of their self-efficacy about performing that behavior on an 11-point scale ranging from 0 (no confidence/highly uncertain) to 10 (total confidence/complete certainty). Total scores range from 0 to 260. Higher scores indicate higher self-efficacy.
12 secondary outcomes
Change from baseline Distress Tolerance Scale (DTS) at 1-month follow-up
Time frame: Baseline, 1-month follow-up
Change from baseline Distress Tolerance Scale (DTS) at 0-5 hours post-treatment
Time frame: Baseline, 0-5 hours post-treatment
Change from baseline Anxiety Sensitivity Index-3 (ASI-3) at 1-month follow-up
Time frame: Baseline, 1-month follow-up
Change from baseline Anxiety Sensitivity Index-3 (ASI-3) at 0-5 hours post-treatment
Time frame: Baseline, 0-5 hours post-treatment
Change from baseline Depression Anxiety Stress Scales-21 (DASS-21) at 1-month follow-up
Time frame: Baseline, 1-month follow-up
Change from baseline Depression Anxiety Stress Scales-21 (DASS-21) at 0-5 hours post-treatment
Time frame: Baseline, 0-5 hours post-treatment
Change from baseline Disgust Scale-Revised (DS-R) at 1-month follow-up
Time frame: Baseline, 1-month follow-up
Change from baseline Disgust Scale-Revised (DS-R) at 0-5 hours post-treatment
Time frame: Baseline, 0-5 hours post-treatment
Change from baseline Anxiety Control Questionnaire (ACQ) at 1-month follow-up
Time frame: Baseline, 1-month follow-up
Change from baseline Anxiety Control Questionnaire (ACQ) at 0-5 hours post-treatment
Time frame: Baseline, 0-5 hours post-treatment
Change from baseline Acceptance and Action Questionnaire-II (AAQ-II) at 1-month follow-up
Time frame: Baseline, 1-month follow-up
Change from baseline Acceptance and Action Questionnaire-II (AAQ-II) at 0-5 hours post-treatment
Time frame: Baseline, 0-5 hours post-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 8 Mar 2021.
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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.
Jon Abramowitz, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CR-EXP, EXP-CR and Stress Management in people with Spider Phobia, run by University of North Carolina, Chapel Hill 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 4 inclusion and 4 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 8 Mar 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?
Change from baseline Behavioral Approach Task (BAT) at 1-month follow-up (time frame: Baseline, 1-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2021.