One-session Treatment for Spider Fears

NCT03410264 | Completed

• 1 other identifier: 15-1609
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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,. 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.

Conditions

Spider Phobia

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  Baseline, 1-month follow-up

Secondary Outcomes (12)

• Change from baseline Distress Tolerance Scale (DTS) at 1-month follow-up

  Baseline, 1-month follow-up

• Change from baseline Distress Tolerance Scale (DTS) at 0-5 hours post-treatment

  Baseline, 0-5 hours post-treatment

• Change from baseline Anxiety Sensitivity Index-3 (ASI-3) at 1-month follow-up

  Baseline, 1-month follow-up

• Change from baseline Anxiety Sensitivity Index-3 (ASI-3) at 0-5 hours post-treatment

  Baseline, 0-5 hours post-treatment

• Change from baseline Depression Anxiety Stress Scales-21 (DASS-21) at 1-month follow-up

  Baseline, 1-month follow-up

Study Arms (3)

CR-EXP

EXPERIMENTAL

Cognitive restructuring before exposure with response prevention (45 minute intervention).

Behavioral: CR-EXP

EXP-CR

EXPERIMENTAL

Exposure with response prevention before cognitive restructuring (45 minute intervention).

Behavioral: EXP-CR

Stress Management

ACTIVE COMPARATOR

Stress management skills.

Behavioral: Stress Management

Interventions

CR-EXP BEHAVIORAL

See arm/group descriptions

CR-EXP

EXP-CR BEHAVIORAL

See arm/group descriptions

EXP-CR

Stress Management BEHAVIORAL

See arm/group descriptions

Stress Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must
• be 18 years or older,
• be fluent in English, and
• meet DSM-5 criteria for specific (spider) phobia to be considered eligible

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Arachnophobia

Study Officials

• Jon Abramowitz, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are prevented from having knowledge of the interventions assigned to individual participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with three treatment conditions.

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 25, 2018
• Study Start: January 20, 2018
• Primary Completion: April 8, 2020
• Study Completion: April 8, 2020
• Last Updated: March 8, 2021

Record last verified: 2020-02

Locations

US (1)