Clinical trial NCT03410264: One-session Treatment for Spider Fears
Official title: One-session Treatment for Spider Fears
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spider Phobia
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with three treatment conditions.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Participants must

  1. be 18 years or older,
  2. be fluent in English, and
  3. meet DSM-5 criteria for specific (spider) phobia to be considered eligible

Exclusion Criteria:

* Participants will be deemed ineligible if they do not meet the above inclusion criteria or

  1. are allergic to spiders or bee stings,
  2. are experiencing current psychosis, mania, or substance abuse, or
  3. successfully complete 10 of 13 possible BAT steps in the pretreatment appointment (to ensure that participants are indeed spider phobic at pretreatment).

Primary outcomes:
measure: Change from baseline Behavioral Approach Task (BAT) at 1-month follow-up
timeFrame: Baseline, 1-month follow-up
measure: Change from baseline Spider Beliefs Questionnaire (SBQ) at 1-month follow-up
timeFrame: Baseline, 1-month follow-up
measure: Change from baseline Spider Self-Efficacy Scale (SSES) at 1-month follow-up
timeFrame: Baseline, 1-month follow-up
Secondary outcomes:
measure: Change from baseline Distress Tolerance Scale (DTS) at 1-month follow-up
timeFrame: Baseline, 1-month follow-up
measure: Change from baseline Distress Tolerance Scale (DTS) at 0-5 hours post-treatment
timeFrame: Baseline, 0-5 hours post-treatment
measure: Change from baseline Anxiety Sensitivity Index-3 (ASI-3) at 1-month follow-up
timeFrame: Baseline, 1-month follow-up
measure: Change from baseline Anxiety Sensitivity Index-3 (ASI-3) at 0-5 hours post-treatment
timeFrame: Baseline, 0-5 hours post-treatment
measure: Change from baseline Depression Anxiety Stress Scales-21 (DASS-21) at 1-month follow-up
timeFrame: Baseline, 1-month follow-up
measure: Change from baseline Depression Anxiety Stress Scales-21 (DASS-21) at 0-5 hours post-treatment
timeFrame: Baseline, 0-5 hours post-treatment
measure: Change from baseline Disgust Scale-Revised (DS-R) at 1-month follow-up
timeFrame: Baseline, 1-month follow-up
measure: Change from baseline Disgust Scale-Revised (DS-R) at 0-5 hours post-treatment
timeFrame: Baseline, 0-5 hours post-treatment
measure: Change from baseline Anxiety Control Questionnaire (ACQ) at 1-month follow-up
timeFrame: Baseline, 1-month follow-up
measure: Change from baseline Anxiety Control Questionnaire (ACQ) at 0-5 hours post-treatment
timeFrame: Baseline, 0-5 hours post-treatment
measure: Change from baseline Acceptance and Action Questionnaire-II (AAQ-II) at 1-month follow-up
timeFrame: Baseline, 1-month follow-up
measure: Change from baseline Acceptance and Action Questionnaire-II (AAQ-II) at 0-5 hours post-treatment
timeFrame: Baseline, 0-5 hours post-treatment
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jon Abramowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: