跳至主要内容
临床试验/NCT03410264
NCT03410264已完成不适用

One-session Treatment for Spider Fears

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2018年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Change from baseline Behavioral Approach Task (BAT) at 1-month follow-up

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors are prevented from having knowledge of the interventions assigned to individual participants.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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).

结局指标

主要结局

Change from baseline Behavioral Approach Task (BAT) at 1-month follow-up

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)
  • Change from baseline Depression Anxiety Stress Scales-21 (DASS-21) at 0-5 hours post-treatment(Baseline, 0-5 hours post-treatment)
  • Change from baseline Disgust Scale-Revised (DS-R) at 1-month follow-up(Baseline, 1-month follow-up)
  • Change from baseline Disgust Scale-Revised (DS-R) at 0-5 hours post-treatment(Baseline, 0-5 hours post-treatment)
  • Change from baseline Anxiety Control Questionnaire (ACQ) at 1-month follow-up(Baseline, 1-month follow-up)
  • Change from baseline Anxiety Control Questionnaire (ACQ) at 0-5 hours post-treatment(Baseline, 0-5 hours post-treatment)
  • Change from baseline Acceptance and Action Questionnaire-II (AAQ-II) at 1-month follow-up(Baseline, 1-month follow-up)
  • Change from baseline Acceptance and Action Questionnaire-II (AAQ-II) at 0-5 hours post-treatment(Baseline, 0-5 hours post-treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

One-session Treatment for Spider Fears | 临床试验