Response Prevention or Response Permission? A Randomized Controlled Trial of the "Judicious Use of Safety Behaviors" During Exposure Therapy (Institutional Review Board Title: Overcome Your Spider Phobia)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline Fear of Spiders Questionnaire Score at 1-month follow-up
研究概览
简要总结
Exposure-based cognitive-behavioral therapy (i.e., "exposure therapy"), which entails repeated and prolonged confrontation with feared situations/stimuli, is the most effective treatment for anxiety disorders (e.g., arachnophobia). Safety behaviors are actions performed to prevent, minimize, or escape a feared catastrophe and/or associated distress (e.g., wearing thick shoes or gloves when around areas where there might be spiders). It is understood that safety behaviors contribute to the development and maintenance of anxiety disorders; accordingly, patients' safety behaviors are traditionally eliminated as soon as possible during exposure therapy (i.e., "response prevention"). Unfortunately, not everyone who receives exposure therapy benefits from this approach. To address the limitations of exposure's effectiveness, some experts have questioned the clinical convention of response prevention during exposure therapy. Specifically, they propose the "judicious use of safety behaviors": the careful and strategic incorporation of safety behaviors during exposure therapy. The controversial role of permitting safety behaviors during exposure has garnered substantial research attention, yet study findings are mixed. The current study, therefore, was designed to improve upon the methodological limitations of previous related research and examine the relative efficacy of traditional exposure with response prevention (E/RP) and the experimental exposure with the judicious use of safety behaviors (E/JU) in a sample of adults with arachnophobia. In light of previous related research, several hypotheses were made regarding the short- (posttreatment) and long-term (1-month follow-up) treatment effects:
- Primary outcomes: E/RP participants will demonstrate greater improvement in spider phobia than the E/JU participants along behavioral and self-report symptom measures at follow-up.
- Secondary outcomes: Treatment acceptability and tolerability will be higher for E/JU participants, relative to E/RP participants, before beginning exposures and at posttreatment, but not at follow-up. In addition, hypothesize that E/RP participants will report greater reductions in peak distress and greater improvements in distress tolerance relative to E/JU participants at follow-up.
- Additional outcome: Exploratory analyses will be conducted to compare the relative rate of behavioral approach and exposure goal completion between treatment conditions.
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
Pre-determined condition allocation was listed in an Excel spreadsheet and concealed with black cell masking color. Interested individuals who met initial eligibility criteria during a pre-enrollment phone screening were entered in the order of screening in the assignment Excel spreadsheet (that was already masked to conceal condition assignment). Only the participant's therapist viewed the allocated condition immediately prior to the first treatment session by temporarily lifting the cell mask.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being at least 18 years old
- •Presence of clinically significant spider phobia
- •English fluency
- •Willingness to attend and audiotape all study sessions
排除标准
- •Spider or bee allergies
- •Previous trial of exposure-based cognitive-behavioral therapy for any anxiety problem
- •Current alcohol or substance use disorder
- •Lifetime symptoms of mania or psychosis
- •Voluntarily report current suicidal ideation
- •Complete 10 or more steps on the behavioral approach task administered at the pre-treatment assessment
研究组 & 干预措施
Exposure and response prevention
Exposure therapy with response prevention involves four hour-long individual sessions with a trained exposure therapist. Session 1 involves functional assessment, psychoeducation, presentation of the treatment rationale, and treatment planning. Sessions 2-4 involve a review of the model/treatment rationale, condition-specific reminders about how to prevent engaging in any safety behaviors during exposure, a 30-minute in-vivo exposure trial involving a live tarantula, and post-exposure processing. Session 4 also involves a discussion of relapse prevention strategies.
干预措施: Exposure therapy (Behavioral)
Exposure with judicious safety behaviors
Exposure therapy with judiciously used safety behaviors for spider phobia involves four hour-long individual sessions with a trained exposure therapist. Session 1 involves functional assessment, psychoeducation, presentation of the treatment rationale, and treatment planning. Sessions 2-4 involve a review of the model/treatment rationale, condition-specific reminders about how to strategically incorporate safety behaviors during exposure, a 30-minute in-vivo exposure trial involving a live tarantula, and post-exposure processing. Session 4 also involves a discussion of relapse prevention strategies.
干预措施: Exposure therapy (Behavioral)
结局指标
主要结局
Change from baseline Fear of Spiders Questionnaire Score at 1-month follow-up
时间窗: Baseline, 1-month follow-up
The Fear of Spiders Questionnaire (FSQ; Szymanski \& O'Donahue, 1995) is an 18-item self-report measure of spider phobia. Participants rate their agreement with each statement (e.g., "If I saw a spider now, I would think it will harm me") on a scale of 0 (totally disagree) to 7 (totally agree). Possible total scores range from 0 to 126, such that higher scores indicate greater spider fear.
Change from baseline Spider Behavioral Approach Task Score at 1-month follow-up
时间窗: Baseline, 1-month follow-up
The Spider 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.
次要结局
- Treatment Acceptability and Adherence Scale Score at Baseline(Baseline)
- TAAS Score at 0-48 hours post-treatment(Within approximately 48 hours post final treatment)
- TAAS Score at 1-month follow-up(1-month follow-up)
- Change from baseline BAT Peak Distress Score at 0-48 hours post-treatment(Baseline, Within approximately 48 hours post final treatment)
- Change from baseline BAT Peak Distress Score at 1-month follow-up(Baseline, 1-month follow-up)
- Change from baseline In-Vivo Distress Tolerance Score at 0-48 hours post-treatment(Baseline, Within approximately 48 hours post final treatment)
- Change from baseline FSQ Score at 0-48 hours post-treatment(Baseline, Within approximately 48 hours post final treatment)
- Change from baseline Spider BAT Score at 0-48 hours post-treatment(Baseline, Within approximately 48 hours post final treatment)
- Change from baseline In-Vivo Distress Tolerance Score at 1-month follow-up(Baseline, 1-month follow-up)