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临床试验/NCT07432945
NCT07432945尚未招募不适用

Comparison of Exposure Trainings for Spider Phobia (German Title: Vergleich Von Expositionstrainings für Spinnenangst)

Ruhr University of Bochum0 个研究点目标入组 72 人开始时间: 2026年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
72
主要终点
Behavioral Approach Test (BAT)

研究概览

简要总结

After screening (including parts of the Mini-DIPS), participants will receive a pre-assessment with a baseline heartrate measurement, self-report measures and two BATs (with the treated spider and the non-treated spider). All participants receive a brief psychoeducation & video demonstration of exposure steps. Participants are randomly assigned to the three study arms and are then set to receive a single session of either in vivo exposure (IVET), videochat based vicarious exposure (VicET) or neither (Waiting List Control, WLC). Approximately 24 hours later, the two BATs with both spiders, a slightly reduced set of self-report measures and an interview will conduct the post-assessment. The order of all BATs, the spider individuals (treated vs. non-treated spider) and assignment to study arms will be randomized using a list that will be worked through in a sequence determined using "www.random.org". At a six-week follow-up, another long-term assessment will be conducted. Here, participants will receive a brief online questionnaire related to their experiences with spiders and self-report measures that were previously administered. Participants previously assigned to the waiting list control (WLC) will be invited to participate in an in-vivo exposure session. A set of questionnaires including demographic information, VAS scales on the current psychological state and wellbeing (administered at the start and end of the first and second assessment day), the BDI-II, the STAI-T and STAI-S, FEE, SPQ, SBQ, FSQ, GSE, SEQ-SP, TC/E for treatment credibility and the "positive attitudes towards technology subscale" of the MTUA will be used. BDI-II, STAI and MTUA are only administered at pre-assessment. The SAS is used for initial screening.

详细描述

Exposure therapy is an effective treatment for phobic fears and anxiety disorders that is considered in treatment guidelines as a first-choice treatment for e.g. specific phobia. However, many anxiety patients do not receive exposure therapy due to practical barriers (time, spaces, practitioner capacities) and reportedly negative treatment expectations of many clinicians. Previous studies on fear extinction and vicarious exposure suggest vicarious learning as a mechanism for treatment of anxiety. One central mechanism of exposure is fear extinction. Interestingly, fear extinction can be induced by the mere observation of videos of non-fearful individuals reacting placidly to a feared stimulus. The extent to which vicarious fear extinction is transferrable to an exposure context remains elusive. Previous studies on vicarious exposure yielded promising results, including a study on long-term effects. After a comparison of videochat based vicarious exposure therapy (VicET) with in-vivo exposure (IVET), the investigators will examine fear and disgust reactions. Further, the investigators will examine fear and disgust generalization. To the best of our knowledge, no study has considered generalization and disgust extinction in a comparison of in-vivo exposure (IVET) with vicarious exposure therapy (VicET) in a controlled laboratory setting. Furthermore, our study proposes a new approach of implementing vicarious exposure therapy as participants observe a spider phobia treatment via videochat. VicET yields potential to surpass aversive components of IVET which may have caused IVET to be more stress-inducing to patients and less acceptable to clinicians. Further, videochat based VicET might be expandable to treatment groups and patients held back by physical barriers, posing a potentially cost-effective treatment for e.g. waitlist patients.

The investigators hypothesize that both treatment groups (IVET & VicET) will perform better than the waiting list control (WLC) group (indicated by stronger reductions in spider fear & avoidance measures, namely increased BAT steps, reduction in heart rate & SUDS fear ratings). The investigators further expect that IVET & VicET will exhibit similar treatment gains (reduction in subjective fear, increase in behavioral approach and decreased heart rate in the BAT), leading to no significant differences in spider fear & avoidance measures. It is predicted that generalization is effective in both the IVET and the VicET group (indicated by a reduction of fear & avoidance measures from Pre-Generalization-BAT to Post-Generalization-BAT). Therefore, the investigators expect the WLC group to exhibit smaller symptom improvements in all BAT measures to the nontreated spider. Given the absence of previous studies examining disgust generalization, no specific hypotheses can be drawn. The investigators expect no differences in measures of spider fear between IVET & VicET at follow-up, with the WLC group exhibiting higher levels of spider fear.

Further analyses will be conducted to investigate possible differences in IVET & VicET regarding subjective fear during treatment (on a behavioral, subjective and psychophysiological level), disgust, self efficacy & generalization. Questionnaires used in these analyses are listed as other outcome measures. An unexpected memory test will be inserted at post assessment to allow for investigation of memory for treatment experiences made during exposure therapy.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of fear of spiders (Potential diagnosis of arachnophobia)

排除标准

  • Reaching level 10 or higher in initial BATs
  • Any acute or chronic mental disease more debilitating than fear of spiders
  • Any debilitating acute or chronic somatic disease that prevents or counteracts exposure treatment effects (such as cardiovascular diseases)
  • Heart Diseases (Pace makers, Bradycardia, Arterial Hypertonia, Heart Arrhythmia)
  • Psychological, psychiatric, neurological or pharmacological treatment
  • Drug or alcohol abuse
  • Pregnancy
  • Insect Sting Allergy

研究组 & 干预措施

In Vivo Exposure (IVET)

Experimental

Participants are subjected to a pre-assessment (questionnaires and BATs with treated spider and non-treated spider) and an in-vivo exposure, exposing them to the treated spider by approaching it in a predetermined sequence of steps. For further analyses, subjective fear, subjective disgust & heart rate are measured during treatment. Post assessment consists of two BATs (treated spider and non-treated spider) and questionnaires. An online follow-up consists of brief questionnaires.

干预措施: In Vivo Exposure Training (IVET) (Behavioral)

Vicarious Exposure (VicET)

Experimental

Participants are set to receive a pre-assessment (questionnaires and BATs with treated spider and non-treated spider) and a vicarious exposure, exposing them to the treated spider by watching the experimenter approach it in a predetermined sequence of step (same as IVET) via two cameras. For further analyses, subjective fear, subjective disgust & heart rate are measured during treatment. Post assessment consists of two BATs (treated spider and non-treated spider) and questionnaires. An online follow-up consists of brief questionnaires.

干预措施: Vicarious Exposure Training (VicET) (Behavioral)

Waitinglist Control (WLC)

No Intervention

Participants are set to receive a pre-assessment (questionnaires and BATs with treated spider and non-treated spider). Subsequent post-assessment consists of two BATs (treated spider and non-treated spider) and questionnaires. An online follow-up consists of brief questionnaires. Participants receive a session of IVET after assessment is completed.

结局指标

主要结局

Behavioral Approach Test (BAT)

时间窗: Pre-Assessment (immediately prior to exposure for the IVET & VicET groups, which corresponds to the end of first assessment day for the WLC group as they receive exposure at the end of the study), Post-Assessment (the next day).

Change in the Behavioral Approach Tests (BAT) from pre- to post-assessment. BATs are conducted with both the treated spider and the non-treated spider. In the Behavioral Approach Test (BAT) the closest distance that a participant approached the spider is measured (final approach distance).

Subjective fear

时间窗: At Pre-Assessment (during BATs, Day 1 & treatments), At Post-Assessment (during BATs, Day 2)

Change in subjective fear from pre- to post-assessment is measured regarding the treated spider and the non-treated spider (SUDS scale during pre-assessment and post-assessment BATs). A comparison of the SUDS at the final approach distance at pre-assessment with the SUDS at the same distance at post-assessment (so called "initial approach") allows for an estimate of subjective fear reduction. Additionally, the change in subjective fear at the final approach distance from pre- to post-assessment can be observed. SUDS are measured on a scale from 0 (no fear) to 100 (highest possible fear).

Subjective disgust

时间窗: Pre-Assessment (during BATs & treatments), Post-Assessment (during BATs)

Change in subjective disgust from pre- to post-assessment is measured regarding the treated spider and the non-treated spider (SUDS scale during Pre-assessment and Post-assessment BAT). A comparison of the SUDS at the final approach distance at pre-assessment with the SUDS at the same distance at post-assessment (so called "initial approach") allows for an estimate of subjective disgust reduction. Additionally, the change in subjective disgust at the final approach distance from pre- to post-assessment can be observed. SUDS are measured on a scale from 0 (no disgust) to 100 (highest possible disgust).

Heart Rate

时间窗: Pre-Assessment (during BATs) & Post-Assessment (during BATs). Measured throughout all of Pre-Assessment (including 5-minute resting heartrate measurement), all of Post-Assessment (including 5-minute resting heartrate measurement) & Treatment.

Change in mean heart rate from pre- to post-assessment BAT with treated spider and non-treated spider.

次要结局

  • Fear of Spiders Questionnaire (FSQ; german: FAS)(Prior to the Pre-Assessment BATs (Day 1), after Post-Assessment BATs (Day 2, 24 hours later) and at Follow-Up (approx. 6 weeks after Day 2).)
  • Spider Beliefs Questionnaire (SBQ)(Prior to the Pre-Assessment BATs (Day 1), after Post-Assessment BATs (Day 2, 24 hours later) and at Follow-Up (approx. 6 weeks after Day 2).)

研究者

发起方
Ruhr University of Bochum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Armin Zlomuzica

Principal Investigator

Ruhr University of Bochum

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