Behavioral and Clinical Neuroscience
Bochum, Germany
Location status: Recruiting
NCT Number: NCT07432945
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.
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Request Info18 year–65 year
All sexes
Interventional
Not applicable
Bochum, Germany
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One session of graded in-vivo exposure with the treated spider. Prior to the exposure, participants receive psychoeducation on spiders, exposure therapy and specific phobia.
Other names: Exposure, Exposure Training
One session of graded video-based vicarious exposure with the treated spider. The steps are modeled by the experimenter. Prior to the exposure, participants receive psychoeducation on spiders, exposure therapy and specific phobia.
Other names: Exposure, Exposure Training
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Scores of spider fear ranging from 0 to 108 (sum), with higher scores indicative of greater fear.
Time frame: 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).
The questionnaire consists of 48 statements of phobia related beliefs. Subjects are asked to rate how much they agree to the statements. Higher scores are indicative of greater fear.
Time frame: 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).
A modified version of the SPQ. The SPQ consists of two dimensions (fear & interference with life). 45 items are rated ("none", "mild", "moderate", "severe", "extreme") on both dimensions. For the present study, we employed the fear subscale and dropped the interference scale. The fear scale was split up into fear and avoidance. This questionnaire allows for an estimate the overall fear and avoidance of 43 potentially phobic situations (+2 "other" options) and a composite score of each of the five phobia subtypes.
Time frame: 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).
The GSE is employed to measure changes in self-efficacy. It consists of ten items that evaluate the participants' confidence in their ability to overcome difficult situations based on their self-reported competence. A sum score of all items is calculated (ranging from 10 to 40). Higher scores are indicative of a higher general self-efficacy.
Time frame: 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).
The SEQ-SP is a 13 item questionnaire on specific animal-related phobic situations, assessing self-efficacy expectations on a five-point scale ranging from one (really sure I couldn't) to 5 (really sure I could).
Time frame: 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).
The FEE is a 37-item questionnaire. It comprises of different situations that might elicit disgust, rated from "not disgusting" to "very disgusting" on a 5-point scale. The FEE is included as a measure of disgust sensitivity, as research points towards relevance of disgust sensitivity in the acquisition and maintenance of anxiety disorders (Schienle et al., 2002).
Contact information is provided by the study sponsor or research team.
Ruhr University of Bochum
Other
Comparison of Exposure Trainings for Spider Phobia (German Title: Vergleich Von Expositionstrainings für Spinnenangst)
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