In Vivo Exposure vs. Videochat-Based Vicarious Exposure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRuhr University of Bochum

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Presence of fear of spiders (Potential diagnosis of arachnophobia)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • In Vivo Exposure Training (IVET)

    Behavioral

    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.

  • Vicarious Exposure Training (VicET)

    Behavioral

    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.

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: In Vivo Exposure (IVET)Experimental treatment 1 intervention
Group B: Vicarious Exposure (VicET)Experimental treatment 1 intervention
Group C: Waitinglist Control (WLC)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Behavioral Approach Test (BAT)

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
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).
2

Subjective fear

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
At Pre-Assessment (during BATs, Day 1 & treatments), At Post-Assessment (during BATs, Day 2)
3

Subjective disgust

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 & treatments), Post-Assessment (during BATs)
4

Heart Rate

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

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.

Secondary outcomes

1

Fear of Spiders Questionnaire (FSQ; german: FAS)

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).
2

Spider Beliefs Questionnaire (SBQ)

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).

Other outcomes

1

Specific Phobia Questionnaire (SPQ)

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).
2

General Self-Efficacy (GSE) Scale

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).
3

Self-Efficacy Questionnaire for Phobic Situations (SEQ-SP)

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).
4

Questionnaire for the Assessment of Disgust Sensitivity (German: Fragebogen zur Erfassung der Ekelempfindlichkeit (FEE))

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).

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).

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