Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03907345
Other study ID # AZ 032019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 6, 2019
Est. completion date October 7, 2022

Study information

Verified date March 2023
Source Ruhr University of Bochum
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigates whether a one-session exposure treatment for spider-related stimuli can lead to a generalization of extinguished fear to height-related stimuli in individuals with comorbid fear of spiders and fear of heights.


Description:

Exposure therapy has been proven to be effective in the treatment of specific phobias and in a variety of fear evoking situations and stimuli. However, since there is a high prevalence of comorbid fears, therapeutic interventions can get very extensive when each fearful situation and / or stimuli needs to be treated separately and over a repeated number of times. It has recently been shown, that exposure to one fearful stimuli (i.e., a spider), can also lead to a reduction of fear to another, perceptually and conceptually related, but untreated fearful stimulus (i.e., a cockroach) (Preusser, Margraf & Zlomuzica, 2017). Potentially, this generalization of exposure effects might also be relevant for coexisting fears that do not share conceptually related fearful stimuli (e.g., fear of spiders and fear of heights). The present study aims to investigate whether successful exposure treatment to one fearful stimulus (i.e., a spider) can also lead to a reduction of fear to an untreated fear evoking stimulus (i.e., height). Participants will be randomly assigned to the treatment or no-treatment condition. The entire experimental procedure will take place in three sessions. The first session incorporates spider and height fear related questionnaires and two Behavioral Approach Tests (BATs): One that involves a spider and one that involves height. These BATs are counterbalanced in each group with half of participants receiving the spider BAT first and the height BAT second, and vice versa. The second session takes place approximately seven days later. The treatment group receives a seven-step in vivo exposure with spiders (duration: 1,5 hours). Twenty-four hours later, session 3 takes place and involves the same measures that were applied in session 1. The treatment and no-treatment group receive an identical set of measures except that the no-treatment group will not be subjected to exposure. The effects of exposure-based anxiety reductions toward spiders (treated fear stimulus) and heights (untreated fear stimulus to assess generalization of treatment outcome) are assessed on the behavioral and subjective level at pretreatment and posttreatment (24 hours after exposure).


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 7, 2022
Est. primary completion date October 7, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Comorbid presence of fear of spiders and fear of heights [Potential diagnosis of specific phobias (arachnophobia and acrophobia) assessed by application of the Diagnostic Short-Interview for Mental Disorders (Mini-Dips)]. Exclusion Criteria: - Any acute or chronic mental and / or somatic disease - Psychological, psychiatric, neurological or pharmacological treatment (Application of the Mini-DIPS to screen for the presence of a psychological condition) - Drug or alcohol abuse - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exposure
The exposure session comprises a hierarchy of 7 steps, reaching from (1) holding a glass with the spider 30cm in from the body / face, to (7) letting the spider walk on the arm. The exposure session has a duration of 120 minutes. Prior to the exposure, participants receive psychoeducation on anxiety and phobias. A house spider (Tegenaria domestica) is used for the exposure.

Locations

Country Name City State
Germany Mental Health Research and Treatment Center Bochum

Sponsors (1)

Lead Sponsor Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Margraf, J. & Cwik, J. C. (2017). Mini-DIPS Open Access: Diagnostic Short-Interview for Mental Disorders. [Mini-DIPS Open Access: Diagnostisches Kurzinterview bei psychischen Störungen]. Bochum: Forschungs- und Behandlungszentrum für psychische Gesundheit, Ruhr-Universität. doi:10.13154/rub.102.9

Preusser F, Margraf J, Zlomuzica A. Generalization of Extinguished Fear to Untreated Fear Stimuli after Exposure. Neuropsychopharmacology. 2017 Dec;42(13):2545-2552. doi: 10.1038/npp.2017.119. Epub 2017 Jun 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Fear and Disgust Rating Self-developed, computerized fear and disgust ratings of 30 pictures of various animals (i.e., different mammals, insects, rodents, reptiles, birds). Participants have to rate their level of fear and disgust for each animal separately on a scale from 0 to 100. Higher scores indicate greater fear and disgust for each animal. Change in Fear and Disgust Rating from pre- to posttreatment (across one week from pretreatment to posttreatment)
Primary Behavioral Approach Test (BAT) for Spiders Change in the Behavioral Approach Test (BAT) with spiders (treated fear stimulus) [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)].
During the Behavioral Approach Test (BAT) the closest distance to a spider as well as subjective fear and heart rate is measured.
Change in BAT scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Primary Behavioral Approach Test (BAT) for Heights Change in the Behavioral Approach Test with heights (untreated fear stimulus) [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)].
During the Behavioral Approach Test (BAT) the level of the approached height as well as subjective fear and heart rate is measured.
Change in BAT scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Secondary Fear of Spiders Questionnaire (FSQ) Change in the Spider-fear related questionnaires [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)].
Self-report questionnaires assessing fear of spiders will be used. The Fear of Spiders Questionnaire (FSQ) will be applied. Scores on this scale range from 0 to 108, with higher scores indicating greater fear of spiders.
Change in FSQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Secondary Spider Fear Questionnaire (SPQ) Change in the Spider-fear related questionnaires [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)].
Self-report questionnaires assessing fear of spiders will be used. The Spider Fear Questionnaire (SPQ) will be applied. Scores on this scale range from 0 to 31, with higher scores indicating greater fear of spiders.
Change in SPQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Secondary Spider Beliefs Questionnaire (SBQ) Change in the Spider-fear related questionnaires [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)].
Self-report questionnaires assessing fear of spiders will be used. The Spider Beliefs Questionnaire (SBQ) will be applied. Scores on this scale range from 0 to 100, with higher scores indicating greater fear of spiders.
Change in SBQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Secondary Acrophobia Questionnaire (AQ) Change in the height related questionnaire [Time Frame: Pretreatment (approx. 1 week before the treatment), Posttreatment (1 day after treatment), Follow-up (4 weeks between treatment and follow-up)].
Self-report questionnaires assessing fear of heights will be used. The German version of the anxiety subscale of the Acrophobia Questionnaire (AQ) will be used. Scores on these scales range from 0 to 120, with higher scores indicating greater fear of heights.
Change in AQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
See also
  Status Clinical Trial Phase
Completed NCT04003753 - Efficacy of a VR Paradigm to Reduce Fear of Heights in a Clinical and Subclinical Population With Fear of Heights N/A
Completed NCT00302978 - Changes in Brain Activity (Functional MRI Study) Before and After Behavioral Therapy of Height Phobia N/A
Enrolling by invitation NCT05824884 - Self-efficacy Enhancement in a Virtual Reality Training for Fear of Heights N/A
Completed NCT04737915 - Virtual Reality Exposure Versus In Vivo Exposure for Fear of Heights N/A
Completed NCT04975854 - Virtual Reality Exposure Therapy for Acrophobia N/A
Completed NCT02361203 - Exercise and Virtual Reality Exposure Therapy for Acrophobia N/A
Suspended NCT03917433 - Augmenting Virtual Reality Exposure Therapy for Acrophobia N/A