Fear of SpidersNCT03907345
Generalized Fear Extinction to Untreated Fear Stimuli in Specific Phobias After Exposure
A study testing Exposure in people with Fear of Spiders and Fear of Heights, run by Ruhr University of Bochum at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Fear of Spiders, Fear of Heights
- What is being tested?
- Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jun 2019to 7 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)].
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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).
- Conditions
- Fear of Spiders, Fear of Heights
- Being tested
- Exposure
- Keywords
- Exposure Therapy, Fear of Spiders, Fear of Heights, Anxiety Disorders, Generalization, Extinction, Specific Phobias
- Medical subject headings
- Arachnophobia, Acrophobia, Anxiety Disorders, Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExposureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exposure | Experimental | Participants of this arm receive one 120-minute session of exposure treatment for spider fear. Receives: Behavioral: Exposure |
| No Exposure | No intervention | Participants of this arm receive no exposure or other adequate treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in BAT scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
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.
Measured: Change in BAT scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Secondary outcomes (4)
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.
Measured: Change in FSQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
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.
Measured: Change in SPQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
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.
Measured: Change in SBQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
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.
Measured: Change in AQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start6 Jun 2019
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fear of SpidersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin Zlomuzica, Ruhr University of Bochum
- Investigators
- Armin Zlomuzica, PhD, Principal investigator, Ruhr-University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907345
- Sponsor's protocol ID
- AZ 032019
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2019
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28589965Margraf, 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generalized Fear Extinction to Untreated Fear Stimuli in Specific Phobias After Exposure
- ClinicalTrials.gov ID
- NCT03907345
- Acronym / sponsor ID
- AZ 032019
- Conditions
- Fear of Spiders, Fear of Heights
- Keywords
- Exposure Therapy, Fear of Spiders, Fear of Heights, Anxiety Disorders, Generalization, Extinction, Specific Phobias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure | Experimental | Behavioral: ExposureParticipants of this arm receive one 120-minute session of exposure treatment for spider fear. |
| No Exposure | No intervention | –Participants of this arm receive no exposure or other adequate treatment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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)].
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExposureThe 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. | Behavioural | Exposure |
Primary outcome
Behavioral Approach Test (BAT) for Spiders
Time frame: Change in BAT scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
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.
Behavioral Approach Test (BAT) for Heights
Time frame: Change in BAT scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
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.
4 secondary outcomes
Fear of Spiders Questionnaire (FSQ)
Time frame: Change in FSQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Spider Fear Questionnaire (SPQ)
Time frame: Change in SPQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Spider Beliefs Questionnaire (SBQ)
Time frame: Change in SBQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Acrophobia Questionnaire (AQ)
Time frame: Change in AQ scores from pre- to posttreatment (across one week from pretreatment to posttreatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Background: PubMed 28589965Preusser 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.
- BackgroundMargraf, 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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin Zlomuzica, PhD principal investigator
Ruhr-University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure in people with Fear of Spiders and Fear of Heights, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Approach Test (BAT) for Spiders (time frame: Change in BAT scores from pre- to posttreatment (across one week from pretreatment to posttreatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03907345, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.