Specific PhobiaNCT03031002
Extinction Generalization in Exposure Therapy
A study testing Exposure treatment for spider fear in people with Specific Phobia, run by Ruhr University of Bochum.
Trial summary
Patients with anxiety disorders oftentimes express fear responses to more than only one fear-inducing object. The principal aim of this study is to examine whether the beneficial effects of exposure on fear reduction in spider phobia can extend to stimuli which are conceptually similar to spiders (i.e. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Specific Phobia
- What is being tested?
- Exposure treatment for spider fear
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jul 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- spider phobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV criteria
Who cannot join
- any neurological or neuropsychiatric condition
- current behavioral or pharmacological treatment
- any mental disorder that is considered more severe than specific phobia
About this study
Official title: Extinction Generalization in Exposure Therapy for Spider Phobia
Patients with anxiety disorders oftentimes express fear responses to more than only one fear-inducing object. The principal aim of this study is to examine whether the beneficial effects of exposure on fear reduction in spider phobia can extend to stimuli which are conceptually similar to spiders (i.e. cockroaches), but have never been presented during the respective treatment.
Read the detailed description
Fear extinction has evolved as the central mechanism underlying exposure-based treatments. Findings from conditioning studies indicate that fear reduction following a fear extinction procedure can generalize from the extinction stimulus to other conceptually and perceptually related stimuli. This study is aimed at translating these findings to a clinical application and will hence examine whether the basic principles of extinction generalization are applicable to exposure.
Patients with spider phobia will either receive two sessions of in-vivo exposure with spiders or no treatment. Prior to as well as after treatment, patient's fear of spiders will be assessed using the Behavioral Approach Test (BATs) and self-report questionnaires. In addition, BATs with cockroaches will be conducted to examine the effects of exposure therapy on extinction generalization.
- Conditions
- Specific Phobia
- Being tested
- Exposure treatment for spider fear
- Keywords
- exposure, spider phobia, generalization, extinction
- Medical subject headings
- Phobia, Specific, Arachnophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure treatment for spider fearBehavioural
Two sessions (each session = 60 minutes) of in-vivo exposure treatment (including psychoeducation) with two different spiders. Exposures comprise a hierarchy of 7 steps, to be completed with both spiders.
| Study group | Role | What they receive |
|---|---|---|
| Exposure Treatment | Experimental | Participants of this arm receive two 60-minute sessions of exposure treatment for spider fear Receives: Behavioral: Exposure treatment for spider fear |
| No Exposure Treatment | 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.
Change in the Behavioral Approach Test (BAT) from pre- to posttreatment
Behavioral Approach Tests with Spiders and Cockroaches will be conducted at pre- and posttreatment. Here, the closest proximity a participant is able to attain to the spider/cockroach will be measured.
Measured: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Secondary outcomes (5)
Change in Subjective Fear / Disgust during the Behavioral Approach Tests (BATs) using the Subjective Units of Distress Scale (SUDS)
Subjective Fear / Disgust during the Behavioral Approach will be assessed at the initial and final approach distances to the spider / cockroach during the respective BATs.
Measured: Pre-and Posttreatment (with approximately 4 days between pre- and posttreatment)
Change in Heart Rate during the Behavioral Approach Tests (BATs) from pre- to posttreatment
During each BAT with spiders and cockroaches, heart rate will be measured. In addition, a 5-minute baseline will be recorded prior to the first BAT at each assessment.
Measured: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Change in the Fear of Spiders Questionnaire (FSQ)
Measured: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Change in the Spider Phobia Questionnaire (SPQ)
Measured: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Change in the Spider Beliefs Questionnaire (SBQ)
Measured: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startFeb 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific PhobiaStudies 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
- None (open label)
- Enrolment
- 77 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, Dr., Principal investigator, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031002
- Sponsor's protocol ID
- ZL 59/2-2
- Status last verified
- Jan 2017
- First submitted
- 14 Jan 2017
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extinction Generalization in Exposure Therapy for Spider Phobia
- ClinicalTrials.gov ID
- NCT03031002
- Acronym / sponsor ID
- ZL 59/2-2
- Conditions
- Specific Phobia
- Keywords
- exposure, spider phobia, generalization, extinction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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.
Patients with anxiety disorders oftentimes express fear responses to more than only one fear-inducing object. The principal aim of this study is to examine whether the beneficial effects of exposure on fear reduction in spider phobia can extend to stimuli which are conceptually similar to spiders (i.e. cockroaches), but have never been presented during the respective treatment.
Detailed description
Fear extinction has evolved as the central mechanism underlying exposure-based treatments. Findings from conditioning studies indicate that fear reduction following a fear extinction procedure can generalize from the extinction stimulus to other conceptually and perceptually related stimuli. This study is aimed at translating these findings to a clinical application and will hence examine whether the basic principles of extinction generalization are applicable to exposure.
Patients with spider phobia will either receive two sessions of in-vivo exposure with spiders or no treatment. Prior to as well as after treatment, patient's fear of spiders will be assessed using the Behavioral Approach Test (BATs) and self-report questionnaires. In addition, BATs with cockroaches will be conducted to examine the effects of exposure therapy on extinction generalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure Treatment | Experimental | Behavioral: Exposure treatment for spider fearParticipants of this arm receive two 60-minute sessions of exposure treatment for spider fear |
| No Exposure Treatment | No intervention | –Participants of this arm receive no exposure or other adequate treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- spider phobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV criteria
Key exclusion criteria (3 listed)
- any neurological or neuropsychiatric condition
- current behavioral or pharmacological treatment
- any mental disorder that is considered more severe than specific phobia
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 |
|---|---|---|
| Exposure treatment for spider fearTwo sessions (each session = 60 minutes) of in-vivo exposure treatment (including psychoeducation) with two different spiders. Exposures comprise a hierarchy of 7 steps, to be completed with both spiders. | Behavioural | Exposure Treatment |
Primary outcome
Change in the Behavioral Approach Test (BAT) from pre- to posttreatment
Time frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Behavioral Approach Tests with Spiders and Cockroaches will be conducted at pre- and posttreatment. Here, the closest proximity a participant is able to attain to the spider/cockroach will be measured.
5 secondary outcomes
Change in Subjective Fear / Disgust during the Behavioral Approach Tests (BATs) using the Subjective Units of Distress Scale (SUDS)
Time frame: Pre-and Posttreatment (with approximately 4 days between pre- and posttreatment)
Change in Heart Rate during the Behavioral Approach Tests (BATs) from pre- to posttreatment
Time frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Change in the Fear of Spiders Questionnaire (FSQ)
Time frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Change in the Spider Phobia Questionnaire (SPQ)
Time frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)
Change in the Spider Beliefs Questionnaire (SBQ)
Time frame: Pre- and Posttreatment (with approximately 4 days between pre- and 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 25 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Specific Phobia
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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, Dr. principal investigator
Ruhr University of Bochum
Questions about this trial
What is this clinical trial studying?
A study testing Exposure treatment for spider fear in people with Specific Phobia, run by Ruhr University of Bochum.
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 3 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 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in the Behavioral Approach Test (BAT) from pre- to posttreatment (time frame: Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2017.