- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06182709
Feasibility of an Online Modeled Exposure in Spider Fearful Individuals (OMEX)
Group Exposure Treatment: Feasibility of an Online Modeled Exposure in Spider Fearful Individuals
Study Overview
Status
Conditions
Detailed Description
The treatment of various anxiety disorders often involves exposure therapy. However, a considerable number of patients do not benefit or experience a resurgence of anxiety following successful treatment. Vicarious safety learning (i.e., modeled exposure) presents a promising avenue to improve therapeutic outcome. Previous evidence indicates that vicarious safety learning can diminish previously acquired fear associations, thereby reducing behavioral avoidance. While single-session interventions have implemented modeled exposure, specific mechanisms of observational learning have not been extensively investigated. Due to high dropout rates in specific phobias, modeled exposure could be utilized as an additional treatment method, potentially yielding better outcomes trough additional learning experience.
This study aims to investigate the applicability of observational learning and its sustainability through mental retrieval cues. Specifically, the study is going to assess the feasibility of modeled exposure conveyed either live or online via video, offering a practical approach within a stepped-care framework. The modeled exposure treatment will be followed by a group exposure treatment to assess the influence of modeled exposure in spider-fearful individuals.
Physically healthy spider-fearful individuals will be either treated with an online or live modeled standardized exposure followed by a group exposure treatment. Half of the participants will receive a mental retrieval cue before the group exposure treatment one day after the modeled exposure treatment. The research aims to determine if long-term reduction of spider fear is achievable through online modeled exposure via video compared to in-person modeled exposure.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hesse
-
Marburg, Hesse, Germany, 35037
- Philipps-University Marburg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Elevated score on Spider Phobia Questionnaire (SPQ) >= 17
Exclusion Criteria:
- Severe allergies to bees/spiders/insects
- Current psychiatric/psychotherapeutic treatment
- Past psychotherapeutic/psychiatric treatment due to anxiety problems
- Current or past psychotic symptoms
- Current suicidal intent
- Experience with exposure-based treatment
- Current psychopharmacological medication
- Severe respiratory, neurological or cardiovascular diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: online modeled exposure + mental retrieval cue group exposure
online modeled exposure training followed by group exposure training, including mental retrieval cue with five standardized exposure steps
|
Participants will watch a short psychoeducation video online.
This will be followed by a modeled exposure online.
In this modeled exposure participants watch a film of an exposure treatment (about 45min) conducted with one participant and the therapist.
The exposure training consists of five exposure steps (step 1: describing the spider, step 2: catching the spider with a glass, step 3: describing the spider, step 4: touching the spider with the dominant index finger, step 5: letting the spider walk on the participant hands; the following steps have to be repeated up to four times: 2,4,5).
Exposure training in the group is conducted live (1 spider per participant, one therapist and co-trainers).
In this group exposure participants complete exposure training (about 45 min) with five exposure steps (step 1: describing the spider, step 2: catching the spider with a glass, step 3: describing the spider, step 4: touching the spider with the dominant index finger, step 5: letting the spider walk on the participant hands; the following steps have to be repeated up to three times: 2,4,5).
Before the group exposure, participants are asked to remember the modeled exposure they had observed the day before.
Therefore, the participants are asked to recall the location where they have been during the modeled exposure and the reaction of the patient during the exposure (e.g., fear decline).
|
|
Active Comparator: live modeled exposure + mental retrieval cue group exposure
live modeled exposure training followed by group exposure training, including mental retrieval cue with five standardized exposure steps
|
Exposure training in the group is conducted live (1 spider per participant, one therapist and co-trainers).
In this group exposure participants complete exposure training (about 45 min) with five exposure steps (step 1: describing the spider, step 2: catching the spider with a glass, step 3: describing the spider, step 4: touching the spider with the dominant index finger, step 5: letting the spider walk on the participant hands; the following steps have to be repeated up to three times: 2,4,5).
Before the group exposure, participants are asked to remember the modeled exposure they had observed the day before.
Therefore, the participants are asked to recall the location where they have been during the modeled exposure and the reaction of the patient during the exposure (e.g., fear decline).
Participants will watch a short psychoeducation video.
This will be followed by a live modeled exposure.
In this modeled exposure participants watch an exposure treatment (about 45min) conducted live with one participant and the therapist.
The exposure training consists of five exposure steps (step 1: describing the spider, step 2: catching the spider with a glass, step 3: describing the spider, step 4: touching the spider with the dominant index finger, step 5: letting the spider walk on the participant hands; the following steps have to be repeated up to four times: 2,4,5).
|
|
Active Comparator: online modeled exposure + standardized group exposure
online modeled exposure training followed by group exposure training with five standardized exposure steps
|
Participants will watch a short psychoeducation video online.
This will be followed by a modeled exposure online.
In this modeled exposure participants watch a film of an exposure treatment (about 45min) conducted with one participant and the therapist.
The exposure training consists of five exposure steps (step 1: describing the spider, step 2: catching the spider with a glass, step 3: describing the spider, step 4: touching the spider with the dominant index finger, step 5: letting the spider walk on the participant hands; the following steps have to be repeated up to four times: 2,4,5).
Exposure training in the group is conducted live (1 spider per participant, one therapist and co-trainers).
In this group exposure participants complete exposure training (about 45 min) with five exposure steps (step 1: describing the spider, step 2: catching the spider with a glass, step 3: describing the spider, step 4: touching the spider with the dominant index finger, step 5: letting the spider walk on the participant hands; the following steps have to be repeated up to three times: 2,4,5).
|
|
Active Comparator: live modeled exposure + standardized group exposure
live modeled exposure training followed by group exposure training with five standardized exposure steps
|
Exposure training in the group is conducted live (1 spider per participant, one therapist and co-trainers).
In this group exposure participants complete exposure training (about 45 min) with five exposure steps (step 1: describing the spider, step 2: catching the spider with a glass, step 3: describing the spider, step 4: touching the spider with the dominant index finger, step 5: letting the spider walk on the participant hands; the following steps have to be repeated up to three times: 2,4,5).
Participants will watch a short psychoeducation video.
This will be followed by a live modeled exposure.
In this modeled exposure participants watch an exposure treatment (about 45min) conducted live with one participant and the therapist.
The exposure training consists of five exposure steps (step 1: describing the spider, step 2: catching the spider with a glass, step 3: describing the spider, step 4: touching the spider with the dominant index finger, step 5: letting the spider walk on the participant hands; the following steps have to be repeated up to four times: 2,4,5).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spider Phobia Questionnaire (SPQ)
Time Frame: Change from baseline to immediately post treatment 1 (after modeled exposure), immediately post treatment 2 (group exposure) and follow-up (7 days after group exposure - post treatment 2)
|
31-Item true/false questionnaire assessing symptoms of arachnophobia.
Scores range from 0 to 31, with greater scores representing greater subjective fear of spiders, where lower scores reflect low subjective fear of spiders
|
Change from baseline to immediately post treatment 1 (after modeled exposure), immediately post treatment 2 (group exposure) and follow-up (7 days after group exposure - post treatment 2)
|
|
Change in avoidance behavior (online virtual Behavioral Approach Task, vBATon)
Time Frame: Change from baseline to immediately post treatment 1 (after modeled exposure), immediately post treatment 2 (group exposure) and follow-up (7 days after group exposure - post treatment 2)
|
Scores range from 0 ("participant refuses entering the room with the spider") to 12 ("participant holds the spider for at least 20 seconds")
|
Change from baseline to immediately post treatment 1 (after modeled exposure), immediately post treatment 2 (group exposure) and follow-up (7 days after group exposure - post treatment 2)
|
|
Change in spider fear: Spider Anxiety Questionnaire (FSQ/SAF)
Time Frame: Change from baseline to immediately post treatment 1 (after modeled exposure), immediately post treatment 2 (group exposure) and follow-up (7 days after group exposure - post treatment 2)
|
14-item questionnaire on a 7-point Likert-Scale (0 = "I don´t agree at all"; 6 = "I completely agree") to assess symptoms of arachnophobia.
Total score can range from 0 to 98 Greater scores representing worse symptom severity of arachnophobia
|
Change from baseline to immediately post treatment 1 (after modeled exposure), immediately post treatment 2 (group exposure) and follow-up (7 days after group exposure - post treatment 2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in spider phobia belief questionnaire (SBQ)
Time Frame: Change from baseline to immediately post treatment 1 (after modeled exposure), immediately post treatment 2 (group exposure) and follow-up (7 days after group exposure -- post treatment 2)
|
Assessment of spider phobia dysfunctional beliefs; 48 items on a scale from 0% ("no approval") to 100% ("full approval"); higher scores indicate more dysfunctional beliefs about the danger of spiders and own coping abilities regarding spiders
|
Change from baseline to immediately post treatment 1 (after modeled exposure), immediately post treatment 2 (group exposure) and follow-up (7 days after group exposure -- post treatment 2)
|
|
Change in Spider Anxiety Screening (SAS)
Time Frame: Change from baseline to immediately post treatment 1 (after modeled exposure), immediately post treatment 2 (group exposure) and follow-up (7 days after group exposure- post treatment 2)
|
Assessment of the four criteria for specific phobia (DSM-IV) with 4 items on a scale from 0 ("does not apply at all") to 6 ("fully applies"), Total score range: 0 to 24, higher scores indicating worse severity of symptoms of arachnophobia
|
Change from baseline to immediately post treatment 1 (after modeled exposure), immediately post treatment 2 (group exposure) and follow-up (7 days after group exposure- post treatment 2)
|
|
Global success rating (GSR)
Time Frame: Change from immediately post treatment 1 (after modeled exposure) to immediately post-treatment 2 (after group exposure) and follow-up (7 days after group exposure- post treatment 2)
|
Self-report measure of subjective state changes on a 7-likert scale from 1 ("much worse") to 7 ("much better")
|
Change from immediately post treatment 1 (after modeled exposure) to immediately post-treatment 2 (after group exposure) and follow-up (7 days after group exposure- post treatment 2)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety Sensitivity (ASI-3)
Time Frame: baseline
|
Self-report measure of anxiety-related body symptoms (i.e.
anxiety sensitivity) with 18 items on a scale from 0 ("does not apply at all") to 4 ("fully applies").
Total score can range from 0 to 72; higher scores indicate worse anxiety sensitivity
|
baseline
|
|
Depression, Anxiety and Stress Scale (DASS)
Time Frame: baseline
|
Self-report measure of main symptoms of depression, anxiety, and stress, 21 items on a 4-point severity/frequency scale from 0 ("didn´t apply to me at all") to 4 ("applied very much to me, or most of the time").
Total score can range from 0 to 84, higher scores indicate higher symptom severity
|
baseline
|
|
Group Entitativity Measure-Group Therapy (GEM-GP)
Time Frame: immediately post-treatment 2 (after group exposure)
|
Single item visual analogue scale to measure group cohesion, scale can range from 1 to 6, higher scores indicate higher group cohesion
|
immediately post-treatment 2 (after group exposure)
|
|
Group Climate Questionnaire (GCQ-S)
Time Frame: immediately post-treatment 2 (after group exposure)
|
Self-report measure assessing perception of group atmosphere on 12 items rated on a 7-point Likert-scale (0 = "not at all" to 6 = "very much/extremely")
|
immediately post-treatment 2 (after group exposure)
|
|
Muenster Epistemic Trustworthiness Inventory (METI)
Time Frame: Change from immediately post treatment 1 (after modeled exposure) to immediately post-treatment 2 (after group exposure)
|
Self-report measure of epistemic trustworthiness, consisting of 14 antonyms on a 7-point scale, higher scales indicate higher epistemic trust
|
Change from immediately post treatment 1 (after modeled exposure) to immediately post-treatment 2 (after group exposure)
|
|
Intolerance of uncertainty (IUS-12)
Time Frame: baseline
|
Self-report measure to assess uncertainty intolerance with 12 items on a 5-point Likert-scale from 1 ("not at all characteristics of me") to 5 ("very characteristic of me"), higher scores indicate greater uncertainty intolerance
|
baseline
|
|
Positive mental health Scale (PMH)
Time Frame: baseline
|
Self-report measure assessing emotional and psychological aspects of wellbeing with 9 items rated on a scale from 0 ("do not agree") to 3 ("agree"), score can range from 0 to 27, higher scores indicate greater wellbeing
|
baseline
|
|
Interpersonal Reactivity Index (IRI)
Time Frame: baseline
|
Self-report measure to assess empathy with 16 Items on a scale from 0 ("never") to 4 ("always"), score can range from 0 to 66, higher scores indicate greater empathy
|
baseline
|
|
State-Trait Anxiety Inventory - Trait (STAI-T)
Time Frame: baseline
|
Self-report measure of general anxiety with 20 Items (range from 1 = "almost never" to 4 = "nearly always"), Score range from 20 (no anxiety) to 80 (high anxiety)
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christiane A. Melzig, PhD, Philipps University Marburg
- Principal Investigator: Jana Gessner, M.Sc., Philipps University Marburg
Publications and helpful links
General Publications
- Craske MG, Treanor M, Conway CC, Zbozinek T, Vervliet B. Maximizing exposure therapy: an inhibitory learning approach. Behav Res Ther. 2014 Jul;58:10-23. doi: 10.1016/j.brat.2014.04.006. Epub 2014 May 9.
- Mystkowski JL, Craske MG, Echiverri AM, Labus JS. Mental reinstatement of context and return of fear in spider-fearful participants. Behav Ther. 2006 Mar;37(1):49-60. doi: 10.1016/j.beth.2005.04.001. Epub 2006 Feb 24.
- Golkar A, Selbing I, Flygare O, Ohman A, Olsson A. Other people as means to a safe end: vicarious extinction blocks the return of learned fear. Psychol Sci. 2013 Nov 1;24(11):2182-90. doi: 10.1177/0956797613489890. Epub 2013 Sep 10.
- Ost LG, Ferebee I, Furmark T. One-session group therapy of spider phobia: direct versus indirect treatments. Behav Res Ther. 1997 Aug;35(8):721-32. doi: 10.1016/s0005-7967(97)00028-4.
- Olsson A, Phelps EA. Social learning of fear. Nat Neurosci. 2007 Sep;10(9):1095-102. doi: 10.1038/nn1968.
- Wannemueller A, Appelbaum D, Kuppers M, Matten A, Teismann T, Adolph D, Margraf J. Large Group Exposure Treatment: a Feasibility Study in Highly Spider Fearful Individuals. Front Psychol. 2016 Aug 9;7:1183. doi: 10.3389/fpsyg.2016.01183. eCollection 2016.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMEX_SPIDER
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arachnophobia
-
University of Texas at AustinUnknown
-
Philipps University MarburgCompletedArachnophobia | Spider FearGermany
-
Ruhr University of BochumRecruiting
-
University of California, Los AngelesCompleted
-
University of Texas at AustinCompletedObsessive-Compulsive Disorder | Claustrophobia | ArachnophobiaUnited States
-
University of Nevada, RenoCompletedSpecific Phobia | Arachnophobia | Spider PhobiaUnited States
-
University of California, Los AngelesTerminated
-
University of South FloridaNational Institute of Mental Health (NIMH)CompletedArachnophobia | Cynophobia | OphidiophobiaUnited States
-
Ruhr University of BochumCompletedOne Week Follow-up Assessment | Six Weeks Follow-up Assessment | Three Months Follow-up AssessmentGermany
-
Walter Reed Army Institute of Research (WRAIR)RecruitingFear of Spiders | Acute Stress ReactionUnited States
Clinical Trials on online psychoeducation video + modeled exposure
-
Yale UniversityCompletedUsing Video Modeled Social Stories to Improve Oral Hygiene in Children With Autism Spectrum DisorderDental Caries | Autism Spectrum DisorderUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR)Completed
-
Uppsala UniversityCompleted
-
University of Texas at AustinCompletedPost Traumatic Stress DisorderUnited States
-
Chinese University of Hong KongCompleted
-
Maastricht University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedIrritable Bowel SyndromeNetherlands
-
Ka YanRadboud University, The NetherlandsCompleted
-
Technical University of MunichCompletedSchizophrenia | Schizoaffective DisorderGermany
-
University of ConnecticutHartford HospitalCompletedObesity | Blood Pressure | Stigma, Social | Cardiovascular Disease Risk Factor
-
University Hospital, MontpellierInstitut National de la Santé Et de la Recherche Médicale, FranceCompleted