Clinical trial NCT06255821: The Effect of Time on Generalization of Exposure-based Benefit
Official title: The Effect of Time on Generalization of Exposure-based Benefit in Spider Fear
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: One Week Follow-up Assessment
Six Weeks Follow-up Assessment
Three Months Follow-up Assessment
Keywords: Exposure Therapy
Generalization of Exposure Effects
Fear of Spiders
Anxiety Disorders
Extinction
Specific phobia
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants will receive a pre-assessment and an exposure with a control spider. This control spider will be presented again at post-training assessments. Participants will then be assigned to one of the follow-up assessments: one week, six weeks or three months. The control spider (spider A) and a novel spider (spider B) will be used again at follow-up BATs to test for generalization of exposure effects.

Detailed description: Several findings from basic research on extinction learning undermine the role of time effects in the contextualization and retrieval of extinguished memories (Archbold et al., 2013; Quirk, 2002; Wiltgen \& Silva, 2007). The latter bears important implications for the evaluation of short- and long-term effects of exposure-based fear reduction and generalization. To date, no study exists examining the role of time on the fear responding to treated stimuli and/or untreated stimuli after successful exposure. It will be investigated whether the differential responding to treated and untreated stimuli after exposure is dependent on the passage of time.

Spider fearful participants will be subjected to a standardized one-session treatment with spiders serving as treatment stimuli. Fear reduction towards treatment stimuli will be assessed at post-treatment. Furthermore, generalization of exposure therapy towards untreated stimuli (i.e., a novel spider) will be assessed. The extent of generalization of exposure-based fear reduction to untreated stimuli will be compared between three groups that will differ with respect to the follow-up length. Here, participants undergoing exposure will be randomly assigned to one of the following follow-up measurements: one week follow-up, six weeks follow-up, and three months follow-up. The extent of exposure induced fear reduction and generalization will be assessed and compared between these groups.

Eligibility criteria: Inclusion Criteria:

* Presence of fear of spiders (Potential diagnosis of arachnophobia)

Exclusion Criteria:

* Reaching level 10 or higher in the initial (Pre-Exposure) Spider BAT
* Any acute or chronic mental and / or somatic disease
* Psychological, psychiatric, neurological or pharmacological treatment
* Drug or alcohol abuse
* Pregnancy

Primary outcomes:
measure: Behavioral Approach Test (BAT)
timeFrame: Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
measure: Subjective fear
timeFrame: Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
measure: Subjective disgust
timeFrame: Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
measure: Heart rate
timeFrame: Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
Secondary outcomes:
measure: Score on General Self-efficacy (GSE) Scale
timeFrame: Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
measure: Self-efficacy Questionnaire for Phobic Situations (SEQ-SP)
timeFrame: Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
measure: Fear of Spiders Questionnaire (FSQ)
timeFrame: Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
measure: Spider Fear Questionnaire (SPQ)
timeFrame: Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
measure: Spider Beliefs Questionnaire (SBQ)
timeFrame: Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Behavioral and Clinical Neuroscience
Study officials:
References: