The Effect of Time on Generalization of Exposure-based Benefit

The Effect of Time on Generalization of Exposure-based Benefit in Spider Fear

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.

Study Overview

• Status: Not yet recruiting
• Conditions: One Week Follow-up Assessment; Six Weeks Follow-up Assessment; Three Months Follow-up Assessment
• Intervention / Treatment: Behavioral: Exposure

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany, 44787
    • Department of Behavioral and Clinical Neuroscience
    • Contact: Iris Kodzaga, M.Sc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Any acute or chronic mental and / or somatic disease
• Psychological, psychiatric, neurological or pharmacological treatment
• Drug or alcohol abuse
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One week follow-up assessment; Participants will receive a pre-assessment and an exposure with a control spider (spider A). This control spider will be presented again at post-training assessments. Participants will then be assigned to the follow-up assessment one week after the exposure session, in which spider A and a novel spider (spider B) will be used to test for generalization of exposure effects.	Behavioral: Exposure; One-session of graded in-vivo exposure with a spider. Each task is first modeled by the experimenter. Prior to the exposure, participants receive psychoeducation on anxiety and phobias.
Experimental: Six weeks follow-up assessment; Participants will receive a pre-assessment and an exposure with a control spider (spider A). This control spider will be presented again at post-training assessments. Participants will then be assigned to the follow-up assessment six weeks after the exposure session, in which spider A and a novel spider (spider B) will be used to test for generalization of exposure effects.	Behavioral: Exposure; One-session of graded in-vivo exposure with a spider. Each task is first modeled by the experimenter. Prior to the exposure, participants receive psychoeducation on anxiety and phobias.
Experimental: Three months follow-up assessment; Participants will receive a pre-assessment and an exposure with a control spider (spider A). This control spider will be presented again at post-training assessments. Participants will then be assigned to the follow-up assessment three months after the exposure session, in which spider A and a novel spider (spider B) will be used to test for generalization of exposure effects.	Behavioral: Exposure; One-session of graded in-vivo exposure with a spider. Each task is first modeled by the experimenter. Prior to the exposure, participants receive psychoeducation on anxiety and phobias.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral Approach Test (BAT)	Change in the Behavioral Approach Test (BAT) at post-assessment and follow-up with the control spider (spider A; treated stimulus) and a novel spider (spider B; untreated fear stimulus). During the Behavioral Approach Test (BAT) the closest distance to a spider is measured.	Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
Subjective fear	Change in subjective fear at post-assessment and follow-up with the control spider (spider A; treated stimulus) and a novel spider (spider B; untreated fear stimulus) is measured during the Behavioral Approach Tests.	Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
Subjective disgust	Change in subjective disgust at post-assessment and follow-up with the control spider (spider A; treated stimulus) and a novel spider (spider B; untreated fear stimulus) is measured during the Behavioral Approach Tests.	Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
Heart rate	Change in heart rate at post-assessment and follow-up with the control spider (spider A; treated stimulus) and a novel spider (spider B; untreated fear stimulus) is measured during the Behavioral Approach Tests.	Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on General Self-efficacy (GSE) Scale	Change in self-efficacy is measured by the GSE Scale. The GSE Scale contains ten items and measures how confident the person feels to overcome difficult situations based on their self-assessed competence. The total score is determined by summing up all item scores, which results in a score between 10 and 40, where the higher scores represent higher GSE.	Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
Self-efficacy Questionnaire for Phobic Situations (SEQ-SP)	The questionnaire consists of 13 items. The items describe specific phobic situations (in relation to animals) for which the participants has to assess their self-efficacy expectations based on a five-point scale (1 = really sure I couldn't, 5 = really sure I could).	Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
Fear of Spiders Questionnaire (FSQ)	Change in the Spider-fear related questionnaires. 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.	Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
Spider Fear Questionnaire (SPQ)	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.	Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)
Spider Beliefs Questionnaire (SBQ)	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.	Pre-assessment (immediately before exposure), post-assessment (one day after exposure), follow-up (one week, six weeks, or three months after exposure)

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Extinction; Anxiety Disorders; Exposure Therapy; Specific phobia; Fear of Spiders; Generalization of Exposure Effects
• Other Study ID Numbers: Ruhr-University Bochum

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No