Clinical trial NCT05424250: Optimizing Exposure Using Occasional Aversive Imagery in Spider Fearful Individuals
Official title: Optimizing Exposure Therapy Via Occasional Aversive Imagery: a Randomized Controlled Trial with Spider Fearful Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spider Fear
Arachnophobia
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effectiveness of an optimized extinction training is investigated in spider-fearful individuals. Participants will undergo a one-session standardized extinction training, either with or without occasional metal imagination of most feared apprehension towards spiders. The effectiveness of the training is measured by symptom improvement according to subjective ratings and behavioural avoidance tests one week later.

Detailed description: The present study aims to investigate the applicability of an optimized exposure training using imagination. Exposure training is an effective approach to the treatment of various anxiety disorders. However, there are a significant number of patients who do not benefit or who develop anxiety following successful treatment. The process of extinction underlying exposure is the focus of current research on optimizing exposure. In this regard, one promising approach for improving extinction learning involves the occasional presentation of fear-generating stimuli (unconditioned stimuli \[US\]; often an electrical stimulus in experimental studies) during extinction (occasional reinforced extinction, ORE). Previous experimental studies provide preliminary evidence for a less pronounced return of fear after extinction training with occasional presentation of the US. In clinical practice, this strategy is recommended to optimize extinction learning in the treatment of individuals with anxiety. However, the transfer of the procedure used (real presentation of an unconditioned stimulus) into clinical practice seems difficult to realize. One way to facilitate the transfer of the ORE approach into clinical practice could be the use of vivid imagination of a personally relevant fear-generating situation during extinction training/exposure (e.g., patients' central concerns). Therefore, the aim of the present study is to examine the applicability of ORE using imagination. In this context, a standardized extinction training either with or without mental imagination of a personally relevant fear situation (e.g., central concern of the consequences when confronted with spiders) will be performed in individuals with spider-fearful individuals. The approach used for individuals with spider fear is well established and has been successfully implemented in previous studies by instructed trainers (e.g., individuals with a bachelor's degree in psychology). The aim of this randomized controlled trial in healthy individuals with increased fear of spiders is to investigate whether optimized extinction training (extinction training + imagination) is more effective in reducing fear of spiders in the long term compared to standard extinction training.

Eligibility criteria: Inclusion Criteria:

* Elevated score on Spider Phobia Questionnaire (SPQ) \> 17

Exclusion Criteria:

* Severe allergies to bees/spiders/insects
* current psychotherapeutic/psychiatric 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 cardiovascular, respiratory or neurological diseases

Primary outcomes:
measure: Spider Phobia Questionnaire (SPQ)
timeFrame: Change from baseline to post-treatment (i.e., 7-9 days)
measure: Behavioral Approach Test (BAT)
timeFrame: Change from baseline to post-treatment (i.e., 7-9 days)
measure: Fear rating
timeFrame: Change from baseline to post-treatment (i.e., 7-9 days)
Secondary outcomes:
measure: Fear of Spider Questionnaire (FSQ)
timeFrame: Change from baseline to post-treatment (i.e., 7-9 days)
measure: Change in anxiety sensitivity (ASI-3)
timeFrame: change from baseline to post-treatment (i.e. 7-9 days)
measure: PROMIS Emotional Distress-Anxiety-Short Form
timeFrame: change from baseline to post-treatment (i.e. 7-9 days)
measure: US expectancy and fear ratings
timeFrame: Baseline
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps-University Marburg
state: Hesse
Study officials:
affiliation: Philipps University Marburg
name: Christoph Benke, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Philipps University Marburg
name: Christiane Pané-Farré, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Philipps University Marburg
name: Dorothee Scheuermann, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Culver NC, Stevens S, Fanselow MS, Craske MG. Building physiological toughness: Some aversive events during extinction may attenuate return of fear. J Behav Ther Exp Psychiatry. 2018 Mar;58:18-28. doi: 10.1016/j.jbtep.2017.07.003. Epub 2017 Jul 25.
citation: Lipp OV, Ryan KM, Luck CC, Craske MG, Waters AM. Presentation of unpaired unconditional stimuli during extinction reduces renewal of conditional fear and slows re-acquisition. Psychophysiology. 2021 Oct;58(10):e13899. doi: 10.1111/psyp.13899. Epub 2021 Jul 6.
citation: Shiban Y, Wittmann J, Weissinger M, Muhlberger A. Gradual extinction reduces reinstatement. Front Behav Neurosci. 2015 Sep 15;9:254. doi: 10.3389/fnbeh.2015.00254. eCollection 2015.
citation: Thompson A, McEvoy PM, Lipp OV. Enhancing extinction learning: Occasional presentations of the unconditioned stimulus during extinction eliminate spontaneous recovery, but not necessarily reacquisition of fear. Behav Res Ther. 2018 Sep;108:29-39. doi: 10.1016/j.brat.2018.07.001. Epub 2018 Jul 3.