Clinical trial NCT06182709: Feasibility of an Online Modeled Exposure in Spider Fearful Individuals
Official title: Group Exposure Treatment: Feasibility of an Online Modeled Exposure in Spider Fearful Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spider Fear
Arachnophobia
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effectiveness of an optimized group exposure treatment is investigated in spider-fearful individuals. Participants will undergo an optimized standardized exposure treatment. After receiving information about the treatment and the phobic stimulus (spider) through a psychoeducation video, participants will observe an exposure treatment of another fearful person, either live or by watching a movie of an exposure treatment online. Subsequently, participants will undergo a live in vivo exposure treatment conducted in a group setting. The effectiveness of the treatment is measured by symptom improvement according to online behavioral avoidance tests and subjective ratings immediately after training and one week later.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Spider Phobia Questionnaire (SPQ)
timeFrame: 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)
measure: Change in avoidance behavior (online virtual Behavioral Approach Task, vBATon)
timeFrame: 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)
measure: Change in spider fear: Spider Anxiety Questionnaire (FSQ/SAF)
timeFrame: 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 outcomes:
measure: Change in spider phobia belief questionnaire (SBQ)
timeFrame: 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)
measure: Change in Spider Anxiety Screening (SAS)
timeFrame: 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)
measure: Global success rating (GSR)
timeFrame: 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 outcomes:
measure: Anxiety Sensitivity (ASI-3)
timeFrame: baseline
measure: Depression, Anxiety and Stress Scale (DASS)
timeFrame: baseline
measure: Group Entitativity Measure-Group Therapy (GEM-GP)
timeFrame: immediately post-treatment 2 (after group exposure)
measure: Group Climate Questionnaire (GCQ-S)
timeFrame: immediately post-treatment 2 (after group exposure)
measure: Muenster Epistemic Trustworthiness Inventory (METI)
timeFrame: Change from immediately post treatment 1 (after modeled exposure) to immediately post-treatment 2 (after group exposure)
measure: Intolerance of uncertainty (IUS-12)
timeFrame: baseline
measure: Positive mental health Scale (PMH)
timeFrame: baseline
measure: Interpersonal Reactivity Index (IRI)
timeFrame: baseline
measure: State-Trait Anxiety Inventory - Trait (STAI-T)
timeFrame: baseline
Locations:
city: Marburg
country: Germany
facility: Philipps-University Marburg
state: Hesse
Study officials:
affiliation: Philipps University Marburg
name: Christiane A. Melzig, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Philipps University Marburg
name: Jana Gessner, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.