Extinction Generalization in Exposure Therapy

• Sponsor: Ruhr University of Bochum (Other)
• Overall Status: Completed
• CT.gov ID: NCT03031002
• Collaborator: (none)
• Enrollment: 77
• Arms: 2
• Duration (Months): 17

Study Details

Study Description

Brief Summary

Patients with anxiety disorders oftentimes express fear responses to more than only one fear-inducing object. The principal aim of this study is to examine whether the beneficial effects of exposure on fear reduction in spider phobia can extend to stimuli which are conceptually similar to spiders (i.e. cockroaches), but have never been presented during the respective treatment.

Condition or Disease	Intervention/Treatment	Phase
Specific Phobia	Behavioral: Exposure treatment for spider fear	N/A

Detailed Description

Fear extinction has evolved as the central mechanism underlying exposure-based treatments. Findings from conditioning studies indicate that fear reduction following a fear extinction procedure can generalize from the extinction stimulus to other conceptually and perceptually related stimuli. This study is aimed at translating these findings to a clinical application and will hence examine whether the basic principles of extinction generalization are applicable to exposure.

Patients with spider phobia will either receive two sessions of in-vivo exposure with spiders or no treatment. Prior to as well as after treatment, patient's fear of spiders will be assessed using the Behavioral Approach Test (BATs) and self-report questionnaires. In addition, BATs with cockroaches will be conducted to examine the effects of exposure therapy on extinction generalization.

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Extinction Generalization in Exposure Therapy for Spider Phobia
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exposure Treatment Participants of this arm receive two 60-minute sessions of exposure treatment for spider fear	Behavioral: Exposure treatment for spider fear; Two sessions (each session = 60 minutes) of in-vivo exposure treatment (including psychoeducation) with two different spiders. Exposures comprise a hierarchy of 7 steps, to be completed with both spiders.
No Intervention: No Exposure Treatment Participants of this arm receive no exposure or other adequate treatment

Outcome Measures

Primary Outcome Measures

1. Change in the Behavioral Approach Test (BAT) from pre- to posttreatment [Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)]

   Behavioral Approach Tests with Spiders and Cockroaches will be conducted at pre- and posttreatment. Here, the closest proximity a participant is able to attain to the spider/cockroach will be measured.

Secondary Outcome Measures

1. Change in Subjective Fear / Disgust during the Behavioral Approach Tests (BATs) using the Subjective Units of Distress Scale (SUDS) [Pre-and Posttreatment (with approximately 4 days between pre- and posttreatment)]

   Subjective Fear / Disgust during the Behavioral Approach will be assessed at the initial and final approach distances to the spider / cockroach during the respective BATs.

2. Change in Heart Rate during the Behavioral Approach Tests (BATs) from pre- to posttreatment [Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)]

   During each BAT with spiders and cockroaches, heart rate will be measured. In addition, a 5-minute baseline will be recorded prior to the first BAT at each assessment.

3. Change in the Fear of Spiders Questionnaire (FSQ) [Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)]

4. Change in the Spider Phobia Questionnaire (SPQ) [Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)]

5. Change in the Spider Beliefs Questionnaire (SBQ) [Pre- and Posttreatment (with approximately 4 days between pre- and posttreatment)]

Other Outcome Measures

1. Epigenetic / DNA methylation [Pre- and posttreatment (with approximately 4 days between pre- and posttreatment)]

   DNA collection kits at pre- and posttreatment

2. Depression Anxiety Stress Scales (DASS) [Pretreatment (assessed once prior to treatment)]

3. Questionnaire for the Assessment of Disgust Sensitivity (FEE) [Pretreatment (assessed once prior to treatment)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• spider phobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV criteria

Exclusion Criteria:

• any neurological or neuropsychiatric condition

• current behavioral or pharmacological treatment

• any mental disorder that is considered more severe than specific phobia

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ruhr University of Bochum

Investigators

• Principal Investigator: Armin Zlomuzica, Dr., Ruhr University of Bochum

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Armin Zlomuzica, Dr., Ruhr University of Bochum
• ClinicalTrials.gov Identifier: NCT03031002
• Other Study ID Numbers: ZL 59/2-2
• First Posted: Jan 25, 2017
• Last Update Posted: Jan 25, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Armin Zlomuzica, Dr., Ruhr University of Bochum: exposure; spider phobia; generalization; extinction
• Additional relevant MeSH terms: Phobic Disorders

Study Results

No Results Posted as of Jan 25, 2017