Efficacy of Targeted Memory Reactivation for Enhancing Exposure Therapy

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Placebo-Controlled, Randomized, Double-Blind Study of the Efficacy of Targeted Memory Reactivation for Enhancing Exposure Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04663672
• Other study ID #: 2018-09-0058
• Status: Completed
• Phase: N/A
• Start date: January 29, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: December 2020
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates whether a scent applied during exposure therapy and during subsequent sleep will increase the durability of treatment effects for individuals with fear of spiders, contamination, and enclosed spaces.

Description:

Newly acquired memories encoded during wakefulness are spontaneously re-activated during sleep, resulting in synaptic potentiation and strengthening of the re-activated traces. Targeted memory reactivation (TMR) typically involves a period of initial learning in the presence of an olfactory or auditory contextual cue, coupled with later presentation of the cue during sleep to ostensibly facilitate memory reactivation and consolidation. Numerous studies have found evidence of improved task performance subsequent to cue-induced neuronal replay, however application of TMR to treatment of naturally acquired, clinically significant fear has been limited.

The present study will will provide a rigorous test of TMR's efficacy as an augmentative strategy for exposure therapy. It is hypothesized that participants who sleep in the presence of the same odor that they are exposed to during exposure therapy will exhibit reduced fear at follow up, relative to participants who sleep in the presence of a different odor, or a non-odorous control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Marked anxiety in at least one fear domain (spiders, contamination, or enclosed spaces), as determined by the presence of both:

1. self-reported peak anxiety of at least 50 on a 100 point scale in response to two behavioral approach tasks

2. self-report measures meeting the following cutoffs for the target fear:

• Fear of Spiders Questionnaire = 50

• Obsessive-Compulsive Inventory-Revised (Washing Subscale) = 4

• Claustrophobia Screener = 2

Exclusion Criteria:

• Diagnosed sleep disorder

• Current sleep medication usage

• Inability to differentiate two different odors from an indoor scent diffuser

• Current psychotherapy for fear of spiders, snakes, enclosed spaces, or contamination

• Current use of air fresheners, scented candles, or other items with odors related to those used in the study

Related Conditions & MeSH terms

• Arachnophobia
• Claustrophobia
• Obsessive-Compulsive Disorder
• Phobic Disorders

Intervention

Other:
• Experimental Scent
Participants will sleep in the presence of the exposure scent, delivered by an Airwick Essential Oils diffuser
• Control Scent
Participants will sleep in the presence of a novel scent, delivered by an Airwick Essential Oils diffuser
• No-Scent Control
Participants will sleep in the presence of an odorless control vehicle, delivered by an Airwick Essential Oils diffuser

Behavioral:
• In-Vivo Exposure
Participants will receive 40 minutes of in-vivo exposure therapy to feared targets in the presence of a distinctive exposure scent.

Locations

Country	Name	City	State
United States	Laboratory for the Study of Anxiety Disorders, University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fear response during two behavioral approach tasks across time points	Change in subjective units of distress (0 = no fear, to 100 = extreme fear) and skin conductance in response to approaching a feared stimulus, from baseline to one month follow-up	Baseline (Day 1); Post-treatment (Day 1; immediately after treatment); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)
Secondary	Change in arachnophobia symptom severity across time-points	Change in total score on the Fear of Spiders Questionnaire from baseline to one month follow-up	Baseline (Day 1); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)
Secondary	Change in claustrophobia symptom severity across time points	Change in total score on the Claustrophobia Questionnaire from baseline to one month follow-up	Baseline (Day 1); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)
Secondary	Change in contamination fear symptom severity across time points	Change in total score on the contamination subscale of the Padua Inventory- Washington State University Revision from baseline to one month follow-up	Baseline (Day 1); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)