Efficacy of Targeted Memory Reactivation for Enhancing Exposure Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder; Claustrophobia; Arachnophobia
• Intervention / Treatment: Other: Experimental Scent; Behavioral: In-Vivo Exposure; Other: Control Scent; Other: No-Scent Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Laboratory for the Study of Anxiety Disorders, University of Texas at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exposure Therapy + Exposure Scent Cue During Sleep; Participants will undergo exposure treatment for their target fear while in the presence of a distinctive odor. Exposure will occur in repeated 4-minute trials. Exposure will continue for 40 minutes or until peak fear decreases by at least 35 points on a 100 point scale, compared to peak fear during the initial trial. Participants will subsequently sleep in the presence of the exposure scent.	Other: Experimental Scent; Participants will sleep in the presence of the exposure scent, 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.
PLACEBO_COMPARATOR: Exposure Therapy + Novel Scent During Sleep; Participants will undergo exposure treatment for their target fear while in the presence of a distinctive odor. Exposure will occur in repeated 4-minute trials. Exposure will continue for 40 minutes or until peak fear decreases by at least 35 points on a 100 point scale, compared to peak fear during the initial trial. Participants will subsequently sleep in the presence of a novel scent.	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.; Other: Control Scent; Participants will sleep in the presence of a novel scent, delivered by an Airwick Essential Oils diffuser
SHAM_COMPARATOR: Exposure Therapy + No-Scent Control During Sleep; Participants will undergo exposure treatment for their target fear while in the presence of a distinctive odor. Exposure will occur in repeated 4-minute trials. Exposure will continue for 40 minutes or until peak fear decreases by at least 35 points on a 100 point scale, compared to peak fear during the initial trial. Participants will subsequently sleep in the presence of an odorless control vehicle.	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.; Other: No-Scent Control; Participants will sleep in the presence of an odorless control vehicle, delivered by an Airwick Essential Oils diffuser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2019
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ACTUAL): March 1, 2020

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (ACTUAL): December 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Sleep; Exposure Therapy; Targeted Memory Reactivation; Memory Consolidation
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Obsessive-Compulsive Disorder; Phobic Disorders
• Other Study ID Numbers: 2018-09-0058

Drug and device information, study documents

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