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Efficacy of Targeted Memory Reactivation for Enhancing Exposure Therapy

Primary Purpose

Claustrophobia, Obsessive-Compulsive Disorder, Arachnophobia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental Scent
Control Scent
No-Scent Control
In-Vivo Exposure
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Claustrophobia focused on measuring Targeted Memory Reactivation, Memory Consolidation, Exposure Therapy, Sleep

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Sham Comparator

Arm Label

Exposure Therapy + Exposure Scent Cue During Sleep

Exposure Therapy + Novel Scent During Sleep

Exposure Therapy + No-Scent Control During Sleep

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Change in claustrophobia symptom severity across time points
Change in total score on the Claustrophobia Questionnaire from baseline to one month follow-up
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

Full Information

First Posted
December 4, 2020
Last Updated
December 4, 2020
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT04663672
Brief Title
Efficacy of Targeted Memory Reactivation for Enhancing Exposure Therapy
Official Title
Placebo-Controlled, Randomized, Double-Blind Study of the Efficacy of Targeted Memory Reactivation for Enhancing Exposure Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Claustrophobia, Obsessive-Compulsive Disorder, Arachnophobia
Keywords
Targeted Memory Reactivation, Memory Consolidation, Exposure Therapy, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposure Therapy + Exposure Scent Cue During Sleep
Arm Type
Experimental
Arm Description
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.
Arm Title
Exposure Therapy + Novel Scent During Sleep
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Exposure Therapy + No-Scent Control During Sleep
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental Scent
Intervention Description
Participants will sleep in the presence of the exposure scent, delivered by an Airwick Essential Oils diffuser
Intervention Type
Other
Intervention Name(s)
Control Scent
Intervention Description
Participants will sleep in the presence of a novel scent, delivered by an Airwick Essential Oils diffuser
Intervention Type
Other
Intervention Name(s)
No-Scent Control
Intervention Description
Participants will sleep in the presence of an odorless control vehicle, delivered by an Airwick Essential Oils diffuser
Intervention Type
Behavioral
Intervention Name(s)
In-Vivo Exposure
Intervention Description
Participants will receive 40 minutes of in-vivo exposure therapy to feared targets in the presence of a distinctive exposure scent.
Primary Outcome Measure Information:
Title
Change in fear response during two behavioral approach tasks across time points
Description
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
Time Frame
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 Measure Information:
Title
Change in arachnophobia symptom severity across time-points
Description
Change in total score on the Fear of Spiders Questionnaire from baseline to one month follow-up
Time Frame
Baseline (Day 1); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)
Title
Change in claustrophobia symptom severity across time points
Description
Change in total score on the Claustrophobia Questionnaire from baseline to one month follow-up
Time Frame
Baseline (Day 1); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)
Title
Change in contamination fear symptom severity across time points
Description
Change in total score on the contamination subscale of the Padua Inventory- Washington State University Revision from baseline to one month follow-up
Time Frame
Baseline (Day 1); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Marked anxiety in at least one fear domain (spiders, contamination, or enclosed spaces), as determined by the presence of both: self-reported peak anxiety of at least 50 on a 100 point scale in response to two behavioral approach tasks 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
Facility Information:
Facility Name
Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

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Efficacy of Targeted Memory Reactivation for Enhancing Exposure Therapy

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