Efficacy of Targeted Memory Reactivation for Enhancing Exposure Therapy

NCT04663672 | Completed

• 1 other identifier: 2018-09-0058
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Claustrophobia; Obsessive-Compulsive Disorder; Arachnophobia

Keywords

Targeted Memory Reactivation; Memory Consolidation; Exposure Therapy; Sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in arachnophobia symptom severity across time-points

  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

  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

  Baseline (Day 1); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)

Study Arms (3)

Exposure Therapy + Exposure Scent Cue During Sleep

EXPERIMENTAL

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; Behavioral: In-Vivo Exposure

Exposure Therapy + Novel Scent During Sleep

PLACEBO COMPARATOR

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.

Other: Control Scent; Behavioral: In-Vivo Exposure

Exposure Therapy + No-Scent Control During Sleep

SHAM COMPARATOR

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.

Other: No-Scent Control; Behavioral: In-Vivo Exposure

Interventions

Experimental Scent OTHER

Participants will sleep in the presence of the exposure scent, delivered by an Airwick Essential Oils diffuser

Exposure Therapy + Exposure Scent Cue During Sleep

Control Scent OTHER

Participants will sleep in the presence of a novel scent, delivered by an Airwick Essential Oils diffuser

Exposure Therapy + Novel Scent During Sleep

No-Scent Control OTHER

Participants will sleep in the presence of an odorless control vehicle, delivered by an Airwick Essential Oils diffuser

Exposure Therapy + No-Scent Control During Sleep

In-Vivo Exposure BEHAVIORAL

Participants will receive 40 minutes of in-vivo exposure therapy to feared targets in the presence of a distinctive exposure scent.

Exposure Therapy + Exposure Scent Cue During Sleep; Exposure Therapy + No-Scent Control During Sleep; Exposure Therapy + Novel Scent During Sleep

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

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

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Claustrophobia; Obsessive-Compulsive Disorder; Arachnophobia

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 11, 2020
• Study Start: January 29, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

US (1)