Placebo-Controlled, Randomized, Double-Blind Study of the Efficacy of Targeted Memory Reactivation for Enhancing Exposure Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Change in fear response during two behavioral approach tasks across time points
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in fear response during two behavioral approach tasks across time points
时间窗: 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)
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
次要结局
- 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))
研究者
Michael J. Telch
Prinicipal Investigator
University of Texas at Austin