跳至主要内容
临床试验/NCT04128761
NCT04128761已完成不适用

Reinforcer Pathology 1B: Decreasing the Temporal Window

Virginia Polytechnic Institute and State University1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2023年9月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
1
主要终点
Change in Alcohol Craving

研究概览

简要总结

In the absence of sufficient monetary resources, individuals must attend to immediate, minimum needs (e.g., food, shelter). This constricts one's temporal window and engenders neglect of the future. In observational studies, scarcity is associated with higher rates of delay discounting. Additionally, socioeconomic status is inversely associated with alcohol use disorder and related problems. Experimentally, scarcity shortens attention, impedes cognitive function, and increases delay discounting in multiple populations. Moreover, scarcity increases demand for fast foods in the obese and increases craving for alcohol in problem drinkers. These data suggest that economic scarcity worsens both components of reinforcer pathology (delay discounting and alcohol overvaluation), thus increasing vulnerability to alcohol use disorder. However, studies investigating the effects of scarcity on alcohol demand discounting rate have been limited. The purpose of Aim 1b is to examine effects of decreasing the temporal window and its concomitant effects on alcohol valuation (demand, and craving) and delay discounting.

详细描述

Participants will be randomly assigned to experimental or control groups, balanced by discounting rates and sex. We plan to have 112 participants complete the study, based on our power analysis. Participants will complete two online sessions. During the first session, they will complete the baseline assessments. During the second session, they will complete the same assessments after being exposed to the scarcity or control narratives (both in audio format).

The assessment will include delay discounting and demand tasks, and measures of alcohol craving. Participants will also complete assessments of their stress and mood response to the narrative intervention, using the Stress Appraisal Measure (SAM) for two purposes. That is, 1) to monitor participant safety, 2) to measure the mediating ability of affect on changes in the temporal window.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •High-risk or harmful drinking (AUDIT>15)
  • •21 years of age or older
  • •Desire to quit or cut down on their drinking, but do not have proximate plans to enroll in treatment for AUD during the study period

排除标准

  • •having a current unmanaged psychotic disorder
  • •reporting current pregnancy or lactation
  • •having dementia

研究组 & 干预措施

Scarcity Narrative

Experimental

Participants assigned to the scarcity group will be asked to listen and consider a hypothetical narrative about a sudden loss of resources.

干预措施: Scarcity Narrative (Behavioral)

Neutral Narrative

Sham Comparator

Participants assigned to the neutral group will be asked to listen and consider a hypothetical narrative about a neutral change in resources.

干预措施: Neutral Narrative (Behavioral)

结局指标

主要结局

Change in Alcohol Craving

时间窗: At the first session (S1; baseline measures) and Session 2 (S2; occurs approximately 2-3 days after S1)

A brief questionnaire (the Alcohol Urges Questionnaire) will be used to assess alcohol craving. The Alcohol Urges Questionnaire is an 8-item survey that produces scores between 8-56, where higher scores indicate greater craving. Change in alcohol craving will be compared within-subjects between Session 1 and Session 2. The scores will be compared between groups (arms) across sessions.

Delay Discounting (DD) Rates

时间窗: At the first session (S1; baseline measures) and Session 2 (S2; occurs approximately 2-3 days after S1)

DD rates were measured using an adjusting amount task where participants were presented with hypothetical choices between smaller immediate or larger later amounts of money after a range of delays (1 day-25 years). Individual indifference points were calculated for each delay and then used to estimate DD rates for each participant using Mazur's (1987) equation: V = A/(1+kD), where V is the value of the indifference point, A is the amount of the larger delayed reward, k is the discounting rate, and D is the delay. Discounting rates (k) were then natural-logarithmically transformed (ln(k)). Higher ln(k) indicates steeper discounting and greater reward devaluation with increases in delay, while a lower ln(k) reflects shallower discounting and less reward devaluation with increases in delay. Changes in ln(k) were compared within-subjects between S1 and S2. Average ln(k) was calculated for each session (S1 and S2) in each condition (scarcity or neutral).

Intensity of Alcohol Demand

时间窗: At the first session (S1; baseline measures) and Session 2 (S2; occurs approximately 2-3 days after S1)

Participants completed a hypothetical Alcohol Purchase Task where they had to indicate how many drinks they would purchase at different prices ($0 to $80 per drink). The number of drinks purchased at $0 was used to calculate the intensity of demand. Changes in intensity of alcohol demand were compared within-subjects between Session 1 and Session 2, and between narrative type (scarcity or neutral).

Change in Alcohol Craving

时间窗: At the first session (S1; baseline measures) and Session 2 (S2; occurs approximately 2-3 days after S1)

A brief questionnaire (the Alcohol Urges Questionnaire) will be used to assess alcohol craving. The Alcohol Urges Questionnaire is an 8-item survey that produces scores between 8-56, where higher scores indicate greater craving. Change in alcohol craving will be compared within-subjects between Session 1 and Session 2. The scores will be compared between groups (arms) across sessions.

次要结局

  • Change in Stress Appraisal Measure(Session 2 (occurs approximately 2-3 days after baseline [S1]))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen LaConte

Professor

Virginia Polytechnic Institute and State University

研究点 (1)

Loading locations...

相似试验