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临床试验/NCT03661853
NCT03661853已完成不适用

Effect of CBT Microinterventions on Mechanisms of Behavior Change Among Adults With AUD: Using Eye Tracking to Measure Pre-Post Cognitive Control, Stimulus Salience, and Craving

University of Massachusetts, Worcester1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2018年8月8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
发起方
入组人数
83
试验地点
1
主要终点
Changes in Drinking Behavior

研究概览

简要总结

This proposed R21, Effect of CBT Microinterventions on Mechanisms of Behavior Change among Adults with AUD: Using Eye Tracking to Measure Pre-Post Cognitive Control, uses a translational team science approach to isolate and examine the effect of three different Cognitive Behavioral Therapy (CBT) interventions (functional analysis (FA), cognitive restructuring for alcohol related thoughts (CR), and dealing with cravings (DC)) on specific hypothesized mechanisms (cognitive control, stimulus salience, or craving/arousal, respectively).

详细描述

This R21 uses an innovative paradigm pairing a "microintervention" design with eye tracking laboratory tasks used successfully to show deficits of cognitive control over cocaine and nicotine cues, and to objectively measure stimulus salience and craving/arousal in response to alcohol cues. To achieve the study's two specific aims, participants with AUD will be assessed with antisaccade (to measure cognitive control) and attentional bias (to measure stimulus salience and pupil diameter) eye tracking tasks.

Specific Aim 1. To isolate and preliminarily assess the impact of specific CBT microinterventions on potentially malleable hypothesized mechanisms of change in drinking using a novel laboratory paradigm and conducted by a translational science team.

Specific Aim 2. To test specificity of CBT interventions' effect on particular Mechanisms of Behavioral Change, the investigators will test each microintervention's effects on all three purported mechanisms (as stated in "Brief Summary".)

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
None

入排标准

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

入选标准

  • •Age 18 or older
  • •Current Alcohol Use Disorder (AUD) Diagnosis
  • •Drank Alcohol within 60 days prior to telephone screen
  • •Able to read and understand English at the 7th grade education level

排除标准

  • •Participant diagnosed with Schizophrenia or Schizoaffective Disorder
  • •Participant has a head injury with symptoms in the last 30 days
  • •Current inpatient or outpatient treatment for AUD or Drug use Disorder (DUD)

研究组 & 干预措施

Control

Active Comparator

This microintervention is intended to control for the effect of nonspecific therapy factors such as therapeutic alliance, time spent with a therapist, talking about alcohol, and/or effects related to assessment reactivity, and consists of 60 minutes of psycho-education on alcohol and drugs. The therapist will talk about historical and scientific information on different types of alcohol and drugs and will not overlap with CBT treatment. The participants will not be encouraged to personalize this information, make any behavioral changes, or do homework. The control does not have any active interventions that would specifically target or affect our outcome variables.

干预措施: Control (Behavioral)

Functional Analysis

Experimental

Functional Analysis (FA) is a core intervention in Cognitive Behavioral Therapy (CBT) for AUD, and helps to "break the chain" of events (external and internal) that lead from cue (trigger) to alcohol use to consequences of use. The FA microintervention teaches the patient to think and behave in new, more controlled ways in response to triggers, to identify maladaptive, impulsive behavior chains and to replace them with more deliberate ones.

干预措施: Functional Analysis (Behavioral)

Cognitive Restructuring

Experimental

Cognitive Restructuring of Thoughts About Alcohol (CR) is a core technique in CBT to help patients identify "automatic" (habituated) thoughts that happen quickly and are often not noticed, and change automatic thoughts occurring in response to alcohol triggers.

干预措施: Cognitive Restructuring (Behavioral)

Dealing with Cravings

Experimental

Dealing with Cravings (DC) is designed to directly target the reward and arousal systems, helping the patient accept the nature of cravings as time limited and deflated by continued abstinence so that craving is no longer associated with urgency. DC also teaches skills to reduce cravings by conjuring images such as a spider floating in a glass of wine, or of older versions of oneself sitting alone and dejected in a bar. Distraction techniques and breathing skills to reduce physiological arousal occurring in response to alcohol cues are also taught.

干预措施: Dealing With Cravings (Behavioral)

结局指标

主要结局

Changes in Drinking Behavior

时间窗: Weekly for up to 3 weeks

Changes in drinking behavior are measured by tracking eye movement patterns using antisaccade + attentional bias eyetracking tasks. Specifically, outcome mediators include changes in cognitive control (# of errors in antisaccade eye-tracking task), changes in stimulus salience (stimulus dwell time measurements), and changes in craving/arousal (pupil diameter changes in response to stimuli presentation.)

次要结局

  • Alcohol Use Questionnaire (AUQ)(Weekly for up to 3 weeks)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Epstein

Principal Investigator

University of Massachusetts, Worcester

研究点 (1)

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