Effect of CBT Microinterventions on Mechanisms of Behavior Change Among Adults With AUD

NCT ID: NCT03661853

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-08

Study Completion Date

2019-07-26

Brief Summary

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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).

Detailed Description

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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".)

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 arms: 3 CBT microinterventions + control condition
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

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.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

60 minute psycho-education on alcohol and drugs.

Functional Analysis

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.

Group Type EXPERIMENTAL

Functional Analysis

Intervention Type BEHAVIORAL

Component of standard CBT that helps to "break the chain" of events (external and internal) that lead from cue (trigger) to alcohol use to consequences of use.

Cognitive Restructuring

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.

Group Type EXPERIMENTAL

Cognitive Restructuring

Intervention Type BEHAVIORAL

CR is used to to help identify and change automatic, habituated thoughts that occur in response to alcohol triggers.

Dealing with Cravings

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.

Group Type EXPERIMENTAL

Dealing With Cravings

Intervention Type BEHAVIORAL

DC is used reduce cravings for alcohol by conjuring negative images associated with alcohol, teaching distraction techniques, and teaching breathing techniques to reduce physiological arousal.

Interventions

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Control

60 minute psycho-education on alcohol and drugs.

Intervention Type BEHAVIORAL

Functional Analysis

Component of standard CBT that helps to "break the chain" of events (external and internal) that lead from cue (trigger) to alcohol use to consequences of use.

Intervention Type BEHAVIORAL

Cognitive Restructuring

CR is used to to help identify and change automatic, habituated thoughts that occur in response to alcohol triggers.

Intervention Type BEHAVIORAL

Dealing With Cravings

DC is used reduce cravings for alcohol by conjuring negative images associated with alcohol, teaching distraction techniques, and teaching breathing techniques to reduce physiological arousal.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Epstein

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Epstein, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

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Elizabeth E Epstein

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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1R21AA025488-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB ID: H00011382

Identifier Type: -

Identifier Source: org_study_id

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