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

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

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).

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Control; Behavioral: Functional Analysis; Behavioral: Cognitive Restructuring; Behavioral: Dealing With Cravings

Detailed Description

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".)

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01730
      • Elizabeth E Epstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Behavioral: Control; 60 minute psycho-education on alcohol and drugs.
EXPERIMENTAL: 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.	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.
EXPERIMENTAL: 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.	Behavioral: Cognitive Restructuring; CR is used to to help identify and change automatic, habituated thoughts that occur in response to alcohol triggers.
EXPERIMENTAL: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Drinking Behavior	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.)	Weekly for up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use Questionnaire (AUQ)	AUQ is an 8-item questionnaire that measures self-reported craving for alcohol. Item scores range from 1-7 and a total score, ranging from 8-56, is calculated by summing all values. Higher scores indicate greater craving.	Weekly for up to 3 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barratt Impulsivity Questionnaire	The Barratt is a 30-item questionnaire that measures self-reported general impulsivity. Item scores range from 1-4 and a total score, ranging from 30-120, is calculated by summing all values. There are three sub scales (Attentional, Motor, and Nonplanning) which are derived from individual items. Higher scores indicate greater attentional, motor, and nonplanning impulsivity and scores range from 8 to 32, 11 to 44, and 11 to 44, respectively.	Weekly for up to 3 weeks
Treatment Services Review	Interview assessing quantity and type of services received (e.g., health, psychological) outside of study intervention. Total scores are calculated by summing the number of outside services used. Total scores have a minimum of 0 and no maximum value.	Given at Week 2 and Week 3 appointments out of 3 week program
Working Alliance Inventory Short Form	12-item self-report measure of the therapeutic alliance. Total scales are calculated by summing all values. Values range from 1-7 with total scores ranging from 12 to 84. Higher scores indicate greater alliance.	Week 2 appointment out of 3 week program
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)	19 item self-report questionnaire assessing client readiness for change. An additional item assesses the client's motivation for coming to therapy. Item scores range from 1 to 5 and a total score, ranging from 19 to 95, is calculated by summing all values. There are three sub scales (Recognition, Ambivalence, and Taking Steps) which are derived from individual items. Higher scores indicate greater recognition, ambivalence and taking steps and scores range from 7 to 35, 4 to 20, and 8 to 40, respectively.	Measurement taken at baseline
Use of Treatment Skills (UTS)	UTS is an 18-item questionnaire that measures adherence to microintervention homework assigned at week 2 appointment. Item scores range from 0 to 4 and a total score, ranging from 0 to 72, is calculated by summing all values. Higher values indicate greater adherence to assigned homework.	Week 3 appointment out of 3 week program

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 8, 2018
• Primary Completion (ACTUAL): June 19, 2019
• Study Completion (ACTUAL): July 26, 2019

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (ACTUAL): September 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: IRB ID: H00011382; 1R21AA025488-01 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with investigators outside the core study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No