Effect of CBT Microinterventions on Mechanisms of Behavior Change Among Adults With AUD
2 other identifiers
interventional
83
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 8, 2018
CompletedFirst Submitted
Initial submission to the registry
September 5, 2018
CompletedFirst Posted
Study publicly available on registry
September 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2019
CompletedJanuary 27, 2021
January 1, 2021
11 months
September 5, 2018
January 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Alcohol Use Questionnaire (AUQ)
Weekly for up to 3 weeks
Other Outcomes (5)
Barratt Impulsivity Questionnaire
Weekly for up to 3 weeks
Treatment Services Review
Given at Week 2 and Week 3 appointments out of 3 week program
Working Alliance Inventory Short Form
Week 2 appointment out of 3 week program
- +2 more other outcomes
Study Arms (4)
Control
ACTIVE COMPARATORThis 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.
Functional Analysis
EXPERIMENTALFunctional 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.
Cognitive Restructuring
EXPERIMENTALCognitive 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.
Dealing with Cravings
EXPERIMENTALDealing 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.
Interventions
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.
CR is used to to help identify and change automatic, habituated thoughts that occur in response to alcohol triggers.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Elizabeth E Epstein
Worcester, Massachusetts, 01730, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Epstein, PhD
University of Massachusetts, Worcester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 5, 2018
First Posted
September 7, 2018
Study Start
August 8, 2018
Primary Completion
June 19, 2019
Study Completion
July 26, 2019
Last Updated
January 27, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared with investigators outside the core study team.