Clinical trial NCT03661853: Effect of CBT Microinterventions on Mechanisms of Behavior Change Among Adults With AUD
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-09-07
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 arms: 3 CBT microinterventions + control condition
Primary purpose: TREATMENT

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).

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".)

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in Drinking Behavior
timeFrame: Weekly for up to 3 weeks
Secondary outcomes:
measure: Alcohol Use Questionnaire (AUQ)
timeFrame: Weekly for up to 3 weeks
Other outcomes:
measure: Barratt Impulsivity Questionnaire
timeFrame: Weekly for up to 3 weeks
measure: Treatment Services Review
timeFrame: Given at Week 2 and Week 3 appointments out of 3 week program
measure: Working Alliance Inventory Short Form
timeFrame: Week 2 appointment out of 3 week program
measure: Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
timeFrame: Measurement taken at baseline
measure: Use of Treatment Skills (UTS)
timeFrame: Week 3 appointment out of 3 week program
Locations:
city: Worcester
country: United States
facility: Elizabeth E Epstein
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Elizabeth Epstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: