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

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ClinicalTrials.gov Identifier: NCT03661853
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Elizabeth Epstein, University of Massachusetts, Worcester

Tracking Information
First Submitted Date  ICMJE September 5, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date September 14, 2018
Actual Study Start Date  ICMJE August 8, 2018
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
Changes in Drinking Behavior [ Time Frame: 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.)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03661853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
Alcohol Use Questionnaire (AUQ) [ Time Frame: Weekly for up to 3 weeks ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 5, 2018)
  • Barratt Impulsivity Questionnaire [ Time Frame: Weekly for up to 3 weeks ]
    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.
  • Treatment Services Review [ Time Frame: Given at Week 2 and Week 3 appointments out of 3 week program ]
    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.
  • Working Alliance Inventory Short Form [ Time Frame: Week 2 appointment out of 3 week program ]
    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.
  • Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) [ Time Frame: Measurement taken at baseline ]
    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.
  • Use of Treatment Skills (UTS) [ Time Frame: Week 3 appointment out of 3 week program ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of CBT Microinterventions on Mechanisms of Behavior Change Among Adults With AUD
Official Title  ICMJE 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
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".)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
4 arms: 3 CBT microinterventions + control condition
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE
  • Behavioral: Control
    60 minute psycho-education on alcohol and drugs.
  • 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.
  • Behavioral: Cognitive Restructuring
    CR is used to to help identify and change automatic, habituated thoughts that occur in response to alcohol triggers.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Control
  • 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.
    Intervention: Behavioral: Functional Analysis
  • 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.
    Intervention: Behavioral: Cognitive Restructuring
  • 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.
    Intervention: Behavioral: Dealing With Cravings
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emily Starratt 508-856-8745 emily.starratt@umassmed.edu
Contact: Michael Rabinovich 617-584-4117 Michael.Rabinovich2@umassmed.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03661853
Other Study ID Numbers  ICMJE IRB ID: H00011382
1R21AA025488-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with investigators outside the core study team.
Responsible Party Elizabeth Epstein, University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Elizabeth Epstein University of Massachusetts, Worcester
PRS Account University of Massachusetts, Worcester
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP