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CompletedNo phase

Neurocognitive and Neurobehavioral Mechanisms of Change Following Psychological Treatment for Alcohol Use Disorder

Key facts

Who runs it
University of New Mexico
Where
Albuquerque, United StatesSee the 2 sites
Trial code
Status
Completed
People taking part
110 people enrolled
Started
14 Nov 2018
Ended
31 Mar 2025
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Cognitive Behavior Therapy
  • Mindfulness Based Relapse Prevention
Record updated
22 April 2025

Who can take part

Age
22 years to 85 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • Age 22-85 years
  • Self-identify as a heavy/binge/weekly drinker
  • Engage in "hazardous and harmful alcohol use" (Babor et al., 2001) based on an AUDIT score > 8 for men and > 7 for women
  • Breath alcohol level of 0.00 at in-person screening
  • Right handed
  • Explicitly be seeking help for their drinking
  • Alcohol use during the past 30 days

Who cannot take part

  • Evidence of recent illicit drug (other than marijuana) use on a urine screen
  • Female participants who think they may be pregnant must pass a urine pregnancy screen prior to each MRI scanning session
  • History of brain injury or neurological diagnoses
  • History of major alcohol withdrawal
  • Evidence of current psychosis
  • Past-year substance dependence other than nicotine or marijuana
  • Contraindications for MRI (e.g., medical devices in the body)
  • Estimated IQ < 80
  • Unable to read or speak English fluently
  • Currently in treatment for alcohol use (or within the past 6 months)

Where in United States

  • The Mind Research NetworkAlbuquerque, United States
  • The University of New MexicoAlbuquerque, United States

About the trial

What the trial wants to find out

Alcohol Use Disorder (AUD) is a significant public health problem, with prevalence rates of 13.9% for current and 29.1% for lifetime diagnosis (Grant et al., 2015). AUD creates harm at the individual, familial, and societal level, with an estimated societal cost of $249 billion (Sacks et al., 2015) per year. The course of AUD typically is characterized by periods of relapse to problematic drinking (Maisto et al., 2014), signaling a need for better treatments and understanding of mechanisms of behavior change.

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The goal of this research is to conduct a randomized clinical trial with 140 participants who have an Alcohol Use Disorder (AUD). Each participant will complete behavioral assessments, self-report surveys and brain imaging before and after receiving psychotherapy treatment to change their drinking behaviors. Various aspects of behavior change will be looked at to better understand changes in brain function and emotional reactivity when someone changes their patterns of alcohol use. The two treatment used in this study have been found to be helpful in reducing alcohol use. Participants will be randomly assigned to either Mindfulness-Based Relapse Prevention (MBRP) or Cognitive Behavior Therapy (CBT) that will be completed in 12 weekly therapy sessions.

It is anticipated that there will be numerous changes in brain function that are found when someone reduces or stops their alcohol use after the completion of 12 weeks of treatment.

The 2 groups in the trial

  • Cognitive-Behavior TherapyExisting treatment, for comparison

    The CBT condition will include 8 weekly, 60-minute sessions, and will be delivered according to the Epstein \& McCrady (2009) cognitive-behavioral treatment manual, excluding material provided in the platform treatment. The treatment manual and accompanying client workbook provide detailed therapist instructions for each session, client exercises, worksheets, and homework assignments. The treatment focuses on cognitive and behavioral coping skills training, and emphasizes problem-solving as an overall approach to dealing with drinking.

  • Mindfulness Based Relapse PreventionExisting treatment, for comparison

    The MBT condition will be adapted from the 8-week version of the mindfulness-based relapse prevention (MBRP) manual (Bowen et al., 2011; Witkiewitz et al., 2005). The main adaptation will be to eliminate the relapse prevention/CBT components and focus attention on mindfulness practices. The mindfulness practices in MBT are designed to increase awareness of triggers and decrease reactivity to distress or discomfort in the presence of triggers (Witkiewitz \& Bowen, 2010). The relevant worksheets and homework assignments focusing on mindfulness tools will be maintained from the MBRP manual.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Neurocognitive and Neurobehavioral Mechanisms of Change Following Psychological
Record updated
22 April 2025