Cognitive Behavioral Therapy + Mindfulness for Alcoholism

(ABQTREAT Trial)

Recruiting at 1 trial location

Overseen By Barbara McCrady, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Disqualifiers: Brain injury, Psychosis, Substance dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 8 weeks

110 Participants Needed

Trial Summary

What is the purpose of this trial?

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. 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.

Research Team

Barbara McCrady, PhD

Principal Investigator

The University of New Mexico

Eligibility Criteria

This trial is for individuals aged 22-85 who have been drinking alcohol in the past month and score high on an alcohol use assessment. They must be right-handed, seeking help for their drinking, not currently pregnant or using drugs other than marijuana, and without major health issues like psychosis, low IQ, or brain injuries.

Inclusion Criteria

Breath alcohol level of 0.00 at in-person screening

Right handed

You have consumed alcohol within the past month.

Exclusion Criteria

You have a history of severe alcohol withdrawal symptoms.

I am not pregnant, as confirmed by a urine test before each MRI scan.

You have had a problem with drugs or alcohol (excluding cigarettes or marijuana) within the past year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Platform Treatment

Participants receive 4 weeks of a platform treatment focusing on enhancing motivation to change

4 weeks

4 visits (in-person)

Treatment

Participants receive either Cognitive Behavioral Therapy (CBT) or Mindfulness Based Treatment (MBT) for 8 weeks

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 months

3 visits (in-person) at 3, 9, and 15 months post-baseline

Treatment Details

Interventions

• Cognitive Behavior Therapy
• Mindfulness Based Relapse Prevention

Trial Overview The study tests how Cognitive Behavior Therapy (CBT) and Mindfulness-Based Relapse Prevention (MBRP) affect brain function and behavior in people with Alcohol Use Disorder. Participants will undergo therapy sessions over 12 weeks with assessments before and after treatment to track changes.

Participant Groups

Group I: Cognitive-Behavior Therapy Active Control 1 Intervention

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.

Group II: Mindfulness Based Relapse Prevention Active Control 1 Intervention

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.

Cognitive Behavior Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Chronic pain management
• Anxiety disorders
• Depressive disorders

Approved in European Union as Cognitive Behavioural Therapy for:

• Chronic pain management
• Anxiety disorders
• Depressive disorders
• Post-traumatic stress disorder

Approved in Canada as Cognitive Behavioral Therapy for:

• Chronic pain management
• Anxiety disorders
• Depressive disorders

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

The Mind Research Network

Collaborator

Trials

27

Recruited

2,300+