Cognitive Behavioral Therapy + Mindfulness for Alcoholism

(ABQTREAT Trial)

No longer recruiting at 1 trial location

Overseen By Katie Witkiewitz, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on finding better ways to help individuals with Alcohol Use Disorder (AUD) change their drinking habits. It compares two types of therapy: Cognitive Behavioral Therapy (CBT), which teaches coping skills and problem-solving, and Mindfulness-Based Relapse Prevention (MBRP), which uses mindfulness techniques to manage triggers. Researchers aim to assess how these treatments affect brain function and emotions. Individuals who have been heavy or frequent drinkers and are seeking help for their drinking may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative therapies that could significantly enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Relapse Prevention (MBRP) are generally safe and well-tolerated treatments for alcohol use disorder.

Studies have found that CBT effectively addresses various substance use issues, including alcohol use. Many people have used CBT without major problems, as it helps develop coping and problem-solving skills, which are safe methods.

Mindfulness-Based Relapse Prevention is also considered safe. It increases awareness and reduces stress through mindfulness techniques. Research has shown it can help lower cravings and stress, common triggers for relapse.

Overall, both treatments in this trial have a strong safety record and are designed to help reduce alcohol use effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for alcoholism, which often focus on medication or traditional therapy, Cognitive Behavioral Therapy (CBT) combined with Mindfulness-Based Relapse Prevention (MBRP) offers a unique approach. Researchers are excited about these treatments because they integrate cognitive and behavioral coping skills with mindfulness practices. This combination helps individuals become more aware of their triggers and manage their reactions to stress without relying solely on medication. By emphasizing problem-solving and mindfulness, these therapies aim to reduce the likelihood of relapse in a holistic and sustainable way.

What evidence suggests that this trial's treatments could be effective for Alcohol Use Disorder?

Research has shown that Cognitive Behavioral Therapy (CBT), one of the treatments in this trial, can effectively treat alcohol use disorder. Studies indicate that CBT can improve outcomes by 15% to 26% compared to those who do not receive treatment. Participants in CBT programs often report higher rates of abstinence, with some studies showing a 73.3% rate during certain weeks of treatment. Meanwhile, Mindfulness-Based Relapse Prevention (MBRP), another treatment option in this trial, has been found to lower the risk of resuming heavy drinking. Participants using MBRP reported a reduced chance of returning to heavy drinking compared to those receiving standard care. Both therapies have been shown to help individuals effectively reduce their alcohol use. ^{2 5 6 7 8}

Who Is on the Research Team?

Barbara McCrady, PhD

Principal Investigator

The University of New Mexico

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9948631/

Efficacy of Cognitive Behavioral Therapy for Alcohol and ... Data on CBT effects for use outcomes by primary substance provide a mixed picture, and at present, most trials have targeted alcohol use ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2824103

A Digital Cognitive Behavioral Therapy Program for Adults ... Mean (SD) rates of PDA from baseline to 6-month follow-up were 49.3% (27.8%) to 69.6% (34.4%) for TAU; 53.7% (29.8%) to 70.2% (35.1%) for CBT; ...

3. addictions.psych.ucla.edu addictions.psych.ucla.edu/wp-content/uploads/sites/160/2020/01/JCCP-A-meta-analysis-of-cognitive-behavioral-therapy-for-alcohol-or-other-drug-use-disorders-Treatment-efficacy-by-contrast-condition.pdf

Journal of Consulting and Clinical Psychology CBT is effective for these conditions with outcomes roughly 15% to 26% better than average outcomes in untreated, or minimally treated, controls.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10572095/

An Evaluation of Cognitive Behavioral Therapy for ... CBT produced small to moderate effects on substance use when compared to inactive treatment and was most effective at early follow-up (1–6 months post-treatment) ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1486338/full

The effects of cognitive behavioral therapy-based digital ... Results: The primary outcome, abstinence rate during weeks 9–12, was significantly higher in the digital intervention group (73.3%) compared to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5714654/

Cognitive Behavioral Interventions for Alcohol and Drug ... Multiple meta analyses and reviews over the past 30 years have concluded that CBT is an effective treatment across a range of substance use disorders (Carroll & ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11428014/

A Digital Cognitive Behavioral Therapy Program for Adults ... Mean (SD) rates of PDA from baseline to 6-month follow-up were 49.3% (27.8%) to 69.6% (34.4%) for TAU; 53.7% (29.8%) to 70.2% (35.1%) for CBT; ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871625002091

Cognitive-behavioral interventions for co-occurring ... The current meta-analysis provides an overview of cognitive-behaviorally-based interventions (CBI) that treat co-occurring alcohol and other drug use (AOD)