Cognitive and Mindfulness Therapies for Alcohol Abuse

(A-ROC-T Trial)

Overseen By Hedy Kober, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Psychoactive medications

Disqualifiers: Severe AUD, Severe SUD, Psychiatric illness, others

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

Compensation: Varies

Number of Visits: 7

Duration: 3 weeks

177 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of the proposed study is to examine whether brief training in regulation of craving (ROC-T) affects alcohol drinking. The study will consist of a basic screening (phone and online), and in person visit to determine eligibility and conduct pre-intervention baseline assessments, 1-4 training (ROC-T) visits, a post-intervention assessment visit, and 1-2 phone/online follow up assessments.The two active conditions of ROC-T are based on cognitive-behavioral treatments (CBT) and mindfulness-based treatments (MBT).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that psychoactive medications (like mood stabilizers) must be at a stable dose unless approved by the study psychiatrist.

What data supports the effectiveness of this treatment for alcohol abuse?

Research shows that mindfulness-based treatments can help manage cravings for alcohol, and studies have found that practicing mindfulness at home is linked to better outcomes in reducing alcohol and drug use. Additionally, mindfulness-based relapse prevention has been shown to be effective in reducing drinking and its consequences. ^{1 2 3 4 5}

Is mindfulness-based therapy safe for treating alcohol use disorder?

Mindfulness-based therapies, which include techniques like mindfulness-based relapse prevention (MBRP), have been studied for their safety and are generally considered safe for treating alcohol use disorder and other addictive behaviors. These therapies focus on improving attention and emotional regulation, and no significant safety concerns have been reported in the research. ^{1 3 4 6 7}

How is the Regulation of Craving (ROC-T) treatment different from other treatments for alcohol use disorder?

The Regulation of Craving (ROC-T) treatment is unique because it combines cognitive-behavioral therapy with mindfulness techniques to help individuals manage their cravings for alcohol. This approach focuses on increasing awareness of triggers and automatic behaviors related to alcohol use, which can help reduce cravings and prevent relapse. ^{1 2 3 8 9}

Research Team

Hedy Kober, Ph.D.

Principal Investigator

Yale University

Eligibility Criteria

This trial is for young adults aged 18-26 who drink heavily and are motivated to cut down. They must speak English, have at least a 6th-grade reading level, internet access, and a smartphone. Pregnant women or those with severe physical diseases, psychiatric illnesses, drug abuse (except tobacco), unstable medication doses, or color blindness cannot join.

Inclusion Criteria

Participants who can commit to the full length of the protocol

I am 18-26 years old and have had 3 or more heavy drinking days last month.

I am willing to be assigned to a treatment group by chance.

Exclusion Criteria

Participants with current clinically-severe alcohol use disorder or current severe alcohol withdrawal

Participants who will not complete at least 70% of past day EMA reports in the pre-intervention phase will not be randomized

Participants with current clinically-severe substance use disorder (except tobacco) or current severe drug withdrawal

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

1 visit (phone and online)

Treatment

Participants undergo 4 x 45-minute web-based sessions of CBT-ROC-T or MBT-ROC-T over three weeks

3 weeks

4 visits (web-based)

Post-intervention Assessment

Participants complete a post-intervention assessment visit

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

1-2 visits (phone/online)

Treatment Details

Interventions

• Regulation of Craving

Trial Overview The study tests if brief training in craving regulation can affect alcohol consumption among young adults. It compares two methods: cognitive-behavioral treatments (CBT) and mindfulness-based treatments (MBT). Participants will undergo assessments before and after the intervention plus follow-ups via phone/online.

Participant Groups

Group I: Mindfulness-Based Treatment Experimental Treatment 1 Intervention

Using mindfulness and meditative strategies to control craving

Group II: Cognitive Behavioral Therapy Experimental Treatment 1 Intervention

Thinking of negative consequences to control craving

Group III: Control Active Control 1 Intervention

No regulatory strategy

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

Participants in the mindfulness-based relapse prevention (MBRP) program significantly increased their home mindfulness practice, which was linked to reduced alcohol and other drug (AOD) use and cravings at 2- and 4-month follow-ups, based on a study of 93 individuals.

The study highlights the importance of integrating mindfulness practice into daily life for sustained recovery, suggesting that ongoing support for home practice could enhance the long-term benefits of MBRP in reducing AOD use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enactment of home practice following mindfulness-based relapse prevention and its association with substance-use outcomes. Grow, JC., Collins, SE., Harrop, EN., et al.[2022]

In a study with 84 heavy drinkers, a distraction-based strategy was found to be more effective than mindfulness or no strategy in reducing cravings for alcohol during exposure to alcohol cues.

The study highlights that while mindfulness is often considered beneficial for managing cravings, immediate distraction techniques may provide better short-term relief from alcohol cravings in high-stress situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness as a strategy for coping with cue-elicited cravings for alcohol: an experimental examination. Murphy, CM., MacKillop, J.[2022]

In a study of 182 individuals seeking to reduce hazardous drinking, mindfulness-based relapse prevention (MBRP) was compared to traditional relapse prevention (RP) over 8 weeks, revealing that mindfulness may reduce drinking primarily by decreasing cravings rather than enhancing effortful control.

The results indicated that the mechanism of craving reduction was consistent across both MBRP and RP treatments, suggesting that both explicit and subtle mindfulness training can effectively help manage alcohol cravings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness mechanisms in alcohol use: Comparing top-down and bottom-up processes. Skrzynski, CJ., Bryan, AD., Hutchison, KE.[2023]

Mindfulness-based therapy (MBT) showed significantly greater reductions in smoking compared to a control group over 16 weeks, indicating its potential long-term effectiveness in managing nicotine dependence.

Both MBT and cognitive behavioral therapy (CBT) effectively reduced cue-induced craving, but only MBT maintained its effectiveness without increasing smoking rates during follow-up, suggesting it may be a more durable intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of mindfulness- and reappraisal-based regulation of craving training among daily cigarette smokers. Roos, CR., Harp, NR., Vafaie, N., et al.[2023]

The mindfulness-based relapse prevention for alcohol dependence (MBRP-A) did not show significant improvements in drinking outcomes compared to usual care alone in a study of 123 alcohol-dependent adults over 26 weeks.

However, participants who attended more MBRP-A sessions and practiced mindfulness techniques at home tended to have better long-term drinking-related outcomes, suggesting that adherence to the intervention may be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for alcohol dependence: Findings from a randomized controlled trial. Zgierska, AE., Burzinski, CA., Mundt, MP., et al.[2020]

Mindfulness-based cognitive therapy (MBCT) can enhance traditional cognitive-behavioral therapy (CBT) for treating substance use disorders, especially when co-occurring mood disorders are present, by addressing specific challenges related to affect regulation.

The article proposes a structured protocol that combines CBT with mindfulness techniques to help individuals in early recovery manage emotional dysregulation, which is crucial for reducing the risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of mindfulness-based cognitive interventions in the treatment of co-occurring addictive and mood disorders. Hoppes, K.[2019]

In a study of 68 individuals with alcohol use disorder, mindfulness-based relapse prevention (MBRP) significantly reduced craving for alcohol cues, with greater reductions linked to more MBRP sessions attended.

The study also found that while active transcranial direct current stimulation (tDCS) did not directly affect craving ratings, it increased brain activity related to emotional responses, suggesting that MBRP may effectively target alcohol cue hypersensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreases in the Late Positive Potential to Alcohol Images Among Alcohol Treatment Seekers Following Mindfulness-Based Relapse Prevention. Brown, DR., Jackson, TCJ., Claus, ED., et al.[2020]

Mindfulness-Based Relapse Prevention (MBRP) is a leading program in addiction treatment that enhances awareness of triggers and automatic behaviors associated with drug abuse.

Research indicates that mindfulness practices can effectively reduce cravings and improve predictions of relapse, showing promising results in supporting individuals recovering from addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness in addiction therapy]. Nallet, A., Briefer, JF., Perret, I.[2015]

Mindfulness-based therapies have shown promising results in reducing substance use in individuals with addictive disorders, with five out of six studies indicating significant reductions in substance use, particularly when follow-up periods were longer.

These interventions not only decreased substance use but also helped participants manage withdrawal-like sensations and emotional responses, suggesting that mindfulness can enhance coping strategies and reduce the risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness based interventions for addictive disorders: a review]. Skanavi, S., Laqueille, X., Aubin, HJ.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Enactment of home practice following mindfulness-based relapse prevention and its association with substance-use outcomes. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Mindfulness as a strategy for coping with cue-elicited cravings for alcohol: an experimental examination. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Mindfulness mechanisms in alcohol use: Comparing top-down and bottom-up processes. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of mindfulness- and reappraisal-based regulation of craving training among daily cigarette smokers. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for alcohol dependence: Findings from a randomized controlled trial. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

The application of mindfulness-based cognitive interventions in the treatment of co-occurring addictive and mood disorders. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Decreases in the Late Positive Potential to Alcohol Images Among Alcohol Treatment Seekers Following Mindfulness-Based Relapse Prevention. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[Mindfulness in addiction therapy]. [2015]

9. France pubmed.ncbi.nlm.nih.gov

[Mindfulness based interventions for addictive disorders: a review]. [2018]