Cognitive and Mindfulness Therapies for Alcohol Abuse
(A-ROC-T Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Yale University
Must not be taking: Psychoactive medications
Disqualifiers: Severe AUD, Severe SUD, Psychiatric illness, others
No Placebo Group
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.
12345Is 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.
13467How 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.
12389Eligibility 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.
+4 more
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
+8 more
Trial 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)
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based TreatmentExperimental Treatment1 Intervention
Using mindfulness and meditative strategies to control craving
Group II: Cognitive Behavioral TherapyExperimental Treatment1 Intervention
Thinking of negative consequences to control craving
Group III: ControlActive Control1 Intervention
No regulatory strategy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale UniversityNew Haven, CT
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
Enactment of home practice following mindfulness-based relapse prevention and its association with substance-use outcomes. [2022]Mindfulness-based treatments have received increasing interest and empirical support in the clinical psychology literature. There are, however, no studies to date that have systematically examined treatment enactment, which is the amount and type of home practice participants incorporate into their daily lives. Because treatment enactment has been cited as a key aspect of treatment fidelity, this study examined the relationships between treatment enactment (i.e., home mindfulness practice) and alcohol and other drug (AOD) use and craving in the context of a larger study of mindfulness-based relapse prevention (MBRP).
Mindfulness as a strategy for coping with cue-elicited cravings for alcohol: an experimental examination. [2022]Mindfulness has been identified as a promising strategy for managing cravings for alcohol and other drugs, but little controlled experimental research has directly studied whether this approach is effective. The current study systematically examined the effects of an acute mindfulness manipulation on craving for alcohol during prolonged exposure to alcohol cues.
Mindfulness mechanisms in alcohol use: Comparing top-down and bottom-up processes. [2023]This study compared two mechanisms by which mindfulness may reduce hazardous drinking: effortful control and craving, "top-down" and "bottom-up" processes, respectively. These relationships were compared in a secondary analysis of a randomized controlled trial of mindfulness-based relapse prevention (MBRP) versus relapse prevention (RP) treatments to explore if they differed based on more explicit versus subtle mindfulness training.
Randomized trial of mindfulness- and reappraisal-based regulation of craving training among daily cigarette smokers. [2023]Craving predicts smoking, yet existing interventions may not adequately target regulation of craving. We evaluated two versions of regulation of craving-training (ROC-T), a computerized intervention with intensive practice of strategies when exposed to smoking-related images.
Mindfulness-based relapse prevention for alcohol dependence: Findings from a randomized controlled trial. [2020]To assess the effects of mindfulness-based relapse prevention for alcohol dependence (MBRP-A) intervention on drinking and related consequences.
The application of mindfulness-based cognitive interventions in the treatment of co-occurring addictive and mood disorders. [2019]This article reviews the theory, clinical application, and empirical findings on mindfulness-based cognitive therapy (MBCT) for mental health and addictive disorders. Expanding upon the research demonstrating the efficacy of cognitive-behavioral therapy (CBT) for addiction, this article develops and explores the rationale for combining mindfulness-based interventions with evidence-based CBTs in treating addictive disorders, with an emphasis on substance use disorders with co-occurring mood disorders. This article proposes that deficits in affect--regulation related to the behavioral and emotional effects of neurobiological changes that occur with long-term substance abuse--pose a unique set of challenges in early recovery. Prolonged use of addictive substances impairs the brain pathways that mediate certain affect regulation functions. These functions involve attention and inhibitory control, the saliency of and response to addictive versus natural reward stimuli, and the ability to detach or maintain perspective in response to strong emotional states. In treating this affective dysregulation, which can contribute to the vulnerability to relapse in the early stages of recovery, the affect-regulation-specific focus of MBCT adds a valuable element to augment CBT for addiction. Summarizing magnetic resonance imaging and positron emission tomography findings on the effects of MBCT and the neurobiology of drug addiction, this article outlines directions for further research on potential benefits of MBCT for the recovering individual. Finally, this article describes a structured protocol, developed at the Mount Sinai School of Medicine in New York City, which combines CBT with mindfulness-based intervention, for the treatment of affect-regulation issues specific to co-occurring addictive and mood disorders.
Decreases in the Late Positive Potential to Alcohol Images Among Alcohol Treatment Seekers Following Mindfulness-Based Relapse Prevention. [2020]Heightened craving among individuals with alcohol use disorder (AUD) has been attributed to a hypersensitivity to alcohol cues in attentional brain networks. Active mindfulness training has been shown to help improve attentional control. Here, we examined alcohol cue-related hypersensitivity among individuals with AUD who received rolling group mindfulness-based relapse prevention (MBRP) in combination with transcranial direct current stimulation (tDCS), over right inferior frontal gyrus.
[Mindfulness in addiction therapy]. [2015]Mindfulness based therapies are nowadays widely spread. During the last decades, several approches and specific programs have been scientifically challenged and developped. In the field of addictions the Mindfulness Based Relapse Prevention is the main reference program. Within this frame, mindfulness increases the awarness regarding triggers and automatic behavior related to drug abuse. It also has a favorable impact when dealing with craving. Currently, the scientific research has come to promissing conclusions as far as craving and relapse prediction are concerned.
[Mindfulness based interventions for addictive disorders: a review]. [2018]In substance use disorders, the lack of empirically supported treatments and the minimal utilization of available programs indicate that innovative approaches are needed. Mindfulness based therapies have been used in addictive disorders for the last 10years. Mindfulness can be defined as the ability to focus open, non-judgmental attention to the full experience of internal and external phenomena, moment by moment. Several therapies based on mindfulness have been developed. The aim of this study is to review the existing data on the use of these programs in addictive disorders.