177 Participants Needed

Cognitive and Mindfulness Therapies for Alcohol Abuse

(A-ROC-T Trial)

CR
HK
Overseen ByHedy Kober, Ph.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two strategies—cognitive-behavioral therapy (focusing on the negative consequences of drinking) and mindfulness (using meditation to manage cravings)—can help reduce alcohol use. The aim is to determine if these approaches, including the Regulation of Craving training, change drinking habits. The trial seeks young adults who have experienced at least three heavy drinking days in the past month and wish to cut back or quit drinking. Participants should be comfortable using a smartphone and have internet access. As an unphased trial, this study provides a unique opportunity to contribute to understanding innovative strategies for reducing alcohol use.

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 prior data suggests that these therapies are safe for treating alcohol use disorder?

Research has shown that mindfulness-based treatments for substance use problems, such as alcohol abuse, are generally easy for people to handle. Studies have found that these treatments work as well as other proven methods in reducing alcohol use. Participants often report positive outcomes, particularly in managing stress and reducing substance use.

Evidence supports cognitive behavioral therapy (CBT) for its safety and effectiveness. It is commonly used to treat alcohol and drug issues. Studies indicate that CBT helps people reduce their drinking and is well-received by participants.

Both mindfulness and cognitive behavioral therapies have strong safety records. Participants typically manage these treatments well, with few reports of negative effects. These therapies are promising options for anyone considering joining a clinical trial for alcohol abuse therapy.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for alcohol abuse because they offer new ways to manage cravings without medication. Mindfulness-Based Treatment uses mindfulness and meditation to help individuals become more aware of their cravings and respond to them more calmly. This approach is different because it focuses on present-moment awareness, which can help reduce impulsive drinking behaviors. On the other hand, Cognitive Behavioral Therapy encourages individuals to think about the negative consequences of alcohol use, helping them to resist cravings by changing their thought patterns. These methods provide alternative strategies to traditional medication-based treatments, potentially offering fewer side effects and empowering individuals to manage their cravings through mental techniques.

What evidence suggests that this trial's treatments could be effective for alcohol abuse?

Research shows that both mindfulness-based treatments (MBT) and cognitive-behavioral therapy (CBT) can help manage alcohol cravings. In this trial, participants will join different treatment arms to evaluate these approaches. The Mindfulness-Based Treatment arm employs mindfulness and meditative strategies to reduce cravings and the chance of relapse. For instance, individuals using mindfulness techniques were less likely to return to heavy drinking. Meanwhile, the Cognitive Behavioral Therapy arm helps participants consider the negative effects of drinking, which can lead to reduced alcohol consumption. Overall, both methods have successfully helped people control cravings and decrease alcohol use.24678

Who Is on the Research Team?

HK

Hedy Kober, Ph.D.

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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.
See 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
See 8 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based TreatmentExperimental Treatment1 Intervention
Group II: Cognitive Behavioral TherapyExperimental Treatment1 Intervention
Group III: ControlActive Control1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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.
Mindfulness mechanisms in alcohol use: Comparing top-down and bottom-up processes.Skrzynski, CJ., Bryan, AD., Hutchison, KE.[2023]
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.
[Mindfulness based interventions for addictive disorders: a review].Skanavi, S., Laqueille, X., Aubin, HJ.[2018]

Citations

Efficacy of Cognitive Behavioral Therapy for Alcohol and ...... data on substance abuse treatment facilities. 2020. Available from ... dependence: National Institute on Drug Abuse Collaborative Cocaine ...
A Meta-Analysis of Cognitive-Behavioral Therapy for ...The effectiveness of drug abuse treatment: A meta-analysis of comparison group studies. Drug and Alcohol Dependence, 67(1), 53–72. 10.1016/S0376-8716(02) ...
A Digital Cognitive Behavioral Therapy Program for Adults ...... Alcohol Abuse and Alcoholism CBT manual. Results from a pilot ... Alcohol Abuse and Dependence: Project MATCH Monograph Series. Vol 3 ...
Journal of Consulting and Clinical Psychologyeffectiveness of drug abuse treatment: A meta-analysis of comparison group studies. Drug and Alcohol Dependence, 67, 53–72. http://dx.doi .org/10.1016/S0376 ...
The effects of cognitive behavioral therapy-based digital ...The DSM-5 emphasizes the need to integrate alcohol dependence and alcohol abuse into a single dimension known as alcohol use disorder, based on ...
Cognitive Behavioral Interventions for Alcohol and Drug ...... Cognitive-Behavioral Skills Training for the Treatment of Crystal Methamphetamine Abuse/Dependence. ... Results of the National Institute on Drug Abuse ...
A Digital Cognitive Behavioral Therapy Program for Adults ...... Alcohol Abuse and Alcoholism CBT manual. Results from a pilot ... Alcohol Abuse and Dependence: Project MATCH Monograph Series. Vol 3 ...
Cognitive-behavioral interventions for co-occurring ...National Institute on Drug Abuse: Therapy Manuals for Drug Addiction [Publication No. (ADM) 98-4308)]. (1998). M. Cleary et al. Psychosocial ...
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