Behavioral Interventions for Alcoholism

Overseen By Ashley A Dennhardt, PHD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Memphis

Must not be taking: Prescription drugs, Illegal drugs

Disqualifiers: Psychosis, AUD/SUD treatment, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help people reduce alcohol use by addressing stress and engaging in positive activities. It tests three approaches: a motivational talk about drinking (Brief Alcohol Intervention), a session focused on personal goals, and relaxation techniques combined with substance-free activities. Suitable participants have recently experienced heavy drinking episodes and are not currently in college or planning to enroll soon. As an unphased trial, this study provides a unique opportunity to explore innovative methods for reducing alcohol use and enhancing well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using prescription drugs nonmedically or illegal drugs (except cannabis) weekly or more, you may not be eligible to participate.

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

Research has shown that brief alcohol interventions (BAI) are generally safe. These short counseling sessions, lasting 5 to 15 minutes, help individuals better understand their drinking habits. Similar to routine health check-ups like blood pressure screenings, they have been safely used in many settings.

Relaxation training (RT) is also well-tolerated. Techniques such as deep breathing and muscle relaxation have been studied and found to safely aid in relaxation and stress reduction. These methods are widely recommended for managing anxiety and stress.

The Substance-free Activity Session (SFAS) encourages participation in activities that do not involve alcohol. Designed to be a positive experience, it focuses on personal goals and enjoyable activities. Studies suggest it is safe and helps individuals reduce alcohol use by finding rewarding alternatives.

Overall, these treatments are non-invasive and have demonstrated safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for alcoholism because they focus on enhancing personal motivation and lifestyle modification, which is quite different from conventional approaches like medication and traditional therapy. The Brief Alcohol Intervention (BAI) combined with the Substance-free Activity Session (SFAS) aims to directly connect personal goals with drinking habits, encouraging a future-focused mindset and engaging in activities that align with these goals. Meanwhile, the Relaxation Training (RT) paired with SFAS introduces stress-reduction techniques like diaphragmatic breathing and mindfulness, which are not common in standard treatments. These approaches emphasize personal empowerment and self-directed change, offering a fresh perspective on managing alcoholism.

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

Studies have shown that Brief Alcohol Interventions (BAI), one of the treatments in this trial, can effectively help people who drink excessively to reduce their intake. These interventions increase awareness of drinking habits and encourage healthier choices. Relaxation Training (RT), another treatment option in this trial, includes breathing exercises and mindfulness, which have been found to reduce anxiety and may help lower alcohol use by promoting calmness. The Substance-free Activity Session (SFAS), included in both experimental arms of this trial, focuses on setting personal goals and finding enjoyable activities that don't involve alcohol. Research indicates that combining BAI or RT with SFAS leads to significant reductions in alcohol use and related problems. Together, these approaches offer a promising way to manage and reduce alcohol consumption. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for non-student emerging adults aged 18-29 who drink heavily but aren't currently using drugs (except cannabis) or seeking addiction treatment. They must speak English, be able to read at a 9th-grade level, and have had multiple heavy drinking episodes recently.

Inclusion Criteria

Not a current student or graduate of a 4-year college with no plans to enroll in a 4-year college in the upcoming semester

Stable domicile and contact information

Fluent English speaker

Exclusion Criteria

Current or past psychosis

Current self-initiated AUD/SUD treatment

Weekly or greater nonmedical use of prescription drugs or illegal drugs except cannabis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either BAI+SFAS or RT+SFAS interventions, or an education control session

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in alcohol use, depression, anxiety, and stress at multiple intervals

12 months

Assessments at 1, 3, 6, and 12 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Brief Alcohol Intervention (BAI)
• Education Control
• Relaxation Training (RT)
• Substance-free Activity Session (SFAS)

Trial Overview The study tests if stress reduction and engaging in positive activities can help reduce alcohol use among young adults. It compares an educational control with substance-free activity sessions, brief alcohol interventions, and relaxation training.

How Is the Trial Designed?

Group I: Relaxation Training (RT) + Substance Free Activity Session (SFAS) Experimental Treatment 2 Interventions

Participants will complete a relaxation training session that will include a clinician leading them through a diaphragmatic breathing exercise, a progressive muscle relaxation protocol, and then a brief breath-counting (mindfulness) exercise. A week later, the participant will receive the SFAS, a 50-minute counseling session designed to increase the salience of the individual's goals, to highlight the connection between their current patterns of behavior (including drinking and substance-free activities) and the attainment of these goals, and to increase future orientation and engagement in enjoyable and goal-directed activities that are inconsistent with substance use (even if the participant has no desire to change their use).

Group II: Brief Alcohol Intervention (BAI) + Substance Free Activity Session (SFAS) Experimental Treatment 2 Interventions

Participants first receive a 50-minute standard brief motivational intervention designed to reduce alcohol use. A week later, they will receive the Substance-free activity session (SFAS), a 50-minute counseling session designed to increase the salience of the individual's goals, to highlight the connection between their current patterns of behavior (including drinking and substance-free activities) and the attainment of these goals, and to increase future orientation and engagement in enjoyable and goal-directed activities that are inconsistent with substance use (even if the participant has no desire to change their use).

Group III: Education Control Active Control 1 Intervention

This minimal contact control condition will include a brief (2-3 minute) discussion where the research assistant (RA) who completed the assessment session will describe the educational handout. This condition is meant to approximate a public health-level approach to providing referral information and some of the content included in the BAI+SFAS condition but without any of the personalized information or motivational interviewing. Participants will receive information on risks associated with alcohol/drug misuse, strategies for reducing alcohol problems, managing stress, and goal-setting. The handout will also include links to hotlines, websites, and apps related to these domains. This condition will not include booster contact

Brief Alcohol Intervention (BAI) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Brief Alcohol Intervention for:

• Reducing alcohol misuse
• Preventing alcohol-related harms

Approved in United States as Screening and Brief Intervention for:

• Reducing hazardous drinking
• Preventing alcohol-related injuries

Approved in Canada as Identification and Brief Advice for:

• Reducing excessive drinking
• Preventing alcohol-related chronic diseases

Who Is Running the Clinical Trial?

University of Memphis

Lead Sponsor

Trials

73

Recruited

12,000+

Published Research Related to This Trial

This study is evaluating the effectiveness of the Screening and Brief Intervention (SBI) approach for illicit drug use through a randomized controlled trial involving 700 participants in emergency departments, aiming to provide valuable insights into its efficacy.

The training of bicultural health educators (HEs) in motivational interviewing and their ongoing evaluation contributed to successful participant recruitment and skill mastery, highlighting the importance of well-prepared staff in delivering effective interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial to evaluate screening and brief intervention for drug-using multiethnic emergency and trauma department patients. Eisenberg, K., Woodruff, SI.[2021]

Nearly 25% of individuals aged 12 and older in the U.S. report excessive drinking at least once in the past month, highlighting the widespread issue of alcohol use in healthcare settings.

Screening and brief intervention (SBI) is an effective, evidence-based strategy recommended by health organizations to reduce alcohol-related harm, and this article offers practical guidance for healthcare providers to implement SBI in their practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative review of guides for implementing alcohol screening and brief interventions into trauma and primary care settings. [2015]

The Alcohol and Wellbeing Self-assessment (A&WS) is a highly feasible and acceptable web-based screening tool, with 81.8% of the 17,628 participants completing it and 95.62% finding it easy to use.

Participants showed significant reductions in alcohol consumption and psychological distress over a 3-month follow-up period, indicating that the A&WS may effectively support individuals in making positive changes, although further randomized controlled trials are needed to confirm these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Clinical Outcomes of the Hello Sunday Morning Alcohol and Wellbeing Self-Assessment: Feasibility and Acceptability Study. Fletcher, K., Moran-Pryor, A., Robert-Hendren, D.[2023]

A study of 20 patients with alcohol-related facial fractures revealed that 65% were at moderate risk for alcohol misuse, indicating a significant opportunity for alcohol screening and brief intervention (SBI) in clinical settings.

Despite recognizing alcohol as a major cause of their injuries, many patients showed resistance to acknowledging their drinking habits, highlighting the need for simple and effective SBI strategies to promote behavioral change and reduce future alcohol-related trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief alcohol intervention in alcohol involved facial fracture patients-a survey of patient attitudes to screening and intervention. Lee, KH., Dastaran, M., Chandu, A.[2018]

A workshop for third-year medical students, which included simulated patient interviews with recovering alcoholics, significantly increased their confidence and perceived importance of conducting alcohol screening and brief interventions (SBI).

The study involved 94 students and showed that those who participated in the workshop had better scores in importance and confidence compared to a control group of 71 students who did not attend, highlighting the effectiveness of experiential learning in medical education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a medical student alcohol intervention workshop using recovering alcoholics as simulated patients. Johnson, JA., Seale, JP., Shellenberger, S., et al.[2021]

In a 12-month randomized controlled trial involving 897 primary care patients with alcohol use disorders, a six-session telephone counseling intervention significantly reduced risky drinking days and total alcohol consumption in men compared to a control group that received only a pamphlet.

While the intervention was effective for men, the results for women were not statistically significant, indicating that the telephone counseling may be more beneficial for male patients with alcohol abuse and dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized-controlled trial of a telephone and mail intervention for alcohol use disorders: three-month drinking outcomes. Brown, RL., Saunders, LA., Bobula, JA., et al.[2021]

Many people with alcohol use disorders do not receive the help they need, highlighting a significant gap in care.

Screening and brief intervention (SBI) is an effective method for reducing risky drinking behaviors, and social workers can play a crucial role in implementing and promoting SBI practices across the United States.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief intervention and social work: a primer for practice and policy. Cochran, G., Field, C.[2015]

Therapist skills, such as empathy and support, are crucial for the effectiveness of psychosocial interventions for alcohol use disorders, with treatment intensity tailored to the severity of the disorder.

Motivational interviewing techniques, which emphasize patient autonomy and personal choice, enhance the effectiveness of psychosocial treatments, focusing on monitoring alcohol use, setting clear goals, and developing coping strategies for cravings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Non-medical management of disorders of the use of alcohol]. Aubin, HJ.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5082433/

Alcohol Electronic Screening and Brief Intervention Excessive drinking is responsible for 1 in 10 deaths among working-age adults in the U.S. annually. Alcohol screening and brief intervention (ASBI) is an ...

2. cdc.gov cdc.gov/alcohol-pregnancy/hcp/alcoholsbi/index.html

Alcohol Screening and Brief Intervention (SBI) Alcohol SBI is a preventive service, like blood pressure or cholesterol screening. It can occur as part of a patient's wellness visit.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871622001958

Alcohol brief intervention, specialty treatment and drinking ... Systematic ABI in adult primary care has the potential to reduce drinking among people with unhealthy drinking considerably on both an individual and ...

4. brownhealth.org brownhealth.org/sites/default/files/lifespan-files/documents/centers/injury-prevention-center/alcohol-screeening-and-brief-intervention-web.pdf

Alcohol Screening and Brief Intervention Brief interventions are counseling sessions that last 5 to 15 minutes. Their purpose is to increase the person's awareness of his or her alcohol use and its ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6491186/

Effectiveness of brief alcohol interventions in primary care ... Brief interventions aim to reduce alcohol consumption and related harm in hazardous and harmful drinkers who are not actively seeking help for alcohol problems.

6. niaaa.nih.gov niaaa.nih.gov/alcohols-effects-health/professional-education-materials/alcohol-screening-and-brief-intervention-youth-practitioners-guide/resources

Alcohol Screening and Brief Intervention for Youth The Alcohol Use Disorders Identification Test (AUDIT) (PDF) focuses on drinking patterns and alcohol-related behaviors. Research supports use of the AUDIT ...

7. samhsa.gov samhsa.gov/substance-use/treatment/sbirt

Screening, Brief Intervention, and Referral to Treatment ... SBIRT is a comprehensive, integrated, public health approach to the delivery of early intervention and treatment services for persons with substance use ...

8. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/unhealthy-alcohol-use-in-adolescents-and-adults-screening-and-behavioral-counseling-interventions

Unhealthy Alcohol Use in Adolescents and Adults ... Screen for unhealthy alcohol use and provide persons engaged in risky or hazardous drinking with brief behavioral counseling interventions.