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

525 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate an intervention approach for non-student emerging adults that attempts to reduce alcohol use by decreasing stress and increasing engagement in positive and goal-directed activities that provide meaningful alternatives to alcohol use.

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.

What data supports the effectiveness of the treatment Behavioral Interventions for Alcoholism?

Research shows that Screening and Brief Intervention (SBI) can reduce drinking among at-risk drinkers and help decrease alcohol-related harm. These interventions provide individuals with a stigma-free opportunity to learn about the risks of drinking and encourage help-seeking behavior. ^{1 2 3 4 5}

Is the behavioral intervention for alcoholism safe for humans?

Screening and brief interventions (SBIs) for alcohol use are generally considered safe and are widely used in healthcare settings to help reduce alcohol-related harm. They provide a stigma-free opportunity for individuals to learn about the risks of drinking and encourage help-seeking behavior without reported safety concerns. ^{1 2 5 6 7}

How is the Behavioral Interventions for Alcoholism treatment different from other treatments for alcoholism?

This treatment is unique because it combines various behavioral techniques like relaxation training and substance-free activities with screening and brief interventions (SBI), which are designed to reduce alcohol consumption by encouraging self-reflection and behavior change. Unlike traditional treatments that may focus solely on abstinence or medication, this approach integrates wellness and mindfulness practices to address both alcohol use and mental health issues simultaneously. ^{1 2 5 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Impact of a medical student alcohol intervention workshop using recovering alcoholics as simulated patients. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Preliminary Clinical Outcomes of the Hello Sunday Morning Alcohol and Wellbeing Self-Assessment: Feasibility and Acceptability Study. [2023]

3. France pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Randomized-controlled trial of a telephone and mail intervention for alcohol use disorders: three-month drinking outcomes. [2021]

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

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

6. Germany pubmed.ncbi.nlm.nih.gov

Brief alcohol intervention in alcohol involved facial fracture patients-a survey of patient attitudes to screening and intervention. [2018]

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

Brief intervention and social work: a primer for practice and policy. [2015]

8. England pubmed.ncbi.nlm.nih.gov

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