Behavioral Economic and Wellness-based Approaches for Reducing Alcohol Use and Consequences Among Emerging Adults

University of Memphis

Status: Active, not recruiting

Conditions: Alcohol Abuse

Treatments: Other: Education Control; Behavioral: Substance-free Activity Session (SFAS); Behavioral: Brief Alcohol Intervention (BAI); Behavioral: Relaxation Training (RT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04776278

R01AA029031

Details and patient eligibility

About

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.

Full description

Brief alcohol interventions (BAI) are among the most cost-effective preventive care measures available and the evaluation of these interventions with high-risk and difficult-to-reach populations is an NIAAA priority. Although emerging adults (EAs) who attend college often have access to brief alcohol interventions (BAIs), there is a critical need to enhance both the efficacy and potential for dissemination of these approaches with high-risk non-student EAs. EAs who are not 4-year college students or graduates report higher levels of alcohol-related problems, greater levels of comorbid drug use and mental health symptoms, and higher risk for chronic alcohol use disorder compared to college graduates. Most BAIs include a single session focused explicitly on discussing risks associated with drinking and correcting normative beliefs about drinking rates without addressing the reasons why EAs may drink, including stress and limited behavioral alternatives to drinking. Because many EAs who do not graduate from college are socially and economically marginalized, an approach that encourages them to drink less without providing the tools to reduce stress and develop mood enhancing behavioral substitutes to drinking or drug use is unlikely to be successful. The Substance-Free Activity Session (SFAS) attempts to increase engagement goal-directed activities that might provide alternatives to alcohol use and also includes strategies for coping with stress/depression. The two-session (plus booster) BAI+SFAS approach has demonstrated efficacy for reducing both alcohol use/problems and depressive symptoms in two randomized clinical trials with college EAs and may be a more promising approach than single-session BAIs for higher-risk non-student EAs. Two critical next steps are to: 1) evaluate the BAI+SFAS with non-student EAs, and 2) determine if a two-session Relaxation Training (RT) +SFAS approach, which would enhance wellness and address two synergistic risk factors for alcohol misuse, demonstrates similar efficacy as the BAI+SFAS intervention. If so, this wellness-based approach may have greater potential for dissemination than approaches that include a BAI because the session content may be more appealing to EAs (managing stress and increasing positive activities). Thus, the primary goal of the proposed study is to establish the efficacy of these novel BAI approaches with high-risk community dwelling EAs, and a secondary goal is to identify factors that may increase potential for dissemination. We will conduct a randomized 3-group (BAI+SFAS vs. RT+SFAS vs. education control) trial with 525 EAs (175 per group; estimated 50% women & 50% African American) who report recent heavy drinking and who are not students or graduates of 4-year colleges. Outcomes will be assessed at 1, 3, 6, and 12 months post-intervention.

Enrollment: 525 estimated patients

Sex: All

Ages: 18 to 29 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 29 years old
• 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
• Adequate literacy (>9th grade reading ability)
• Two or more heavy episodic drinking episodes in the past month (>5/4 standard drinks for males/ females) or exceeding NIAAA guidelines for high risk drinking (>14/7 drinks per week for men/women).

Exclusion criteria

• Current/past psychosis
• Current self-initiated AUD/SUD treatment
• Weekly or greater nonmedical use of prescription drugs or illegal drugs except cannabis
• Risk for alcohol withdrawal as evidenced by either 1) a recent history of alcohol withdrawal symptoms (tremors, anxiety, hallucinations, and seizures that occur after stopping drinking) or 2) very heavy weekly drinking reports on the alcohol screener (> 40 standard drinks in a typical week in the past month, a value that is > 2 standard deviations above the average drinks per week level observed in our previous brief alcohol intervention studies).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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525 participants in 3 patient groups

Brief Alcohol Intervention (BAI) + Substance Free Activity Session (SFAS)

Experimental group

Description:

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).

Treatment:

Behavioral: Brief Alcohol Intervention (BAI)

Behavioral: Substance-free Activity Session (SFAS)

Relaxation Training (RT) + Substance Free Activity Session (SFAS)

Experimental group

Description:

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).

Treatment:

Behavioral: Relaxation Training (RT)

Behavioral: Substance-free Activity Session (SFAS)

Education Control

Active Comparator group

Description:

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

Treatment:

Other: Education Control