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

NCT04776278 | Active Not Recruiting

• 1 other identifier: R01AA029031
• Study Type: interventional
• Target: 525
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Abuse

Keywords

Alcohol; Brief Intervention

Outcome Measures

Primary Outcomes (8)

• Change from Baseline Alcohol Consumption and Drug Use at 1-month

  At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.

  Enrollment, 1-month post intervention

• Change from Baseline Alcohol Consumption and Drug Use at 3-months

  At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.

  Enrollment, 3-months post intervention

• Change from Baseline Alcohol Consumption and Drug Use at 6-months

  At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.

  Enrollment, 6-months post-intervention

• Change from Baseline Alcohol Consumption and Drug Use at 12-months

  At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.

  Enrollment, 12-months post intervention

• Change from Baseline Alcohol-related Consequences at 1-month

  The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.

  Enrollment, 1-month

• Change from Baseline Alcohol-related Consequences at 3-months

  The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.

  Enrollment, 3-months

• Change from Baseline Alcohol-related Consequences at 6-months

  The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.

  Enrollment, 6-months

• Change from Baseline Alcohol-related Consequences at 12-months

  The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.

  Enrollment, 12-months

Secondary Outcomes (16)

• Change from Baseline Substance-free and Substance-related Activity Participation at 1-month

  Enrollment, 1-month post intervention

• Change from Baseline Substance-free and Substance-related Activity Participation at 3-months

  Enrollment, 3-months post intervention

• Change from Baseline Substance-free and Substance-related Activity Participation at 6-months

  Enrollment, 6-months post intervention

• Change from Baseline Substance-free and Substance-related Activity Participation at 12-months

  Enrollment, 12-months post intervention

• Change from Baseline Alcohol Purchase Task responses at 1-month

  Enrollment, 1-month post intervention

Study Arms (3)

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

EXPERIMENTAL

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).

Behavioral: Brief Alcohol Intervention (BAI); Behavioral: Substance-free Activity Session (SFAS)

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

EXPERIMENTAL

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).

Behavioral: Substance-free Activity Session (SFAS); Behavioral: Relaxation Training (RT)

Education Control

ACTIVE COMPARATOR

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

Other: Education Control

Interventions

Brief Alcohol Intervention (BAI) BEHAVIORAL

This session includes a discussion related to harm reduction and the participant's autonomy to make decisions about the information provided in the session; an alcohol use decisional balance exercise; personalized alcohol-related feedback, and goal-setting. Elements included in the feedback are: (a) comparison of the participant's perception of how much he or she drinks and actual norms, (b) a comparison of the participant's alcohol consumption vs. norms, (c) an estimate of the participant's peak blood alcohol content in the past month, (d) alcohol-related problems experienced, (e) money spent on alcohol, and (f) calories consumed from alcohol. Participants discuss the personalized feedback with the clinician and review protective behavioral strategies if he or she indicates interest.

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

Substance-free Activity Session (SFAS) BEHAVIORAL

The SFAS session includes : a) discussion of life goals, b) discussion of associations between alcohol and drug use, goals, and substance-free activities; c) a graph depicting the participant's ratings of the relative importance of various aspects of their life and how their actions in the past week have been consistent with these priorities; d) personalized feedback on recent time allocation to activities across life domains, and a discussion of any changes the participant would like to make; e) feedback on symptoms of stress, anxiety and discussion of adaptive coping strategies; f) discussion of enjoyable substance-free activities and hobbies and substance-free recreational activity suggestions tailored to individual's interests and neighborhood; g) a goal setting exercise for specific behavior change plans; h) a Future Thinking Writing Exercise. Participants will receive weekly text-message based booster prompts for four weeks after their SFAS session.

Brief Alcohol Intervention (BAI) + Substance Free Activity Session (SFAS); Relaxation Training (RT) + Substance Free Activity Session (SFAS)

Relaxation Training (RT) BEHAVIORAL

The clinician will begin by establishing the credibility of the session by providing the participant with the rationale that developing relaxation or mindfulness training strategies can reduce stress and enhance wellness. The clinician will then lead the participant through a diaphragmatic breathing exercise, followed by a progressive muscle RT protocol, and then a brief breath-counting (mindfulness) exercise. The session will conclude with a brief discussion of additional stress and anxiety management strategies (e.g., apps to monitor heartrate and breathing). Participants will be asked about their reaction to the techniques and, if interested, encouraged to commit to a specific plan for practicing these techniques.

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

Education Control OTHER

This condition will not include any clinical contact other than a brief (2-3 minute) discussion with the research assistant (RA) who completed the assessment session and who will describe the educational handout. This condition is meant to approximate a low-threshold 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 MI/clinical contact. Thus, participants will receive information on risks associated with alcohol and drug misuse, strategies for reducing use/problems, and strategies for managing stress and setting and follow-through with achievable goals. The handout will also include links to hotlines, websites, and apps related to these domains. This condition will not include booster contact.

Education Control

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Memphis: lead

Study Sites (1)

University of Memphis

Memphis, Tennessee, 38152, United States

Location

Related Publications (2)

• Murphy JG, Dennhardt AA, Tempchin J, Colgonis HE, McDevitt-Murphy ME, Borsari B, Berlin KS. Behavioral economic and wellness-based approaches for reducing alcohol use and consequences among diverse non-student emerging adults: study protocol for Project BLUE, a randomized controlled trial. Trials. 2024 Mar 9;25(1):173. doi: 10.1186/s13063-024-08009-9.

  PMID: 38459579 DERIVED

• Murphy JG, Dennhardt AA, Tempchin J, Colgonis HE, McDevitt-Murphy M, Borsari B, Berlin KS. Behavioral Economic and Wellness-based Approaches for Reducing Alcohol Use and Consequences Among Diverse Non-Student Emerging Adults: Study Protocol for Project BLUE, a Randomized Controlled Trial. Res Sq [Preprint]. 2024 Feb 7:rs.3.rs-3732598. doi: 10.21203/rs.3.rs-3732598/v1.

  PMID: 38405755 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol; Methods; Relaxation Therapy

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Investigative Techniques; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 1, 2021
• Study Start: January 17, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: In this clinical trial, clinical assessments to establish baseline subject characteristics and eligibility criteria will be collected from all research participants at the screening and randomization visits, prior to the completion of the behavioral intervention. Assessment to measure changes in drinking and other dependent variables will take place a 1, 3, 6, and 12 months post-intervention.
• Access Criteria: Qualified researchers

Locations

US (1)