Interactive Alcohol Decision-Making Programs

NCT ID: NCT05398315

Last Updated: 2023-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-04-01

Brief Summary

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This project aims to develop a maximally effective, computer-delivered brief intervention (CDBI) for reducing heavy alcohol use. More specifically, the investigators will examine outcomes of different versions of a CDBI in which the presence/absence of empathic statements, the gender of the narrator, the presence/absence of a narrator backstory, and the use/non-use of motivational interviewing techniques are systematically manipulated using a factorial design. Participants (352 heavy drinkers) will be randomly assigned to 1 of 16 intervention conditions, representing all combinations of the 4 variables being manipulated. The investigators hypothesize that there will be significant main effects of all four factors being manipulated on (a) subjective reactions to the CDBI and (b) alcohol outcomes at 1-month follow-up

Detailed Description

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The National Survey on Drug Use and Health estimates that 19.3 million individuals ages 12 and over met criteria for an alcohol use disorder in the past year, fully 87.4% of whom neither received any treatment in the past 12 months, nor wanted it. Recognition of this tremendous gap has led to efforts, both nationally and internationally, to implement proactive screening and brief intervention. Brief interventions have proven efficacious in reducing unhealthy drinking with effect sizes in meta-analyses ranging from small to moderate. Brief interventions are also uniquely applicable to non-treatment-seeking populations, who may refuse extended treatment but accept a minimal, opportunistic intervention. However, the public health impact of brief interventions has been limited by substantial difficulty with implementation. Further, positive overall findings in meta-analyses obscure the results of multiple rigorous efficacy trials showing no brief intervention effect on alcohol use. Both of these issues-the implementation challenges and the inconsistency in outcomes-suggest that changes are needed before brief alcohol interventions can meet their full potential.

Technology offers exciting potential in both respects. First, computer-delivered brief interventions (CDBIs) can be presented inexpensively, with perfect fidelity, and without the need for training or provider time. Second, their replicability, flexibility, and modularity makes them the perfect platform for (a) isolating the active ingredients that are associated with positive outcomes; and thereby (b) continually optimizing CDBIs to achieve cumulative increases in efficacy.

The overall goal of this research is to develop a maximally effective and replicable CDBI for reducing heavy alcohol use. To accomplish this, the investigators will use the Multiphase Optimization Strategy (MOST), an efficient method for optimizing intervention content that uses factorial designs to evaluate main and interaction effects of specific intervention components. The selection of components will be guided by: (a) Common Factors Theory, which highlights the tremendous contribution of relational factors, such as empathy, alliance and positive regard to therapy outcomes, but which is of unknown relevance to CDBIs; and (b) the Media Equation Theory, which suggests that people automatically respond to computers in social ways, particularly when those computers replicate human characteristics. Guided by this literature, the investigators will examine outcomes of a CDBI in which empathic statements, the gender of the narrator, the presence/absence of a narrator backstory, and the use/non-use of motivational interviewing techniques are systematically manipulated using a factorial design.

Specific aims are as follows:

1. Develop 16 distinct, time-consistent, computer-delivered sessions representing all possible combinations of the following four factors (each of which will be binary; i.e. either present vs. absent or male vs. female): (1) narrator gender, (2) empathic statements and reflections, (3) narrator backstory, and (4) use of motivational techniques.
2. Evaluate main and interaction effects of the five factors by randomly assigning 352 heavy drinkers to the 16 sessions (each of the four factors being presented to half of the participants) and evaluating (1) subjective reactions to the CDBI at baseline and (2) alcohol use at 1-month follow-up.

Hypothesis 1. Subjective reactions to the CDBI, disclosure of alcohol use and consequences, and motivation to reduce alcohol use will be higher and alcohol use at follow-up will be lower in the presence of (1) empathic statements, (2) a narrator backstory and (3) motivational techniques. The effects of narrator gender will be examined in an exploratory way (i.e., no a priori hypotheses).

Hypothesis 2. Subjective reactions will be more positive, disclosure and motivation to reduce alcohol use will be higher, and alcohol use at follow-up will be lower when the two relational factors (empathy and narrator backstory) are combined with the presence of motivational content.

Conditions

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Heavy Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Four intervention components will be manipulated in a full factorial design, such that each participant either does or does not receive each intervention component.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participants will be randomly assigned to a condition by a computer program. The entire study will take place online. Participants will not be aware of the condition they are in until after the study ends. Investigators/outcome assessors will only see de-identified data and will have no contact with participants.

Study Groups

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Empathic Statements, MI, Male, No Backstory

Presence of empathic statements and MI techniques. Male narrator. No narrator backstory.

Group Type EXPERIMENTAL

Empathic Statements/Reflections

Intervention Type BEHAVIORAL

Presence of Empathic Statements

Male Narrator

Intervention Type BEHAVIORAL

Presence of a male narrator

MI Techniques

Intervention Type BEHAVIORAL

Presence of MI techniques

No Empathic Statements, No MI, Female, No Backstory

No empathic statements, MI techniques or narrator backstory. Female narrator

Group Type EXPERIMENTAL

Female Narrator

Intervention Type BEHAVIORAL

Presence of a female narrator

No Empathic Statements, No MI, Female, Backstory

No empathic statements or MI techniques. Presence of narrator backstory. Female narrator

Group Type EXPERIMENTAL

Narrator Backstory

Intervention Type BEHAVIORAL

Presence of a narrator backstory

Female Narrator

Intervention Type BEHAVIORAL

Presence of a female narrator

Empathic Statements, MI, Female, Backstory

Presence of empathic statements, MI techniques and narrator backstory. Female narrator

Group Type EXPERIMENTAL

Empathic Statements/Reflections

Intervention Type BEHAVIORAL

Presence of Empathic Statements

Narrator Backstory

Intervention Type BEHAVIORAL

Presence of a narrator backstory

Female Narrator

Intervention Type BEHAVIORAL

Presence of a female narrator

MI Techniques

Intervention Type BEHAVIORAL

Presence of MI techniques

No Empathic Statements, No MI, Male, No Backstory

No empathic statements, MI techniques or narrator backstory. Male narrator

Group Type EXPERIMENTAL

Male Narrator

Intervention Type BEHAVIORAL

Presence of a male narrator

Empathic Statements, MI, Male, Backstory

Presence of empathic statements, MI techniques and narrator backstory. Male narrator.

Group Type EXPERIMENTAL

Empathic Statements/Reflections

Intervention Type BEHAVIORAL

Presence of Empathic Statements

Narrator Backstory

Intervention Type BEHAVIORAL

Presence of a narrator backstory

Male Narrator

Intervention Type BEHAVIORAL

Presence of a male narrator

MI Techniques

Intervention Type BEHAVIORAL

Presence of MI techniques

No Empathic Statements, MI, Female, Backstory

Presence of MI techniques and narrator backstory. No empathic statements. Female narrator.

Group Type EXPERIMENTAL

Narrator Backstory

Intervention Type BEHAVIORAL

Presence of a narrator backstory

Female Narrator

Intervention Type BEHAVIORAL

Presence of a female narrator

MI Techniques

Intervention Type BEHAVIORAL

Presence of MI techniques

Empathic Statements, No MI, Male, No Backstory

Presence of empathic statements. No MI techniques or narrator backstory. Male narrator.

Group Type EXPERIMENTAL

Empathic Statements/Reflections

Intervention Type BEHAVIORAL

Presence of Empathic Statements

Male Narrator

Intervention Type BEHAVIORAL

Presence of a male narrator

No Empathic Statements, MI, Male, Backstory

Presence of MI techniques and narrator backstory. No empathic statements. Male narrator.

Group Type EXPERIMENTAL

Narrator Backstory

Intervention Type BEHAVIORAL

Presence of a narrator backstory

Male Narrator

Intervention Type BEHAVIORAL

Presence of a male narrator

MI Techniques

Intervention Type BEHAVIORAL

Presence of MI techniques

Empathic Statements, No MI, Female, No Backstory

Presence of empathic statements. No MI techniques or narrator backstory. Female narrator.

Group Type EXPERIMENTAL

Empathic Statements/Reflections

Intervention Type BEHAVIORAL

Presence of Empathic Statements

Female Narrator

Intervention Type BEHAVIORAL

Presence of a female narrator

Empathic Statements, MI, Female, No Backstory

Presence of empathic statements and MI techniques. Female narrator. No narrator backstory.

Group Type EXPERIMENTAL

Empathic Statements/Reflections

Intervention Type BEHAVIORAL

Presence of Empathic Statements

Female Narrator

Intervention Type BEHAVIORAL

Presence of a female narrator

MI Techniques

Intervention Type BEHAVIORAL

Presence of MI techniques

No Empathic Statements, No MI, Male, Backstory

Presence of narrator backstory. No empathic statements or MI techniques. Male narrator.

Group Type EXPERIMENTAL

Narrator Backstory

Intervention Type BEHAVIORAL

Presence of a narrator backstory

Male Narrator

Intervention Type BEHAVIORAL

Presence of a male narrator

Empathic Statements, No MI, Female, Backstory

Presence of empathic statements and narrator backstory. No MI techniques. Female narrator.

Group Type EXPERIMENTAL

Empathic Statements/Reflections

Intervention Type BEHAVIORAL

Presence of Empathic Statements

Narrator Backstory

Intervention Type BEHAVIORAL

Presence of a narrator backstory

Female Narrator

Intervention Type BEHAVIORAL

Presence of a female narrator

Empathic Statements, No MI, Male, Backstory

Presence of empathic statements and narrator backstory. No MI techniques. Male narrator.

Group Type EXPERIMENTAL

Empathic Statements/Reflections

Intervention Type BEHAVIORAL

Presence of Empathic Statements

Narrator Backstory

Intervention Type BEHAVIORAL

Presence of a narrator backstory

Male Narrator

Intervention Type BEHAVIORAL

Presence of a male narrator

No Empathic Statements, MI, Female, No Backstory

Presence of MI techniques. No empathic statements or narrator backstory. Female narrator.

Group Type EXPERIMENTAL

Female Narrator

Intervention Type BEHAVIORAL

Presence of a female narrator

MI Techniques

Intervention Type BEHAVIORAL

Presence of MI techniques

No Empathic Statements, MI, Male, No Backstory

Presence of MI techniques. No empathic statements or narrator backstory. Male narrator.

Group Type EXPERIMENTAL

Male Narrator

Intervention Type BEHAVIORAL

Presence of a male narrator

MI Techniques

Intervention Type BEHAVIORAL

Presence of MI techniques

Interventions

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Empathic Statements/Reflections

Presence of Empathic Statements

Intervention Type BEHAVIORAL

Narrator Backstory

Presence of a narrator backstory

Intervention Type BEHAVIORAL

Male Narrator

Presence of a male narrator

Intervention Type BEHAVIORAL

Female Narrator

Presence of a female narrator

Intervention Type BEHAVIORAL

MI Techniques

Presence of MI techniques

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Over age 18
* Access to the internet.
* Males must consume at least 14 drinks per week or 4 drinks per day
* Females must consume at least 7 drinks per week or 3 drinks per day

Exclusion Criteria

* Under age 18
* No internet access
* Males who consume less than 14 drinks per week or 4 drinks per day
* Females who consume less than 7 drinks per week or 3 drinks per day
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wayne State University

OTHER

Sponsor Role lead

Responsible Party

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Emily Grekin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily Grekin, PhD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

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Wayne State University

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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Grekin ER, Thomas HA, Ondersma SJ. Testing the efficacy of narrator empathy, self-disclosure, gender, and use of brief motivational interviewing techniques in a brief internet-based intervention for alcohol use. Psychol Addict Behav. 2024 May;38(3):231-242. doi: 10.1037/adb0001003. Epub 2024 Mar 14.

Reference Type DERIVED
PMID: 38483522 (View on PubMed)

Other Identifiers

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22-01-4352

Identifier Type: -

Identifier Source: org_study_id

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