NCT05398315

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

1.8 years

First QC Date

May 19, 2022

Last Update Submit

June 4, 2023

Conditions

Keywords

AlcoholCommon FactorsMotivational InterviewingFactorial Design

Outcome Measures

Primary Outcomes (3)

  • Change in Quantity and Frequency of Alcohol Use

    The Timeline Followback Questionnaire (TLFB) will be given to assess past month alcohol use.

    Given pre-intervention and at 1-month follow-up

  • Change in Alcohol-Related Consequences

    Assessed with the Brief Young Adult Alcohol Consequences Questionnaire which assess the occurrence/ non-occurrence of 24 alcohol consequences.

    Given pre-intervention and at 1-month follow-up

  • Participant Satisfaction with the Intervention

    Fifteen item measure assessing how much participants liked the intervention and felt respected by it.

    Given immediately after completing the intervention

Study Arms (16)

Empathic Statements, MI, Male, No Backstory

EXPERIMENTAL

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

Behavioral: Empathic Statements/ReflectionsBehavioral: Male NarratorBehavioral: MI Techniques

No Empathic Statements, No MI, Female, No Backstory

EXPERIMENTAL

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

Behavioral: Female Narrator

No Empathic Statements, No MI, Female, Backstory

EXPERIMENTAL

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

Behavioral: Narrator BackstoryBehavioral: Female Narrator

Empathic Statements, MI, Female, Backstory

EXPERIMENTAL

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

Behavioral: Empathic Statements/ReflectionsBehavioral: Narrator BackstoryBehavioral: Female NarratorBehavioral: MI Techniques

No Empathic Statements, No MI, Male, No Backstory

EXPERIMENTAL

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

Behavioral: Male Narrator

Empathic Statements, MI, Male, Backstory

EXPERIMENTAL

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

Behavioral: Empathic Statements/ReflectionsBehavioral: Narrator BackstoryBehavioral: Male NarratorBehavioral: MI Techniques

No Empathic Statements, MI, Female, Backstory

EXPERIMENTAL

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

Behavioral: Narrator BackstoryBehavioral: Female NarratorBehavioral: MI Techniques

Empathic Statements, No MI, Male, No Backstory

EXPERIMENTAL

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

Behavioral: Empathic Statements/ReflectionsBehavioral: Male Narrator

No Empathic Statements, MI, Male, Backstory

EXPERIMENTAL

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

Behavioral: Narrator BackstoryBehavioral: Male NarratorBehavioral: MI Techniques

Empathic Statements, No MI, Female, No Backstory

EXPERIMENTAL

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

Behavioral: Empathic Statements/ReflectionsBehavioral: Female Narrator

Empathic Statements, MI, Female, No Backstory

EXPERIMENTAL

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

Behavioral: Empathic Statements/ReflectionsBehavioral: Female NarratorBehavioral: MI Techniques

No Empathic Statements, No MI, Male, Backstory

EXPERIMENTAL

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

Behavioral: Narrator BackstoryBehavioral: Male Narrator

Empathic Statements, No MI, Female, Backstory

EXPERIMENTAL

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

Behavioral: Empathic Statements/ReflectionsBehavioral: Narrator BackstoryBehavioral: Female Narrator

Empathic Statements, No MI, Male, Backstory

EXPERIMENTAL

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

Behavioral: Empathic Statements/ReflectionsBehavioral: Narrator BackstoryBehavioral: Male Narrator

No Empathic Statements, MI, Female, No Backstory

EXPERIMENTAL

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

Behavioral: Female NarratorBehavioral: MI Techniques

No Empathic Statements, MI, Male, No Backstory

EXPERIMENTAL

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

Behavioral: Male NarratorBehavioral: MI Techniques

Interventions

Presence of Empathic Statements

Empathic Statements, MI, Female, BackstoryEmpathic Statements, MI, Female, No BackstoryEmpathic Statements, MI, Male, BackstoryEmpathic Statements, MI, Male, No BackstoryEmpathic Statements, No MI, Female, BackstoryEmpathic Statements, No MI, Female, No BackstoryEmpathic Statements, No MI, Male, BackstoryEmpathic Statements, No MI, Male, No Backstory

Presence of a narrator backstory

Empathic Statements, MI, Female, BackstoryEmpathic Statements, MI, Male, BackstoryEmpathic Statements, No MI, Female, BackstoryEmpathic Statements, No MI, Male, BackstoryNo Empathic Statements, MI, Female, BackstoryNo Empathic Statements, MI, Male, BackstoryNo Empathic Statements, No MI, Female, BackstoryNo Empathic Statements, No MI, Male, Backstory
Male NarratorBEHAVIORAL

Presence of a male narrator

Empathic Statements, MI, Male, BackstoryEmpathic Statements, MI, Male, No BackstoryEmpathic Statements, No MI, Male, BackstoryEmpathic Statements, No MI, Male, No BackstoryNo Empathic Statements, MI, Male, BackstoryNo Empathic Statements, MI, Male, No BackstoryNo Empathic Statements, No MI, Male, BackstoryNo Empathic Statements, No MI, Male, No Backstory
Female NarratorBEHAVIORAL

Presence of a female narrator

Empathic Statements, MI, Female, BackstoryEmpathic Statements, MI, Female, No BackstoryEmpathic Statements, No MI, Female, BackstoryEmpathic Statements, No MI, Female, No BackstoryNo Empathic Statements, MI, Female, BackstoryNo Empathic Statements, MI, Female, No BackstoryNo Empathic Statements, No MI, Female, BackstoryNo Empathic Statements, No MI, Female, No Backstory
MI TechniquesBEHAVIORAL

Presence of MI techniques

Empathic Statements, MI, Female, BackstoryEmpathic Statements, MI, Female, No BackstoryEmpathic Statements, MI, Male, BackstoryEmpathic Statements, MI, Male, No BackstoryNo Empathic Statements, MI, Female, BackstoryNo Empathic Statements, MI, Female, No BackstoryNo Empathic Statements, MI, Male, BackstoryNo Empathic Statements, MI, Male, No Backstory

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Emily Grekin, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Four intervention components will be manipulated in a full factorial design, such that each participant either does or does not receive each intervention component.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 19, 2022

First Posted

May 31, 2022

Study Start

July 1, 2021

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

June 6, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations