Clinical trial NCT02952872: Brief Alcohol E-Interventions Study
Official title: Optimizing E-interventions for Alcohol Use: Do Common Factors Apply?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking in College
Keywords: Computerized Brief Intervention
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The project seeks to develop an effective computer-delivered brief intervention to reduce alcohol use using the Multiphase Optimization Strategy (MOST). Sixteen different versions of the intervention will be tested with manipulation of common factors (empathy \& positive regard), use of a voice, and use of an animated narrator. Participants will include 352 undergraduate students randomly assigned to one intervention condition; follow-up assessments will take place at one and 3 months. The main outcome will be means drink per day over the past 30 day.

Detailed description: The proposed project seeks to develop a maximally effective computer-delivered brief intervention (CDBI) for reducing heavy alcohol use. To accomplish this, we will use the Multiphase Optimization Strategy (MOST), an efficient method for optimizing intervention content, beginning with factorial designs evaluating main and interaction effects of specific intervention components. Our selection of components will be guided by: (a) Common Factors Theory, which highlights the tremendous contribution of non-specific factors, such as empathy and positive regard, to therapy outcomes, but which is of unknown relevance to CDBIs; and (b) Media Equation Theory, which suggests that people automatically respond to computers in social ways, particularly when those computers replicate human characteristics. To accomplish these goals, we will examine outcomes of computer-delivered brief interventions in which common factors (empathy \& positive regard), use of a voice, and use of an animated narrator are systematically manipulated using a factorial design. We will also systematically manipulate the presence vs. absence of motivational content in order to examine possible interactions between common factors and specific motivational techniques. Participants will be 352 undergraduates who are randomly assigned to 1 of 16 intervention conditions. Mean drinks per day over the past 30 days will be measured at 1 and 3-month follow-ups. Secondary analyses will also examine past month heavy drinking days, alcohol-related consequences, and intention to reduce alcohol use. We hypothesize that there will be significant main effects for (1) the factor consistent with Common Factors Theory (empathy and positive regard), (2) the two factors consistent with Media Equation Theory (voice and narrator), and (3) the presence of motivational content. We further hypothesize that mean drinks/day will be lower when (1) the common factors (empathy, positive regard) are combined with a voice and/or narrator or (2) motivational content is combined with common factors and/or a voice/narrator.

Eligibility criteria: Inclusion Criteria:

Participants must be students at Wayne State University, aged 18 or older. Additionally, participants must report either (1) consuming 3 (women)/4 (men) drinks per day or 7 (women)/14 (men) drinks per week, (2) getting drunk at least once per week over the past 6 months or (3) binge drinking at least once per week over the past 6 months (i.e. more than 4 (women)/5 (men) drinks in a 2 hr. period).

Exclusion Criteria:

Individuals who are under the age of 18, or who do not meet the study's drinking criteria

Primary outcomes:
measure: Mean Drinks Per Day
timeFrame: 1 month and 3 months after baseline
Secondary outcomes:
measure: Number of Heavy Drinking Days Per Month
timeFrame: 1 month and 3 months after baseline
measure: Report of Alcohol Related Consequences
timeFrame: 1 month and 3 months after baseline
measure: Intention to Reduce Alcohol Use
timeFrame: 1 month and 3 months after baseline
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Wayne State University
name: Emily Grekin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grekin ER, Beatty JR, McGoron L, Kugler KC, McClure JB, Pop DE, Ondersma SJ. Testing the efficacy of motivational strategies, empathic reflections, and lifelike features in a computerized intervention for alcohol use: A factorial trial. Psychol Addict Behav. 2019 Sep;33(6):511-519. doi: 10.1037/adb0000502. Epub 2019 Aug 22.