Clinical trial NCT03889873: Evaluating Change in Drinking Identity as a Mechanism for Reducing Hazardous Drinking - Study 2
Official title: Evaluating Change in Drinking Identity as a Mechanism for Reducing Hazardous Drinking - Study 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drinking; Excess, Habit (Continual)
Identity, Social
Keywords: Drinking identity
Hazardous drinking
Social networks
Self-efficacy
Alcohol craving
Cognitive control
Narrative writing
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-03-26
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants are randomly assigned to a condition to receive one of eight writing prompt variants in a 2x2x2 study design. There is also a within subjects component as participants complete the same writing prompt 3 times (once per week over a 3-week period).
Primary purpose: OTHER

Brief summary: The purpose of the proposed research is to evaluate whether changes in drinking identity (DI; how much one associates one's self with drinking) can reduce hazardous drinking (HD; heavy alcohol use and negative alcohol-related consequences) among current college students. The study seeks to explore whether manipulating DI among participants will have changes in self-efficacy, craving, and HD. If such an effect can be found, DI may be a mechanism for HD behavior change and will allow researchers to develop and improve interventions aimed at HD behaviors in high-risk young adults.

Detailed description: Experimentally manipulate DI to increase self-efficacy, decrease alcohol craving and reduce HD. We will recruit 328 student hazardous drinkers and use an expressive writing task to manipulate their DI, the salience of their social network, and their writing perspective. The last factor is included because writing in a self-distanced (3rd person) vs. self-immersed (1st person) perspective has been linked to greater cognitive control. We will evaluate the manipulation's immediate effects on DI, self-efficacy, and craving. Participants will also complete two weekly follow-up "booster" sessions. Longer-term effects on DI, self-efficacy, craving and HD will be evaluated at additional 2-week, 1-month, and 3-month follow-ups.

With the outbreak of the COVID-19 pandemic, new subject enrollment was paused between March and September 2020. In light of the continued COVID-19 pandemic, the study team made the decision to move the in-person, lab-based session (where participants completed the writing task) to online sessions as of October 2020. With the move to online sessions, we have discontinued the cue reactivity task and the accompanying craving assessment. Inclusion criteria have shifted slightly -- we now explicitly require participants to be currently living in Washington State (this criterion was implicit in our previous criteria and procedures) . The structure of the study otherwise remains the same.

Eligibility criteria: Inclusion Criteria:

* Participants must be full-time UW students, fluent in the English language, and recent (past week) drinkers who self-report drinking hazardously (i.e., score an 8 or above on the Alcohol Use Disorder Identification Test, AUDIT). Participants must also own a smartphone.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Changes in Implicit Drinking identity
timeFrame: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
measure: Changes in Explicit Drinking identity
timeFrame: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
measure: changes in self-efficacy
timeFrame: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
measure: cue-related craving
timeFrame: Cue related craving will be assessed following the cue reactivity task, which occurs during the third and final lab-based session (technically, the third week of the study)
measure: changes in past week craving
timeFrame: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
measure: changes in alcohol consumption
timeFrame: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
measure: changes in last 3 month alcohol problems
timeFrame: Assessed at lab 1 (week1) and 3-month follow up; data will be reported through study completion (3 month follow up)
measure: changes in last two week alcohol problems
timeFrame: assessed at lab 2 and 3 (weeks 2 and 3) and at 2 week and 1 month follow up; data will be reported through 1 month follow up
Secondary outcomes:
measure: changes in future drinking intentions
timeFrame: assessed at lab 1, lab 2, lab 3 (weeks 1-3); data will be reported through week 3
measure: changes in frequency of heavy & extreme binge drinking
timeFrame: assessed at lab 1 (week 1) &
measure: Changes in Readiness to Change Drinking
timeFrame: post-writing (lab 1, lab 2, lab 3) long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
measure: Changes in single-item assessing self-efficacy to limit one's drinking
timeFrame: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
Other outcomes:
measure: Changes in social network composition
timeFrame: will be assessed at baseline and 3-month follow up; data will be reported through study completion (3 month follow up)
measure: Changes in desire thinking about alcohol
timeFrame: assessed at lab 1 (week 1) and long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
measure: Changes in smartphone addiction proneness
timeFrame: Assessed at lab 1 (week 1) and long-term follow up (2 week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
measure: Changes in smartphone use
timeFrame: Assessed at lab 1 (week 1) and long-term follow up (2 week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
measure: changes in affect
timeFrame: assessed pre-post-writing during lab 1, lab 2, lab 3 (weeks 1-3); data will be reported through week 3
measure: Manipulation check questions about the narrative writing task
timeFrame: will be assessed and reported for each of the 3 lab sessions (weeks 1, 2, and 3)
measure: Changes in single-item assessing self-efficacy to limit one's smartphone use
timeFrame: will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Kristen P Lindgren, PhD
role: PRINCIPAL_INVESTIGATOR
References: