Evaluating Change in Drinking Identity as a Mechanism for Reducing Hazardous Drinking - Study 2

Identity, Social Clinical Trial

Official title:

Evaluating Change in Drinking Identity as a Mechanism for Reducing Hazardous Drinking - Study 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889873
• Other study ID #: STUDY00006542
• Secondary ID: 1R01AA024732-01
• Status: Completed
• Phase: N/A
• Start date: April 18, 2019
• Est. completion date: June 7, 2021

Study information

• Verified date: September 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: June 7, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drinking; Excess, Habit (Continual)
• Identity, Social

Intervention

Behavioral:
• Narrative Writing
An writing task in which participants are given a description of a possible future self (that varies 3 factors: topic; drinking vs. smartphone; perspective: 1st vs. 3rd-person; and social network: specifically asked to be included vs. not specifically asked to be included). Participants are asked to imagine that future self vividly and to write about the thoughts and feeling describe themselves and their experiences, the characteristics they hope or wish they will ideally possess, the characteristics that they would need to have and the roles they will take on or things they will be doing. Participants are given 20 minutes to think and write. They will write and think about the same future on each of three lab-sessions (which occur at 1-week intervals).

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in social network composition	Important people measure will ask about the 10 most important individuals in one's social network, including whether or not each one drinks; the variables that are derived include the density of drinkers in the network; higher density = more drinkers (worse outcome)	will be assessed at baseline and 3-month follow up; data will be reported through study completion (3 month follow up)
Other	Changes in desire thinking about alcohol	Assessed via the Desire Thinking Questionnaire; response options range from 1 to 4; total scores (range from 10 to 40) indicate amount of desire thinking about alcohol; higher scores = more desire thinking (worse outcome)	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)
Other	Changes in smartphone addiction proneness	Assessed via the smartphone addiction proneness scale; will use total score (sum); response options range from 1 to 4; total scores (range from 15 to 60), higher scores = more addiction proneness (worse outcome)	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)
Other	Changes in smartphone use	item assessing frequency of use and length of time not using; higher frequency of use = worse outcome; higher length of time not using = better outcome	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)
Other	changes in affect	State (current) affect will be assessed immediately prior to and after the narrative writing task; two items (one assessing positive affect and one assessing negative affect); item response range from 0 to 100, with 100 indicating greater intensity of feeling; affect will be assess each time participants complete the narrative writing task (i.e. lab 1, lab 2, lab 3); no changes in affect are expected	assessed pre-post-writing during lab 1, lab 2, lab 3 (weeks 1-3); data will be reported through week 3
Other	Manipulation check questions about the narrative writing task	Following the narrative writing task (which occurs at each of the lab session), participants will be asked 5 items about what they wrote and imagined; each item will be evaluated separately; response options range from -3 to +3; items assess how vividly they imagined what they wrote; how easy it was to imagine what they wrote; how much writing made them seem their life differently; how plausible what they imagined was; how relatable what they wrote about was; for all items higher scores = better outcomes	will be assessed and reported for each of the 3 lab sessions (weeks 1, 2, and 3)
Other	Changes in single-item assessing self-efficacy to limit one's smartphone use	Item developed by Cervone & Shadel; item response options range from 0 to 10; higher scores = greater self-efficacy to limit one's smartphone use; higher scores = better outcome	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)
Primary	Changes in Implicit Drinking identity	drinking identity implicit association test (IAT)	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)
Primary	Changes in Explicit Drinking identity	Alcohol Self-concept Scale; item responses range from -3 to +3; average score on all items is calculated; lower scores represent a better outcome	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)
Primary	changes in self-efficacy	drinking refusal self-efficacy questionnaire	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)
Primary	cue-related craving	current craving from cue reactivity task; assessed via alcohol urge questionnaire	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)
Primary	changes in past week craving	Penn Alcohol Craving Scale; item responses range from 0 to 6; total score on all items is calculated (can range from 0 to 30); lower scores = better outcome	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)
Primary	changes in alcohol consumption	Modified timeline follow back will assess past daily alcohol consumption (# standard drinks per day); higher consumption = worse outcomes	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)
Primary	changes in last 3 month alcohol problems	Rutgers Alcohol Problems Inventory (RAPI) will be used to assess alcohol problems; item response options range from 0 to 4; total score ranges from 0 to 100; higher scores = worse outcomes	Assessed at lab 1 (week1) and 3-month follow up; data will be reported through study completion (3 month follow up)
Primary	changes in last two week alcohol problems	adapted from RAPI & Young Adult Alcohol Problems Screening Test (YAAPST); item responses are 0 (did not happen) or 1 (happened); higher scores (range from 0 to 10) = worse outcomes	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	changes in future drinking intentions	adapted from daily drinking questionnaire; assesses how much individuals think they will drink each day of the next week	assessed at lab 1, lab 2, lab 3 (weeks 1-3); data will be reported through week 3
Secondary	changes in frequency of heavy & extreme binge drinking	frequency of heavy episodic (4/5 or more drinks for women/men on a single occasion) and extreme binge drinking (at least 8/10 drinks or at least 12/15 drinks for women/men on a single occasion); definitions are from the National Institute of Alcohol and Alcoholism	assessed at lab 1 (week 1) &
Secondary	Changes in Readiness to Change Drinking	single item about readiness to change one's drinking (from Rollnick, Mason, & Butler, 1999); ranges from 0 to 6; higher scores = more readiness to change one's drinking; higher scores = better outcome	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)
Secondary	Changes in single-item assessing self-efficacy to limit one's drinking	Item developed by Cervone & Shadel; item ranges from 0 to10; higher scores = greater self-efficacy to limit one's drinking; higher scores = better outcome	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)