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

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ClinicalTrials.gov Identifier: NCT03889873
Recruitment Status : Enrolling by invitation
First Posted : March 26, 2019
Last Update Posted : October 27, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Kristen Lindgren, University of Washington

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.

Condition or disease Intervention/treatment Phase
Drinking; Excess, Habit (Continual) Identity, Social Behavioral: Narrative Writing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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).
Masking: Single (Investigator)
Masking Description: The PI, the project coordinator, and experimenters will not know which participants have been assigned to each condition. Outcomes are assessed via computer/online survey. There is no human outcome assessor in this study.
Primary Purpose: Other
Official Title: Evaluating Change in Drinking Identity as a Mechanism for Reducing Hazardous Drinking - Study 2
Actual Study Start Date : April 18, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: Drinking; No network; First-person
In this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using first-person pronouns.
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).

Experimental: Drinking; Network; First-person
In this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using first-person pronouns.
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).

Experimental: Drinking; No network; Third-person
In this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using third-person pronouns.
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).

Experimental: Drinking; Network; Third-person
In this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using third-person pronouns.
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).

Experimental: Smartphone; No network; First-person
In this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using first-person pronouns.
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).

Experimental: Smartphone; Network; First-person
In this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using first-person pronouns.
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).

Experimental: Smartphone; No network; Third-person
In this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using third-person pronouns.
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).

Experimental: Smartphone; Network; Third-person
In this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using third-person pronouns.
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).




Primary Outcome Measures :
  1. Changes in Implicit Drinking identity [ Time Frame: 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) ]
    drinking identity implicit association test (IAT)

  2. Changes in Explicit Drinking identity [ Time Frame: 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) ]
    Alcohol Self-concept Scale; item responses range from -3 to +3; average score on all items is calculated; lower scores represent a better outcome

  3. changes in self-efficacy [ Time Frame: 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) ]
    drinking refusal self-efficacy questionnaire

  4. cue-related craving [ Time Frame: 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) ]
    current craving from cue reactivity task; assessed via alcohol urge questionnaire

  5. changes in past week craving [ Time Frame: 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) ]
    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

  6. changes in alcohol consumption [ Time Frame: 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) ]
    Modified timeline follow back will assess past daily alcohol consumption (# standard drinks per day); higher consumption = worse outcomes

  7. changes in last 3 month alcohol problems [ Time Frame: Assessed at lab 1 (week1) and 3-month follow up; data will be reported through study completion (3 month follow up) ]
    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

  8. changes in last two week alcohol problems [ Time Frame: 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 ]
    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


Secondary Outcome Measures :
  1. changes in future drinking intentions [ Time Frame: assessed at lab 1, lab 2, lab 3 (weeks 1-3); data will be reported through week 3 ]
    adapted from daily drinking questionnaire; assesses how much individuals think they will drink each day of the next week

  2. changes in frequency of heavy & extreme binge drinking [ Time Frame: assessed at lab 1 (week 1) & ]
    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

  3. Changes in Readiness to Change Drinking [ Time Frame: 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) ]
    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

  4. Changes in single-item assessing self-efficacy to limit one's drinking [ Time Frame: 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) ]
    Item developed by Cervone & Shadel; item ranges from 0 to10; higher scores = greater self-efficacy to limit one's drinking; higher scores = better outcome


Other Outcome Measures:
  1. Changes in social network composition [ Time Frame: will be assessed at baseline and 3-month follow up; data will be reported through study completion (3 month follow up) ]
    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)

  2. Changes in desire thinking about alcohol [ Time Frame: 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) ]
    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)

  3. Changes in smartphone addiction proneness [ Time Frame: 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) ]
    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)

  4. Changes in smartphone use [ Time Frame: 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) ]
    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

  5. changes in affect [ Time Frame: assessed pre-post-writing during lab 1, lab 2, lab 3 (weeks 1-3); data will be reported through week 3 ]
    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

  6. Manipulation check questions about the narrative writing task [ Time Frame: will be assessed and reported for each of the 3 lab sessions (weeks 1, 2, and 3) ]
    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

  7. Changes in single-item assessing self-efficacy to limit one's smartphone use [ Time Frame: 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) ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889873


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Kristen P Lindgren, PhD University of Washington
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Responsible Party: Kristen Lindgren, Associate Professor, School of Medicine: Psychiatry, University of Washington
ClinicalTrials.gov Identifier: NCT03889873    
Other Study ID Numbers: STUDY00006542
1R01AA024732-01 ( U.S. NIH Grant/Contract )
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share responses to questionnaires and writing exercises with co-investigators. We do not currently have plans to store data in a repository/database (for example, via the Open Science Framework [OSF] - https://osf.io/), though we may ultimately do so should this be a condition of publishing in a scientific journal or necessary for other unforeseen reasons. Should we do so, we would not publish or make available or the narrative writing responses verbatim. Similarly, we would also not publish or make available the variables that describe the 10 most important people on the important people measure. No direct identifiers will be included in any data shared.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Analytic Code
Time Frame: Data will become available after the grant period of award is completed unless there is a requirement to make data publicly available as a condition of publication.
Access Criteria: Data access requests will be reviewed by the PI and study research coordinator. Requestors will be required to sign a data use agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristen Lindgren, University of Washington:
Drinking identity
Hazardous drinking
Social networks
Self-efficacy
Alcohol craving
Cognitive control
Narrative writing