- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03889873
Evaluating Change in Drinking Identity as a Mechanism for Reducing Hazardous Drinking - Study 2
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98105
- University of Washington
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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drinking identity implicit association test (IAT)
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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)
|
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
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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)
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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)
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drinking refusal self-efficacy questionnaire
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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)
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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)
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current craving from cue reactivity task; assessed via alcohol urge questionnaire
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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)
|
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
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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)
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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)
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Modified timeline follow back will assess past daily alcohol consumption (# standard drinks per day); higher consumption = worse outcomes
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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)
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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)
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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)
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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
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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
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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
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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
|
assessed at lab 1 (week 1) &
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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
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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)
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
will be assessed at baseline and 3-month follow up; data will be reported through study completion (3 month follow up)
|
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)
|
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)
|
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)
|
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)
|
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
|
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)
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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
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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
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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
|
will be assessed and reported for each of the 3 lab sessions (weeks 1, 2, and 3)
|
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
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristen P Lindgren, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00006542
- 1R01AA024732-01 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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