Alcohol PBS and Thinking About the Past

April 11, 2023 updated by: Sherecce A Fields, Texas A&M University

Alcohol Protective Behavioral Strategies and Thinking About the Past

Individuals often think of how a situation or outcome could have turned out differently -- if only something was different or something had changed, then the outcome could have been better or worse. This is a common type of thinking, known as counterfactual thinking, that often takes the form of "if only" statements. These thoughts are frequent after negative events, but have also been found to occur after positive events and 'near misses'. Research has shown that their evaluative nature elicits a variety of consequences, such as biased decision making, changes in an event's meaningfulness, heightened positive or negative affect, and future behavioral changes (such as intentions, motivation, persistence/effort. Specifically, many areas of research involving counterfactuals have often looked into key elements that are often discussed in other health behavior literature, such as self-efficacy, motivation, and intentions. One such area that incorporates these elements is health promotion literature, such as Protective Behavioral Strategies (PBS) and alcohol consumption. The objectives of this study are laid out as such: First, to further explore the role counterfactuals play in increasing an individual's intentions toward behavioral change. Second, to further elucidate the inner and outer workings of Protective Behavioral Strategies for increasing positive health behaviors. Finally, to address the applicability of a counterfactual intervention on promoting intentions to use PBS.

Study Overview

Study Type

Interventional

Enrollment (Actual)

413

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Texas
      • College Station, Texas, United States, 77843
        • Texas A&M University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • minimum age of 18 years

Exclusion Criteria:

  • no exclusions at baseline
  • participants who do not follow the instructions for the specific writing task will be unable to sign-up for the remaining follow up sessions (Parts 2-6) and will be excluded the final data analyses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Negative Event Only
Participants will be asked to think of a specific example of the most (or one of the most) negative, unpleasant event with alcohol they have experienced; the event they choose must have occurred at least a year ago. Or they will be asked to think of the most significant event that has occurred in the past year. After thinking of a specific event, they will be given three minutes to write about their experience. The writing prompt will ask that they express the event information in a few sentences. This writing prompt will help participants place themselves back into that moment and access salient emotions and cognition about it. Similar negative event prompts have been used in counterfactual thinking studies (McFarland & Alvaro, 2000; White & Lehman, 2005).
Participants are asked to write about a negative event related to alcohol and write about it
Active Comparator: Negative Event + Factual Thinking Task
Participants in this group, the event plus the factual thinking task condition, will be told the following after completing the negative event writing task, "After disappointing and/or negative experiences like the one you described on the previous page, people often think about the details of the situation. For example, when it happened, who was involved, and what happened right before or after the incident occurred. In the space below please provide examples of some of these details.." There will be 10 blank boxes below the instructions and participants will be asked to provide some examples of details from their traumatic event. They will be asked to only list as many as they can naturally recall without repeating any. This procedure is derived from Kray and colleague's (2010) study on counterfactual thinking and meaning in life.
Active Control condition where participants write about a negative event and list three facts about it
Experimental: Negative Event + Counterfactual Task
Participants will be told after completing the negative event writing task, "After disappointing and/or negative experiences like the one you described, people sometimes cannot help thinking "what if…" or "if only…" and imagining how things might have gone differently. That is, if only I had done something differently, the negative drinking situation could have been avoided or turned out better. In the box below please identify things that, had they been different, would have improved the outcome of the negative drinking situation you described earlier and briefly describe how the outcome would have been better." Participants will be asked to list three counterfactuals about the event. Participants will also be asked to think of situations where these strategies could be used, to list out any obstacles that might prevent them from implementing these strategies and to indicate their intention to use each strategy over the next week.
Participants will complete a counterfactual based intervention where they come up with three if only..then statements about how a past drinking behavior could have been altered to be better and to think about protective behavioral strategies that they could use in a future similar situation to make the outcome better.
Experimental: Personalized Normative Feedback
Participants in this group, the personalized normative feedback, will be asked to rate the frequency and quantity of TAMU students that use PBS when drinking.
Participants will be asked to rate the frequency and quantity of students who use protective behavioral strategies while drinking. They will be given feedback on how close their estimate is from the national averages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Protective Behavioral Strategies-20
Time Frame: Weeks 1 - 6
The Protective Behavioral Strategy-20 measure is a 20-item questionnaire assessing the use of three types of Protective Behavioral Strategies: serious harm reduction (8 items), stopping/limiting drinking (7 items), and manner of drinking (5 items). Each item has response options consisting of 1 (Never), 2 (Rarely), 3 (Occasionally), 4 (Sometimes), 5 (Usually), 6 (Always); there is also a Do not wish to respond option. Protective Behavioral Strategy Use scores are average scores for each subscale, with minimum scores of 0 and maximum scores of 6. Higher scores indicate greater use of protective behavioral strategies.
Weeks 1 - 6
Young Adult Alcohol Consequences Questionnaire
Time Frame: Week 1
The Young Adult Alcohol Consequences Questionnaire is a 48-item questionnaire assessing problems from alcohol consumption within the last three months. Each item is categorized into one of eight problem domains: social/interpersonal, academic/occupational, risky behavior, impaired control, poor self-care, diminished self-perception, blackout drinking, and physiological dependence. For each item, participants select Yes, No, or Do not wish to respond to indicate whether they have experienced each problem from alcohol consumption (e.g., "I have become very rude, obnoxious or insulting after drinking"). If a participant selects Yes that is indicative of the participant having experienced that specific consequence from alcohol consumption.
Week 1
Alcohol Use Contemplation to Change Ladder
Time Frame: Week 1
To assess an individual's contemplation to change their alcohol drinking behavior, a Contemplation to Change Ladder (Biener & Abrams, 1991) will be used. This ladder displays response options on a ladder graphic, with rungs starting at 0 and ending at 10; each rung increases by one point value as you go up the ladder. Anchors with text descriptions are located at points 0 (No thought of quitting), 2 (Think I need to consider quitting someday), 5 (Think I should quit but not quite ready), 8 (Starting to think about how to change my drinking patterns), and 10 (Taking action to quit e.g., cutting down, enrolling in a program). The higher a participant selects a rung on the ladder, the higher the contemplation to change their alcohol drinking behavior.
Week 1
Change in Indication of Drinking and Strategy Use
Time Frame: Week 2 - Week 6
A measure that assesses an individual's ability to avoid alcohol if they wanted to as well as binge-drinking or the ability to drink less in the next week
Week 2 - Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Perceived Behavioral Control
Time Frame: Week 1 and Week 2
The Perceived Behavioral Control questionnaire measure is made up of six items. Three items assess the individual's ability to avoid alcohol if they wanted to and three items assess binge-drinking or the ability to drink less than 7(females) or 10 (males) units in a single session in the next week. Each item is scored on separate 7-point bipolar adjective scales (e.g., "For me to avoid drinking alcohol is…" very difficult to very easy). The six items will be averaged together to obtain an overall score for Perceived Behavioral Control. Higher scores indicate greater perceived behavioral control to control drinking behavior.
Week 1 and Week 2
Change in Delay Discounting
Time Frame: Week 1, Week 4 and Week 6
A measure of the amount participants discount delayed rewards
Week 1, Week 4 and Week 6
Change in Counterfactual Use and Intentions
Time Frame: Week 2 - Week 6
Participants responses about whether they did counterfactuals in the past week and their intentions to use those behaviors in the next week.
Week 2 - Week 6
Change in Personal Assessment of Responsible Drinker Identity Scale
Time Frame: Week 1, Week 4 and Week 6
Participants are asked to indicate how true each statement in the Personal Assessment of Responsible Drinker Identity Scale is of the participant's experiences overall. Each item of this measure has response options ranging from 1 (not at all true) to 5 (completely true). Higher scores reflect greater agreement with identifying as a responsible drinker.
Week 1, Week 4 and Week 6
Change in Perceptions of Protective Behavioral Strategies
Time Frame: Week 1 - Week 6
Questions about the percentage and frequency of use of protective behavioral strategies among college students.
Week 1 - Week 6
Change in Contemplation to Change Ladder
Time Frame: Week 1 and Week 2
To assess an individual's contemplation to change their alcohol drinking behavior, a Contemplation to Change Ladder (Biener & Abrams, 1991) will be used. This ladder displays response options on a ladder graphic, with rungs starting at 0 and ending at 10; each rung increases by one point value as you go up the ladder. Anchors with text descriptions are located at points 0 (No thought of quitting), 2 (Think I need to consider quitting someday), 5 (Think I should quit but not quite ready), 8 (Starting to think about how to change my drinking patterns), and 10 (Taking action to quit e.g., cutting down, enrolling in a program). The higher a participant selects a rung on the ladder, the higher the contemplation to change their alcohol drinking behavior.
Week 1 and Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rob Dvorak, PhD, University of Central Florida
  • Principal Investigator: Rachel Smallman, PhD, Texas A&M University
  • Principal Investigator: Sherecce Fields, PhD, Texas A&M University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Actual)

November 20, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

January 25, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB20201070D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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