Alcohol PBS and Thinking About the Past

Sponsor
Texas A&M University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05208593
Collaborator
University of Central Florida (Other)
350
4
10.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Negative Event + Counterfactual Task
  • Behavioral: Personalized Normative Feedback
  • Behavioral: Negative Event + Factual Thinking Task
  • Behavioral: Negative Event Only
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Alcohol Protective Behavioral Strategies and Thinking About the Past
Anticipated Study Start Date :
Feb 15, 2022
Anticipated Primary Completion Date :
Dec 20, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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).

Behavioral: Negative Event Only
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.

Behavioral: Negative Event + Factual Thinking Task
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.

Behavioral: Negative Event + Counterfactual Task
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.

Behavioral: Personalized Normative Feedback
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.

Outcome Measures

Primary Outcome Measures

  1. Change in Protective Behavioral Strategies-20 [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.

  2. Young Adult Alcohol Consequences Questionnaire [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.

  3. Alcohol Use Contemplation to Change Ladder [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.

  4. Change in Indication of Drinking and Strategy Use [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

Secondary Outcome Measures

  1. Change in Perceived Behavioral Control [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.

  2. Change in Delay Discounting [Week 1, Week 4 and Week 6]

    A measure of the amount participants discount delayed rewards

  3. Change in Counterfactual Use and Intentions [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.

  4. Change in Personal Assessment of Responsible Drinker Identity Scale [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.

  5. Change in Perceptions of Protective Behavioral Strategies [Week 1 - Week 6]

    Questions about the percentage and frequency of use of protective behavioral strategies among college students.

  6. Change in Contemplation to Change Ladder [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Texas A&M University
  • University of Central Florida

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Sherecce A Fields, Professor, Texas A&M University
ClinicalTrials.gov Identifier:
NCT05208593
Other Study ID Numbers:
  • IRB20201070D
First Posted:
Jan 26, 2022
Last Update Posted:
Jan 26, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2022