Back to results

Alcohol PBS and Thinking About the Past

Primary Purpose

Alcohol Drinking in College

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Negative Event + Counterfactual Task

Personalized Normative Feedback

Negative Event + Factual Thinking Task

Negative Event Only

About this trial

This is an interventional treatment trial for Alcohol Drinking in College

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Texas A&M University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Negative Event Only

Negative Event + Factual Thinking Task

Negative Event + Counterfactual Task

Personalized Normative Feedback

Arm Description

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 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.

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 in this group, the personalized normative feedback, will be asked to rate the frequency and quantity of TAMU students that use PBS when drinking.

Outcomes

Primary Outcome Measures

Change in Protective Behavioral Strategies-20

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.

Young Adult Alcohol Consequences Questionnaire

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.

Alcohol Use Contemplation to Change Ladder

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.

Change in Indication of Drinking and Strategy Use

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

Change in Perceived Behavioral Control

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.

Change in Delay Discounting

A measure of the amount participants discount delayed rewards

Change in Counterfactual Use and Intentions

Participants responses about whether they did counterfactuals in the past week and their intentions to use those behaviors in the next week.

Change in Personal Assessment of Responsible Drinker Identity Scale

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.

Change in Perceptions of Protective Behavioral Strategies

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

Change in Contemplation to Change Ladder

Full Information

NCT ID

NCT05208593

First Posted

September 14, 2021

Last Updated

April 11, 2023

Sponsor

Texas A&M University

Collaborators

University of Central Florida

1. Study Identification

Unique Protocol Identification Number

NCT05208593

Brief Title

Alcohol PBS and Thinking About the Past

Official Title

Alcohol Protective Behavioral Strategies and Thinking About the Past

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

February 15, 2022 (Actual)

Primary Completion Date

November 20, 2022 (Actual)

Study Completion Date

December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Texas A&M University

Collaborators

University of Central Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Drinking in College

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

413 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Negative Event Only

Arm Type

Placebo Comparator

Arm Description

Arm Title

Negative Event + Factual Thinking Task

Arm Type

Active Comparator

Arm Description

Arm Title

Negative Event + Counterfactual Task

Arm Type

Experimental

Arm Description

Arm Title

Personalized Normative Feedback

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Negative Event + Counterfactual Task

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Personalized Normative Feedback

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Negative Event + Factual Thinking Task

Intervention Description

Active Control condition where participants write about a negative event and list three facts about it

Intervention Type

Behavioral

Intervention Name(s)

Negative Event Only

Intervention Description

Participants are asked to write about a negative event related to alcohol and write about it

Primary Outcome Measure Information:

Title

Change in Protective Behavioral Strategies-20

Description

Time Frame

Weeks 1 - 6

Title

Young Adult Alcohol Consequences Questionnaire

Description

Time Frame

Week 1

Title

Alcohol Use Contemplation to Change Ladder

Description

Time Frame

Week 1

Title

Change in Indication of Drinking and Strategy Use

Description

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

Time Frame

Week 2 - Week 6

Secondary Outcome Measure Information:

Title

Change in Perceived Behavioral Control

Description

Time Frame

Week 1 and Week 2

Title

Change in Delay Discounting

Description

A measure of the amount participants discount delayed rewards

Time Frame

Week 1, Week 4 and Week 6

Title

Change in Counterfactual Use and Intentions

Description

Participants responses about whether they did counterfactuals in the past week and their intentions to use those behaviors in the next week.

Time Frame

Week 2 - Week 6

Title

Change in Personal Assessment of Responsible Drinker Identity Scale

Description

Time Frame

Week 1, Week 4 and Week 6

Title

Change in Perceptions of Protective Behavioral Strategies

Description

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

Time Frame

Week 1 - Week 6

Title

Change in Contemplation to Change Ladder

Description

Time Frame

Week 1 and Week 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rob Dvorak, PhD

Organizational Affiliation

University of Central Florida

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rachel Smallman, PhD

Organizational Affiliation

Texas A&M University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sherecce Fields, PhD

Organizational Affiliation

Texas A&M University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Texas A&M University

City

College Station

State/Province

Texas

ZIP/Postal Code

77843

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

Citation

Ajzen, I., & Sheikh, S. (2013). Action versus inaction: Anticipated affect in the theory of planned behavior. Journal of Applied Social Psychology, 43(1), 155-162. https://doi.org/10.1111/j.1559-1816.2012.00989.x

Results Reference

background

PubMed Identifier

17185302

Citation

Cooke R, Sniehotta F, Schuz B. Predicting binge-drinking behaviour using an extended TPB: examining the impact of anticipated regret and descriptive norms. Alcohol Alcohol. 2007 Mar-Apr;42(2):84-91. doi: 10.1093/alcalc/agl115. Epub 2006 Dec 21.

Results Reference

background

PubMed Identifier

21272356

Citation

Coolidge T, Skaret E, Heima M, Johnson EK, Hillstead MB, Farjo N, Asmyhr O, Weinstein P. Thinking about going to the dentist: a Contemplation Ladder to assess dentally-avoidant individuals' readiness to go to a dentist. BMC Oral Health. 2011 Jan 27;11:4. doi: 10.1186/1472-6831-11-4.

Results Reference

background

PubMed Identifier

18453477

Citation

Epstude K, Roese NJ. The functional theory of counterfactual thinking. Pers Soc Psychol Rev. 2008 May;12(2):168-92. doi: 10.1177/1088868308316091.

Results Reference

background

PubMed Identifier

20307121

Citation

Hogue A, Dauber S, Morgenstern J. Validation of a contemplation ladder in an adult substance use disorder sample. Psychol Addict Behav. 2010 Mar;24(1):137-44. doi: 10.1037/a0017895.

Results Reference

background

PubMed Identifier

20106607

Citation

McGee R, Williams S, Kypri K. College students' readiness to reduce binge drinking: criterion validity of a brief measure. Drug Alcohol Depend. 2010 Jun 1;109(1-3):236-8. doi: 10.1016/j.drugalcdep.2009.12.009. Epub 2010 Jan 27.

Results Reference

background

Citation

Roese, N. J., Epstude, K. (2017). The functional theory of counterfactual thinking: New evidence, new challenges, new insights. Advances in Experimental Social Psychology, 56, 1-79.

Results Reference

background

PubMed Identifier

20161221

Citation

Smallman R, Roese NJ. Counterfactual Thinking Facilitates Behavioral Intentions. J Exp Soc Psychol. 2009 Jul;45(4):845-852. doi: 10.1016/j.jesp.2009.03.002.

Results Reference

background

Citation

Tal-Or, N., Boninger, D. S., & Gleicher, F. (2004). On becoming what we might have been: Counterfactual thinking and self-efficacy. Self and Identity, 3(1), 5-26.

Results Reference

background

Citation

Wong, E. M. (2007). Narrating near-histories: The effects of counterfactual communication on motivation and performance. Management & Organizational History, 2(4), 351-370. https://doi.org/10.1177/1744935907086119

Results Reference

background

Learn more about this trial

Alcohol PBS and Thinking About the Past

We'll reach out to this number within 24 hrs