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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05208593
Other study ID # IRB20201070D
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2022
Est. completion date December 30, 2022

Study information

Verified date April 2023
Source Texas A&M University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 413
Est. completion date December 30, 2022
Est. primary completion date November 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
Negative Event + Factual Thinking Task
Active Control condition where participants write about a negative event and list three facts about it
Negative Event Only
Participants are asked to write about a negative event related to alcohol and write about it

Locations

Country Name City State
United States Texas A&M University College Station Texas

Sponsors (2)

Lead Sponsor Collaborator
Texas A&M University University of Central Florida

Country where clinical trial is conducted

United States, 

References & Publications (10)

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

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. — View 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. — View 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. — View 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. — View 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. — View 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.

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. — View 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.

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Weeks 1 - 6
Primary 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. Week 1
Primary 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. Week 1
Primary 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 Week 2 - Week 6
Secondary 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. Week 1 and Week 2
Secondary Change in Delay Discounting A measure of the amount participants discount delayed rewards Week 1, Week 4 and Week 6
Secondary 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. Week 2 - Week 6
Secondary 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. Week 1, Week 4 and Week 6
Secondary Change in Perceptions of Protective Behavioral Strategies Questions about the percentage and frequency of use of protective behavioral strategies among college students. Week 1 - Week 6
Secondary Change in 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. Week 1 and Week 2
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