Cross-tailored Dynamic Feedback for Alcohol Drinking in College

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Kentucky, Lexington, KY
Alcohol Drinking in College+2 More
Cross-tailored Dynamic Feedback - Behavioral
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

NCT05011903

See full description

Eligible Conditions

  • Alcohol Drinking in College
  • Sexual Behaviour

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Cross-tailored Dynamic Feedback will improve 8 primary outcomes in patients with Alcohol Drinking in College. Measurement will happen over the course of Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months.

Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported alcohol use quantity
Change in self-reported alcohol-related sexual behavior frequency
Change in self-reported alcohol-related sexual behavior quantity
Change in self-reported condom use
Change in self-reported heavy episodic drinking
Change in self-reported high intensity drinking
Change in self-reported quantity of sex partners
Change in self-reported sexual behavior frequency

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Control
1 of 4
PFI+GHI with diary surveys
1 of 4
PFI-only with no diary surveys
1 of 4
PFI+CDF with diary surveys
1 of 4
Active Control
Experimental Treatment

This trial requires 600 total participants across 4 different treatment groups

This trial involves 4 different treatments. Cross-tailored Dynamic Feedback is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

PFI+GHI with diary surveys
Behavioral
Participants in this condition receive a Personalized Feedback Intervention (PFI) related to alcohol use and related sexual behavior, and generic health information (GHI). They also complete weekend diary surveys in which they are asked to self-report on weekend behaviors.
PFI-only with no diary surveys
Behavioral
Participants in this condition receive a Personalized Feedback Intervention (PFI) related to alcohol use and related sexual behavior. They do not complete weekend diary surveys.
PFI+CDF with diary surveysParticipants in this condition receive a Personalized Feedback Intervention (PFI) and Cross-tailored Dynamic Feedback (CDF) related to alcohol use and related sexual behavior. They also complete weekend diary surveys in which they are asked to self-report on weekend behaviors.
ControlParticipants in this condition get no intervention and do not complete weekend diary surveys.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Personalized Feedback Intervention
2003
Completed Phase 2
~490

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 1-month, 2-month, 3-months, 6-months, and 13-months for reporting.

Closest Location

University of Kentucky - Lexington, KY

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
sexually active, defined as having oral, anal, or vaginal sex within the past 12 months
status as first-year college student at University of Kentucky or UNT-Denton
18-20 years old
one binge drinking episode within the past 30 days (4+/5+ drinks for women/men in one sitting)
not in a monogamous relationship (defined as single, not dating, or dating, not serious)

Patient Q&A Section

What are common treatments for alcohol drinking?

"Alcohol consumption is a major health issue associated with excessive alcohol use. There are many different intervention options available that are proven to be effective in reducing the number of days of alcohol use or alcoholism in individuals." - Anonymous Online Contributor

Unverified Answer

What are the signs of alcohol drinking?

"Alcohol dependence is the principal clinical sign of alcoholism. Alcoholics show marked impairment in cognitive and behavioural functioning. The diagnostic status of dependence is usually established with the help of self and other-reported symptom scales.\n" - Anonymous Online Contributor

Unverified Answer

How many people get alcohol drinking a year in the United States?

"Alcohol use continues to be rampant in the nation. While current trends suggest that the proportion of adults who are heavy drinkers has declined substantially from 1986-1994, the majority remains heavy consumers. The National Health Interview Survey data were used to monitor this issue and quantify the size of the alcohol seeking population. Because only 8% of the US population met the criteria for heavy alcohol use, this data should reassure drinkers that they are not losing out. Efforts should be made to educate alcohol-seeking consumers of the risks and importance of excessive alcohol use." - Anonymous Online Contributor

Unverified Answer

What is alcohol drinking?

"Alcohol consumption may be associated with the risk of development of hypertension. More so for binge drinkers, when alcohol intake increases >or= 3 drinks per week for men or >or= 2 drinks per week for women, compared with nondrinkers. These conclusions could be a part of the association of alcohol intake with risk of hypertension and should be evaluated prospectively in future trials." - Anonymous Online Contributor

Unverified Answer

What causes alcohol drinking?

"As suggested by B&B (2009), drinking by men was probably linked to being a 'free rider', as they were less likely to be pregnant and had fewer partners. In contrast, the 'female free rider' hypothesis does not hold up as evidence is lacking to suggest that female drinking is linked to being childless and not having men in her life for any length of time, although women generally have shorter marriage time durations in comparison to men. Furthermore, data suggests that drinking has a strong genetic component and is more common among those who have good parenting. In addition, drinking is associated with a number of social and psychological factors, such as high neuroticism, low conscientiousness, and low self-efficacy." - Anonymous Online Contributor

Unverified Answer

Can alcohol drinking be cured?

"Alcoholics with mild alcoholism can be controlled fairly well, even after many years of drinking. However, some alcoholics will have severe alcohol dependence which cannot be cured by treatment. Alcoholics with severe alcoholism should be admitted to hospital for long-term medical care. There should be a close follow-up from a medical team with experience in alcoholism to monitor the progress of their sobriety. Some patients with severe alcoholism should be offered alcohol detoxification followed by abstinence." - Anonymous Online Contributor

Unverified Answer

Is cross-tailored dynamic feedback typically used in combination with any other treatments?

"The study is highly indicative of the complexity of the implementation process. In a recent study, findings showed that all the patients enrolled were assigned an appropriate program. However, some issues still remain to be clarified such as more intensive use of the personalized training package as a whole as well as more thorough exploration among healthcare workers regarding patient needs and how to best address them." - Anonymous Online Contributor

Unverified Answer

What is the latest research for alcohol drinking?

"Inadequate levels of alcohol use, overconsumption of alcohol, and alcohol-related conditions and diseases adversely impact millions of lives worldwide. There is ample scientific evidence for alcohol's harmful health consequences. This paper summarizes recent research on alcohol use and associated conditions. The evidence strongly suggests that heavy use of alcohol causes or contributes to death and the burden of alcohol-related disorders will continue to escalate over the next 10 years. The WHO recommends a drinking limit of two alcoholic beverages per day for men and one alcoholic beverage per day for women. This will only prevent about 1.2 million premature deaths. Most of the premature deaths, over 12.5 million deaths, will occur among less-developed countries with much greater consumption of alcohol than in developed countries." - Anonymous Online Contributor

Unverified Answer

How does cross-tailored dynamic feedback work?

"Recent findings show that the impact of the intervention is limited in the short term. Therefore, future research should focus on how to improve compliance with interventions, and explore more effective, long-lasting and inexpensive, and tailored, digital interventions for the public and primary healthcare practitioners." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for alcohol drinking?

"Findings of this study suggest that individuals with alcohol consumption of >80/150 ml ethanol/d should consider trial participation when compared to people with alcohol consumption of ≥150/300 ml alcohol/d. Individuals with alcohol consumption of 45-80 g ethanol/d should consider clinical trial participation if compared to people with alcohol consumption of ~15-45 g ethanol/d. [Bordkorb, W., J. Huxley, L. Gazzola, M. Marcello, and D. Leckman, 2016." - Anonymous Online Contributor

Unverified Answer

What is cross-tailored dynamic feedback?

"The dynamic feedback was not cross-tailored to an individual case-based approach. The application of computer-based feedback to a larger group of patients, however, revealed positive changes in alcohol drinking patterns, and should be investigated further. [http://www.researchgate." - Anonymous Online Contributor

Unverified Answer

How serious can alcohol drinking be?

"Alcohol, a natural product present in the human diet, protects against serious diseases. Thus drinking small amounts of alcohol every day lowers the risk of heart disease and stroke in nondialysis patients. However, excessive alcohol consumption is a cause of many health complications even for people with chronic kidney disease on dialysis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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