An interventional study of Alcohol Cue Reactivity Personalized Feedback Intervention in Alcohol Drinking and Problem Drinking, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
This study aims to develop a brief intervention that incorporates ecological momentary assessments (EMAs; i.e., four brief surveys per day for 17 days) to create personalized feedback targeting high-risk alcohol use among young adult drinkers. The intervention mainly focuses on providing feedback on individuals' drinking desire and how it varies as a function of a number of real-world factors. Other psycho-educational alcohol-related content is also provided in the intervention including strategies for decreasing exposure to cues that increase drinking desires and how to cope with increased desire to drink. This brief intervention will be used in a randomized controlled trial (RCT) comparing young adults who receive the intervention with those who only complete identical assessments.
The purpose of this study is to develop and test a brief intervention that provides personalized feedback to young adults using participants' own event-level, real-world experiences. The aim of the intervention is to increase young adults' awareness of their desire to drink as it varies as a function of a number of real-world factors including alcohol cues, social context, physical context, anticipation of later drinking, mood, and time of day. The intervention also aims to equip young adults with strategies for reducing exposure to factors that increase their desire to drink, how to cope with an increased desire to drink, and how to reduce potential harms from drinking.
This brief personalized feedback intervention is used in a randomized controlled trial comparing young adults who receive the intervention with those who complete the EMAs but do not receive any personalized feedback. Assessments include an eligibility survey, baseline assessment, 17 days of EMAs (4x/day), and follow-up assessments occurring 2-weeks and 3-months post-intervention. The 2-week and 3-month follow-ups occurred 2-weeks and 3-months, respectively, from Day 17 of the EMA period, because the intervention was delivered on Day 17. The intervention will be examined for its feasibility, acceptability, and its effects in reducing alcohol-related outcomes at the follow-up assessments.
925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.
This study's enrollment of 99 is close to the median of 108 across 802 interventional studies indexed under Alcohol Drinking.
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Exclusion Criteria:
Participants randomized to the Cue Reactivity PFI condition will receive personalized feedback at the end of completing 17 days of ecological momentary assessments (EMAs) four times a day. The personalized feedback will be delivered online and contains information summarizing participants' desire to drink as it varied as a function of several real-world factors across the 17-day EMA period.
Behavioral: Alcohol Cue Reactivity Personalized Feedback Intervention
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults.
Daily Drinking Questionnaire
Number of standard drinks consumed on each day of a typical week during the \[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\]. Participants responded on a scale from 0 (0 drinks) to 25 (25 or more drinks). Totals for each day are summed to calculate the typical number of drinks consumed per week.
Time frame: Baseline, 2 week follow-up, and 3 month follow-up
Number of Heavy Episodic Drinking Occasions
Participants were asked, "During the past two weeks, how many times did you have \[4/5 for females/males\] or more drinks at one sitting?". Participants responded on a scale from 0 (0 times) to 10 (10 or more times) and possible range was 0-10.
Time frame: Baseline, 2 week follow-up, and 3 month follow-up
Penn Alcohol Craving Scale
Self-reported subjective alcohol craving during the past week. Response options were scored from "0" to "6" with text varying across items. A sum score of the five items was calculated and the possible range was from 0-30. Higher scores reflect more craving.
Time frame: Baseline, 2 week follow-up, and 3 month follow-up
Brief Young Adult Alcohol Consequences Questionnaire
Participants responded "no" (0) or "yes" (1) to whether they experienced each of 24 consequences during the \[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\]. A sum of the number of negative alcohol-related consequences was calculated and the possible range was 0-24.
Time frame: Baseline, 2 week follow-up, and 3 month follow-up
Participants were recruited from Washington state using a variety of recruitment methods (e.g., predominantly Instagram, random selection of students from university registrar's lists). Individuals were invited to complete an online eligibility survey for participation in a randomized clinical trial to test the effect of an online personalized feedback intervention. Recruitment/enrollment period went from April 2022 to January 2023.
| Milestone | Assessment-only Control | Cue Reactivity Personalized Feedback Intervention (PFI) |
|---|---|---|
| Started | 48 | 51 |
| Completed | 46 | 49 |
| Not completed | 2 | 2 |
| Withdrew: Lost to follow-up | 2 | 2 |
Number of standard drinks consumed on each day of a typical week during the \[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\]. Participants responded on a scale from 0 (0 drinks) to 25 (25 or more drinks). Totals for each day are summed to calculate the typical number of drinks consumed per week.
| Drinks per week | Assessment-only Control | Cue Reactivity Personalized Feedback Intervention (PFI) |
|---|---|---|
| Baseline | 12.23 ± 11.85 | 11.78 ± 7.24 |
| 2-Week Follow-Up | 10.31 ± 10.77 | 9.40 ± 6.28 |
| 3-Month Follow-Up | 7.54 ± 7.16 | 8.49 ± 7.16 |
Participants were asked, "During the past two weeks, how many times did you have \[4/5 for females/males\] or more drinks at one sitting?". Participants responded on a scale from 0 (0 times) to 10 (10 or more times) and possible range was 0-10.
| Number heavy episodic drinking occasions | Assessment-only Control | Cue Reactivity Personalized Feedback Intervention (PFI) |
|---|---|---|
| Baseline | 2.46 ± 2.32 | 2.43 ± 1.97 |
| 2-Week Follow-Up | 2.46 ± 2.10 | 2.28 ± 1.72 |
| 3-Month Follow-Up | 1.63 ± 1.82 | 1.98 ± 1.93 |
Self-reported subjective alcohol craving during the past week. Response options were scored from "0" to "6" with text varying across items. A sum score of the five items was calculated and the possible range was from 0-30. Higher scores reflect more craving.
| Score on a scale | Assessment-only Control | Cue Reactivity Personalized Feedback Intervention (PFI) |
|---|---|---|
| Baseline | 6.58 ± 5.12 | 7.92 ± 5.07 |
| 2-Week Follow-Up | 7.80 ± 4.55 | 8.66 ± 5.81 |
| 3-Month Follow-Up | 5.80 ± 4.28 | 7.46 ± 5.01 |
Participants responded "no" (0) or "yes" (1) to whether they experienced each of 24 consequences during the \[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\]. A sum of the number of negative alcohol-related consequences was calculated and the possible range was 0-24.
| Number of consequences (range 0-24) | Assessment-only Control | Cue Reactivity Personalized Feedback Intervention (PFI) |
|---|---|---|
| Baseline | 7.81 ± 5.02 | 8.78 ± 4.13 |
| 2-Week Follow-Up | 4.78 ± 4.35 | 4.52 ± 3.61 |
| 3-Month Follow-Up | 6.37 ± 5.65 | 6.04 ± 5.12 |
Collected over Adverse event data were collected between initial screening and final follow-up for each participant, a period of approximately 4 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Assessment-only Control | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
| Cue Reactivity Personalized Feedback Intervention (PFI) | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Age, Categorical(Participants) | Assessment-only Control | Cue Reactivity Personalized Feedback Intervention (PFI) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 48 | 51 | 99 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Assessment-only Control | Cue Reactivity Personalized Feedback Intervention (PFI) | Total |
|---|---|---|---|
| Mean | 21.42 ± 1.75 | 21.69 ± 1.86 | 21.56 ± 1.80 |
| Sex: Female, Male(Participants) | Assessment-only Control | Cue Reactivity Personalized Feedback Intervention (PFI) | Total |
|---|---|---|---|
| Female | 26 | 28 | 54 |
| Male | 22 | 23 | 45 |
| Ethnicity (NIH/OMB)(Participants) | Assessment-only Control | Cue Reactivity Personalized Feedback Intervention (PFI) | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 5 | 7 |
| Not Hispanic or Latino | 46 | 46 | 92 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Assessment-only Control | Cue Reactivity Personalized Feedback Intervention (PFI) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 7 | 10 | 17 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 3 | 1 | 4 |
| White | 30 | 34 | 64 |
| More than one race | 6 | 3 | 9 |
| Unknown or Not Reported | 2 | 2 | 4 |
| Region of Enrollment(participants) | Assessment-only Control | Cue Reactivity Personalized Feedback Intervention (PFI) | Total |
|---|---|---|---|
| United States | 48 | 51 | 99 |
| Current educational status(Participants) | Assessment-only Control | Cue Reactivity Personalized Feedback Intervention (PFI) | Total |
|---|---|---|---|
| 4-year student | 27 | 28 | 55 |
| Not a 4-year student | 21 | 23 | 44 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — We plan to share limited, de-identified datasets for the purposes of data analysis and dissemination.
Supporting information: Sap, Analytic code
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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