Trial Outcomes & Findings for Testing Brief Personalized Feedback Integrating EMA Alcohol Cue Information (NCT NCT05373706)
NCT ID: NCT05373706
Last Updated: 2024-06-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
Baseline, 2 week follow-up, and 3 month follow-up
Results posted on
2024-06-04
Participant Flow
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.
Participant milestones
| Measure |
Assessment-only Control
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
|
Cue Reactivity Personalized Feedback Intervention (PFI)
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.
Alcohol Cue Reactivity Personalized Feedback Intervention: This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
51
|
|
Overall Study
COMPLETED
|
46
|
49
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Assessment-only Control
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
|
Cue Reactivity Personalized Feedback Intervention (PFI)
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.
Alcohol Cue Reactivity Personalized Feedback Intervention: This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Testing Brief Personalized Feedback Integrating EMA Alcohol Cue Information
Baseline characteristics by cohort
| Measure |
Assessment-only Control
n=48 Participants
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
|
Cue Reactivity Personalized Feedback Intervention (PFI)
n=51 Participants
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.
Alcohol Cue Reactivity Personalized Feedback Intervention: This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
21.42 years
STANDARD_DEVIATION 1.75 • n=5 Participants
|
21.69 years
STANDARD_DEVIATION 1.86 • n=7 Participants
|
21.56 years
STANDARD_DEVIATION 1.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
51 participants
n=7 Participants
|
99 participants
n=5 Participants
|
|
Current educational status
4-year student
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Current educational status
Not a 4-year student
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 week follow-up, and 3 month follow-upPopulation: Young adults
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.
Outcome measures
| Measure |
Assessment-only Control
n=48 Participants
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
|
Cue Reactivity Personalized Feedback Intervention (PFI)
n=51 Participants
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.
Alcohol Cue Reactivity Personalized Feedback Intervention: 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
Baseline
|
12.23 Drinks per week
Standard Deviation 11.85
|
11.78 Drinks per week
Standard Deviation 7.24
|
|
Daily Drinking Questionnaire
2-Week Follow-Up
|
10.31 Drinks per week
Standard Deviation 10.77
|
9.40 Drinks per week
Standard Deviation 6.28
|
|
Daily Drinking Questionnaire
3-Month Follow-Up
|
7.54 Drinks per week
Standard Deviation 7.16
|
8.49 Drinks per week
Standard Deviation 7.16
|
PRIMARY outcome
Timeframe: Baseline, 2 week follow-up, and 3 month follow-upPopulation: Young adults
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.
Outcome measures
| Measure |
Assessment-only Control
n=48 Participants
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
|
Cue Reactivity Personalized Feedback Intervention (PFI)
n=51 Participants
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.
Alcohol Cue Reactivity Personalized Feedback Intervention: This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults.
|
|---|---|---|
|
Number of Heavy Episodic Drinking Occasions
Baseline
|
2.46 Number heavy episodic drinking occasions
Standard Deviation 2.32
|
2.43 Number heavy episodic drinking occasions
Standard Deviation 1.97
|
|
Number of Heavy Episodic Drinking Occasions
2-Week Follow-Up
|
2.46 Number heavy episodic drinking occasions
Standard Deviation 2.10
|
2.28 Number heavy episodic drinking occasions
Standard Deviation 1.72
|
|
Number of Heavy Episodic Drinking Occasions
3-Month Follow-Up
|
1.63 Number heavy episodic drinking occasions
Standard Deviation 1.82
|
1.98 Number heavy episodic drinking occasions
Standard Deviation 1.93
|
PRIMARY outcome
Timeframe: Baseline, 2 week follow-up, and 3 month follow-upPopulation: Young adults
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.
Outcome measures
| Measure |
Assessment-only Control
n=48 Participants
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
|
Cue Reactivity Personalized Feedback Intervention (PFI)
n=51 Participants
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.
Alcohol Cue Reactivity Personalized Feedback Intervention: This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults.
|
|---|---|---|
|
Penn Alcohol Craving Scale
Baseline
|
6.58 Score on a scale
Standard Deviation 5.12
|
7.92 Score on a scale
Standard Deviation 5.07
|
|
Penn Alcohol Craving Scale
2-Week Follow-Up
|
7.80 Score on a scale
Standard Deviation 4.55
|
8.66 Score on a scale
Standard Deviation 5.81
|
|
Penn Alcohol Craving Scale
3-Month Follow-Up
|
5.80 Score on a scale
Standard Deviation 4.28
|
7.46 Score on a scale
Standard Deviation 5.01
|
PRIMARY outcome
Timeframe: Baseline, 2 week follow-up, and 3 month follow-upPopulation: Young adults
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.
Outcome measures
| Measure |
Assessment-only Control
n=48 Participants
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
|
Cue Reactivity Personalized Feedback Intervention (PFI)
n=51 Participants
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.
Alcohol Cue Reactivity Personalized Feedback Intervention: This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults.
|
|---|---|---|
|
Brief Young Adult Alcohol Consequences Questionnaire
Baseline
|
7.81 Number of consequences (range 0-24)
Standard Deviation 5.02
|
8.78 Number of consequences (range 0-24)
Standard Deviation 4.13
|
|
Brief Young Adult Alcohol Consequences Questionnaire
2-Week Follow-Up
|
4.78 Number of consequences (range 0-24)
Standard Deviation 4.35
|
4.52 Number of consequences (range 0-24)
Standard Deviation 3.61
|
|
Brief Young Adult Alcohol Consequences Questionnaire
3-Month Follow-Up
|
6.37 Number of consequences (range 0-24)
Standard Deviation 5.65
|
6.04 Number of consequences (range 0-24)
Standard Deviation 5.12
|
Adverse Events
Assessment-only Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cue Reactivity Personalized Feedback Intervention (PFI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place