Trial Outcomes & Findings for Testing Brief Personalized Feedback Integrating Lab-based Alcohol Cue Information (NCT NCT05873556)
NCT ID: NCT05873556
Last Updated: 2025-03-25
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
93 participants
Primary outcome timeframe
Baseline, 2 week follow-up, and 3 month follow-up
Results posted on
2025-03-25
Participant Flow
Participants were recruited from Washington state (e.g., via Instagram). 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 (i.e., posting ads on social media) went from April 2023 to December 2023. Participant enrollment (i.e., completion of lab session) went from May 2023 to December 2023.
Participant milestones
| Measure |
Assessment-only Control
Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.
|
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
51
|
|
Overall Study
COMPLETED
|
38
|
50
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Assessment-only Control
Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.
|
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
Baseline Characteristics
Testing Brief Personalized Feedback Integrating Lab-based Alcohol Cue Information
Baseline characteristics by cohort
| Measure |
Assessment-only Control
n=42 Participants
Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.
|
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
n=51 Participants
Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
|
Total
n=93 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
|
42 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
93 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
|
21.93 years
STANDARD_DEVIATION 1.66 • n=5 Participants
|
21.04 years
STANDARD_DEVIATION 1.87 • n=7 Participants
|
21.44 years
STANDARD_DEVIATION 1.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
78 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
51 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Student Status
4-year student
|
21 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Student Status
Not a 4-year student
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 week follow-up, and 3 month follow-upNumber 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=42 Participants
Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.
|
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
n=51 Participants
Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
|
|---|---|---|
|
Daily Drinking Questionnaire
Baseline
|
10.24 Drinks per week
Standard Deviation 5.16
|
12.27 Drinks per week
Standard Deviation 7.95
|
|
Daily Drinking Questionnaire
2-Week Follow-Up
|
8.79 Drinks per week
Standard Deviation 7.25
|
9.73 Drinks per week
Standard Deviation 6.95
|
|
Daily Drinking Questionnaire
3-Month Follow-Up
|
6.97 Drinks per week
Standard Deviation 5.46
|
9.14 Drinks per week
Standard Deviation 7.70
|
PRIMARY outcome
Timeframe: Baseline, 2 week follow-up, and 3 month follow-upParticipants 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=42 Participants
Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.
|
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
n=51 Participants
Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
|
|---|---|---|
|
Heavy Episodic Drinking
Baseline
|
2.45 Heavy Drinking Occasions
Standard Deviation 1.92
|
2.47 Heavy Drinking Occasions
Standard Deviation 2.17
|
|
Heavy Episodic Drinking
2-Week Follow-Up
|
1.86 Heavy Drinking Occasions
Standard Deviation 1.78
|
2.18 Heavy Drinking Occasions
Standard Deviation 1.75
|
|
Heavy Episodic Drinking
3-Month Follow-Up
|
1.53 Heavy Drinking Occasions
Standard Deviation 1.37
|
1.86 Heavy Drinking Occasions
Standard Deviation 1.95
|
PRIMARY outcome
Timeframe: Baseline, 2 week follow-up, and 3 month follow-upSelf-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=42 Participants
Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.
|
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
n=51 Participants
Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
|
|---|---|---|
|
Penn Alcohol Craving Scale
Baseline
|
6.93 Score on a scale
Standard Deviation 3.96
|
8.04 Score on a scale
Standard Deviation 4.11
|
|
Penn Alcohol Craving Scale
2-Week Follow-Up
|
7.31 Score on a scale
Standard Deviation 4.81
|
8.04 Score on a scale
Standard Deviation 5.44
|
|
Penn Alcohol Craving Scale
3-Month Follow-Up
|
5.74 Score on a scale
Standard Deviation 4.23
|
7.24 Score on a scale
Standard Deviation 5.09
|
PRIMARY outcome
Timeframe: Baseline, 2 week follow-up, and 3 month follow-upParticipants 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. Higher values represent a worse outcome (i.e., more consequences).
Outcome measures
| Measure |
Assessment-only Control
n=42 Participants
Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.
|
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
n=51 Participants
Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
|
|---|---|---|
|
Brief Young Adult Alcohol Consequences Questionnaire
Baseline
|
8.74 Score on a scale
Standard Deviation 5.18
|
9.92 Score on a scale
Standard Deviation 5.02
|
|
Brief Young Adult Alcohol Consequences Questionnaire
2-Week Follow-Up
|
4.88 Score on a scale
Standard Deviation 4.80
|
5.78 Score on a scale
Standard Deviation 5.11
|
|
Brief Young Adult Alcohol Consequences Questionnaire
3-Month Follow-Up
|
6.11 Score on a scale
Standard Deviation 5.26
|
7.06 Score on a scale
Standard Deviation 5.37
|
Adverse Events
Assessment-only Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lab-based 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