Trial Outcomes & Findings for EMA/EMI for Psychiatrically Hospitalized Emerging Adults Who Drink to Cope (NCT NCT05074030)
NCT ID: NCT05074030
Last Updated: 2026-08-20
Results Overview
Drinks per drinking day assessed using the Addiction Severity Index
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
6-week follow-up
Results posted on
2026-08-20
Participant Flow
Participant milestones
| Measure |
Personalized Normative Feedback (PNF)
Participants in the PNF condition will receive normative feedback only on their alcohol use.
|
PFIcope+EMI
The 6-week PFIcope+EMI includes: 1) an in-person personalized feedback session to present feedback on problems with drinking to cope, discuss the individual's use of alcohol to cope, and generate coping skills messages to be used in the EMI intervention; 2) EMA to monitor affect, intention to drink, coping skills usage, alcohol use, drinking to cope post-discharge; 3) tailored text messages (EMI) based on EMA (individualized coping skills messages when NA and intention to drink are reported).
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
|
Overall Study
COMPLETED
|
21
|
25
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EMA/EMI for Psychiatrically Hospitalized Emerging Adults Who Drink to Cope
Baseline characteristics by cohort
| Measure |
Personalized Normative Feedback (PNF)
n=29 Participants
Participants in the PNF condition will receive normative feedback only on their alcohol use.
|
PFIcope+EMI
n=31 Participants
The 6-week PFIcope+EMI includes: 1) an in-person personalized feedback session to present feedback on problems with drinking to cope, discuss the individual's use of alcohol to cope, and generate coping skills messages to be used in the EMI intervention; 2) EMA to monitor affect, intention to drink, coping skills usage, alcohol use, drinking to cope post-discharge; 3) tailored text messages (EMI) based on EMA (individualized coping skills messages when NA and intention to drink are reported).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.72 years
STANDARD_DEVIATION 1.71 • n=5 Participants
|
22.10 years
STANDARD_DEVIATION 1.87 • n=109 Participants
|
22.40 years
STANDARD_DEVIATION 1.81 • n=133 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
21 Participants
n=109 Participants
|
42 Participants
n=133 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=109 Participants
|
18 Participants
n=133 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=109 Participants
|
5 Participants
n=133 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
23 Participants
n=109 Participants
|
47 Participants
n=133 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=109 Participants
|
5 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
2 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
4 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
30 Participants
n=109 Participants
|
56 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
drinks per drinking day
|
5.83 drinks per drinking day
STANDARD_DEVIATION 3.85 • n=5 Participants
|
5.13 drinks per drinking day
STANDARD_DEVIATION 2.69 • n=109 Participants
|
5.47 drinks per drinking day
STANDARD_DEVIATION 3.29 • n=133 Participants
|
|
anxiety coping drinking motive
|
3.44 Scores on a scale
STANDARD_DEVIATION .88 • n=5 Participants
|
3.51 Scores on a scale
STANDARD_DEVIATION .89 • n=109 Participants
|
3.48 Scores on a scale
STANDARD_DEVIATION .88 • n=133 Participants
|
|
depression coping drinking motive
|
3.28 Scores on a scale
STANDARD_DEVIATION 1.03 • n=5 Participants
|
3.37 Scores on a scale
STANDARD_DEVIATION 1.24 • n=109 Participants
|
3.33 Scores on a scale
STANDARD_DEVIATION 1.14 • n=133 Participants
|
|
positive expectancies
|
3.04 Scores on a scale
STANDARD_DEVIATION .32 • n=5 Participants
|
3.09 Scores on a scale
STANDARD_DEVIATION .45 • n=109 Participants
|
3.07 Scores on a scale
STANDARD_DEVIATION .39 • n=133 Participants
|
|
negative expectancies
|
2.59 scores on a scale
STANDARD_DEVIATION .58 • n=5 Participants
|
2.66 scores on a scale
STANDARD_DEVIATION .55 • n=109 Participants
|
2.63 scores on a scale
STANDARD_DEVIATION .57 • n=133 Participants
|
|
alcohol-related problems
|
14.69 Scores on a scale
STANDARD_DEVIATION 5.91 • n=5 Participants
|
14.39 Scores on a scale
STANDARD_DEVIATION 5.51 • n=109 Participants
|
14.53 Scores on a scale
STANDARD_DEVIATION 5.66 • n=133 Participants
|
PRIMARY outcome
Timeframe: 6-week follow-upDrinks per drinking day assessed using the Addiction Severity Index
Outcome measures
| Measure |
Personalized Normative Feedback (PNF)
n=23 Participants
Participants in the PNF condition will receive normative feedback only on their alcohol use.
|
PFIcope+EMI
n=22 Participants
The 6-week PFIcope+EMI includes: 1) an in-person personalized feedback session to present feedback on problems with drinking to cope, discuss the individual's use of alcohol to cope, and generate coping skills messages to be used in the EMI intervention; 2) EMA to monitor affect, intention to drink, coping skills usage, alcohol use, drinking to cope post-discharge; 3) tailored text messages (EMI) based on EMA (individualized coping skills messages when NA and intention to drink are reported).
|
|---|---|---|
|
Drinks Per Drinking Day
|
2.87 drinks per drinking day
Standard Deviation 2.72
|
3.25 drinks per drinking day
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: 6-week follow-upMean Scores on the Drinking to Cope with Anxiety subscale of the Modified Drinking Motives Questionnaire (range from 1 to 5; higher values reflect greater drinking to cope)
Outcome measures
| Measure |
Personalized Normative Feedback (PNF)
n=23 Participants
Participants in the PNF condition will receive normative feedback only on their alcohol use.
|
PFIcope+EMI
n=25 Participants
The 6-week PFIcope+EMI includes: 1) an in-person personalized feedback session to present feedback on problems with drinking to cope, discuss the individual's use of alcohol to cope, and generate coping skills messages to be used in the EMI intervention; 2) EMA to monitor affect, intention to drink, coping skills usage, alcohol use, drinking to cope post-discharge; 3) tailored text messages (EMI) based on EMA (individualized coping skills messages when NA and intention to drink are reported).
|
|---|---|---|
|
Anxiety Coping Drinking Motives
|
2.96 Scores on a scale
Standard Deviation 1.08
|
2.92 Scores on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 6-weeksMean Scores on the Drinking to Cope with Depression subscale of the Modified Drinking Motives Questionnaire (range from 1 to 5; higher values reflect greater drinking to cope)
Outcome measures
| Measure |
Personalized Normative Feedback (PNF)
n=23 Participants
Participants in the PNF condition will receive normative feedback only on their alcohol use.
|
PFIcope+EMI
n=25 Participants
The 6-week PFIcope+EMI includes: 1) an in-person personalized feedback session to present feedback on problems with drinking to cope, discuss the individual's use of alcohol to cope, and generate coping skills messages to be used in the EMI intervention; 2) EMA to monitor affect, intention to drink, coping skills usage, alcohol use, drinking to cope post-discharge; 3) tailored text messages (EMI) based on EMA (individualized coping skills messages when NA and intention to drink are reported).
|
|---|---|---|
|
Depression Coping Drinking Motives
|
2.70 Scores on a scale
Standard Deviation 1.14
|
2.66 Scores on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: 6-week follow-upMean positive alcohol expectancies subscale of the the Comprehensive Effects of Alcohol Measure (CEOA) (range from 1 to 4; higher values reflect greater positive alcohol expectancies)
Outcome measures
| Measure |
Personalized Normative Feedback (PNF)
n=23 Participants
Participants in the PNF condition will receive normative feedback only on their alcohol use.
|
PFIcope+EMI
n=25 Participants
The 6-week PFIcope+EMI includes: 1) an in-person personalized feedback session to present feedback on problems with drinking to cope, discuss the individual's use of alcohol to cope, and generate coping skills messages to be used in the EMI intervention; 2) EMA to monitor affect, intention to drink, coping skills usage, alcohol use, drinking to cope post-discharge; 3) tailored text messages (EMI) based on EMA (individualized coping skills messages when NA and intention to drink are reported).
|
|---|---|---|
|
Positive Alcohol Outcome Expectancies
|
2.70 Scores on a Scale
Standard Deviation .68
|
2.81 Scores on a Scale
Standard Deviation .46
|
SECONDARY outcome
Timeframe: 6-weeksMean negative alcohol expectancies subscale of the the Comprehensive Effects of Alcohol Measure (CEOA) (range from 1 to 4; higher values reflect greater negative alcohol expectancies)
Outcome measures
| Measure |
Personalized Normative Feedback (PNF)
n=23 Participants
Participants in the PNF condition will receive normative feedback only on their alcohol use.
|
PFIcope+EMI
n=25 Participants
The 6-week PFIcope+EMI includes: 1) an in-person personalized feedback session to present feedback on problems with drinking to cope, discuss the individual's use of alcohol to cope, and generate coping skills messages to be used in the EMI intervention; 2) EMA to monitor affect, intention to drink, coping skills usage, alcohol use, drinking to cope post-discharge; 3) tailored text messages (EMI) based on EMA (individualized coping skills messages when NA and intention to drink are reported).
|
|---|---|---|
|
Negative Alcohol Expectancies
|
2.46 Scores on a scale
Standard Deviation .78
|
2.55 Scores on a scale
Standard Deviation .82
|
SECONDARY outcome
Timeframe: 6-week follow-upSummed total of alcohol-related problems measured using the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) (range is 0 to 24; higher number reflect more alcohol-related problems)
Outcome measures
| Measure |
Personalized Normative Feedback (PNF)
n=23 Participants
Participants in the PNF condition will receive normative feedback only on their alcohol use.
|
PFIcope+EMI
n=25 Participants
The 6-week PFIcope+EMI includes: 1) an in-person personalized feedback session to present feedback on problems with drinking to cope, discuss the individual's use of alcohol to cope, and generate coping skills messages to be used in the EMI intervention; 2) EMA to monitor affect, intention to drink, coping skills usage, alcohol use, drinking to cope post-discharge; 3) tailored text messages (EMI) based on EMA (individualized coping skills messages when NA and intention to drink are reported).
|
|---|---|---|
|
Alcohol-related Problems
|
7.78 Scores on a scale
Standard Deviation 7.95
|
6.28 Scores on a scale
Standard Deviation 5.86
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-month follow-upDrinks per drinking day assessed using the Timeline Followback (TLFB)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-week follow-upMean Scores on the Drinking to Cope subscale of the Modified Drinking Motives Questionnaire (range from 5 to 25; higher values reflect greater drinking to cope)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-month follow-upMean Scores on the Drinking to Cope subscale of the Modified Drinking Motives Questionnaire (range from 5 to 25; higher values reflect greater drinking to cope)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-week follow-upNumber of consequences of alcohol use assessed with the Rutgers Alcohol Problems Index
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-month follow-upNumber of consequences of alcohol use assessed with the Rutgers Alcohol Problems Index
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-week follow-upThe number of benefits and costs associated with changing drinking behaviors as measured by the Alcohol Outcome Expectancies Questionnaire
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-month follow-upThe number of benefits and costs associated with changing drinking behaviors as measured by the Alcohol Outcome Expectancies Questionnaire
Outcome measures
Outcome data not reported
Adverse Events
Personalized Normative Feedback (PNF)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PFIcope+EMI
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Personalized Normative Feedback (PNF)
n=29 participants at risk
Participants in the PNF condition will receive normative feedback only on their alcohol use.
|
PFIcope+EMI
n=31 participants at risk
The 6-week PFIcope+EMI includes: 1) an in-person personalized feedback session to present feedback on problems with drinking to cope, discuss the individual's use of alcohol to cope, and generate coping skills messages to be used in the EMI intervention; 2) EMA to monitor affect, intention to drink, coping skills usage, alcohol use, drinking to cope post-discharge; 3) tailored text messages (EMI) based on EMA (individualized coping skills messages when NA and intention to drink are reported).
|
|---|---|---|
|
Psychiatric disorders
medication side effects (nausea)
|
0.00%
0/29 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
3.2%
1/31 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
|
Gastrointestinal disorders
fatty live and stomach ulcers
|
0.00%
0/29 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
3.2%
1/31 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
|
General disorders
wisdom tooth removal
|
3.4%
1/29 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
0.00%
0/31 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
|
Infections and infestations
sinus infection
|
0.00%
0/29 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
3.2%
1/31 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
|
Surgical and medical procedures
top surgery
|
3.4%
1/29 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
0.00%
0/31 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
|
Renal and urinary disorders
urinary tract infection
|
0.00%
0/29 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
3.2%
1/31 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
|
Musculoskeletal and connective tissue disorders
wrist pain from injury
|
3.4%
1/29 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
0.00%
0/31 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
|
Injury, poisoning and procedural complications
fractured rib
|
0.00%
0/29 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
3.2%
1/31 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
|
Renal and urinary disorders
kidney infection
|
0.00%
0/29 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
3.2%
1/31 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
|
Nervous system disorders
migraines
|
0.00%
0/29 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
3.2%
1/31 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
|
Infections and infestations
mononucleosis
|
0.00%
0/29 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
3.2%
1/31 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
|
Skin and subcutaneous tissue disorders
abscess under arm
|
0.00%
0/29 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
3.2%
1/31 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
|
Psychiatric disorders
initiated higher level of care for alcohol problems
|
3.4%
1/29 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
0.00%
0/31 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
|
Ear and labyrinth disorders
ear infection
|
3.4%
1/29 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
0.00%
0/31 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
|
Respiratory, thoracic and mediastinal disorders
exacerbation of asthma
|
3.4%
1/29 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
0.00%
0/31 • enrollment until end of treatment, up to 6 weeks
Events were assessed at 6 weeks using the SAFTEE
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place