Trial Outcomes & Findings for The Development of a Personalized, Real-time Intervention (NCT NCT03518619)

NCT ID: NCT03518619

Last Updated: 2022-11-16

Results Overview

Drinking to cope with negative affect, 5 items on scale of 1-5 with higher values meaning more use

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2022-11-16

Participant Flow

Participants were recruited from a Young Adult Partial Hospitalization program at a private psychiatric institution. Recruitment occurred between September 2018 and February 2019.

Participant milestones

Measure	PFIcope+EMI This will include: 1) an in-person personalized feedback session to present normative information and feedback on problems associated with drinking to cope, to discuss the individual's use of alcohol to cope, and to generate relapse prevention coping skills messages to be used in the EMI text intervention; 2) EMA to monitor affect and intention to drink after discharge; 3) tailored text messages (EMI) based on EMA responses (i.e., individualized coping skills messages when individuals report negative affect and intention to drink); and 4) additional EMA to monitor coping skills usage, alcohol use, and drinking to cope. PFIcope+EMI: The intervention will be comprised of (1) an initial orientation session where the intervention is introduced, receipt of personalized normative information, motives feedback, and the development of an individual's personalized relapse prevention coping skills messages to be utilized through the course of the intervention; (2) EMA for monitoring of affect, drinking intention, alcohol use, and coping skills use; (3) EMI-tailored text messages sent based on EMA responses: individualized, self-chosen relapse prevention coping skills messages when participants report negative affect and intent to drink.
Overall Study STARTED	20
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Development of a Personalized, Real-time Intervention

Baseline characteristics by cohort

Measure	PFIcope+EMI n=20 Participants This will include: 1) an in-person personalized feedback session to present normative information and feedback on problems associated with drinking to cope, to discuss the individual's use of alcohol to cope, and to generate relapse prevention coping skills messages to be used in the EMI text intervention; 2) EMA to monitor affect and intention to drink after discharge; 3) tailored text messages (EMI) based on EMA responses (i.e., individualized coping skills messages when individuals report negative affect and intention to drink); and 4) additional EMA to monitor coping skills usage, alcohol use, and drinking to cope. PFIcope+EMI: The intervention will be comprised of (1) an initial orientation session where the intervention is introduced, receipt of personalized normative information, motives feedback, and the development of an individual's personalized relapse prevention coping skills messages to be utilized through the course of the intervention; (2) EMA for monitoring of affect, drinking intention, alcohol use, and coping skills use; (3) EMI-tailored text messages sent based on EMA responses: individualized, self-chosen relapse prevention coping skills messages when participants report negative affect and intent to drink.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	21.74 years STANDARD_DEVIATION 2.23 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
Percent Days Drinking	35 Percentage of days STANDARD_DEVIATION 25 • n=5 Participants
Drinks per Drinking Day (DDD)	3.56 alcoholic drinks STANDARD_DEVIATION 1.67 • n=5 Participants
Percent Days Binge Drinking	21.70 Percentage of days STANDARD_DEVIATION 8.25 • n=5 Participants
Social Drinking Motives	3.3 units on a scale STANDARD_DEVIATION 0.43 • n=5 Participants
Coping with Anxiety Drinking Motives	3.42 units on a scale STANDARD_DEVIATION 1.14 • n=5 Participants
Coping with Depression Drinking Motives	2.85 units on a scale STANDARD_DEVIATION 1.49 • n=5 Participants
Enhancement Drinking Motives	3.37 units on a scale STANDARD_DEVIATION 0.93 • n=5 Participants
Conformity Drinking Motives	1.6 units on a scale STANDARD_DEVIATION 0.6 • n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Drinking to cope with negative affect, 5 items on scale of 1-5 with higher values meaning more use

Outcome measures

Measure

PFIcope+EMI n=15 Participants This will include: 1) an in-person personalized feedback session to present normative information and feedback on problems associated with drinking to cope, to discuss the individual's use of alcohol to cope, and to generate relapse prevention coping skills messages to be used in the EMI text intervention; 2) EMA to monitor affect and intention to drink after discharge; 3) tailored text messages (EMI) based on EMA responses (i.e., individualized coping skills messages when individuals report negative affect and intention to drink); and 4) additional EMA to monitor coping skills usage, alcohol use, and drinking to cope. PFIcope+EMI: The intervention will be comprised of (1) an initial orientation session where the intervention is introduced, receipt of personalized normative information, motives feedback, and the development of an individual's personalized relapse prevention coping skills messages to be utilized through the course of the intervention; (2) EMA for monitoring of affect, drinking intention, alcohol use, and coping skills use; (3) EMI-tailored text messages sent based on EMA responses: individualized, self-chosen relapse prevention coping skills messages when participants report negative affect and intent to drink.

Drinking Motives Questionnaire-Revised (DMQ-R) Coping Motive

2.15 score on a scale Standard Deviation .82

PRIMARY outcome

Timeframe: 6 weeks

Alcohol use, yes/no for each day of past 30

Outcome measures

Measure

PFIcope+EMI n=15 Participants This will include: 1) an in-person personalized feedback session to present normative information and feedback on problems associated with drinking to cope, to discuss the individual's use of alcohol to cope, and to generate relapse prevention coping skills messages to be used in the EMI text intervention; 2) EMA to monitor affect and intention to drink after discharge; 3) tailored text messages (EMI) based on EMA responses (i.e., individualized coping skills messages when individuals report negative affect and intention to drink); and 4) additional EMA to monitor coping skills usage, alcohol use, and drinking to cope. PFIcope+EMI: The intervention will be comprised of (1) an initial orientation session where the intervention is introduced, receipt of personalized normative information, motives feedback, and the development of an individual's personalized relapse prevention coping skills messages to be utilized through the course of the intervention; (2) EMA for monitoring of affect, drinking intention, alcohol use, and coping skills use; (3) EMI-tailored text messages sent based on EMA responses: individualized, self-chosen relapse prevention coping skills messages when participants report negative affect and intent to drink.

Percentage of Days of Alcohol Use in the Last Month

19 percentage of drinking days Standard Deviation 22

Adverse Events

PFIcope+EMI

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure

PFIcope+EMI n=20 participants at risk This will include: 1) an in-person personalized feedback session to present normative information and feedback on problems associated with drinking to cope, to discuss the individual's use of alcohol to cope, and to generate relapse prevention coping skills messages to be used in the EMI text intervention; 2) EMA to monitor affect and intention to drink after discharge; 3) tailored text messages (EMI) based on EMA responses (i.e., individualized coping skills messages when individuals report negative affect and intention to drink); and 4) additional EMA to monitor coping skills usage, alcohol use, and drinking to cope. PFIcope+EMI: The intervention will be comprised of (1) an initial orientation session where the intervention is introduced, receipt of personalized normative information, motives feedback, and the development of an individual's personalized relapse prevention coping skills messages to be utilized through the course of the intervention; (2) EMA for monitoring of affect, drinking intention, alcohol use, and coping skills use; (3) EMI-tailored text messages sent based on EMA responses: individualized, self-chosen relapse prevention coping skills messages when participants report negative affect and intent to drink.

Psychiatric disorders Psychiatric Inpatient Hospitalization

10.0% 2/20 • Number of events 2 • 6 weeks It does not differ from clinicaltrials.gov

Other adverse events

Adverse event data not reported

Additional Information

Ana M. Abrantes, Ph.D.

Butler Hospital

Phone: 401-455-6440

Email: Ana_Abrantes@Brown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place