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The Development of a Personalized, Real-time Intervention

The Development of a Personalized, Real-time Intervention for Substance-using Emerging Adults Leaving Psychiatric Partial Hospitalization

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03518619
Acronym
PFIcope+EMI
Enrollment
20
Registered
2018-05-08
Start date
2018-09-24
Completion date
2019-05-01
Last updated
2022-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drinking, Alcohol

Brief summary

The investigators propose to enhance our existing coping motive-specific normative feedback intervention (PFIcope intervention) by capitalizing on EMA/EMI technology to pair real-time affective monitoring with tailored real-time relapse prevention texts for individuals with anxiety and depression who drink to cope. The goals of the PFIcope+EMI study are to help individuals to identify motives for drinking and to utilize alternate coping strategies for negative affect in place of alcohol.

Detailed description

Emerging adulthood (ages 18-25) represents and common and problematic time for alcohol use and mental health issues, particularly anxiety and depression. Anxiety and depression increase the likelihood of developing risky patterns of alcohol use. Indeed, individuals who drink alcohol to cope with negative affect, such as anxiety and depression, report more alcohol use and more severe use-related consequences. As such, it is important to address alcohol use, particularly among a psychiatric population of emerging adults. Despite their co-occurrence, treatment as usual for anxiety and depression typically does not address alcohol use, and alcohol interventions for emerging adults largely ignore anxiety and depression. Emerging research suggests interventions that specifically focus on drinking to cope with negative affect are promising in reducing problematic outcomes. For example, the investigators previously developed a brief, personalized feedback intervention that specifically targeted use of alcohol to cope with negative affect among a normative sample of emerging adults (Personalized Feedback Intervention for Coping - PFIcope), which resulted in decreased drinking to cope. In order to adapt PFIcope for a psychiatric population and augment treatment effects, the investigators propose adding ecological momentary assessment (EMA) and intervention (EMI) in order to identify when emerging adults are at most risk for problematic alcohol use and intervene when needed. EMA can assess symptoms in real time and identify high-risk situations for problematic use (i.e., when experiencing negative affect and reports intention to use), which can trigger an in-the-moment EMI during that high-risk situation (i.e., individually-chosen relapse prevention coping skills messages). The investigators propose to develop a 6-week PFIcope+EMI intervention for 20 emerging adults in a psychiatric partial hospitalization program who report drinking alcohol to cope with negative affect. 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. The PFIcope+EMI intervention, including its associated real-time assessment and messaging systems, is low-cost, easy to program, and can deliver an intervention when individuals are at most risk for engaging in problematic alcohol use.

Interventions

BEHAVIORALPFIcope+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.

Sponsors

National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
Butler Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

(a) between 18 and 25 years of age, (b) reported alcohol use at least 3x weekly over past month, (c) self-reported use of coping motive (mean of 2+ on coping subscale of MDMQ-R), (d) current anxiety and/or depression symptomatology (as assessed CES-D score of 16+ and GAD-7 scores 10+), (e) has access to a smartphone capable of receiving EMA and text, and access to email.

Exclusion criteria

(a) current DSM-5 diagnosis of moderate/severe other substance use disorder (i.e., other than alcohol), (b) a history of psychotic disorder or current psychotic symptoms, (c) current suicidal/homicidal ideation.

Design outcomes

Primary

MeasureTime frameDescription
Drinking Motives Questionnaire-Revised (DMQ-R) Coping Motive6 weeksDrinking to cope with negative affect, 5 items on scale of 1-5 with higher values meaning more use
Percentage of Days of Alcohol Use in the Last Month6 weeksAlcohol use, yes/no for each day of past 30

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

ArmCount
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.
20
Total20

Baseline characteristics

CharacteristicPFIcope+EMI
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
Age, Continuous21.74 years
STANDARD_DEVIATION 2.23
Conformity Drinking Motives1.6 units on a scale
STANDARD_DEVIATION 0.6
Coping with Anxiety Drinking Motives3.42 units on a scale
STANDARD_DEVIATION 1.14
Coping with Depression Drinking Motives2.85 units on a scale
STANDARD_DEVIATION 1.49
Drinks per Drinking Day (DDD)3.56 alcoholic drinks
STANDARD_DEVIATION 1.67
Enhancement Drinking Motives3.37 units on a scale
STANDARD_DEVIATION 0.93
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
16 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
Percent Days Binge Drinking21.70 Percentage of days
STANDARD_DEVIATION 8.25
Percent Days Drinking35 Percentage of days
STANDARD_DEVIATION 25
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
17 Participants
Region of Enrollment
United States
20 participants
Sex: Female, Male
Female
12 Participants
Sex: Female, Male
Male
8 Participants
Social Drinking Motives3.3 units on a scale
STANDARD_DEVIATION 0.43

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 20
other
Total, other adverse events
0 / 20
serious
Total, serious adverse events
2 / 20

Outcome results

Primary

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

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

Time frame: 6 weeks

ArmMeasureValue (MEAN)Dispersion
PFIcope+EMIDrinking Motives Questionnaire-Revised (DMQ-R) Coping Motive2.15 score on a scaleStandard Deviation 0.82
p-value: <0.05t-test, 2 sided
Primary

Percentage of Days of Alcohol Use in the Last Month

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

Time frame: 6 weeks

ArmMeasureValue (MEAN)Dispersion
PFIcope+EMIPercentage of Days of Alcohol Use in the Last Month19 percentage of drinking daysStandard Deviation 22
p-value: <0.01t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026