EMA/EMI for Psychiatrically Hospitalized Emerging Adults Who Drink to Cope

Project CHOICE: Developing a Personalized-Feedback EMA/EMI Intervention for Emerging Adults Leaving Psychiatric Partial Hospitalization

The goal of this proposed study is to evaluate an ecological momentary assessment plus an ecological momentary intervention (EMA+EMI) for emerging adults in a psychiatric partial hospitalization program who drink to cope with negative affect (NA) as compared to personalized feedback only. This intervention combines a personalized feedback intervention (PFI) with EMA technology and tailored EMI text messaging (PFICope+EMI). PFICope+EMI not only aims to reduce drinking to cope, but also alcohol use and NA. This study consists of a 6-week randomized controlled treatment trial to test the PFIcope+EMI intervention as compared to personalized normative feedback only (PNF).

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Personalized Normative Feedback; Behavioral: Coping-Motive Specific Personalized Feedback Intervention plus an Ecological Momentary Intervention (PFIcope+EMI)

Detailed Description

Given the relationship between mental health and alcohol problems, there is a need to address comorbidity among emerging adults (EAs) with anxiety and/or depression. The weeks after psychiatric hospitalization are a risky time for problematic alcohol use and recurrence of psychiatric symptoms. The delivery of tailored, coping skills-based, real-time messages could have a significant impact on problematic drinking and depression/anxiety outcomes by reducing the likelihood that an individual drinks to cope with NA.

The aim of this study is to test a 6-week PFIcope+EMI intervention as compared to personalized normative feedback only (PNF) for EA in a partial hospitalization program who drink to cope and binge drink (n=60). The 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). The Personalized Normative Feedback condition (PNF) will receive a personalized normative feedback report but no EMA or EMI.

Participants' alcohol outcomes and psychiatric symptomatology at 6-weeks, 12-weeks, and 6-months will be assessed to determine outcomes and feasibility/acceptability. It is hypothesized that:

1. Individuals in PFIcope+EMI arm will report between-subjects reductions in drinking to cope, alcohol use, alcohol-related problems, and NA as compared to PNF.
2. PFIcope+EMI will be feasible to implement and result in high rates of participant satisfaction.

Mechanisms that may underlie the efficacy of the intervention for the PFIcope+EMI group utilizing the daily EMA data will be explored. It is hypothesized that:

1. In response to NA, participants will report an increase in coping skills utilization and decreased intent to drink at the following EMA assessment point.
2. NA reductions and increased coping skills utilization will be related to improvements in alcohol use rates and problems at the following EMA assessment.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. between 18 and 25 years of age
2. reported alcohol use at least 3x weekly over past month and at least one day per week, on average, of binge drinking (as defined as 4+ drinks/2 hours for men and 3+ drinks/2 hours for women)
3. self-reported use of coping motive (mean of 2+ on coping subscale of MDMQ-R, indicating they drink to cope at least "some of the time")
4. current anxiety and/or depression symptomatology (as assessed CES-D scores above cut-off for high risk for clinical depression and GAD-7 scores above cut-off for moderate to severe anxiety)
5. owns a smartphone capable of downloading EMA app.

Exclusion Criteria:

1. current DSM-5 diagnosis of moderate/severe substance use disorder (other than alcohol, cannabis, or nicotine) as assessed by research staff via SCID
2. a history of psychotic disorder or current psychotic symptoms as assessed by research staff via SCID
3. current suicidal/homicidal ideation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PNF; Participants in the PNF condition will receive normative feedback only on their alcohol use.	Behavioral: Personalized Normative Feedback; Normative Feedback on drinking behaviors.
Experimental: 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).	Behavioral: Coping-Motive Specific Personalized Feedback Intervention plus an Ecological Momentary Intervention (PFIcope+EMI); An EMA plus EMI intervention to decrease drinking to cope behaviors among emerging adults receiving psychiatric treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drinks per Drinking Days	Drinks per drinking day assessed using the Timeline Followback (TLFB)	6-week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drinking Motives	Mean 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)	6-week follow-up
Alcohol-related problems	Number of consequences of alcohol use assessed with the Rutgers Alcohol Problems Index	6-week follow-up
Alcohol Outcome Expectancies	The number of benefits and costs associated with changing drinking behaviors as measured by the Alcohol Outcome Expectancies Questionnaire	6-week follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drinks per Drinking Days	Drinks per drinking day assessed using the Timeline Followback (TLFB)	12-week follow-up
Drinks per Drinking Days	Drinks per drinking day assessed using the Timeline Followback (TLFB)	6-month follow-up
Drinking Motives	Mean 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)	12-week follow-up
Drinking Motives	Mean 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)	6-month follow-up
Alcohol-related problems	Number of consequences of alcohol use assessed with the Rutgers Alcohol Problems Index	12-week follow-up
Alcohol-related problems	Number of consequences of alcohol use assessed with the Rutgers Alcohol Problems Index	6-month follow-up
Alcohol Outcome Expectancies	The number of benefits and costs associated with changing drinking behaviors as measured by the Alcohol Outcome Expectancies Questionnaire	12-week follow-up
Alcohol Outcome Expectancies	The number of benefits and costs associated with changing drinking behaviors as measured by the Alcohol Outcome Expectancies Questionnaire	6-month follow-up

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Ana M Abrantes, Ph.D., Butler Hospital/Alpert Medical School of Brown University

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: 2104-001; R34AA028572 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No