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

NCT05074030 | Active Not Recruiting

• 2 other identifiers: 2104-001R34AA028572
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Drinks per Drinking Days

  Drinks per drinking day assessed using the Timeline Followback (TLFB)

  6-week follow-up

Secondary Outcomes (3)

• Drinking Motives

  6-week follow-up

• Alcohol-related problems

  6-week follow-up

• Alcohol Outcome Expectancies

  6-week follow-up

Other Outcomes (8)

• Drinks per Drinking Days

  12-week follow-up

• Drinks per Drinking Days

  6-month follow-up

• Drinking Motives

  12-week follow-up

Study Arms (2)

PNF

ACTIVE COMPARATOR

Participants in the PNF condition will receive normative feedback only on their alcohol use.

Behavioral: Personalized Normative Feedback

PFIcope+EMI

EXPERIMENTAL

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)

Interventions

Personalized Normative Feedback BEHAVIORAL

Normative Feedback on drinking behaviors.

PNF

Coping-Motive Specific Personalized Feedback Intervention plus an Ecological Momentary Intervention (PFIcope+EMI) BEHAVIORAL

An EMA plus EMI intervention to decrease drinking to cope behaviors among emerging adults receiving psychiatric treatment.

PFIcope+EMI

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• between 18 and 25 years of age
• 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)
• 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")
• 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)
• owns a smartphone capable of downloading EMA app.

You may not qualify if:

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

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ana M Abrantes, Ph.D.

  Butler Hospital/Alpert Medical School of Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 12, 2021
• Study Start: February 6, 2023
• Primary Completion: September 30, 2025
• Study Completion: October 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)