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PFIcope+EMI for Alcoholism

N/A
Recruiting
Led By Ana M Abrantes, Ph.D.
Research Sponsored by Butler Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current anxiety and/or depression symptomatology (as assessed by CES-D scores above cut-off for high risk for clinical depression and GAD-7 scores above cut-off for moderate to severe anxiety)
Between 18 and 25 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-month follow-up
Awards & highlights

Study Summary

This trial will test if an intervention combining personalized feedback and text messaging can reduce drinking to cope, alcohol use, and negative affect in young adults.

Who is the study for?
This trial is for young adults aged 18-25 who drink alcohol heavily at least three times a week and use it to cope with negative feelings. They must have symptoms of anxiety or depression, own a smartphone, but not be currently suicidal or have severe substance use disorders (except for alcohol, cannabis, or nicotine) or psychotic conditions.Check my eligibility
What is being tested?
The study tests an intervention combining personalized feedback on drinking habits with real-time support through text messages against just receiving personalized feedback. The goal is to see if this approach can reduce the need to drink due to stress and overall alcohol consumption over six weeks.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, traditional side effects are not expected. However, participants may experience discomfort discussing personal habits or receive distressing feedback about their drinking patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently experiencing significant symptoms of anxiety and/or depression.
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I am between 18 and 25 years old.
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I drink alcohol 3 times a week and binge drink at least once a week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Other outcome measures
Alcohol Outcome Expectancies
Alcohol-related problems
Drinking Motives
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PFIcope+EMIExperimental Treatment1 Intervention
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).
Group II: PNFActive Control1 Intervention
Participants in the PNF condition will receive normative feedback only on their alcohol use.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The PFICope+EMI intervention for alcoholism combines Personalized Feedback Intervention (PFI), Ecological Momentary Assessment (EMA), and Ecological Momentary Intervention (EMI). PFI provides individualized feedback based on the patient's drinking patterns, helping to increase awareness and motivation for change. EMA involves real-time monitoring of behaviors and emotions, offering insights into triggers and patterns of alcohol use. EMI delivers tailored support and coping strategies via text messages at critical moments, aiding in immediate decision-making and reducing relapse risk. These mechanisms are crucial for alcoholism patients as they offer continuous, personalized support and real-time interventions, enhancing the effectiveness of treatment and promoting sustained recovery.
Measurement invariance of the University of Rhode Island Change Assessment Scale in Project MATCH: An exploratory structural equation modeling approach.Variance in the Efficacy of Brief Interventions to Reduce Hazardous and Harmful Alcohol Consumption Between Injury and Noninjury Patients in Emergency Departments: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Using smartphones to decrease substance use via self-monitoring and recovery support: study protocol for a randomized control trial.

Find a Location

Who is running the clinical trial?

Butler HospitalLead Sponsor
130 Previous Clinical Trials
16,433 Total Patients Enrolled
4 Trials studying Alcoholism
404 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
812 Previous Clinical Trials
1,158,377 Total Patients Enrolled
428 Trials studying Alcoholism
778,297 Patients Enrolled for Alcoholism
Ana M Abrantes, Ph.D.Principal InvestigatorButler Hospital/Alpert Medical School of Brown University
3 Previous Clinical Trials
199 Total Patients Enrolled

Media Library

Coping-Motive Specific Personalized Feedback Intervention plus an Ecological Momentary Intervention (PFIcope+EMI) Clinical Trial Eligibility Overview. Trial Name: NCT05074030 — N/A
~20 spots leftby Feb 2025
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