What side effects are associated with this type of intervention?

The PFICope+EMI intervention, which combines personalized feedback with EMA and EMI text messaging, primarily involves behavioral and psychological strategies. These approaches generally have minimal physical side effects but may cause emotional discomfort as individuals confront their drinking behaviors and underlying issues. Common pharmacological treatments for alcoholism, such as naltrexone, acamprosate, and disulfiram, can have side effects including nausea, headache, dizziness, and in the case of disulfiram, severe reactions if alcohol is consumed. Behavioral therapies like cognitive-behavioral therapy (CBT) and motivational interviewing (MI) are also used and are generally well-tolerated, though they may cause temporary emotional distress as patients work through challenging issues.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of alcoholism, including disulfiram, naltrexone, and acamprosate. Disulfiram works by causing unpleasant effects when alcohol is consumed, thereby deterring drinking. Naltrexone blocks the euphoric effects of alcohol, reducing the desire to drink, and is available in both oral and extended-release injectable forms. Acamprosate helps to stabilize the chemical balance in the brain that is disrupted by alcohol dependence. While these medications are effective, the PFICope+EMI trial represents a novel approach by integrating personalized feedback and real-time interventions through ecological momentary assessment and tailored text messaging, aiming to reduce alcohol use and improve coping mechanisms.

What other types of research exist?

Promising novel alternatives to PFICope+EMI for alcoholism patients include: 1) Digital Cognitive Behavioral Therapy (CBT) programs, which can be delivered via telemedicine or mobile apps, providing structured therapy sessions and coping strategies. 2) Mobile health (mHealth) applications that offer real-time monitoring and personalized feedback to reduce alcohol consumption. 3) Virtual reality (VR) therapy, which immerses patients in controlled environments to practice coping skills and reduce cravings. 4) Pharmacotherapy combined with digital support tools, such as apps that remind patients to take medications like naltrexone or acamprosate and track their progress. 5) Group-based online support programs that provide peer support and accountability through virtual meetings and forums.

← Back to Search

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

Must not have

Current suicidal/homicidal ideation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a treatment that combines personalized advice with supportive text messages for young adults in a psychiatric program who drink to cope with negative emotions. The goal is to provide real-time support to manage emotions and reduce drinking.

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.

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.

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

Select...

I am currently experiencing significant symptoms of anxiety and/or depression.

Select...

I am between 18 and 25 years old.

Select...

I drink alcohol 3 times a week and binge drink at least once a week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have thoughts of harming myself or others.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-month follow-up

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Other study objectives

Alcohol Outcome Expectancies

Alcohol-related problems

Drinking Motives

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met

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.