PFIcope+EMI for Alcoholism

Overseen by Ana M Abrantes, Ph.D.

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Butler Hospital

Disqualifiers: Substance use disorder, Psychotic disorder, Suicidal ideation

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the PFIcope+EMI treatment for alcoholism?

Research shows that using personalized feedback and real-time assessments, like those in PFIcope+EMI, can help people reduce their drinking by understanding their motivations and self-confidence. Studies have found that daily tracking of motivation and self-efficacy (belief in one's ability to succeed) can predict drinking behavior, suggesting that these methods can be effective in treating alcohol use disorder. ^{1 2 3 4 5}

Is PFIcope+EMI safe for humans?

The research articles provided do not contain specific safety data for PFIcope+EMI or its related interventions. They focus on understanding behavior and relapse in alcohol use disorder using ecological momentary assessment, but do not address safety concerns. ^{1 2 6 7 8}

How is the PFIcope+EMI treatment for alcoholism different from other treatments?

The PFIcope+EMI treatment is unique because it combines personalized feedback on coping motives with real-time interventions delivered in everyday situations, helping individuals manage their drinking by addressing specific high-risk scenarios and improving coping strategies. ^{9 10 11 12 13}

Research Team

Ana M Abrantes, Ph.D.

Principal Investigator

Butler Hospital/Alpert Medical School of Brown University

Eligibility Criteria

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.

Inclusion Criteria

Owns a smartphone capable of downloading EMA app.

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

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')

Exclusion Criteria

History of psychotic disorder or current psychotic symptoms as assessed by research staff via SCID

Current DSM-5 diagnosis of moderate/severe substance use disorder (other than alcohol, cannabis, or nicotine) as assessed by research staff via SCID

I do not have thoughts of harming myself or others.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-week PFIcope+EMI intervention, including personalized feedback sessions, EMA monitoring, and tailored EMI text messages.

6 weeks

Follow-up

Participants are monitored for alcohol outcomes and psychiatric symptomatology at 6-weeks, 12-weeks, and 6-months to determine outcomes and feasibility/acceptability.

6 months

Treatment Details

Interventions

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

Trial Overview 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.

Participant Groups

Group I: PFIcope+EMI Experimental Treatment 1 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: PNF Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials

133

Recruited

16,700+

Matt Schnur

Butler Hospital

Chief Executive Officer

Doctor of Pharmacy from Duquesne University

Dr. Monique Butler

Butler Hospital

Chief Medical Officer since 2018

MD from Wayne State University, MBA from the University of Tennessee

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Dr. George F. Koob

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Executive Officer since 2014

PhD in Neurobiology from the Scripps Research Institute

Dr. Patricia Powell

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Medical Officer since 2015

MD from an accredited institution

Findings from Research

Dynamical systems modeling was used to analyze behavior change mechanisms in individuals with alcohol use disorder, revealing that these mechanisms are complex and interact dynamically over time.

The study found that patients who successfully reduced their drinking exhibited similar patterns of behavior change, highlighting the effectiveness of personalized approaches in understanding treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamical Systems Modeling to Identify a Cohort of Problem Drinkers with Similar Mechanisms of Behavior Change. Bekele-Maxwell, K., Everett, RA., Shao, S., et al.[2023]

In a study of 43 alcohol-dependent outpatients using Ecological Momentary Assessment, it was found that negative affect is linked to increased temptation to drink, suggesting that emotional states can trigger cravings for alcohol.

Lapsers (those who drank against treatment goals) reported higher levels of craving and lower motivation to abstain compared to abstainers, indicating that monitoring these factors could help professionals support patients in maintaining sobriety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Affect, motivation, temptation, and drinking among alcohol-dependent outpatients trying to maintain abstinence: An Ecological Momentary Assessment study. Waters, AJ., Schoenmakers, TM., Snelleman, M., et al.[2023]

The study involved 96 treatment-seeking problem drinkers who completed daily surveys over 7 weeks, revealing that daily changes in motivation and self-efficacy significantly predicted drinking behavior in the following 24 hours.

The findings highlight the potential of ecological momentary assessment (EMA) and intensive longitudinal data (ILD) methods to enhance research on alcohol use disorder (AUD) treatment, although some expected moderating factors did not show support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Within-person associations between daily motivation and self-efficacy and drinking among problem drinkers in treatment. Morgenstern, J., Kuerbis, A., Houser, J., et al.[2018]

In a study involving 89 problem drinkers, the non-directive elements of Motivational Interviewing (SOMI) led to higher daily confidence in moderating drinking compared to traditional MI, suggesting that less directive approaches may be more effective in boosting self-efficacy.

Contrary to expectations, the traditional MI approach did not show a stronger link between daily commitment to change and actual drinking behavior, indicating that the effectiveness of MI may not rely solely on its relational and technical elements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining motivational interviewing's effect on confidence and commitment using daily data. Kuerbis, A., Lynch, KG., Shao, S., et al.[2020]

In a study of 89 problem drinkers undergoing brief treatments for alcohol use disorder, those with high confidence and commitment to change showed the greatest reduction in drinking, indicating that motivation plays a crucial role in successful moderation.

The research identified three distinct profiles of drinkers based on their confidence and commitment levels, suggesting that tailoring interventions to these profiles could enhance treatment outcomes for alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profiles of confidence and commitment to change as predictors of moderated drinking: a person-centered approach. Kuerbis, A., Armeli, S., Muench, F., et al.[2021]

A study involving 42 participants in their first year of recovery from alcohol use disorder found that both high mean stress levels and high stress variability were linked to fewer days of abstinence from alcohol, indicating a greater risk of lapses.

The research highlights the importance of considering stress variability, alongside mean stress levels, in understanding and predicting alcohol use lapses, suggesting a more complex relationship between stress and alcohol use than previously thought.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mean Versus Variability: Disentangling Stress Effects on Alcohol Lapses Among Individuals in the First Year of Alcohol Use Disorder Recovery. Eddie, D., Barr, M., Njeim, L., et al.[2022]

The study involved 112 participants and utilized high-resolution ecological momentary assessment (HR-EMA) to evaluate real-time alcohol responses during drinking episodes, revealing that moderate-severe alcohol use disorder (MS-AUD) individuals consumed the most alcohol and experienced the highest blood alcohol concentration (0.14 g/dL) compared to light drinkers (0.02 g/dL).

Risky drinkers (MS-AUD and heavy social drinkers) reported greater positive effects from alcohol, such as stimulation and liking, indicating that they are more sensitive to the pleasurable effects of alcohol throughout their drinking episodes, rather than just seeking these effects after consuming large amounts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing real-time positive subjective effects of alcohol using high-resolution ecological momentary assessment in risky versus light drinkers. Fridberg, DJ., Lee, Z., Fischer, AM., et al.[2023]

The study found that cravings significantly increase the likelihood of relapse, with individuals experiencing heightened cravings being 14 times more likely to relapse shortly after.

Coping styles play a crucial role in relapse risk; those using distraction and disengagement are at higher risk, while those employing acceptance as a coping strategy are at lower risk, suggesting that personalized treatment approaches could be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ecological momentary assessment of the effects of craving and affect on risk for relapse during substance abuse treatment. Moore, TM., Seavey, A., Ritter, K., et al.[2018]

In a study of 80 problem drinkers undergoing a brief outpatient treatment, those who used more cognitive coping strategies (like thinking through consequences) showed better improvement after treatment.

The findings suggest that actively using cognitive coping responses can help reduce the likelihood of relapse in problem drinkers, highlighting the importance of these strategies in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between posttreatment drinking and alternative responses to high-risk situations proposed during treatment by problem drinkers. Breslin, FC., Sobell, MB., Sobell, LC., et al.[2019]

In a study of 50 social drinkers, it was found that individuals with stronger coping motives for drinking consumed more alcohol after experiencing stress, especially when they had low adaptive coping skills.

The results indicate that while coping motives are linked to increased alcohol consumption, the interaction between coping motives and adaptive coping did not predict drinking frequency or quantity in the past month, highlighting the importance of addressing both factors in interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactions between adaptive coping and drinking to cope in predicting naturalistic drinking and drinking following a lab-based psychosocial stressor. Merrill, JE., Thomas, SE.[2021]

In a study of 1063 adults with alcohol use disorder, coping strategies were found to mediate the effectiveness of cognitive-behavioral therapy (CBT) on drinking outcomes, but only for those with high baseline dependence severity.

For out-patient clients with high dependence, CBT led to better drinking outcomes at the 1-year follow-up through improved coping, while this effect was not observed in clients with low or moderate dependence severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping mediates the effects of cognitive-behavioral therapy for alcohol use disorder among out-patient clients in Project MATCH when dependence severity is high. Roos, CR., Maisto, SA., Witkiewitz, K.[2018]

In a study involving 21 early problem drinkers, targeted naltrexone taken on an 'as-needed' basis led to significant reductions in drinking intensity, demonstrating its potential effectiveness for this population.

The positive effects of targeted naltrexone were still noticeable three months after treatment, suggesting lasting benefits, but further research is necessary to optimize its use in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted naltrexone treatment of early problem drinkers. Kranzler, HR., Tennen, H., Penta, C., et al.[2019]

In a study of 112 individuals with alcohol dependence, those using an emotional-avoidant coping style exhibited more severe psychopathological symptoms and less mature defense mechanisms compared to those using task-oriented coping.

Individuals who relied on task-oriented coping strategies showed better adaptation and healthier functioning when facing difficulties, highlighting the importance of coping patterns in the treatment and understanding of alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychopathological symptoms, defense mechanisms and time perspectives among subjects with alcohol dependence (AD) presenting different patterns of coping with stress. Iwanicka, K., Gerhant, A., Olajossy, M.[2020]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Dynamical Systems Modeling to Identify a Cohort of Problem Drinkers with Similar Mechanisms of Behavior Change. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Affect, motivation, temptation, and drinking among alcohol-dependent outpatients trying to maintain abstinence: An Ecological Momentary Assessment study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Within-person associations between daily motivation and self-efficacy and drinking among problem drinkers in treatment. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

Examining motivational interviewing's effect on confidence and commitment using daily data. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Profiles of confidence and commitment to change as predictors of moderated drinking: a person-centered approach. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Mean Versus Variability: Disentangling Stress Effects on Alcohol Lapses Among Individuals in the First Year of Alcohol Use Disorder Recovery. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Assessing real-time positive subjective effects of alcohol using high-resolution ecological momentary assessment in risky versus light drinkers. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Ecological momentary assessment of the effects of craving and affect on risk for relapse during substance abuse treatment. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Relationship between posttreatment drinking and alternative responses to high-risk situations proposed during treatment by problem drinkers. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Interactions between adaptive coping and drinking to cope in predicting naturalistic drinking and drinking following a lab-based psychosocial stressor. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Coping mediates the effects of cognitive-behavioral therapy for alcohol use disorder among out-patient clients in Project MATCH when dependence severity is high. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Targeted naltrexone treatment of early problem drinkers. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Psychopathological symptoms, defense mechanisms and time perspectives among subjects with alcohol dependence (AD) presenting different patterns of coping with stress. [2020]