~19 spots leftby Mar 2026
Overseen ByAna 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.

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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.

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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.

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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')
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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

Participant Groups

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.
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.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Butler HospitalProvidence, RI
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Who Is Running the Clinical Trial?

Butler HospitalLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator

References

Dynamical Systems Modeling to Identify a Cohort of Problem Drinkers with Similar Mechanisms of Behavior Change. [2023]One challenge to understanding mechanisms of behavior change (MOBC) completely among individuals with alcohol use disorder is that processes of change are theorized to be complex, dynamic (time varying), and at times non-linear, and they interact with each other to influence alcohol consumption. We used dynamical systems modeling to better understand MOBC within a cohort of problem drinkers undergoing treatment. We fit a mathematical model to ecological momentary assessment data from individual patients who successfully reduced their drinking by the end of the treatment. The model solutions agreed with the trend of the data reasonably well, suggesting the cohort patients have similar MOBC. This work demonstrates using a personalized approach to psychological research, which complements standard statistical approaches that are often applied at the population level.
Affect, motivation, temptation, and drinking among alcohol-dependent outpatients trying to maintain abstinence: An Ecological Momentary Assessment study. [2023]Using Ecological Momentary Assessment we aimed to describe the time course of temptation episodes in alcohol-dependent outpatients in a real-life setting. We also examined whether affective and motivational variables were cross-sectionally and prospectively associated with temptation episodes. Additionally, we tested whether outpatients who drank against treatment goals (i.e., "lapsers") differed in craving, affect, and motivation from abstainers.
Within-person associations between daily motivation and self-efficacy and drinking among problem drinkers in treatment. [2018]Gaining a better understanding of the change process holds promise to improve alcohol treatment. Ecological momentary assessment (EMA) coupled with intensive longitudinal data (ILD) approaches have been proposed as promising methods that can advance change process research but have been used infrequently in alcohol use disorder (AUD) treatment research. The current study used these approaches to examine the within-person associations of motivation and self-efficacy and drinking among treatment-seeking problem drinkers. Participants (N = 96) received daily EMA surveys before, during, and after treatment for 7 weeks spread over a 9-month period. Multilevel modeling was used to test the within-person relationships between the change processes and drinking, controlling for between-person associations and prior drinking. Results indicated that daily fluctuations in motivation and self-efficacy significantly predicted drinking over the next 24 hours; however, several theory-driven hypotheses regarding factors that might moderate that relationship were not supported. Overall, results support the advantages of EMA and ILD as methods that can advance AUD treatment research. (PsycINFO Database Record
Examining motivational interviewing's effect on confidence and commitment using daily data. [2020]Mechanisms of behavior change (MOBC) within Motivational Interviewing (MI) are thought to operate via both relational and technical elements. These elements are hypothesized to increase client motivation and self-efficacy for change and subsequently decrease drinking. Only partial support for this causal chain exists, particularly when using within-session change talk as the primary intervening variable. This study explored whether commitment to moderate or abstain from drinking and confidence to moderate drinking in the next day measured via ecological momentary assessment (EMA) provided alternative support for the theory. Data were from a pilot randomized controlled trial testing active ingredients of MI. Problem drinkers (N = 89) seeking to moderate their drinking were randomly assigned to one of the three conditions: 1) MI; 2) Spirit only MI (SOMI), consisting of non-directive elements of MI, e.g., reflective listening; and 3) a non-therapy control. Participants completed daily EMA that measured confidence, both types of commitment, and drinks per day for a week prior to and during seven weeks of treatment. Hypotheses were not supported, and results were unexpected. Participants in SOMI were more likely to have higher daily confidence than those in MI; there were no condition differences for either type of commitment. All daily measures significantly predicted drinking; however, the MI group did not demonstrate a stronger relationship between the intervening variables and drinking, as hypothesized. Instead, participants in SOMI yielded the strongest relationship between daily commitment to abstain and drinking compared to the other two conditions. Multiple possible explanations for the unexpected findings are discussed.
Profiles of confidence and commitment to change as predictors of moderated drinking: a person-centered approach. [2021]Identifying who, among problem drinkers, is best suited for moderation and has the greatest likelihood to control drinking has important public health implications. The current study aimed to identify profiles of problem drinkers who may be more or less successful in moderating drinking within the context of a randomized clinical trial of a brief treatment for alcohol use disorder. A person-centered approach was implemented, utilizing composite, baseline daily diary values of confidence and commitment to reduce drinking. Problem drinkers (N = 89) were assessed, provided feedback about their drinking, and randomly assigned to 1 of 3 conditions: 2 brief alcohol use disorder treatments or a third group asked to change on their own. Global self-report assessments were administered at baseline and Week 8 (end of treatment). Daily diary composites were created from data collected via an interactive voice recording system during the week prior to baseline. A K-means cluster analysis identified 3 groups: high, moderate, and low confidence and commitment to change drinking. Group differences were explored, and then group membership was entered into generalized estimating equations to predict drinking trajectories over time. Findings revealed that the groups differentially reduced their drinking, such that the high group had greater reduction in drinking and a faster rate of reduction than the other 2 groups, and the moderate group had greater reduction than the low group. Findings suggest that baseline motivation and self-efficacy are important for predicting prognoses related to successful moderated drinking. Limitations and arenas for future research are discussed.
Mean Versus Variability: Disentangling Stress Effects on Alcohol Lapses Among Individuals in the First Year of Alcohol Use Disorder Recovery. [2022]Although stress is a well-known predictor of alcohol use lapses among individuals seeking recovery from alcohol use disorder (AUD), most research has relied on retrospective self-report using conventional questionnaires that explore stress effects at the level of the mean. Ecological momentary assessment (EMA) overcomes many of the shortcomings of questionnaire-based, retrospective self-report by using real-time, in-the-environment evaluations for the acquisition of ecologically valid data that can also capture stress variability. The present investigation used EMA to disentangle stress effects on alcohol lapses among individuals in the first year of an AUD recovery attempt by exploring associations between mean-level stress, stress variability, and subsequent alcohol use.
Assessing real-time positive subjective effects of alcohol using high-resolution ecological momentary assessment in risky versus light drinkers. [2023]High-resolution ecological momentary assessment (HR-EMA) can assess acute alcohol responses during naturalistic heavy drinking episodes. The goal of this study was to use HR-EMA to examine drinking behavior and subjective responses to alcohol in risky drinkers (moderate-severe alcohol use disorder [MS-AUD], heavy social drinkers [HD]) and light drinkers (LD). We expected that risky drinkers would endorse greater alcohol stimulation and reward, with lower sedation, than LD, even when controlling for amount of alcohol consumed.
Ecological momentary assessment of the effects of craving and affect on risk for relapse during substance abuse treatment. [2018]The primary goals of this study were to use ecological momentary assessment (EMA) to examine the extent to which proximal factors (cravings and affect) were temporally associated with relapse, and to assess the role of distal factors (e.g., coping styles) in moderating these associations. We also examined whether using EMA procedures impacted relapse rates. A sample of 100 male (n = 66) and female (n = 34) patients entering outpatient treatment for substance abuse completed a baseline assessment of substance dependence, stress, social support, coping styles, family history of substance abuse, and self-efficacy. Half of the participants were randomly assigned to receive training in using a handheld computer to respond to 3 random prompts each day for 4 months regarding cravings, affect, and substance use. All participants completed 2- and 4-month follow-up assessments of substance use. Results showed that using EMA procedures did not influence relapse rates. Hierarchical linear modeling showed that individuals who reported an increase in cravings on a given prompt were 14 times more likely to report relapse on the subsequent prompt than individuals who did not experience an increase in cravings. In addition, women, older individuals, and individuals who use distraction and disengagement as coping styles were at increased risk for relapse when experiencing an increase in cravings. Individuals who use acceptance as a coping style were at decreased risk for relapse when experiencing an increase in cravings. The study highlights the importance of tailoring treatments to address the needs of particular individuals and risk factors.
Relationship between posttreatment drinking and alternative responses to high-risk situations proposed during treatment by problem drinkers. [2019]Problem drinkers' alternatives to high-risk situations were evaluated and related to treatment outcome. participants were 80 problem drinkers (64% males, 36% females) who completed a brief outpatient Guided Self-Change treatment. Treatment included a homework exercise where clients identified two to three high-risk situations and generated alternative responses for each situation. Based on a coding scheme developed by Moser and Annis (1996), responses were coded as (a) cognitive or behavioral, and (b) active or avoidant. Results indicated that the proportion of cognitive coping responses (e.g., thinking through the consequences) was positively related to posttreatment improvement. This prospective study suggests that intention to use active cognitive coping responses influences the relapse process.
Interactions between adaptive coping and drinking to cope in predicting naturalistic drinking and drinking following a lab-based psychosocial stressor. [2021]Using alcohol to cope (i.e., coping motivation) and general coping style both are theorized and demonstrated empirically to lead to problematic drinking. In the present study, we sought to examine whether these factors interact to predict alcohol use, both retrospectively reported and in the lab following a stressor task. Social drinkers (N=50, 50% women) received the Trier Social Stress Test (TSST), and then consumed beer under the guise of a taste test. A Timeline Followback interview to assess past month alcohol use, the Drinking Motives Questionnaire (DMQ), and the COPE (to assess adaptive coping) were administered prior to the laboratory challenge. Multiple regression models were used to examine DMQ coping motives, adaptive coping, and their interaction as predictors of milliliters (mls) of beer consumed in a clinical laboratory setting. The association between coping motives and mls beer was positive at both high and low levels of adaptive coping, but at low levels of adaptive coping, this association was stronger. In contrast, there was no interaction between adaptive coping and coping motives in predicting quantity and frequency of drinking in the prior month. Findings suggest that stronger coping motives for drinking predict greater alcohol consumption following a stress provocation to a greater extent when an individual is lacking in adaptive coping strategies. As both general coping skills and coping motives for alcohol use are responsive to intervention, study of the conditions under which they exert unique and interactive effects is important.
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]There is inconsistent evidence that alcohol-specific coping is a mechanism of change in cognitive-behavioral therapy (CBT) for alcohol use disorder (AUD). Our primary aim was to test whether baseline dependence severity moderates the mediational effect of CBT on drinking outcomes via coping.
Targeted naltrexone treatment of early problem drinkers. [2019]Naltrexone is approved for daily use in the treatment of alcohol dependence. We evaluated the feasibility of using targeted naltrexone (i.e., on an "as-needed" basis) to treat early problem drinkers. Twenty-one subjects (52% male) received brief coping skills training weekly for 4 weeks, along with naltrexone (50 mg), which they were instructed to use 2 to 5 times per week in anticipation of high-risk drinking situations. During treatment, statistically and clinically significant declines were observed across a variety of drinking-related outcomes, including the intensity of drinking, the decline in which was correlated with medication use. Beneficial effects of the intervention were still evident during the 3-month posttreatment period. Further research, including a placebo-controlled evaluation of targeted naltrexone, is needed to determine the optimal treatment strategy for early problem drinkers, many of whom are seen in the primary-care medical setting.
13.United Statespubmed.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]The problem of coping with stress is an important one in the context of development and persistence of alcohol dependence. In the literature to date very little attention has been paid to coping patterns construed as a configuration of specific coping styles, particularly as regards the functioning of addicted individuals. The aim of the study was to verify whether individuals with alcohol dependence characterized by different coping patterns differ with respect to the severity of psychopathological symptoms, defense mechanisms and time perspectives.