Alcohol Use DisorderNCT05074030
EMA/EMI for Psychiatrically Hospitalized Emerging Adults Who Drink to Cope
A study testing Personalized Normative Feedback and Coping-Motive Specific Personalized Feedback Intervention plus an Ecological Momentary Intervention (PFIcope+EMI) in people with Alcohol Use Disorder, run by Butler Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Personalized Normative Feedback and Coping-Motive Specific Personalized Feedback Intervention plus an Ecological Momentary Intervention (PFIcope+EMI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 30 Jun 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project CHOICE: Developing a Personalized-Feedback EMA/EMI Intervention for Emerging Adults Leaving Psychiatric Partial Hospitalization
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).
Read the detailed description
Given the relationship between mental health and alcohol problems, there is a need to address comorbidity among emerging adults (EAs) with anxiety and/or depression. The weeks after psychiatric hospitalization are a risky time for problematic alcohol use and recurrence of psychiatric symptoms. The delivery of tailored, coping skills-based, real-time messages could have a significant impact on problematic drinking and depression/anxiety outcomes by reducing the likelihood that an individual drinks to cope with NA.
The aim of this study is to test a 6-week PFIcope+EMI intervention as compared to personalized normative feedback only (PNF) for EA in a partial hospitalization program who drink to cope and binge drink (n=60). The 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). The Personalized Normative Feedback condition (PNF) will receive a personalized normative feedback report but no EMA or EMI.
Participants' alcohol outcomes and psychiatric symptomatology at 6-weeks, 12-weeks, and 6-months will be assessed to determine outcomes and feasibility/acceptability. It is hypothesized that:
- Individuals in PFIcope+EMI arm will report between-subjects reductions in drinking to cope, alcohol use, alcohol-related problems, and NA as compared to PNF.
- PFIcope+EMI will be feasible to implement and result in high rates of participant satisfaction.
Mechanisms that may underlie the efficacy of the intervention for the PFIcope+EMI group utilizing the daily EMA data will be explored. It is hypothesized that:
- In response to NA, participants will report an increase in coping skills utilization and decreased intent to drink at the following EMA assessment point.
- NA reductions and increased coping skills utilization will be related to improvements in alcohol use rates and problems at the following EMA assessment.
- Conditions
- Alcohol Use Disorder
- Being tested
- Personalized Normative Feedback, Coping-Motive Specific Personalized Feedback Intervention plus an Ecological Momentary Intervention (PFIcope+EMI)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Normative FeedbackBehavioural
Normative Feedback on drinking behaviors.
Coping-Motive Specific Personalized Feedback Intervention plus an Ecological Momentary Intervention (PFIcope+EMI)Behavioural
An EMA plus EMI intervention to decrease drinking to cope behaviors among emerging adults receiving psychiatric treatment.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Normative Feedback (PNF) | Active comparator | Participants in the PNF condition will receive normative feedback only on their alcohol use. Receives: 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). Receives: Behavioral: Coping-Motive Specific Personalized Feedback Intervention plus an Ecological Momentary Intervention (PFIcope+EMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinks Per Drinking Day
Drinks per drinking day assessed using the Addiction Severity Index
Measured: 6-week follow-up
Secondary outcomes (5)
Anxiety Coping Drinking Motives
Mean Scores on the Drinking to Cope with Anxiety subscale of the Modified Drinking Motives Questionnaire (range from 1 to 5; higher values reflect greater drinking to cope)
Measured: 6-week follow-up
Depression Coping Drinking Motives
Mean Scores on the Drinking to Cope with Depression subscale of the Modified Drinking Motives Questionnaire (range from 1 to 5; higher values reflect greater drinking to cope)
Measured: 6-weeks
Positive Alcohol Outcome Expectancies
Mean positive alcohol expectancies subscale of the the Comprehensive Effects of Alcohol Measure (CEOA) (range from 1 to 4; higher values reflect greater positive alcohol expectancies)
Measured: 6-week follow-up
Negative Alcohol Expectancies
Mean negative alcohol expectancies subscale of the the Comprehensive Effects of Alcohol Measure (CEOA) (range from 1 to 4; higher values reflect greater negative alcohol expectancies)
Measured: 6-weeks
Alcohol-related Problems
Summed total of alcohol-related problems measured using the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) (range is 0 to 24; higher number reflect more alcohol-related problems)
Measured: 6-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start6 Feb 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Ana M Abrantes, Ph.D., Principal investigator, Butler Hospital/Alpert Medical School of Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074030
- Sponsor's protocol ID
- 2104-001
- Other IDs
- R34AA028572
- Status last verified
- Jun 2026
- First submitted
- 17 Sep 2021
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No