EMA/EMI for Psychiatrically Hospitalized Emerging Adults Who Drink to Cope

Alcohol Use Disorder Clinical Trial

Official title:

Project CHOICE: Developing a Personalized-Feedback EMA/EMI Intervention for Emerging Adults Leaving Psychiatric Partial Hospitalization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05074030
• Other study ID #: 2104-001
• Secondary ID: R34AA028572
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Butler Hospital
• Contact: Ana M Abrantes, Ph.D.
• Phone: 401-455-6440
• Email: Ana_Abrantes[@]Brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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:

1. 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.

2. 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:

1. In response to NA, participants will report an increase in coping skills utilization and decreased intent to drink at the following EMA assessment point.

2. NA reductions and increased coping skills utilization will be related to improvements in alcohol use rates and problems at the following EMA assessment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

1. between 18 and 25 years of age

2. 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)

3. 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")

4. 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)

5. owns a smartphone capable of downloading EMA app.

Exclusion Criteria:

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

2. a history of psychotic disorder or current psychotic symptoms as assessed by research staff via SCID

3. current suicidal/homicidal ideation.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Personalized Normative Feedback
Normative Feedback on drinking behaviors.
• Coping-Motive Specific Personalized Feedback Intervention plus an Ecological Momentary Intervention (PFIcope+EMI)
An EMA plus EMI intervention to decrease drinking to cope behaviors among emerging adults receiving psychiatric treatment.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Drinks per Drinking Days	Drinks per drinking day assessed using the Timeline Followback (TLFB)	12-week follow-up
Other	Drinks per Drinking Days	Drinks per drinking day assessed using the Timeline Followback (TLFB)	6-month follow-up
Other	Drinking Motives	Mean Scores on the Drinking to Cope subscale of the Modified Drinking Motives Questionnaire (range from 5 to 25; higher values reflect greater drinking to cope)	12-week follow-up
Other	Drinking Motives	Mean Scores on the Drinking to Cope subscale of the Modified Drinking Motives Questionnaire (range from 5 to 25; higher values reflect greater drinking to cope)	6-month follow-up
Other	Alcohol-related problems	Number of consequences of alcohol use assessed with the Rutgers Alcohol Problems Index	12-week follow-up
Other	Alcohol-related problems	Number of consequences of alcohol use assessed with the Rutgers Alcohol Problems Index	6-month follow-up
Other	Alcohol Outcome Expectancies	The number of benefits and costs associated with changing drinking behaviors as measured by the Alcohol Outcome Expectancies Questionnaire	12-week follow-up
Other	Alcohol Outcome Expectancies	The number of benefits and costs associated with changing drinking behaviors as measured by the Alcohol Outcome Expectancies Questionnaire	6-month follow-up
Primary	Drinks per Drinking Days	Drinks per drinking day assessed using the Timeline Followback (TLFB)	6-week follow-up
Secondary	Drinking Motives	Mean Scores on the Drinking to Cope subscale of the Modified Drinking Motives Questionnaire (range from 5 to 25; higher values reflect greater drinking to cope)	6-week follow-up
Secondary	Alcohol-related problems	Number of consequences of alcohol use assessed with the Rutgers Alcohol Problems Index	6-week follow-up
Secondary	Alcohol Outcome Expectancies	The number of benefits and costs associated with changing drinking behaviors as measured by the Alcohol Outcome Expectancies Questionnaire	6-week follow-up