EMA/EMI for Psychiatrically Hospitalized Emerging Adults Who Drink to Cope
Primary Purpose
Alcohol Use Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Normative Feedback
Coping-Motive Specific Personalized Feedback Intervention plus an Ecological Momentary Intervention (PFIcope+EMI)
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Butler HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
PNF
PFIcope+EMI
Arm Description
Participants in the PNF condition will receive normative feedback only on their alcohol use.
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).
Outcomes
Primary Outcome Measures
Drinks per Drinking Days
Drinks per drinking day assessed using the Timeline Followback (TLFB)
Secondary Outcome Measures
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)
Alcohol-related problems
Number of consequences of alcohol use assessed with the Rutgers Alcohol Problems Index
Alcohol Outcome Expectancies
The number of benefits and costs associated with changing drinking behaviors as measured by the Alcohol Outcome Expectancies Questionnaire
Full Information
NCT ID
NCT05074030
First Posted
September 17, 2021
Last Updated
February 15, 2023
Sponsor
Butler Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05074030
Brief Title
EMA/EMI for Psychiatrically Hospitalized Emerging Adults Who Drink to Cope
Official Title
Project CHOICE: Developing a Personalized-Feedback EMA/EMI Intervention for Emerging Adults Leaving Psychiatric Partial Hospitalization
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PNF
Arm Type
Active Comparator
Arm Description
Participants in the PNF condition will receive normative feedback only on their alcohol use.
Arm Title
PFIcope+EMI
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Personalized Normative Feedback
Intervention Description
Normative Feedback on drinking behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Coping-Motive Specific Personalized Feedback Intervention plus an Ecological Momentary Intervention (PFIcope+EMI)
Intervention Description
An EMA plus EMI intervention to decrease drinking to cope behaviors among emerging adults receiving psychiatric treatment.
Primary Outcome Measure Information:
Title
Drinks per Drinking Days
Description
Drinks per drinking day assessed using the Timeline Followback (TLFB)
Time Frame
6-week follow-up
Secondary Outcome Measure Information:
Title
Drinking Motives
Description
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)
Time Frame
6-week follow-up
Title
Alcohol-related problems
Description
Number of consequences of alcohol use assessed with the Rutgers Alcohol Problems Index
Time Frame
6-week follow-up
Title
Alcohol Outcome Expectancies
Description
The number of benefits and costs associated with changing drinking behaviors as measured by the Alcohol Outcome Expectancies Questionnaire
Time Frame
6-week follow-up
Other Pre-specified Outcome Measures:
Title
Drinks per Drinking Days
Description
Drinks per drinking day assessed using the Timeline Followback (TLFB)
Time Frame
12-week follow-up
Title
Drinks per Drinking Days
Description
Drinks per drinking day assessed using the Timeline Followback (TLFB)
Time Frame
6-month follow-up
Title
Drinking Motives
Description
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)
Time Frame
12-week follow-up
Title
Drinking Motives
Description
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)
Time Frame
6-month follow-up
Title
Alcohol-related problems
Description
Number of consequences of alcohol use assessed with the Rutgers Alcohol Problems Index
Time Frame
12-week follow-up
Title
Alcohol-related problems
Description
Number of consequences of alcohol use assessed with the Rutgers Alcohol Problems Index
Time Frame
6-month follow-up
Title
Alcohol Outcome Expectancies
Description
The number of benefits and costs associated with changing drinking behaviors as measured by the Alcohol Outcome Expectancies Questionnaire
Time Frame
12-week follow-up
Title
Alcohol Outcome Expectancies
Description
The number of benefits and costs associated with changing drinking behaviors as measured by the Alcohol Outcome Expectancies Questionnaire
Time Frame
6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana M Abrantes, Ph.D.
Phone
401-455-6440
Email
Ana_Abrantes@Brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana M Abrantes, Ph.D.
Organizational Affiliation
Butler Hospital/Alpert Medical School of Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana M Abrantes, Ph.D.
Phone
401-455-6440
Email
Ana_Abrantes@Brown.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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EMA/EMI for Psychiatrically Hospitalized Emerging Adults Who Drink to Cope
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