Alcohol Use Disorder
Conditions
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: 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.
Interventions
BEHAVIORALPersonalized Normative Feedback
Normative Feedback on drinking behaviors.
BEHAVIORALCoping-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.
Sponsors
Butler Hospital
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drinks Per Drinking Day | 6-week follow-up | Drinks per drinking day assessed using the Addiction Severity Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Coping Drinking Motives | 6-week follow-up | 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) |
| Depression Coping Drinking Motives | 6-weeks | 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) |
| Positive Alcohol Outcome Expectancies | 6-week follow-up | 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) |
| Negative Alcohol Expectancies | 6-weeks | 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) |
| Alcohol-related Problems | 6-week follow-up | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAna M Abrantes, Ph.D.
Butler Hospital/Alpert Medical School of Brown University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 22.10 years STANDARD_DEVIATION 1.87 |
| alcohol-related problems | 14.69 Scores on a scale STANDARD_DEVIATION 5.91 |
| anxiety coping drinking motive | 3.44 Scores on a scale STANDARD_DEVIATION 0.88 |
| depression coping drinking motive | 3.28 Scores on a scale STANDARD_DEVIATION 1.03 |
| drinks per drinking day | 5.83 drinks per drinking day STANDARD_DEVIATION 3.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| negative expectancies | 2.66 scores on a scale STANDARD_DEVIATION 0.55 |
| positive expectancies | 3.04 Scores on a scale STANDARD_DEVIATION 0.32 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 31 |
| other Total, other adverse events | 6 / 29 | 9 / 31 |
| serious Total, serious adverse events | 0 / 29 | 0 / 31 |
Outcome results
None listed