Ignite Creation Date:
2024-05-06 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05074030
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2021-09-17
Brief Title:
EMAEMI for Psychiatrically Hospitalized Emerging Adults Who Drink to Cope
Sponsor:
Butler Hospital
Organization:
Butler Hospital
Study Overview
Official Title:
Project CHOICE Developing a Personalized-Feedback EMAEMI Intervention for Emerging Adults Leaving Psychiatric Partial Hospitalization
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this proposed study is to evaluate an ecological momentary assessment plus an ecological momentary intervention EMAEMI 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 PFICopeEMI PFICopeEMI 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 PFIcopeEMI 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 andor 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 depressionanxiety outcomes by reducing the likelihood that an individual drinks to cope with NA
The aim of this study is to test a 6-week PFIcopeEMI intervention as compared to personalized normative feedback only PNF for EA in a partial hospitalization program who drink to cope and binge drink n60 The PFIcopeEMI includes 1 an in-person personalized feedback session to present feedback on problems with drinking to cope discuss the individuals 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 feasibilityacceptability It is hypothesized that
1 Individuals in PFIcopeEMI arm will report between-subjects reductions in drinking to cope alcohol use alcohol-related problems and NA as compared to PNF
2 PFIcopeEMI will be feasible to implement and result in high rates of participant satisfaction
Mechanisms that may underlie the efficacy of the intervention for the PFIcopeEMI 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
The aim of this study is to test a 6-week PFIcopeEMI intervention as compared to personalized normative feedback only PNF for EA in a partial hospitalization program who drink to cope and binge drink n60 The PFIcopeEMI includes 1 an in-person personalized feedback session to present feedback on problems with drinking to cope discuss the individuals 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 feasibilityacceptability It is hypothesized that
1 Individuals in PFIcopeEMI arm will report between-subjects reductions in drinking to cope alcohol use alcohol-related problems and NA as compared to PNF
2 PFIcopeEMI will be feasible to implement and result in high rates of participant satisfaction
Mechanisms that may underlie the efficacy of the intervention for the PFIcopeEMI 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34AA028572 | NIH | None | httpsreporternihgovquickSearchR34AA028572 |