Viewing Study NCT03518619



Ignite Creation Date: 2024-05-06 @ 11:26 AM
Last Modification Date: 2024-10-26 @ 12:45 PM
Study NCT ID: NCT03518619
Status: COMPLETED
Last Update Posted: 2022-11-16
First Post: 2018-04-25

Brief Title: The Development of a Personalized Real-time Intervention
Sponsor: Butler Hospital
Organization: Butler Hospital

Study Overview

Official Title: The Development of a Personalized Real-time Intervention for Substance-using Emerging Adults Leaving Psychiatric Partial Hospitalization
Status: COMPLETED
Status Verified Date: 2022-10
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: PFIcopeEMI
Brief Summary: The investigators propose to enhance our existing coping motive-specific normative feedback intervention PFIcope intervention by capitalizing on EMAEMI technology to pair real-time affective monitoring with tailored real-time relapse prevention texts for individuals with anxiety and depression who drink to cope The goals of the PFIcopeEMI study are to help individuals to identify motives for drinking and to utilize alternate coping strategies for negative affect in place of alcohol
Detailed Description: Emerging adulthood ages 18-25 represents and common and problematic time for alcohol use and mental health issues particularly anxiety and depression Anxiety and depression increase the likelihood of developing risky patterns of alcohol use Indeed individuals who drink alcohol to cope with negative affect such as anxiety and depression report more alcohol use and more severe use-related consequences As such it is important to address alcohol use particularly among a psychiatric population of emerging adults Despite their co-occurrence treatment as usual for anxiety and depression typically does not address alcohol use and alcohol interventions for emerging adults largely ignore anxiety and depression Emerging research suggests interventions that specifically focus on drinking to cope with negative affect are promising in reducing problematic outcomes For example the investigators previously developed a brief personalized feedback intervention that specifically targeted use of alcohol to cope with negative affect among a normative sample of emerging adults Personalized Feedback Intervention for Coping - PFIcope which resulted in decreased drinking to cope In order to adapt PFIcope for a psychiatric population and augment treatment effects the investigators propose adding ecological momentary assessment EMA and intervention EMI in order to identify when emerging adults are at most risk for problematic alcohol use and intervene when needed EMA can assess symptoms in real time and identify high-risk situations for problematic use ie when experiencing negative affect and reports intention to use which can trigger an in-the-moment EMI during that high-risk situation ie individually-chosen relapse prevention coping skills messages

The investigators propose to develop a 6-week PFIcopeEMI intervention for 20 emerging adults in a psychiatric partial hospitalization program who report drinking alcohol to cope with negative affect This will include 1 an in-person personalized feedback session to present normative information and feedback on problems associated with drinking to cope to discuss the individuals use of alcohol to cope and to generate relapse prevention coping skills messages to be used in the EMI text intervention 2 EMA to monitor affect and intention to drink after discharge 3 tailored text messages EMI based on EMA responses ie individualized coping skills messages when individuals report negative affect and intention to drink and 4 additional EMA to monitor coping skills usage alcohol use and drinking to cope The PFIcopeEMI intervention including its associated real-time assessment and messaging systems is low-cost easy to program and can deliver an intervention when individuals are at most risk for engaging in problematic alcohol use

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
U54GM115677 NIH None httpsreporternihgovquickSearchU54GM115677