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Clinical Trial Summary

Suicide is a high priority public health problem and an increasingly prevalent alcohol-related consequence. One-third of people who die by suicide consume alcohol at hazardous rates in the year preceding death. Most people in an acute suicide crisis who present for treatment are admitted to acute psychiatric hospitalization. Yet, the 30-day period following discharge from hospitalization is by far the riskiest period for another suicide crisis. The specific aim for this project is to use a successive cohort design to iteratively develop an intervention called mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS). The study team will adapt and iteratively refine a cognitive-behavioral skills training intervention in emotion regulation to be administered in an acute care setting and paired with a post-discharge mHealth app that encourages application of these skills to real life. Two cohorts of five participants each will be enrolled in the project. Participants will complete mSTARS, an intervention that combines inpatient skills training and the mHealth telephone app. Upon completion of the 30-day period, participants will complete self-report measures and participate in an interview designed to evaluate their experience with the mSTARS intervention.


Clinical Trial Description

Suicide is a high priority public health problem and an increasingly prevalent alcohol-related consequence. One-third of people who die by suicide consume alcohol at hazardous rates in the year preceding death. Most people in an acute suicide crisis who present for treatment are admitted to acute psychiatric hospitalization. Yet, the 30-day period following discharge from hospitalization is by far the riskiest period for another suicide crisis, (post-discharge rates of suicide are 600 times the global rate). Critically, 50% of suicidal inpatients report alcohol misuse, which further heightens post-discharge risk for suicide. Acute psychiatric hospitalization focuses on rapid crisis resolution before discharging patients back into their environments with a referral for outpatient care. Outpatient-based cognitive-behavioral skills training in emotion regulation successfully treats concurrent alcohol misuse and suicidal behavior by targeting deficits in emotion regulation associated with both behaviors. Yet, fewer than 50% of psychiatric inpatients follow up with outpatient care once discharged, and those who seek care are often unable to receive it for weeks. Persistently low use of outpatient therapies coupled with alarming post-discharge rates of suicide represents an urgent quality gap. Alternative strategies for inpatient care that extend treatment into the critical post-discharge period are clearly needed to prevent suicide in psychiatric inpatients who misuse alcohol. The specific aim for this project is to use a successive cohort design to iteratively develop an intervention called mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS). The study team will adapt and iteratively refine a cognitive-behavioral skills training intervention in emotion regulation to be administered in an acute care setting and paired with a post-discharge mHealth app that encourages application of these skills to real life. Two cohorts of five participants each will be enrolled in the project. Participants will complete mSTARS, an intervention that combines inpatient skills training and the mHealth telephone app. Inpatient skills training will be completed while participants are receiving inpatient psychiatric treatment. Skills training includes content designed to improve emotional regulation skills, including motivational enhancement, emotional awareness and acceptance, thinking flexibly, changing emotions, countering cravings, and relapse prevention. Upon discharge from Duke's inpatient program, patients will download the mHealth app on their personal phones to use in the personal environments for 30 days. The app is designed to encourage participants to apply skills acquired in inpatient skills training to real-life situations. Upon completion of the 30-day period, participants will complete self-report measures and participate in a semi-structured qualitative interview designed to evaluate their experience with the mSTARS intervention. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05847504
Study type Interventional
Source Duke University
Contact Jeremy Grove, PhD
Phone 919-668-0704
Email jeremy.grove@duke.edu
Status Not yet recruiting
Phase N/A
Start date June 1, 2024
Completion date June 30, 2025

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