Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05847504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-04-27
Brief Title:
mHealth-supported Skills Training for Alcohol-Related Suicidality
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Successive Cohort Design to Iteratively Develop mSTARS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
mSTARS
Brief 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
Detailed 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 Dukes 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
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 Dukes 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 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