mHealth-supported Skills Training for Alcohol-Related Suicidality Phase 3 — mSTARS  

Suicide Clinical Trial

Official title: Pilot RCT to Evaluate Feasibility and Acceptability of mSTARS

Status Not yet recruiting

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 evaluate the feasibility and acceptability of an intervention called mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS). Thirty-five inpatients with suicidal thoughts or behaviors who misuse alcohol will be randomized to one of three study conditions -- mSTARS, treatment as usual, or treatment as usual with skills training.

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 evaluate the feasibility and acceptability of an intervention called mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS). Inpatients (N = 35) with suicidal thoughts or behaviors who misuse alcohol will be randomized to one of three study conditions: 1) mSTARS (n = 15), 2) treatment as usual (TAU) plus skills training (n = 10), or 3) TAU alone (n = 10). Primary outcomes include feasibility (e.g., recruitment, retention) and acceptability (e.g., patient satisfaction). Secondary outcomes include suicidal thoughts/behaviors, alcohol use, skills utilization, and rehospitalization.

Participants will complete four study visits, including consent and screening, inpatient treatment, post-treatment assessment, and a 3-month follow-up assessment. After the screening visit, participants will be block-randomized to one of three study conditions listed in item 1.a. above. All participants will receive standard inpatient care. Participants randomized to the mSTARS condition will also receive an intervention that combines inpatient skills training and the mHealth telephone app. Inpatient skills training will be completed while participants are receiving inpatient treatment at BHIP. 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 BHIP, 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. Participants assigned to the TAU plus skills training will receive standard inpatient care plus the inpatient skills training described above. Participants assigned to the TAU condition will receive standard inpatient care only. All participants will be seen for a post-treatment assessment at 30-days and 3-months post-discharge. ;

Related Conditions & MeSH terms

• Alcohol Drinking
• Suicide

• NCT number: NCT05847582
• 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: July 1, 2025
• Completion date: August 31, 2027