mSTARS for Alcohol-Related Suicide Risk

(mSTARS Trial)

JG
AC
Overseen ByAngela C Kirby, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on developing a new treatment called mSTARS, which combines skills training with a mobile app to help individuals manage emotions and reduce suicide risk after hospital discharge. It targets those hospitalized for a suicide crisis who also have patterns of heavy drinking. Participants will learn techniques to better regulate their emotions and will use a smartphone app to apply these skills in daily life. Ideal candidates are those who have been hospitalized for a suicide crisis, drink heavily, own a smartphone, and are fluent in English. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could significantly improve emotional regulation and reduce suicide risk.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the mSTARS intervention is safe?

Research shows that mSTARS, which combines skills training with a mobile health app, aims to help people manage emotions and reduce the risk of suicide linked to alcohol misuse. Although large studies have not directly confirmed its safety, smaller studies have examined similar methods. These studies have not reported major negative effects, suggesting the treatment is generally well-tolerated.

Additionally, mSTARS employs cognitive-behavioral skills, which have been safely used in other contexts. This approach teaches people to better handle emotions, which is generally considered safe. The mobile health app component of mSTARS encourages users to practice these skills daily, further supporting its safe use.

While specific data on mSTARS continues to be gathered, the use of these well-known methods and the absence of major side effects in early testing suggest it is likely safe for most participants.12345

Why are researchers excited about this trial?

Researchers are excited about mSTARS because it offers a novel approach to reducing alcohol-related suicide risk by combining cognitive-behavioral skills with technology. Unlike traditional therapies that rely solely on in-person sessions, mSTARS includes a mobile health (mHealth) app to support users in applying emotion regulation skills in real-life situations after they leave therapy sessions. This integration of digital tools with therapeutic practices aims to enhance accessibility and provide continuous support, potentially increasing the effectiveness of interventions for individuals at risk.

What evidence suggests that mSTARS could be an effective treatment for alcohol-related suicide risk?

Research has shown that drinking alcohol closely links to the risk of suicide. People with alcohol use problems often experience suicidal thoughts or attempts. In this trial, the mSTARS treatment aims to lower this risk by teaching skills to manage emotions and actions. It combines cognitive-behavioral therapy (CBT), which helps change negative thinking, with a mobile health app for ongoing support. Early findings suggest this approach can help people apply these skills in real-life situations, potentially reducing the chance of another crisis.26789

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been hospitalized for a suicide crisis and engage in hazardous drinking, as defined by specific scores on the AUDIT-C test. They must own a smartphone, speak English fluently, and report an average of at least 3 heavy drinking days per week.

Inclusion Criteria

hospitalized for suicide crisis at Duke BHIP
owns a smart phone
an AUDIT-C score indicating hazardous past-month drinking (4 for men; 3 for women) + a 90-day calendar timeline follow-back (TLFB) indicating a minimum of 3 heavy drinking days per week on average (per NIAAA standards)
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Skills Training

Participants receive cognitive-behavioral skills training in emotion regulation while receiving inpatient psychiatric treatment

Duration not specified
Inpatient stay

Post-discharge mHealth App Usage

Participants use a mHealth app to apply skills acquired during inpatient training to real-life situations

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including self-report measures and interviews

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • mSTARS
Trial Overview The mSTARS intervention is being tested to help people manage emotions after they leave the hospital from a suicide crisis. It includes cognitive-behavioral skills training during their stay and continued support through a mobile app post-discharge.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: mSTARSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Citations

mSTARS for Alcohol-Related Suicide Risk (mSTARS Trial)What data supports the effectiveness of the treatment mSTARS for reducing alcohol-related suicide risk? The research suggests that while alcohol use is linked ...
Suicide Risk in Alcohol Use Disorders: Literature Review and ...Studies indicate that individuals with AUD report a lifetime prevalence of 40% for at least one instance of attempted suicide.
Alcohol-Related Risk of Suicidal Ideation, Suicide Attempt, ...The exposure of interest was AUD. The primary outcomes were suicidal ideation, suicide attempt, and completed suicide. We assessed heterogeneity ...
Identifying Factors of Suicide Risk via Behavioral ...The purpose of this study is to see how alcohol use and decision-making can affect suicidal thoughts and behaviors during self-guided therapy for alcohol use ...
Effects of Internet-Based Cognitive Behavioral Therapy for ...This trial aims to investigate the effects of a web-based alcohol program with or without therapist guidance among anonymous adult help-seekers.
Emotion Regulation Skills Training to Enhance Acute ...To inform mHealth app development, we will conduct a 6-week ecological momentary assessment (EMA) study on suicidal psychiatric inpatients who misuse alcohol (N ...
mHealth-supported Skills Training for Alcohol-Related ...Thirty-five inpatients with suicidal thoughts or behaviors who misuse alcohol will be randomized to one of three study conditions -- mSTARS, treatment as usual, ...
A Suicide Prevention Intervention for Emerging Adult ...In the STARS intervention, our transdisciplinary team will develop and pilot-test an intervention to reduce suicidal ideation and behaviors ...
Eric Dedert | Duke Department of Psychiatry & Behavioral ...Grants. Development of mHealth-Supported Skills Training for Alcohol and Related Suicidality (mSTARS): Emotion Regulation Skills Training ...
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