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

Sponsor
Duke University
Study ID
NCT05847582
Status
Not Yet Recruiting

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Conditions

  • Alcohol Drinking
  • Suicide

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard inpatient psychiatric care — BEHAVIORAL
    All participants involved in this study will receive standard of care treatment at Duke University Medical Center's Behavioral Health Inpatient Program.
  • Inpatient Skills Training — BEHAVIORAL
    Inpatient skills training will be completed while participants are receiving inpatient treatment at BHIP. Skills training includes content designed to improve emotional regulation skills.
  • mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS) — BEHAVIORAL
    mSTARS includes inpatient skills training and a mobile health (mHealth) telephone app designed to encourage participants to apply skills acquired in inpatient skills training to real-life situations.

Study Details

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.

Key Dates

First listed
May 6, 2023
Start date
Aug 1, 2026
Status verified
Mar 2026
Primary completion
Oct 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: mSTARS
    Participants randomized to the mSTARS condition will receive standard inpatient care while hospitalized at Duke. They will also receive an intervention that combines inpatient skills training and the mHealth telephone app. Inpatient emotional regulation skills training will be completed while participants are receiving inpatient treatment at Duke. Upon discharge from Duke, patients will download the mHealth app on their personal phones to use in their personal environments for 30 days. The app is designed to encourage participants to apply skills acquired in inpatient skills training to real-life situations.
  • Active Comparator: Treatment As Usual
    Participants randomized to the treatment-as-usual condition will receive standard inpatient care provided at Duke.
  • Active Comparator: Treatment As Usual + Skills Training
    Participants randomized to this condition will receive standard inpatient care and inpatient emotional regulation skills training.

Primary Outcome Measure

Number of participants who are recruited to participate [ Time Frame: 30 days ]

Central Contacts

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