mHealth-supported Skills Training for Alcohol-Related Suicidality Phase 3
mSTARS
Pilot RCT to Evaluate Feasibility and Acceptability of mSTARS
1 other identifier
interventional
35
0 countries
N/A
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedStudy Start
First participant enrolled
August 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2027
Study Completion
Last participant's last visit for all outcomes
December 31, 2027
March 9, 2026
March 1, 2026
1.2 years
April 27, 2023
March 5, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Number of participants who are recruited to participate
This is an indication of feasibility of being able to recruit enough participants in a timely manner into the protocol.
30 days
Number of participants who complete the post-treatment visit
Retention will be defined as the number of participants who complete the post-treatment visit that occurs 30 days post-discharge.
30 days
Number of participants who rate the intervention a 16 or more on the Client Satisfaction Questionnaire.
Acceptability of treatment will be measured by an 8-item measure designed to evaluate client satisfaction. Scores range from 8 to 32, with higher scores indicating higher satisfaction.
30 days
Number of participants who score above threshold (34 or more) on the mHealth Satisfaction Questionnaire
Acceptability of treatment will be measured by a 14-item measure designed to measure usability of mobile health apps. Scores range from 14 to 70. Higher scores indicate higher satisfaction.
30 days
Secondary Outcomes (16)
Average score on the Beck Scale for Suicidal Ideation
30 days
Average score on the Beck Scale for Suicidal Ideation
3-month follow-up
Average number of drinking days
30 days
Average number of drinking days
3-month follow-up
Number of participants who report re-hospitalization to an inpatient psychiatry unit.
30 days
- +11 more secondary outcomes
Study Arms (3)
mSTARS
EXPERIMENTALParticipants 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.
Treatment As Usual
ACTIVE COMPARATORParticipants randomized to the treatment-as-usual condition will receive standard inpatient care provided at Duke.
Treatment As Usual + Skills Training
ACTIVE COMPARATORParticipants randomized to this condition will receive standard inpatient care and inpatient emotional regulation skills training.
Interventions
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 will be completed while participants are receiving inpatient treatment at BHIP. Skills training includes content designed to improve emotional regulation skills.
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.
Eligibility Criteria
You may qualify if:
- Age 18+
- hospitalized for suicide crisis at Duke BHIP
- 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)
- owns a smart phone
- fluent in English.
You may not qualify if:
- current psychotic or mania symptoms indicated by the MINI Neuropsychiatric Interview 6.0.(MINI)
- receiving ECT at the time of hospitalization, which could inhibit learning
- engaged in weekly outpatient psychotherapy
- discharging to another high level of psychiatric care.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2023
First Posted
May 6, 2023
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
October 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share