mHealth-supported Skills Training for Alcohol-Related Suicidality
mSTARS
Successive Cohort Design to Iteratively Develop mSTARS
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2026
Typical duration for not_applicable
1 active site
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
February 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 4, 2028
February 11, 2026
February 1, 2026
2 years
April 27, 2023
February 9, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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
Number of participants who score 54 or more on a measure of emotion regulation skills use.
The Emotion Regulation Skills Questionnaire is a 27-item measure of the extent to which an individual was able to successfully use emotion regulation skills typically taught in emotion regulation skills training interventions. Scores range from 0 to 108, and higher scores indicate more successful use of emotional regulation skills.
30 days
Secondary Outcomes (7)
Number of participants who score above clinical range on an emotion regulation scale
30 Days
Number of participants who score above the clinical range (T score of 70+) on the global severity index of the Symptom Checklist-90
30 days
Average score on the Beck Scale for Suicidal Ideation
30 days
Number of participants who score 40 or less on a measure of perceived efficacy to abstain from alcohol
30 days
Number of participants who score 21 or less on the Brief Inventory of Psychosocial Functioning
30 days
- +2 more secondary outcomes
Study Arms (1)
mSTARS
EXPERIMENTALmHealth-supported Skills Training for Alcohol-Related Suicidality, or mSTARS, is an intervention that combines a cognitive-behavioral skills training intervention in emotion regulation skills with a post-discharge mobile health (mHealth) app that encourages application of these skills to real life.
Interventions
mSTARS combines inpatient cognitive-behavioral skills training and outpatient use of a mobile app encouraging application of acquired skills 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
Study Sites (1)
Duke School of Medicine
Durham, North Carolina, 27704, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2023
First Posted
May 6, 2023
Study Start
February 6, 2026
Primary Completion (Estimated)
February 4, 2028
Study Completion (Estimated)
February 4, 2028
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share