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Alcohol DrinkingmSTARSNCT05847582

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

A study testing Standard inpatient psychiatric care, Inpatient Skills Training and mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS) in people with Alcohol Drinking and Suicide, run by Duke University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Drinking, Suicide
What is being tested?
Standard inpatient psychiatric care, Inpatient Skills Training and mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jeremy Grove, PhD contact

919-668-0704

jeremy.grove@duke.edu

Angela C Kirby, MS contact

angela.kirby@duke.edu

About this study

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

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.

Read the detailed 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.

Being tested
Standard inpatient psychiatric care, Inpatient Skills Training, mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS)
Medical subject headings
Alcohol Drinking, Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard inpatient psychiatric careBehavioural

    All participants involved in this study will receive standard of care treatment at Duke University Medical Center's Behavioral Health Inpatient Program.

  • Inpatient Skills TrainingBehavioural

    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)Behavioural

    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 groups in NCT05847582
Study groupRoleWhat they receive
mSTARSExperimentalParticipants 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.
Receives: Behavioral: Standard inpatient psychiatric care; Behavioral: Inpatient Skills Training; Behavioral: mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS)
Treatment As UsualActive comparatorParticipants randomized to the treatment-as-usual condition will receive standard inpatient care provided at Duke.
Receives: Behavioral: Standard inpatient psychiatric care
Treatment As Usual + Skills TrainingActive comparatorParticipants randomized to this condition will receive standard inpatient care and inpatient emotional regulation skills training.
Receives: Behavioral: Standard inpatient psychiatric care; Behavioral: Inpatient Skills Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days

  2. 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.

    Measured: 30 days

  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.

    Measured: 30 days

  4. 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.

    Measured: 30 days

Secondary outcomes (16)
  1. Average score on the Beck Scale for Suicidal Ideation

    Participants will complete the Beck Scale for Suicidal Ideation, a 19-item scale to assess ideation, plans, and/or intent to suicide. Scores range from 0 to 48, with higher scores indicating higher suicide risk.

    Measured: 30 days

  2. Average score on the Beck Scale for Suicidal Ideation

    Participants will complete the Beck Scale for Suicidal Ideation, a 19-item scale to assess ideation, plans, and/or intent to suicide. Scores range from 0 to 48, with higher scores indicating higher suicide risk.

    Measured: 3-month follow-up

  3. Average number of drinking days

    Patients will self-report the number of drinking days in the period between their post-treatment visit and the 3-month follow-up visit.

    Measured: 30 days

  4. Average number of drinking days

    Patients will self-report the number of drinking days in the period between their post-treatment visit and the 3-month follow-up visit.

    Measured: 3-month follow-up

  5. Number of participants who report re-hospitalization to an inpatient psychiatry unit.

    Treatment inefficacy will be measured by the number of participants who are re-hospitalized in the 30 day period following their enrollment in the study.

    Measured: 30 days

  6. Number of participants who report re-hospitalization to an inpatient psychiatry unit.

    Treatment inefficacy will be measured by the number of participants who are re-hospitalized in the 30 day period following their enrollment in the study.

    Measured: 3-month follow-up

  7. Number of participants who score above 80 on an emotion regulation scale

    Number of participants who score above 80 on an emotion regulation scale

    Measured: 30 days

  8. Number of participants who score above 80 on an emotion regulation scale

    Number of participants who score above 80 on an emotion regulation scale

    Measured: 3-month follow-up

  9. 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.

    Measured: 30 days

  10. 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.

    Measured: 3-month follow-up

  11. Number of participants who score above the clinical range (T score of 70+) on the global severity index of the Symptom Checklist-90

    The Symptom Checklist-90 is A self-report 90-item measure of psychological distress with a T-score range of 30 to 120. Higher scores indicate higher distress.

    Measured: 30 days

  12. Number of participants who score above the clinical range (T score of 70+) on the global severity index of the Symptom Checklist-90

    The Symptom Checklist-90 is A self-report 90-item measure of psychological distress with a T-score range of 30 to 120. Higher scores indicate higher distress.

    Measured: 3-month follow-up

  13. Number of participants who score 40 or less on a measure of perceived efficacy to abstain from alcohol

    Participants will complete the 20-item Alcohol Abstinence Self-Efficacy scale indicating how confident they are in ability to abstain from alcohol in certain situations. Scores range from 20 to 100, with higher scores indicating higher confidence to abstain from alcohol use.

    Measured: 30 days

  14. Number of participants who score 40 or less on a measure of perceived efficacy to abstain from alcohol

    Participants will complete the 20-item Alcohol Abstinence Self-Efficacy scale indicating how confident they are in ability to abstain from alcohol in certain situations. Scores range from 20 to 100, with higher scores indicating higher confidence to abstain from alcohol use.

    Measured: 3-month follow-up

  15. 18. Number of participants who score 40 or less on a measure of perceived efficacy to abstain from alcohol

    Participants will complete the 20-item Alcohol Abstinence Self-Efficacy scale indicating how confident they are in ability to abstain from alcohol in certain situations. Scores range from 20 to 100, with higher scores indicating higher confidence to abstain from alcohol use

    Measured: 30 days

  16. 18. Number of participants who score 40 or less on a measure of perceived efficacy to abstain from alcohol

    Participants will complete the 20-item Alcohol Abstinence Self-Efficacy scale indicating how confident they are in ability to abstain from alcohol in certain situations. Scores range from 20 to 100, with higher scores indicating higher confidence to abstain from alcohol use

    Measured: 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05847582
Sponsor's protocol ID
Pro00113104_1
Acronym
mSTARS
Status last verified
Mar 2026
First submitted
27 Apr 2023
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Standard inpatient psychiatric care, Inpatient Skills Training and mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS) in people with Alcohol Drinking and Suicide, run by Duke University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jeremy Grove, PhD (919-668-0704, jeremy.grove@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who are recruited to participate (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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