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Not yet recruiting NCT05847582

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

No phase Interventional Alcohol Drinking Suicide

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard inpatient psychiatric care, Inpatient Skills Training, mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS).
Who it may be relevant to
Registry conditions: Alcohol Drinking, Suicide. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Pilot RCT to Evaluate Feasibility and Acceptability of mSTARS

Overview

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.

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.

Interventions

  • Behavioral Standard inpatient psychiatric care
    All participants involved in this study will receive standard of care treatment at Duke University Medical Center's Behavioral Health Inpatient Program.
  • Behavioral Inpatient Skills Training
    Inpatient skills training will be completed while participants are receiving inpatient treatment at BHIP. Skills training includes content designed to improve emotional regulation skills.
  • Behavioral mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS)
    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.

Primary outcome measures

  • Number of participants who are recruited to participate [Time frame: 30 days]
  • Number of participants who complete the post-treatment visit [Time frame: 30 days]
  • Number of participants who rate the intervention a 16 or more on the Client Satisfaction Questionnaire. [Time frame: 30 days]
  • Number of participants who score above threshold (34 or more) on the mHealth Satisfaction Questionnaire [Time frame: 30 days]
Secondary outcome measures (12)
  • Average score on the Beck Scale for Suicidal Ideation [Time frame: 30 days]
  • Average score on the Beck Scale for Suicidal Ideation [Time frame: 3-month follow-up]
  • Average number of drinking days [Time frame: 30 days]
  • Average number of drinking days [Time frame: 3-month follow-up]
  • Number of participants who report re-hospitalization to an inpatient psychiatry unit. [Time frame: 30 days]
  • Number of participants who report re-hospitalization to an inpatient psychiatry unit. [Time frame: 3-month follow-up]
  • Number of participants who score above 80 on an emotion regulation scale [Time frame: 30 days]
  • Number of participants who score above 80 on an emotion regulation scale [Time frame: 3-month follow-up]
  • Number of participants who score 54 or more on a measure of emotion regulation skills use [Time frame: 30 days]
  • Number of participants who score 54 or more on a measure of emotion regulation skills use [Time frame: 3-month follow-up]
  • Number of participants who score above the clinical range (T score of 70+) on the global severity index of the Symptom Checklist-90 [Time frame: 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 [Time frame: 3-month follow-up]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05847582 · Pro00113104_1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗