Clinical trial NCT05847504: mHealth-supported Skills Training for Alcohol-Related Suicidality
Official title: Successive Cohort Design to Iteratively Develop mSTARS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Suicide
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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. Inpatient skills training will be completed while participants are receiving inpatient psychiatric treatment. 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's inpatient program, 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. Upon completion of the 30-day period, participants will complete self-report measures and participate in a semi-structured qualitative interview designed to evaluate their experience with the mSTARS intervention.

Eligibility criteria: Inclusion Criteria:

1. Age 18+
2. hospitalized for suicide crisis at Duke BHIP
3. 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)
4. owns a smart phone
5. fluent in English.

Exclusion Criteria:

1. current psychotic or mania symptoms indicated by the MINI Neuropsychiatric Interview 6.0.(MINI)
2. receiving ECT at the time of hospitalization, which could inhibit learning
3. engaged in weekly outpatient psychotherapy
4. discharging to another high level of psychiatric care.

Primary outcomes:
measure: Number of participants who rate the intervention a 16 or more on the Client Satisfaction Questionnaire.
timeFrame: 30 days
measure: Number of participants who score above threshold (34 or more) on the mHealth Satisfaction Questionnaire
timeFrame: 30 days
measure: Number of participants who score 54 or more on a measure of emotion regulation skills use.
timeFrame: 30 days
Secondary outcomes:
measure: Number of participants who score above clinical range on an emotion regulation scale
timeFrame: 30 Days
measure: Number of participants who score above the clinical range (T score of 70+) on the global severity index of the Symptom Checklist-90
timeFrame: 30 days
measure: Average score on the Beck Scale for Suicidal Ideation
timeFrame: 30 days
measure: Number of participants who score 40 or less on a measure of perceived efficacy to abstain from alcohol
timeFrame: 30 days
measure: Number of participants who score 21 or less on the Brief Inventory of Psychosocial Functioning
timeFrame: 30 days
measure: Average number of drinking days
timeFrame: 30 days
measure: Number of participants who report re-hospitalization to an inpatient psychiatry unit.
timeFrame: 30 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke School of Medicine
state: North Carolina
Study officials:
References: