Clinical trial NCT05847582: mHealth-supported Skills Training for Alcohol-Related Suicidality Phase 3
Official title: Pilot RCT to Evaluate Feasibility and Acceptability of 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: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 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.

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.

Primary outcomes:
measure: Number of participants who are recruited to participate
timeFrame: 30 days
measure: Number of participants who complete the post-treatment visit
timeFrame: 30 days
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
Secondary outcomes:
measure: Average score on the Beck Scale for Suicidal Ideation
timeFrame: 30 days
measure: Average score on the Beck Scale for Suicidal Ideation
timeFrame: 3-month follow-up
measure: Average number of drinking days
timeFrame: 30 days
measure: Average number of drinking days
timeFrame: 3-month follow-up
measure: Number of participants who report re-hospitalization to an inpatient psychiatry unit.
timeFrame: 30 days
measure: Number of participants who report re-hospitalization to an inpatient psychiatry unit.
timeFrame: 3-month follow-up
measure: Number of participants who score above 80 on an emotion regulation scale
timeFrame: 30 days
measure: Number of participants who score above 80 on an emotion regulation scale
timeFrame: 3-month follow-up
measure: Number of participants who score 54 or more on a measure of emotion regulation skills use
timeFrame: 30 days
measure: Number of participants who score 54 or more on a measure of emotion regulation skills use
timeFrame: 3-month follow-up
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: Number of participants who score above the clinical range (T score of 70+) on the global severity index of the Symptom Checklist-90
timeFrame: 3-month follow-up
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 40 or less on a measure of perceived efficacy to abstain from alcohol
timeFrame: 3-month follow-up
measure: 18. Number of participants who score 40 or less on a measure of perceived efficacy to abstain from alcohol
timeFrame: 30 days
measure: 18. Number of participants who score 40 or less on a measure of perceived efficacy to abstain from alcohol
timeFrame: 3-month follow-up
Other outcomes:
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