跳至主要内容
临床试验/NCT05847582
NCT05847582尚未招募不适用

Pilot RCT to Evaluate Feasibility and Acceptability of mSTARS

Duke University0 个研究点目标入组 35 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
35
主要终点
Number of participants who are recruited to participate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

mSTARS

Experimental

Participants 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.

干预措施: Standard inpatient psychiatric care (Behavioral)

mSTARS

Experimental

Participants 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.

干预措施: Inpatient Skills Training (Behavioral)

mSTARS

Experimental

Participants 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.

干预措施: mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS) (Behavioral)

Treatment As Usual

Active Comparator

Participants randomized to the treatment-as-usual condition will receive standard inpatient care provided at Duke.

干预措施: Standard inpatient psychiatric care (Behavioral)

Treatment As Usual + Skills Training

Active Comparator

Participants randomized to this condition will receive standard inpatient care and inpatient emotional regulation skills training.

干预措施: Standard inpatient psychiatric care (Behavioral)

Treatment As Usual + Skills Training

Active Comparator

Participants randomized to this condition will receive standard inpatient care and inpatient emotional regulation skills training.

干预措施: Inpatient Skills Training (Behavioral)

结局指标

主要结局

Number of participants who are recruited to participate

时间窗: 30 days

This is an indication of feasibility of being able to recruit enough participants in a timely manner into the protocol.

Number of participants who score above threshold (34 or more) on the mHealth Satisfaction Questionnaire

时间窗: 30 days

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.

Number of participants who complete the post-treatment visit

时间窗: 30 days

Retention will be defined as the number of participants who complete the post-treatment visit that occurs 30 days post-discharge.

Number of participants who rate the intervention a 16 or more on the Client Satisfaction Questionnaire.

时间窗: 30 days

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.

次要结局

  • Average number of drinking days(3-month follow-up)
  • Number of participants who score 54 or more on a measure of emotion regulation skills use(3-month follow-up)
  • Number of participants who report re-hospitalization to an inpatient psychiatry unit.(3-month follow-up)
  • 18. Number of participants who score 40 or less on a measure of perceived efficacy to abstain from alcohol(3-month follow-up)
  • Average score on the Beck Scale for Suicidal Ideation(3-month follow-up)
  • Number of participants who score above 80 on an emotion regulation scale(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(3-month follow-up)
  • Number of participants who score 40 or less on a measure of perceived efficacy to abstain from alcohol(3-month follow-up)
  • Average score on the Beck Scale for Suicidal Ideation(30 days)
  • Average number of drinking days(30 days)
  • Number of participants who report re-hospitalization to an inpatient psychiatry unit.(30 days)
  • Number of participants who score above 80 on an emotion regulation scale(30 days)
  • Number of participants who score 54 or more on a measure of emotion regulation skills use(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)
  • Number of participants who score 40 or less on a measure of perceived efficacy to abstain from alcohol(30 days)
  • 18. Number of participants who score 40 or less on a measure of perceived efficacy to abstain from alcohol(30 days)

研究者

申办方类型
Other
责任方
Sponsor

相似试验