跳至主要内容
临床试验/NCT05847504
NCT05847504Enrolling By Invitation不适用

Successive Cohort Design to Iteratively Develop mSTARS

Duke University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
10
试验地点
1
主要终点
Number of participants who rate the intervention a 16 or more on the Client Satisfaction Questionnaire.

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 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.

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 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

mHealth-supported Skills Training for Alcohol-Related Suicidality, or mSTARS, is an intervention that combines a cognitive-behavioral skills training intervention in emotion regulation skills with a post-discharge mobile health (mHealth) app that encourages application of these skills to real life.

干预措施: mSTARS (Behavioral)

结局指标

主要结局

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.

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 score 54 or more on a measure of emotion regulation skills use.

时间窗: 30 days

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.

次要结局

  • 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 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)
  • Average score on the Beck Scale for Suicidal Ideation(30 days)
  • Number of participants who score 21 or less on the Brief Inventory of Psychosocial Functioning(30 days)
  • Number of participants who score above clinical range on an emotion regulation scale(30 Days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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