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mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS)

Primary Purpose

Alcohol Drinking, Suicide

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mSTARS
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    mSTARS

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Number of participants who score above clinical range on an emotion regulation scale
    Emotion regulation will be measured with the Difficulties in Emotion Regulation Scale, a 36-item scale designed to evaluate emotion regulation. Scores range from 36 to 180, with higher scores indicating poorer emotion regulation. A cut score of 80 will be used.
    Number of participants who score above the clinical range (T score of 70+) on the global severity index of the Symptom Checklist-90
    Participants will complete the Symptom Checklist-90, a self-report, 90-item measure of psychological distress with a T-score range of 30 to 120. Higher scores indicate higher distress.
    Average score on the Beck Scale for Suicidal Ideation
    Participants will complete the Beck Scale for Suicidal Ideation, a 19-item scale to assess ideation, plans, and/or intent to suicide. Scores range from 0 to 48, with higher scores indicating higher suicide risk.
    Number of participants who score 40 or less on a measure of perceived efficacy to abstain from alcohol
    Participants will complete the 20-item Alcohol Abstinence Self-Efficacy scale indicating how confident they are in ability to abstain from alcohol in certain situations. Scores range from 20 to 100, with higher scores indicating higher confidence to abstain from alcohol use.
    Number of participants who score 21 or less on the Brief Inventory of Psychosocial Functioning
    Participants will complete the 7-item Brief Inventory of Psychosocial Functioning which is a measure of how individuals are doing in their various domains of psychosocial functioning. Scores range from 0 to 49, with higher scores indicating poorer psychosocial functioning.
    Average number of drinking days
    Patients will self-report the number of drinking days in the past 30 days.
    Number of participants who report re-hospitalization to an inpatient psychiatry unit.
    Treatment inefficacy will be measured by the number of participants who are re-hospitalized in the 30 day period following their enrollment in the study.

    Full Information

    First Posted
    April 27, 2023
    Last Updated
    September 11, 2023
    Sponsor
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05847504
    Brief Title
    mHealth-supported Skills Training for Alcohol-Related Suicidality
    Acronym
    mSTARS
    Official Title
    Successive Cohort Design to Iteratively Develop mSTARS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2024 (Anticipated)
    Primary Completion Date
    June 30, 2025 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Drinking, Suicide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    mSTARS
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    mSTARS
    Intervention Description
    mSTARS combines inpatient cognitive-behavioral skills training and outpatient use of a mobile app encouraging application of acquired skills to real life situations.
    Primary Outcome Measure Information:
    Title
    Number of participants who rate the intervention a 16 or more on the Client Satisfaction Questionnaire.
    Description
    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.
    Time Frame
    30 days
    Title
    Number of participants who score above threshold (34 or more) on the mHealth Satisfaction Questionnaire
    Description
    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.
    Time Frame
    30 days
    Title
    Number of participants who score 54 or more on a measure of emotion regulation skills use.
    Description
    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.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Number of participants who score above clinical range on an emotion regulation scale
    Description
    Emotion regulation will be measured with the Difficulties in Emotion Regulation Scale, a 36-item scale designed to evaluate emotion regulation. Scores range from 36 to 180, with higher scores indicating poorer emotion regulation. A cut score of 80 will be used.
    Time Frame
    30 Days
    Title
    Number of participants who score above the clinical range (T score of 70+) on the global severity index of the Symptom Checklist-90
    Description
    Participants will complete the Symptom Checklist-90, a self-report, 90-item measure of psychological distress with a T-score range of 30 to 120. Higher scores indicate higher distress.
    Time Frame
    30 days
    Title
    Average score on the Beck Scale for Suicidal Ideation
    Description
    Participants will complete the Beck Scale for Suicidal Ideation, a 19-item scale to assess ideation, plans, and/or intent to suicide. Scores range from 0 to 48, with higher scores indicating higher suicide risk.
    Time Frame
    30 days
    Title
    Number of participants who score 40 or less on a measure of perceived efficacy to abstain from alcohol
    Description
    Participants will complete the 20-item Alcohol Abstinence Self-Efficacy scale indicating how confident they are in ability to abstain from alcohol in certain situations. Scores range from 20 to 100, with higher scores indicating higher confidence to abstain from alcohol use.
    Time Frame
    30 days
    Title
    Number of participants who score 21 or less on the Brief Inventory of Psychosocial Functioning
    Description
    Participants will complete the 7-item Brief Inventory of Psychosocial Functioning which is a measure of how individuals are doing in their various domains of psychosocial functioning. Scores range from 0 to 49, with higher scores indicating poorer psychosocial functioning.
    Time Frame
    30 days
    Title
    Average number of drinking days
    Description
    Patients will self-report the number of drinking days in the past 30 days.
    Time Frame
    30 days
    Title
    Number of participants who report re-hospitalization to an inpatient psychiatry unit.
    Description
    Treatment inefficacy will be measured by the number of participants who are re-hospitalized in the 30 day period following their enrollment in the study.
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jeremy Grove, PhD
    Phone
    919-668-0704
    Email
    jeremy.grove@duke.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Angela C Kirby, MS
    Email
    angela.kirby@duke.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    mHealth-supported Skills Training for Alcohol-Related Suicidality

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