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Just-in-Time Interventions for Reducing Short-Term Suicide Risk

Primary Purpose

Suicide

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Phone call
Text messaging
Automated interactive smartphone-based tool
Non-interactive pop-up messages
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Suicide, Suicidal Thoughts, Micro-Randomized Trial, Ecological Momentary Assessment, Just-in-Time Intervention

Eligibility Criteria

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

Inclusion Criteria: Experiencing suicidal thoughts as part of their inpatient admission Access to a smartphone following discharge Ability to speak and write English fluently Exclusion Criteria: Any factor that impairs the ability to effectively participate in the study (e.g., significant cognitive impairment, intellectual disability, presence of violent behavior, psychotic illness/symptoms determined by the treating clinician to impair ability to understand the study or provide informed consent) Failure to correctly answer all true/false questions in the consent form

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Just-in-time intervention for promoting use of the safety plan or its components

    Arm Description

    Completed surveys will be assigned to a risk level based on self-reported level of suicidal urge and intent. Participants will be "micro-randomized" to one of the available intervention options based on the survey's risk level. All interventions will include reminders to use the safety plan or its components. At high risk (intent >= 8 OR (urge >= 8 AND intent > 0)), participants will be randomized to either receive a phone call from a clinician, text messaging from a clinician, or automated interactive smartphone tool. At medium risk ((intent = 5-7) OR (urge = 5-7 AND intent < 8 but > 0) OR (urge >= 8 AND intent = 0)), participants will be randomized to receive an automated interactive smartphone tool, non-interactive pop-up messages, or no intervention. At low risk ((intent = 1-4) OR (urge = 1-4 AND intent < 5)), participants will be randomized to receive non-interactive pop-up messages or no intervention. No intervention will be given at no risk (intent=0 AND urge=0).

    Outcomes

    Primary Outcome Measures

    Self-reported safety plan and coping strategy use
    Participants will be prompted within two hours of each micro-randomization to complete a brief follow-up smartphone survey that assesses safety plan and/or coping strategy use since the initial survey prompting micro-randomization.
    Self-reported momentary suicidal urges and intent
    Participants will be prompted within two hours of each micro-randomization to complete a brief follow-up smartphone survey that assesses momentary suicidal urge and intent (on a 0 to 10 scale).

    Secondary Outcome Measures

    Objective indicator of safety plan viewing
    The app used for real-time assessments and to deploy the just-in-time interventions will passively capture whether or not the participant opened their safety plan and the time spent viewing their safety plan.

    Full Information

    First Posted
    March 20, 2023
    Last Updated
    March 30, 2023
    Sponsor
    Massachusetts General Hospital
    Collaborators
    National Institutes of Health (NIH), University of Michigan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05793541
    Brief Title
    Just-in-Time Interventions for Reducing Short-Term Suicide Risk
    Official Title
    Micro-randomized Trial to Assess Brief, Just-in-time Interventions for Reducing Short-term Suicide Risk
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2025 (Anticipated)
    Primary Completion Date
    December 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital
    Collaborators
    National Institutes of Health (NIH), University of Michigan

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this study is to test the effects of just-in-time intervention strategies aimed to promote implementation of the safety plan and its components at different levels of suicidal urges and intent. The main questions the investigators aim to answer are: What is the acceptability and feasibility of the just-in-time intervention strategies? What are the proximal effects of just-in-time intervention strategies aimed to promote use of the safety plan and its components? What internal and external contextual factors moderate the just-in-time intervention effects? Participants (adults hospitalized for suicidal thoughts or behaviors) will: Answer questions about current suicidal thoughts on their smartphone up to 6 times each day during both hospitalization and the 4 weeks after they leave the hospital Each time they submit a survey, be immediately randomized to receive (or not receive) a just-in-time intervention tailored to their level of current suicidal thoughts Answer brief follow-up questions on their smartphone within a couple hours of each randomization Provide feedback on their experience with the just-in-time interventions
    Detailed Description
    As the 12th leading cause of death in the United States, suicide is an alarmingly prevalent public health problem. The time period of highest risk for suicide and related behavior (SRB) is immediately (e.g., the weeks) following psychiatric hospitalization. Effective and scalable strategies for preventing SRB among individuals recently discharged from inpatient treatment are urgently needed. Encouragingly, brief evidence-based interventions now exist that reduce risk for suicide after acute psychiatric care. A primary example is safety planning, which involves developing a prioritized list of coping strategies and sources of support that people can use to mitigate future suicidal crises; this intervention is now recommended as part of standard inpatient clinical care. However, it has been shown that well over one-third of suicidal patients who have a safety plan never use it. Additionally, little is known about when (and for whom) specific components of the safety plan, which includes internal coping strategies, social support activities, and help-seeking behaviors, are most accessible and effective. Optimizing real-world safety plan use with scalable intervention strategies delivered via mobile technology has great potential to improve the effectiveness of an already promising intervention and advance precision treatment for high-risk individuals. This project will employ the recently developed micro-randomized trial (MRT) design to test the effectiveness of brief, just-in-time interventions aimed to promote real-world use of the safety plan and its specific components. Both the method (e.g., phone call or text messaging by a human or automated forms of smartphone-based messaging) and content (e.g., recommendation to use the safety plan in its entirety or a specific component) will be randomized according to individuals' current levels of suicidal urges and intent. Participants will be psychiatric inpatients admitted for suicidal thoughts or behaviors who agree to participate in an intensive longitudinal monitoring protocol involving real-time smartphone-based surveys for the 28 days after hospitalization; after each completed survey, participants will be repeatedly "micro-randomized" to one of several just-in-time interventions. The investigators will test the hypotheses that the brief just-in-time interventions will be both acceptable and feasible, and associated with increased use of safety plan components (target mechanism) and reductions in suicidal thoughts (proximal outcome) at high, medium, and low levels of suicidal thoughts, and that intervention effects will vary by both intervention method and content. The investigators will also explore internal and external contextual moderators (e.g., affect, social support) of proximal intervention effects, and collect qualitative data that will inform intervention refinement as well as the future development and implementation of just-in-time adaptive interventions. The investigators will first conduct a small pilot MRT (N=10 participants), after which qualitative feedback collected on the intervention methods, content, amount of support, timing, and triggering, as well as overall data on acceptability and feasibility, will be used to refine the interventions before the full MRT (per Question #1 outlined above). The full MRT of the refined just-in-time interventions will be conducted in N=175 participants (and answer Questions #2 and #3 above).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicide
    Keywords
    Suicide, Suicidal Thoughts, Micro-Randomized Trial, Ecological Momentary Assessment, Just-in-Time Intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    During the four weeks following discharge from psychiatric hospitalization for suicidal thoughts or behaviors, participants will be prompted to complete up to six brief smartphone surveys per day that assess current suicidal urges and intent on a 0 to 10 scale. After each completed survey, participants will be "micro-randomized" to one of several brief just-in-time interventions; both the intervention method (phone call from a clinician, text messaging from a clinician, automated interactive smartphone-based tool, or automated non-interactive pop-up messages) and intervention content (reminder to either use their safety plan [any and all included components] or a specific component of their safety plan) will be randomized according to the current level of suicidal urges and intent.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    185 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Just-in-time intervention for promoting use of the safety plan or its components
    Arm Type
    Experimental
    Arm Description
    Completed surveys will be assigned to a risk level based on self-reported level of suicidal urge and intent. Participants will be "micro-randomized" to one of the available intervention options based on the survey's risk level. All interventions will include reminders to use the safety plan or its components. At high risk (intent >= 8 OR (urge >= 8 AND intent > 0)), participants will be randomized to either receive a phone call from a clinician, text messaging from a clinician, or automated interactive smartphone tool. At medium risk ((intent = 5-7) OR (urge = 5-7 AND intent < 8 but > 0) OR (urge >= 8 AND intent = 0)), participants will be randomized to receive an automated interactive smartphone tool, non-interactive pop-up messages, or no intervention. At low risk ((intent = 1-4) OR (urge = 1-4 AND intent < 5)), participants will be randomized to receive non-interactive pop-up messages or no intervention. No intervention will be given at no risk (intent=0 AND urge=0).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Phone call
    Intervention Description
    A phone call from a trained study clinician that uses a standardized phone script to (a) conduct a risk assessment and (b) recommend that the participant use their safety plan (any and all included components), which will be reviewed and revised as-needed during the call, as well as briefly identifying and troubleshooting barriers to using the safety plan.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Text messaging
    Intervention Description
    A text message conversation initiated by a trained study clinician that uses a standardized text messaging script to (a) conduct a risk assessment and (b) recommend that the participant use their safety plan (any and all included components), which will be reviewed and revised as-needed during the text messaging interaction, as well as briefly identifying and troubleshooting barriers to using the safety plan.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Automated interactive smartphone-based tool
    Intervention Description
    An automated interactive, smartphone-based tool that will (a) (at High risk only) guide the participant through a risk assessment and (b) (at High and Medium Risk) present recommendation to use the safety plan, a review of the safety plan, as well as briefly identifying and troubleshooting any barriers to using the safety plan.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Non-interactive pop-up messages
    Intervention Description
    Automated non-interactive, static pop-up messages that recommends use of the safety plan or its components.
    Primary Outcome Measure Information:
    Title
    Self-reported safety plan and coping strategy use
    Description
    Participants will be prompted within two hours of each micro-randomization to complete a brief follow-up smartphone survey that assesses safety plan and/or coping strategy use since the initial survey prompting micro-randomization.
    Time Frame
    Within two hours of each micro-randomization
    Title
    Self-reported momentary suicidal urges and intent
    Description
    Participants will be prompted within two hours of each micro-randomization to complete a brief follow-up smartphone survey that assesses momentary suicidal urge and intent (on a 0 to 10 scale).
    Time Frame
    Within two hours of each micro-randomization
    Secondary Outcome Measure Information:
    Title
    Objective indicator of safety plan viewing
    Description
    The app used for real-time assessments and to deploy the just-in-time interventions will passively capture whether or not the participant opened their safety plan and the time spent viewing their safety plan.
    Time Frame
    Within two hours of each micro-randomization
    Other Pre-specified Outcome Measures:
    Title
    Suicide attempt
    Description
    The distal outcome of whether or not a suicide attempt occurs during the 28 days after hospital discharge will be captured via nightly smartphone-based self-report survey and manual review of electronic health records.
    Time Frame
    28 days after hospital discharge
    Title
    Hospital visit for suicidal thoughts or suicide-related behavior (SRB)
    Description
    The distal outcome of whether or not a hospital visit occurs for suicidal thoughts or SRB during the 28 days after hospital discharge will be captured via nightly smartphone-based self-report survey and manual review of electronic health records.
    Time Frame
    28 days after hospital discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Experiencing suicidal thoughts as part of their inpatient admission Access to a smartphone following discharge Ability to speak and write English fluently Exclusion Criteria: Any factor that impairs the ability to effectively participate in the study (e.g., significant cognitive impairment, intellectual disability, presence of violent behavior, psychotic illness/symptoms determined by the treating clinician to impair ability to understand the study or provide informed consent) Failure to correctly answer all true/false questions in the consent form
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kate Bentley, PhD
    Phone
    617-724-7741
    Email
    kbentley@mgh.harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Walter Dempsey, PhD
    Email
    wdem@umich.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28564699
    Citation
    Chung DT, Ryan CJ, Hadzi-Pavlovic D, Singh SP, Stanton C, Large MM. Suicide Rates After Discharge From Psychiatric Facilities: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2017 Jul 1;74(7):694-702. doi: 10.1001/jamapsychiatry.2017.1044.
    Results Reference
    background
    PubMed Identifier
    30904843
    Citation
    Chung D, Hadzi-Pavlovic D, Wang M, Swaraj S, Olfson M, Large M. Meta-analysis of suicide rates in the first week and the first month after psychiatric hospitalisation. BMJ Open. 2019 Mar 23;9(3):e023883. doi: 10.1136/bmjopen-2018-023883.
    Results Reference
    background
    PubMed Identifier
    32584936
    Citation
    Doupnik SK, Rudd B, Schmutte T, Worsley D, Bowden CF, McCarthy E, Eggan E, Bridge JA, Marcus SC. Association of Suicide Prevention Interventions With Subsequent Suicide Attempts, Linkage to Follow-up Care, and Depression Symptoms for Acute Care Settings: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2020 Oct 1;77(10):1021-1030. doi: 10.1001/jamapsychiatry.2020.1586.
    Results Reference
    background
    PubMed Identifier
    33663651
    Citation
    Hedegaard H, Curtin SC, Warner M. Suicide Mortality in the United States, 1999-2019. NCHS Data Brief. 2021 Feb;(398):1-8.
    Results Reference
    background
    PubMed Identifier
    26651463
    Citation
    Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.
    Results Reference
    background
    Citation
    National Action Alliance for Suicide Prevention: Transforming Health Systems Initiative Work Group. Recommended standard care for people with suicide risk: Making health care suicide safe. Washington, DC: Education Development Center, Inc.; 2018.
    Results Reference
    background
    Citation
    Stanley B, Brown GK. Safety planning intervention: A brief intervention to mitigate suicide risk. Cognitive and Behavioral Practice. 2012; 19(2): 256-264.
    Results Reference
    background
    PubMed Identifier
    26828397
    Citation
    Stanley B, Chaudhury SR, Chesin M, Pontoski K, Bush AM, Knox KL, Brown GK. An Emergency Department Intervention and Follow-Up to Reduce Suicide Risk in the VA: Acceptability and Effectiveness. Psychiatr Serv. 2016 Jun 1;67(6):680-3. doi: 10.1176/appi.ps.201500082. Epub 2016 Feb 1.
    Results Reference
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