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NCT Number: NCT05793541

Just-in-time Interventions for Reducing Short-term Suicide Risk

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:

1. What is the acceptability and feasibility of the just-in-time intervention strategies? 2. What are the proximal effects of just-in-time intervention strategies aimed to promote use of the safety plan and its components? 3. 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 4 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mass General Brigham

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Kate Bentley, PhD

CONTACT

[email protected]

617-724-7741

About this study

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 varying 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phone call

Behavioral

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. This intervention occurs at High Risk only.

Text messaging

Behavioral

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. This intervention occurs at High Risk only.

Automated interactive smartphone-based tool

Behavioral

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/Low Risk) present recommendation to use and a review of the safety plan.

Non-interactive pop-up messages

Behavioral

Automated non-interactive, static pop-up messages that recommend use of the safety plan or its components (Medium/Low Risk only).

Primary outcomes

  1. Self-reported safety plan and coping strategy use

    Time frame: Within two hours of each micro-randomization

    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.

  2. Self-reported momentary suicidal urges and intent

    Time frame: Within two hours of each micro-randomization

    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 outcomes

  1. Objective indicator of safety plan viewing

    Time frame: Within two hours of each micro-randomization

    The app used for real-time assessments and to deploy the just-in-time interventions will also capture whether or not the participant opened their safety plan.

Other outcomes

  1. Suicide attempt

    Time frame: 28 days after hospital discharge

    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.

  2. Hospital visit for suicidal thoughts or suicide-related behavior (SRB)

    Time frame: 28 days after hospital discharge

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kate Bentley, PhD

CONTACT

[email protected]

617-724-7741

Walter Dempsey, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Michigan

Registry information

Official study title

Micro-randomized Trial to Assess Brief, Just-in-time Interventions for Reducing Short-term Suicide Risk

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2023
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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