Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT05793541

Conditions

Suicide

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Phone call

Text messaging

Automated interactive smartphone-based tool

Non-interactive pop-up messages

Study Details

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:

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

Conditions

Suicide

Study ID

NCT05793541

Start date

Nov 19, 2024

Status verified date

Oct, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

185 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Completed surveys will be assigned to a risk level (High Risk, Medium/Low Risk, or No Risk) 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, 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/Low risk, participants will be randomized to receive an automated interactive smartphone tool, non-interactive pop-up messages, or no intervention. No randomization will occur (and no intervention given) at No Risk.

Interventions

Phone call

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

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

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

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

Primary outcome measure

  • Self-reported safety plan and coping strategy use [ Time Frame: Within two hours of each micro-randomization ]
  • Self-reported momentary suicidal urges and intent [ Time Frame: Within two hours of each micro-randomization ]

Central Contacts and Locations

Central contacts

Kate Bentley, PhD

617-724-7741kbentley@mgh.harvard.edu

Walter Dempsey, PhD

wdem@umich.edu

Locations

Mass General Brigham

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Kate Bentley, PhD

617-724-7741kbentley@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 23, 2025

Last verified

Oct, 2025

Keywords

  • Suicide
  • Suicidal Thoughts
  • Micro-Randomized Trial
  • Ecological Momentary Assessment
  • Just-in-Time Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-10-23.