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

NCT05793541 | Recruiting DMC

• 1 other identifier: 2023P000595
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Within two hours of each 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).

  Within two hours of each micro-randomization

Secondary Outcomes (1)

• Objective indicator of safety plan viewing

  Within two hours of each micro-randomization

Other Outcomes (2)

• Suicide attempt

  28 days after hospital discharge

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

  28 days after hospital discharge

Study Arms (1)

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

EXPERIMENTAL

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.

Behavioral: Phone call; Behavioral: Text messaging; Behavioral: Automated interactive smartphone-based tool; Behavioral: Non-interactive pop-up messages

Interventions

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.

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

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.

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

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.

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

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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experiencing suicidal thoughts as part of their inpatient admission
• Access to a smartphone following discharge
• Ability to speak and write English fluently

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of Michigan: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 28564699 BACKGROUND

• 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.

  PMID: 30904843 BACKGROUND

• 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.

  PMID: 32584936 BACKGROUND

• Hedegaard H, Curtin SC, Warner M. Suicide Mortality in the United States, 1999-2019. NCHS Data Brief. 2021 Feb;(398):1-8.

  PMID: 33663651 BACKGROUND

• 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.

  PMID: 26651463 BACKGROUND

• 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.

  BACKGROUND

• Stanley B, Brown GK. Safety planning intervention: A brief intervention to mitigate suicide risk. Cognitive and Behavioral Practice. 2012; 19(2): 256-264.

  BACKGROUND

• 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.

  PMID: 26828397 BACKGROUND

MeSH Terms

Conditions

Suicide; Suicidal Ideation

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Kate Bentley, PhD

CONTACT

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

Walter Dempsey, PhD

CONTACT

wdem@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: During the four weeks following discharge from psychiatric hospitalization for suicidal thoughts or behaviors, participants will be prompted to complete up to 4 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.

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: March 31, 2023
• Study Start: November 19, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)