- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05793541
Just-in-Time Interventions for Reducing Short-Term Suicide Risk
Micro-randomized Trial to Assess Brief, 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:
- 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
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kate Bentley, PhD
- Phone Number: 617-724-7741
- Email: kbentley@mgh.harvard.edu
Study Contact Backup
- Name: Walter Dempsey, PhD
- Email: wdem@umich.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Just-in-time intervention for promoting use of the safety plan or its components
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).
|
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.
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.
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.
Automated non-interactive, static pop-up messages that recommends use of the safety plan or its components.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Within two hours of each micro-randomization
|
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).
|
Within two hours of each micro-randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 passively capture whether or not the participant opened their safety plan and the time spent viewing their safety plan.
|
Within two hours of each micro-randomization
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
28 days after hospital discharge
|
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.
|
28 days after hospital discharge
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Hedegaard H, Curtin SC, Warner M. Suicide Mortality in the United States, 1999-2019. NCHS Data Brief. 2021 Feb;(398):1-8.
- 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.
- Stanley B, Brown GK. Safety planning intervention: A brief intervention to mitigate suicide risk. Cognitive and Behavioral Practice. 2012; 19(2): 256-264.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023P000595
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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