Just-in-time Interventions for Suicide Risk

Overseen By Walter Dempsey, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cognitive impairment, Intellectual disability, Psychotic illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

185 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether just-in-time interventions can help individuals use safety plans during suicidal thoughts. Participants will receive various types of support, such as phone calls or text messages, based on their risk level. The trial will assess the ease of use and effectiveness of these interventions. It suits adults hospitalized for suicidal thoughts who have smartphone access after discharge. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could enhance mental health support strategies.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these just-in-time intervention strategies are safe for participants?

Research has shown that just-in-time interventions (JITAIs) can be safe and effective for preventing suicide. These tools provide help exactly when needed. Studies highlight that automated smartphone tools, like ResourceBot, show promise in encouraging people to use crisis services at critical times. This approach aims to be supportive without being intrusive.

Text messaging has been well-received in earlier research. Specifically, a study with young people at risk of suicide found that text-based support helped reduce suicidal thoughts and behaviors. The texts offered caring contact, which had a positive impact.

Phone calls from trained professionals have also been studied. Research shows that people often find these calls helpful during a crisis. They provide immediate support and encourage seeking further help, which can be reassuring.

For non-interactive pop-up messages, the research is less detailed, but they are part of the broader JITAI approach. These messages are designed to offer support at the right moment without needing an immediate response.

These interventions are generally well-tolerated. They aim to provide timely support without overwhelming users. If considering joining a trial using these strategies, this evidence suggests they are safe and have been positively received by others in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for suicide risk because they offer personalized, just-in-time support tailored to an individual's current risk level. Unlike traditional treatments, which often involve scheduled therapy sessions or medication, these tools provide immediate, risk-level-specific responses, such as a phone call from a clinician at high risk or an interactive smartphone tool at medium risk. This innovative approach aims to engage individuals with timely and relevant interventions, potentially preventing crises before they escalate.

What evidence suggests that this trial's interventions could be effective for reducing suicidal thoughts?

Research has shown that just-in-time adaptive interventions (JITAIs), studied in this trial, can help reduce suicide risk. Participants may receive different interventions based on their risk level. Automated smartphone tools, one intervention option, encourage people to use crisis services during critical times. Studies indicate that crisis calls, another option, effectively support 98% of callers, with 88% avoiding self-harm. Text messaging, also tested in this trial, led to a 22% decrease in repeated self-harm, proving it a simple and effective method. Non-interactive pop-up messages, another option, aim to provide timely support by reminding individuals to use their safety plan. Overall, these interventions show promise in providing help when needed most. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults hospitalized due to suicidal thoughts or behaviors who have access to a smartphone and can speak and write English fluently. It's not suitable for those who don't meet these criteria.

Inclusion Criteria

I am having suicidal thoughts during my hospital stay.

Access to a smartphone following discharge

Ability to speak and write English fluently

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pilot Micro-randomized Trial

Conduct a small pilot MRT with 10 participants to collect qualitative feedback on intervention methods and refine interventions

4 weeks

Daily smartphone-based surveys

Full Micro-randomized Trial

Conduct the full MRT with 175 participants to test the effectiveness of just-in-time interventions for promoting safety plan use

4 weeks

Daily smartphone-based surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment, including capturing suicide attempts and hospital visits

28 days

Nightly smartphone-based self-report survey

What Are the Treatments Tested in This Trial?

Interventions

• Automated interactive smartphone-based tool
• Non-interactive pop-up messages
• Phone call
• Text messaging

Trial Overview

The study tests just-in-time interventions like text messages, phone calls, non-interactive pop-ups, and an automated tool on smartphones to see if they help people follow their safety plans when feeling suicidal urges after hospital discharge.

How Is the Trial Designed?

Group I: Just-in-time intervention for promoting use of the safety plan or its components Experimental Treatment 4 Interventions

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

A systematic review of 38 recently approved medical devices for just-in-time interventions (JITIs) revealed that only 26.3% provided a clear understanding of how they operate, indicating a lack of transparency in device functionality.

The review found that only 13.2% of product summaries included results from clinical studies assessing the effectiveness of these devices, highlighting a significant gap in available evidence on their performance and clinical impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of US Food and Drug Administration-Approved Digital Medical Devices for Just-in-Time Interventions: A Systematic Review. Phi, NTT., Oikonomidi, T., Ravaud, P., et al.[2023]

The suicide rate in the U.S. has remained largely unchanged for the past century, highlighting the urgent need for innovative prevention strategies.

Just-In-Time Adaptive Interventions (JITAIs) using smartphones and wearables could provide timely, personalized support for individuals experiencing suicidal thoughts, potentially improving the effectiveness of suicide prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Just-in-Time Adaptive Interventions for Suicide Prevention: Promise, Challenges, and Future Directions. Coppersmith, DDL., Dempsey, W., Kleiman, EM., et al.[2023]

Just-in-time adaptive interventions (JITAIs) aim to provide personalized support for health behaviors by adapting to an individual's changing circumstances, leveraging advanced mobile and sensing technologies.

To effectively develop JITAIs, researchers need to base their designs on robust health behavior theories and empirical evidence, ensuring that interventions are both timely and relevant to enhance adherence and retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Nahum-Shani, I., Smith, SN., Spring, BJ., et al.[2022]

The study highlights the importance of involving historically marginalized families, particularly BIPOC communities, in the co-design of mobile health interventions, specifically for improving sun protection behaviors.

Using a value tension framework, the researchers identified key design challenges and opportunities, allowing them to make informed design decisions that address the differing needs of children and adults in these families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-design Tensions Between Parents, Children, and Researchers Regarding Mobile Health Technology Design Needs and Decisions: Case Study. Yip, J., Wong, K., Oh, I., et al.[2023]

A review of 28 popular smartphone apps for depression found that none utilized just-in-time adaptive intervention (JITAI) mechanisms, which are designed to provide tailored support based on an individual's state of vulnerability and receptivity.

Most apps relied on self-reported outcomes (71%) but did not use these measurements to customize content or timing, indicating a significant gap in leveraging the potential of JITAI mechanisms to enhance the effectiveness of depression interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Just-in-Time Adaptive Mechanisms of Popular Mobile Apps for Individuals With Depression: Systematic App Search and Literature Review. Teepe, GW., Da Fonseca, A., Kleim, B., et al.[2023]

A systematic review of 88 just-in-time adaptive interventions (JITAIs) found that only 17% were fully automated, meaning most still required involvement from healthcare professionals or patients.

77% of the JITAIs lacked sufficient reporting details necessary for replication, particularly in how intervention components were selected, highlighting a need for improved transparency in study reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic scoping review of just-in-time, adaptive interventions finds limited automation and incomplete reporting. Oikonomidi, T., Ravaud, P., LeBeau, J., et al.[2023]

The B-MOBILE just-in-time adaptive intervention (JITAI) effectively prompted overweight/obese individuals to take walking breaks, with the 3- and 6-minute conditions leading to the highest adherence and number of breaks taken.

Frequent, short prompts were more effective in encouraging physical activity, suggesting that this approach may be optimal for reducing sedentary behavior, although further research is needed to ensure long-term adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral response to a just-in-time adaptive intervention (JITAI) to reduce sedentary behavior in obese adults: Implications for JITAI optimization. Thomas, JG., Bond, DS.[2022]

The study involved 274 participants using the Ally app, a smartphone-based intervention designed to increase physical activity through incentives, planning, and self-monitoring prompts, over a 6-week period.

The research aims to identify effective components of the intervention and the contexts in which participants are most receptive to notifications, potentially leading to a more tailored and effective approach to promoting physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating Intervention Components and Exploring States of Receptivity for a Smartphone App to Promote Physical Activity: Protocol of a Microrandomized Trial. Kramer, JN., Künzler, F., Mishra, V., et al.[2020]

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JITAIs hold promise for suicide prevention because they could increase access to evidence-based interventions during moments of high need, function as a tool.

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Automated Real-Time Tool for Promoting Crisis Resource Use ...

The goal of this study was to develop and test an automated tool (ResourceBot) that promotes the use of crisis services (eg, 988) in real time.

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Automated Real-Time Tool for Promoting Crisis Resource ...

The goal of this study was to develop and test an automated tool (ResourceBot) that promotes the use of crisis services (eg, 988) in real time.