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

Trial Summary

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 data supports the effectiveness of the treatment Just-in-Time Adaptive Interventions (JITAIs) for suicide risk?

Research suggests that Just-in-Time Adaptive Interventions (JITAIs) can be effective for mental health conditions like depression by providing timely support based on a person's needs, which may also help in suicide prevention by offering the right support at the right time. ^{1 2 3 4 5}

Is the Just-in-Time Adaptive Intervention (JITAI) generally safe for humans?

The available research does not specifically address the safety of Just-in-Time Adaptive Interventions (JITAIs) in humans, but these interventions are designed to provide timely support using smartphones and wearables, which are generally considered safe technologies. ^{1 2 3 5 6}

How is the Just-in-time Interventions for Suicide Risk treatment different from other treatments for suicide prevention?

This treatment is unique because it uses smartphones and wearable technology to provide personalized support exactly when it's needed, adapting to changes in a person's mental state and environment. Unlike traditional methods, it offers real-time, tailored interventions based on the individual's current situation, making it more accessible and responsive. ^{1 2 3 7 8}

What is the purpose of this trial?

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Just-in-Time Adaptive Mechanisms of Popular Mobile Apps for Individuals With Depression: Systematic App Search and Literature Review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Just-in-Time Adaptive Interventions for Suicide Prevention: Promise, Challenges, and Future Directions. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Co-design Tensions Between Parents, Children, and Researchers Regarding Mobile Health Technology Design Needs and Decisions: Case Study. [2023]

4. Canada 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A systematic scoping review of just-in-time, adaptive interventions finds limited automation and incomplete reporting. [2023]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Assessment of US Food and Drug Administration-Approved Digital Medical Devices for Just-in-Time Interventions: A Systematic Review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. [2022]