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Suicidal IdeationNCT06764108

Multimodality Adaptive Intervention for Post-Inpatient Hospitalization Suicide Risk Reduction

A study testing Self-monitoring, JITAI and Self-guided SSI in people with Suicidal Ideation and Suicidal Behavior, run by Massachusetts General Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn whether a combination of brief digital and clinician-delivered interventions can help adults leaving a psychiatric hospitalization cope with suicidal thoughts and prevent suicide-related events. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Suicidal Ideation, Suicidal Behavior
What is being tested?
Self-monitoring, JITAI and Self-guided SSI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
No sites listed yet
Study dates
Oct 2026to Jan 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult status (18+ years-old)
  • Ownership of a smartphone (iOS or Android)
  • Inpatient admission due to suicidal thoughts or suicide attempt

Who cannot join

  • Presence of any factor that impairs an individual's ability to comprehend and effectively participate in the study, including an inability to speak or write English fluently, the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Rebecca G Fortgang, PhD contact

617-726-2000

rfortgang@mgh.harvard.edu

About this study

The goal of this clinical trial is to learn whether a combination of brief digital and clinician-delivered interventions can help adults leaving a psychiatric hospitalization cope with suicidal thoughts and prevent suicide-related events.

The main questions it aims to answer are:

Read more
  • Are people who receive automated smartphone messages when they report suicidal thoughts after leaving the hospital less likely to have a suicide-related event than those who do smartphone self-monitoring alone?
  • Are people who have additional session(s) with a clinician in the four weeks after leaving the hospital less likely to have a suicide-related event than those who receive additional brief self-guided intervention(s)?

Participants will be asked to:

  • Make a personalized safety plan (of coping strategies to use when feeling suicidal) before leaving the hospital
  • Do self-monitoring of suicidal thoughts and related experiences on their smartphone for four weeks after leaving the hospital
  • Complete a longer set of research questionnaires at the start of the study and five more times during the 12 weeks after leaving the hospital

Depending on which study group they are in and whether they benefit from initial smartphone interventions, participants may or may not:

  • Receive automated smartphone messages reminding them of coping strategies to use for suicidal thoughts
  • Receive up to three additional sessions with a study clinician
  • Receive up to three brief online self-guided interventions

The study interventions last for the four weeks after leaving the hospital. Participants will also be asked permission to share information from their health records about care received for 12 weeks after leaving the hospital.

Read the detailed description

Over 49,000 Americans die by suicide each year, making suicide the 11th leading cause of death across all ages. The highest-risk time for suicidal behavior is the three months after inpatient psychiatric hospitalization, during which engagement with traditional outpatient care is low. Recent real-time monitoring research has revealed that suicidal thoughts fluctuate rapidly, over hours or even minutes, highlighting the need for dynamic interventions that adapt to time-varying changes in risk. Just-in-time adaptive interventions (JITAIs) can help promote timely coping strategy use during periods of elevated suicidal thinking. Some people, however, will require additional interventions that explicitly target common barriers to coping effectively with suicidal thoughts. Evidence-based single-session interventions (SSIs) that address coping with suicidal thoughts exist and can be delivered in either clinician-delivered or self-guided formats. This study will use a hybrid experimental design that leverages both Sequential Multiple Assignment Randomized Trial and Micro-Randomized Trial (MRT) methods to build and evaluate a multimodality adaptive intervention comprising stepped evidence-based intervention components sequenced and adapted at multiple timescales following inpatient hospitalization.

Aim 1 will compare two first-stage interventions: JITAI vs. self-monitoring alone for four weeks after inpatient discharge. The investigators will determine the effectiveness of the JITAI for reducing the risk of suicide-related events (SREs) over three months and whether the JITAI engages target mechanisms related to coping.

Aim 2 will compare two second-stage interventions for those who do not sufficiently respond to the first-stage interventions: clinician-delivered or self-guided SSIs targeting individualized barriers to coping strategy use. Response status will be assessed weekly for four weeks post-hospitalization. The investigators will determine the effectiveness of clinician-delivered vs. self-guided SSIs for reducing the risk of SREs among insufficient responders, as well as effect differences between embedded adaptive interventions among all participants.

Aim 3 will determine the within-person effects of just-in-time messages on proximal outcomes (next-hour coping strategy use and momentary suicidal thoughts) for participants in the JITAI condition. Just-in-time message effects will be evaluated when averaging across second-stage conditions and contrasting message and SSI types.

This study will result in a scalable and optimized stepped approach to reducing suicide risk during a key care transition period.

Being tested
Self-monitoring, JITAI, Self-guided SSI, Clinician-delivered SSI
Keywords
just-in-time adaptive intervention, JITAI, micro-randomized trial, MRT, Sequential Multiple Assignment Randomized Trial, SMART, single-session intervention, SSI, hybrid experimental design
Medical subject headings
Suicidal Ideation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-monitoringBehavioural

    Self-monitoring will involve completing one brief smartphone-based survey (at a fixed time) per day on suicidal thoughts and related affect states and experiences over the past day during the four weeks after psychiatric hospitalization.

  • JITAIBehavioural

    The JITAI will involve prompts to complete additional randomly timed self-monitoring surveys throughout the day. When suicidal thoughts are reported on any self-monitoring survey, random assignment to receive or not receive a series of automated smartphone-based messages that recommend using specific coping strategies from either a personalized safety plan or general evidence-based coping strategies that others tend to find helpful.

  • Self-guided SSIBehavioural

    The brief (10-12 minute) online self-guided SSI will help individuals identify and address barriers to using coping strategies for suicidal thoughts. It may be delivered up to three times during the four weeks after hospitalization for those who do not sufficiently respond to the initial (self-monitoring only or self-monitoring plus JITAI) interventions.

  • Clinician-delivered SSIBehavioural

    The clinician-delivered SSI will consist of a brief (30-minute) Zoom or phone meeting in which a study clinician will help individuals identify and address barriers to using coping strategies for suicidal thoughts. Those who do not sufficiently respond to the initial (self-monitoring only or self-monitoring plus JITAI) interventions may receive up to three clinician-delivered SSIs during the four weeks after hospitalization.

Study groups in NCT06764108
Study groupRoleWhat they receive
Self-monitoring onlyExperimentalParticipants in the self-monitoring condition will complete smartphone-based self-monitoring of suicidal thoughts and related experiences during the four weeks after hospitalization. Those who exhibit a response to self-monitoring alone will not receive any add-on interventions.
Receives: Behavioral: Self-monitoring
Self-monitoring plus JITAIExperimentalParticipants in the self-monitoring plus just-in-time adaptive intervention (JITAI) condition will complete smartphone-based self-monitoring of suicidal thoughts and related experiences during the four weeks after hospitalization. When they report experiencing suicidal thoughts on a self-monitoring survey, they may be randomly assigned to receive a JITAI comprising a brief series of automated smartphone-based messages recommending coping strategies for suicidal thoughts. Those who exhibit a response to self-monitoring plus JITAI will not receive any add-on interventions.
Receives: Behavioral: Self-monitoring; Behavioral: JITAI
Self-monitoring only plus self-guided SSIExperimentalParticipants who are initially assigned to self-monitoring alone and do not sufficiently respond to this intervention (based on the previous week of self-monitoring data) may be randomly assigned to receive up to three brief online self-guided single-session interventions (SSIs) aimed to identify and address barriers to coping strategy use during the four weeks after hospitalization.
Receives: Behavioral: Self-monitoring; Behavioral: Self-guided SSI
Self-monitoring only plus clinician-delivered SSIExperimentalParticipants who are initially assigned to self-monitoring alone and do not sufficiently respond to this intervention (based on the previous week of self-monitoring data) may be randomly assigned to receive up to three single-session interventions (SSIs) with a study clinician aimed to identify and address barriers to coping strategy use during the four weeks after hospitalization.
Receives: Behavioral: Self-monitoring; Behavioral: Clinician-delivered SSI
Self-monitoring plus JITAI plus self-guided SSIExperimentalParticipants who are initially assigned to self-monitoring plus JITAI and do not sufficiently respond to this intervention (based on the previous week of self-monitoring data) may be randomly assigned to receive up to three brief online self-guided SSIs aimed to identify and address barriers to coping strategy use during the four weeks after hospitalization.
Receives: Behavioral: Self-monitoring; Behavioral: JITAI; Behavioral: Self-guided SSI
Self-monitoring plus JITAI plus clinician-delivered SSIExperimentalParticipants who are initially assigned to self-monitoring plus JITAI and do not sufficiently respond to this intervention (based on the previous week of self-monitoring data) may be randomly assigned to receive up to three sessions with a study clinician aimed to identify and address barriers to coping strategy use during the four weeks after hospitalization.
Receives: Behavioral: Self-monitoring; Behavioral: JITAI; Behavioral: Clinician-delivered SSI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Suicide-related event (SRE)

    SRE defined as suicide attempt or emergency visit/re-hospitalization for suicide risk

    Measured: From inpatient discharge to the end of the study intervention period at 4 weeks

Secondary outcomes (6)
  1. Suicide-related event (SRE)

    SRE defined as suicide attempt or emergency visit/re-hospitalization for suicide risk

    Measured: From inpatient discharge to the end of the study at 12 weeks

  2. Coping strategy use

    Past-day coping strategy use will be operationalized with a variable indicating the proportion of days with suicidal thoughts when coping strategies for suicidal thoughts were used

    Measured: From inpatient discharge to the end of the study intervention period at 4 weeks

  3. Coping self-efficacy

    Past-week coping self-efficacy will be operationalized with Suicide-Related Coping Scale total scores, which range from 0 to 68, with higher scores indicating better coping.

    Measured: From inpatient discharge to the end of the study intervention period at 4 weeks

  4. Coping strategy use

    Coping strategy use since the last self-monitoring survey will be operationalized with a binary variable indicating whether evidence-based coping strategies were used to manage suicidal thoughts since the last survey.

    Measured: From inpatient discharge to the end of the study intervention period at 4 weeks

  5. Suicide urge intensity

    Momentary (current) suicide urge intensity will be rated on a 0 (not at all) - 10 (very strong) scale.

    Measured: MomentFrom inpatient discharge to the end of the study intervention period at 4 weeksary

  6. Suicide intent intensity

    Momentary (current) suicide intent intensity will be rated on a 0 - 10 scale.

    Measured: From inpatient discharge to the end of the study intervention period at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2025
  2. Study startOct 2026 (estimated)
  3. Primary completionSep 2029 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
This study uses a hybrid experimental design that embeds a Sequential Multiple Assignment Randomized Trial (SMART) and a Micro-Randomized Trial (MRT).
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06764108
Sponsor's protocol ID
R01MH139522
Status last verified
Jul 2026
First submitted
23 Dec 2024
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: In accordance with NIH guidelines, individual participant data collected in this study (including self-report and demographic data), as well as a corresponding data dictionary, will be shared via the National Institute of Mental Health National Data Archive (NDA).

Questions about this trial

What is this clinical trial studying?

A study testing Self-monitoring, JITAI and Self-guided SSI in people with Suicidal Ideation and Suicidal Behavior, run by Massachusetts General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rebecca G Fortgang, PhD (617-726-2000, rfortgang@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Suicide-related event (SRE) (time frame: From inpatient discharge to the end of the study intervention period at 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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