Multimodality Adaptive Intervention for Post-Inpatient Hospitalization Suicide Risk Reduction

NCT06764108 | Not Yet Recruiting DMC

• 1 other identifier: R01MH139522
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief 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. The main questions it aims to answer are:

• 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.

Conditions

Suicidal Ideation; Suicidal Behavior

Keywords

just-in-time adaptive intervention; JITAI; micro-randomized trial; MRT; Sequential Multiple Assignment Randomized Trial; SMART; single-session intervention; SSI; hybrid experimental design

Outcome Measures

Primary Outcomes (1)

• Suicide-related event (SRE)

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

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

Secondary Outcomes (6)

• Suicide-related event (SRE)

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

• Coping strategy use

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

• Coping self-efficacy

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

• Coping strategy use

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

• Suicide urge intensity

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

Study Arms (6)

Self-monitoring only

EXPERIMENTAL

Participants 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.

Behavioral: Self-monitoring

Self-monitoring plus JITAI

EXPERIMENTAL

Participants 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.

Behavioral: Self-monitoring; Behavioral: JITAI

Self-monitoring only plus self-guided SSI

EXPERIMENTAL

Participants 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.

Behavioral: Self-monitoring; Behavioral: Self-guided SSI

Self-monitoring only plus clinician-delivered SSI

EXPERIMENTAL

Participants 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.

Behavioral: Self-monitoring; Behavioral: Clinician-delivered SSI

Self-monitoring plus JITAI plus self-guided SSI

EXPERIMENTAL

Participants 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.

Behavioral: Self-monitoring; Behavioral: JITAI; Behavioral: Self-guided SSI

Self-monitoring plus JITAI plus clinician-delivered SSI

EXPERIMENTAL

Participants 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.

Behavioral: Self-monitoring; Behavioral: JITAI; Behavioral: Clinician-delivered SSI

Interventions

Self-monitoring BEHAVIORAL

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.

Self-monitoring only; Self-monitoring only plus clinician-delivered SSI; Self-monitoring only plus self-guided SSI; Self-monitoring plus JITAI; Self-monitoring plus JITAI plus clinician-delivered SSI; Self-monitoring plus JITAI plus self-guided SSI

JITAI BEHAVIORAL

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-monitoring plus JITAI; Self-monitoring plus JITAI plus clinician-delivered SSI; Self-monitoring plus JITAI plus self-guided SSI

Self-guided SSI BEHAVIORAL

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.

Self-monitoring only plus self-guided SSI; Self-monitoring plus JITAI plus self-guided SSI

Clinician-delivered SSI BEHAVIORAL

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.

Self-monitoring only plus clinician-delivered SSI; Self-monitoring plus JITAI plus clinician-delivered SSI

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Suicidal Ideation

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Central Study Contacts

Kate H Bentley, PhD

CONTACT

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

Study Design

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

Model Details: This study uses a hybrid experimental design that embeds a Sequential Multiple Assignment Randomized Trial (SMART) and a Micro-Randomized Trial (MRT).

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 8, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share