Multimodality Adaptive Intervention for Post-Inpatient Hospitalization Suicide Risk Reduction

Sponsor
Massachusetts General Hospital
Study ID
NCT06764108
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Suicidal Behavior
  • Suicidal Ideation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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-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.
  • 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.

Study Details

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.

Key Dates

First listed
Jan 8, 2025
Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Self-monitoring only
    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.
  • Experimental: Self-monitoring plus JITAI
    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.
  • Experimental: Self-monitoring only plus self-guided SSI
    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.
  • Experimental: Self-monitoring only plus clinician-delivered SSI
    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.
  • Experimental: Self-monitoring plus JITAI plus self-guided SSI
    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.
  • Experimental: Self-monitoring plus JITAI plus clinician-delivered SSI
    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.

Primary Outcome Measure

Suicide-related event (SRE) [ Time Frame: From inpatient discharge to the end of the study intervention period at 4 weeks ]

Central Contacts

Related Studies