Multimodality Adaptive Intervention for Post-Inpatient Hospitalization Suicide Risk Reduction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult status (18+ years-old)
Ownership of a smartphone (iOS or Android)
Inpatient admission due to suicidal thoughts or suicide attempt
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
Self-monitoring
BehavioralSelf-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
BehavioralThe 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
BehavioralThe 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
BehavioralThe 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.
Treatment groups
360 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Self-monitoring onlyExperimental treatment 1 intervention
Group B: Self-monitoring plus JITAIExperimental treatment 2 interventions
Group C: Self-monitoring only plus self-guided SSIExperimental treatment 2 interventions
Group D: Self-monitoring only plus clinician-delivered SSIExperimental treatment 2 interventions
Group E: Self-monitoring plus JITAI plus self-guided SSIExperimental treatment 3 interventions
Group F: Self-monitoring plus JITAI plus clinician-delivered SSIExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Suicide-related event (SRE)
SRE defined as suicide attempt or emergency visit/re-hospitalization for suicide risk
Time frame
From inpatient discharge to the end of the study intervention period at 4 weeksSecondary outcomes
1
Suicide-related event (SRE)
SRE defined as suicide attempt or emergency visit/re-hospitalization for suicide risk
Time frame
From inpatient discharge to the end of the study at 12 weeks2
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
Time frame
From inpatient discharge to the end of the study intervention period at 4 weeks3
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.
Time frame
From inpatient discharge to the end of the study intervention period at 4 weeks4
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.
Time frame
From inpatient discharge to the end of the study intervention period at 4 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov
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