An interventional study of Enhanced Outreach Intervention (EOI) plus Care as Usual in Suicide, Suicide, Attempted and Suicidal Ideation, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to test an enhanced outreach intervention (EOI) delivered by Samaritans of Boston (a community organization that provides support during mental health crises) for people after they leave an emergency department (ED) visit for suicidal thoughts. The main questions the trial aims to answer are:
Participants will:
The period after discharge from an emergency department (ED) is a critical time of increased risk for suicide and related behavior (SRB). Brief "caring contact" interventions that provide follow-up and support after a healthcare visit have been shown to reduce SRB and are now recommended best practices for suicide prevention in healthcare systems. However, system- and individual-level barriers to widespread implementation exist. For example, deployment of brief contact interventions requires dedicated resources and staffing within already overburdened healthcare settings, and even single-session interventions require robust provider training and ongoing oversight for successful implementation.
The purpose of this study is to evaluate a recently developed Enhanced Outreach Intervention (EOI) for post-ED discharge that combines multiple evidence-based suicide prevention components (e.g., safety planning, risk assessment, caring contacts, and care engagement) and is delivered through a partnership between a healthcare system (Mass General Brigham [MGB]) and a local crisis line organization (Samaritans of Boston). Combining multiple evidence-based interventions has the potential to increase effectiveness over usual practices, and partnering with a community organization vastly increases scalability.
Samaritans staff will undergo robust, multifaceted training on the EOI, and use standardized decision trees to guide EOI delivery. In this trial, the investigators will develop operational workflows for using a suicide risk algorithm to identify patients to receive the EOI, conduct a small open pilot of the EOI (N = 20), and assess the barriers and facilitators, and feasibility, acceptability, and fidelity of implementing the EOI in an academic medical setting to inform intervention refinement.
281 studies on the registry are indexed under Suicide, Attempted; 91 are open to participants now.
This study's planned enrollment of 20 is below the median of 129 across 224 interventional studies indexed under Suicide, Attempted.
Browse Suicide, Attempted studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Compared within Suicide, Attempted, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Suicide. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the Enhanced Outreach Intervention (EOI) plus care as usual for 12 weeks after ED discharge.
Behavioral: Enhanced Outreach Intervention (EOI) plus Care as Usual
The EOI will contain four main components: safety planning, caring contacts, care engagement, and risk assessment. A phone call (or text messaging) from Samaritans staff will be conducted every week of the 12 week intervention. Conversations will use a standardized phone script to (a) conduct a risk assessment, (b) develop and review a list of coping skills to use if you have suicidal thoughts, and (c) discuss participants' plans for receiving mental health care. Samaritans staff will also send a caring text message or email at least once per week. Participants will also receive standard care that hospitals give for individuals who present to the ED with suicidal thoughts.
Self-Report Ratings of Intervention Acceptability
The acceptability of the EOI will be measured by the Acceptability of Intervention Measure (AIM). The scale values range from 1 to 5. Higher scores mean higher acceptability.
Time frame: Week 12 of the intervention
Self-Report Ratings of Intervention Feasibility
The feasibility of the EOI will be measured by the Feasibility of Intervention Measure (FIM). The scale values range from 1 to 5. Higher scores mean higher feasibility.
Time frame: Week 12 of the intervention
Suicide Attempts
Whether or not a suicide attempt occurs during the 12-week intervention period will be captured by manual review of electronic health records and through the Self-Injurious Thoughts \& Behaviors Interview (SITBI).
Time frame: 4 weeks, 8 weeks, and 12 weeks
Treatment Attendance
Treatment attendance during the 12-week intervention period will be captured by manual review of electronic health records and a participant-reported outcome survey.
Time frame: 4 weeks, 8 weeks, and 12 weeks
Depressive Symptoms
Depressive symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9). The scale values ranges from 0 to 3. Higher total scores mean more severe symptoms.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Intensity of Suicidal Ideation
The intensity of suicidal ideation will be measured using the Beck Scale for Suicide Ideation (BSS). The scale values ranges from 0 to 2. Higher total scores mean more intense suicidal ideation.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Plan to share: No
Started Jul 2026 (actual). Primary completion is estimated for Jan 2027, 6 months after the start.
Of 145 non-industry interventional studies with no phase under Suicide, Attempted, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 56. This study's planned 6 months is below that.
Counting every sponsor, half of 147 studies reached it within 37 months; a quarter within 20 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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