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NCT Number: NCT05825820

Pilot Study of Health System/Community Partnership for Enhanced Outreach to Prevent Suicide Attempts

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:

* Is the EOI feasible and acceptable? * Can the EOI be delivered with fidelity by Samaritans staff?

Participants will:

* Receive outreach (by call or text) once per week for 12 weeks after ED visit. During these conversations, Samaritans staff will ask participants questions about their suicidal thoughts and behaviors, develop and review a list of coping skills to use if they have suicidal thoughts, and discuss plans for receiving mental health care. * Receive caring messages from Samaritans staff at least once per week. * Be asked to complete monthly self-report questionnaires, and participate in a phone interview with study staff at the end of the study.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Currently a patient being treated and evaluated by psychiatry service in an MGB ED
  • Participants enrolled in another study (NCT05671133; PI Nock) conducted by the research team who fall into the top 50% of risk based on the suicide risk prediction algorithm used in that study
  • Able to read English
  • Ownership of a smartphone (iOS or Android) and consistent access to their smartphone following discharge from the current treatment unit or program; ability to be reliably contacted
  • Willing to provide contact information for collateral contact
  • Willing to share contact information and key clinical information with Samaritans of Boston
  • Consent to unencrypted text or email communications
  • Willing to provide social security number (SSN) or individual taxpayer identification number (ITIN) for study compensation

Exclusion criteria

  • Any factor that impairs an individual's ability to comprehend and effectively participate in informed consent, including the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, or acute intoxication
  • Presence of extremely agitated or violent behavior at the time of consent or enrollment

Treatment and study plan

Enhanced Outreach Intervention (EOI) plus Care as Usual

Behavioral

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.

Primary outcomes

  1. Self-Report Ratings of Intervention Acceptability

    Time frame: Week 12 of the intervention

    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.

  2. Self-Report Ratings of Intervention Feasibility

    Time frame: Week 12 of the intervention

    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.

Secondary outcomes

  1. Suicide Attempts

    Time frame: 4 weeks, 8 weeks, and 12 weeks

    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).

  2. Treatment Attendance

    Time frame: 4 weeks, 8 weeks, and 12 weeks

    Treatment attendance during the 12-week intervention period will be captured by manual review of electronic health records and a participant-reported outcome survey.

  3. Depressive Symptoms

    Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks

    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.

  4. Intensity of Suicidal Ideation

    Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kate Bentley, PhD

CONTACT

[email protected]

617-724-7741

Rebecca Fortgang, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institutes of Health (NIH)
  • Samaritans of Boston

Registry information

Official study title

Pilot Study Health System/Community Partnership for Enhanced Outreach to Prevent Suicide Attempts

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2023
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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