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

NCT05837026 | Not Yet Recruiting DMC

• 1 other identifier: 2023P000611-B
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study 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 it aims to answer are:

• Does the EOI reduce suicide-related behaviors?
• Does the EOI increase outpatient treatment attendance?
• Is the EOI acceptable and feasible?
• Can the EOI be delivered with fidelity by Samaritans? Participants will be randomized to the EOI plus care as usual or care as usual alone. Participants in the EOI plus care as usual group will:
• Receive outreach (by call or text) at a planned time once per week for the next 12 weeks. 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.
• Receive standard care that hospitals give for patients who present with suicidal thoughts.
• Be asked to complete monthly self-report questionnaires. For care as usual alone, participants will:
• Receive standard care that hospitals give for patients who present with suicidal thoughts.
• Be asked to complete monthly self-report questionnaires.

Conditions

Suicide, Attempted; Suicide; Suicidal Ideation

Keywords

Suicide; Suicidal Thoughts

Outcome Measures

Primary Outcomes (3)

• Number of 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 the Self-Injurious Thoughts \& Behaviors Interview (SITBI).

  4 weeks

• Number of 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 the Self-Injurious Thoughts \& Behaviors Interview (SITBI).

  8 weeks

• Number of 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 the Self-Injurious Thoughts \& Behaviors Interview (SITBI).

  12 weeks

Secondary Outcomes (3)

• Treatment Attendance

  4 weeks, 8 weeks, and 12 weeks

• Depressive Symptoms

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Intensity of Suicidal Ideation

  Baseline, 4 weeks, 8 weeks, and 12 weeks

Study Arms (2)

Enhanced Outreach Intervention plus Care as Usual (CAU)

EXPERIMENTAL

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 (CAU)

Care as Usual (CAU)

OTHER

Participants will receive the standard care (i.e., CAU) that the hospital provides to patients who present with suicidal thoughts.

Other: Care as Usual (CAU)

Interventions

Enhanced Outreach Intervention (EOI) plus Care as Usual (CAU) BEHAVIORAL

The EOI will contain four main components: safety planning, caring contacts, care engagement, and risk assessment. Outreach (via phone 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 the participant has suicidal thoughts, and (c) discuss 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 provide to patients who present with suicidal thoughts.

Enhanced Outreach Intervention plus Care as Usual (CAU)

Care as Usual (CAU) OTHER

Participants will receive standard care that hospitals provide to patients who present with suicidal thoughts.

Care as Usual (CAU)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• Samaritans of Boston: collaborator

Related Publications (4)

• Doupnik SK, Rudd B, Schmutte T, Worsley D, Bowden CF, McCarthy E, Eggan E, Bridge JA, Marcus SC. Association of Suicide Prevention Interventions With Subsequent Suicide Attempts, Linkage to Follow-up Care, and Depression Symptoms for Acute Care Settings: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2020 Oct 1;77(10):1021-1030. doi: 10.1001/jamapsychiatry.2020.1586.

  PMID: 32584936 BACKGROUND

• Milner AJ, Carter G, Pirkis J, Robinson J, Spittal MJ. Letters, green cards, telephone calls and postcards: systematic and meta-analytic review of brief contact interventions for reducing self-harm, suicide attempts and suicide. Br J Psychiatry. 2015 Mar;206(3):184-90. doi: 10.1192/bjp.bp.114.147819.

  PMID: 25733570 BACKGROUND

• National Action Alliance for Suicide Prevention: Transforming Health Systems Initiative Work Group. Recommended standard care for people with suicide risk: Making health care suicide safe. Education Development Center, Inc. Published online 2018.

  BACKGROUND

• Office of the Surgeon General (OSG). The Surgeon General's Call to Action to Implement the National Strategy for Suicide Prevention [Internet]. Washington (DC): US Department of Health and Human Services; 2021-. Available from http://www.ncbi.nlm.nih.gov/books/NBK592704/

  PMID: 37347878 BACKGROUND

MeSH Terms

Conditions

Suicide; Suicide, Attempted; Suicidal Ideation

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Jordan Smoller, MD, ScD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate Bentley, PhD

CONTACT

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

Rebecca Fortgang, PhD

CONTACT

RFORTGANG@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief for Research, Department of Psychiatry

Model Details: Effectiveness-implementation Hybrid Type 1 randomized trial. Participants will be randomized to EOI plus care as usual (CAU) or CAU alone using an equal (1:1) allocation ratio.

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 1, 2023
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share