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

NCT05825820 | Not Yet Recruiting DMC

• 1 other identifier: 2023P000611-A
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Suicide; Suicide, Attempted; Suicidal Ideation

Keywords

Suicide; Suicidal Thoughts

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Week 12 of the intervention

Secondary Outcomes (4)

• Suicide Attempts

  4 weeks, 8 weeks, and 12 weeks

• 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 (1)

Enhanced Outreach Intervention plus Care as Usual

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

Interventions

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.

Enhanced Outreach Intervention plus Care as Usual

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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief for Research, Department of Psychiatry

Model Details: Open, non-randomized single-arm design

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share