Suicide Clinical Trial
Official title:
Randomized Controlled Trial of Health System/Community Partnership for Enhanced Outreach to Prevent Suicide Attempts
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.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | December 2027 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Currently a patient being treated and evaluated by psychiatry service in an MGB ED 2. 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 3. Able to read English 4. 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 5. Willing to provide contact information for collateral contact 6. Willing to share contact information and key clinical information with Samaritans of Boston 7. Consent to unencrypted text or email communications 8. Willing to provide social security number (SSN) or individual taxpayer identification number (ITIN) for study compensation Exclusion Criteria: 1. 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 2. Presence of extremely agitated or violent behavior at the time of consent or enrollment |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | National Institutes of Health (NIH), Samaritans of Boston |
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. — View Citation
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. — View Citation
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.
U.S. Department of Health and Human Services. The Surgeon General's call to action to implement the national strategy for suicide prevention. Published online 2021.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Treatment Attendance | Treatment attendance during the 12-week intervention period will be captured by manual review of electronic health records and participant-reported outcome survey. | 4 weeks, 8 weeks, and 12 weeks | |
Secondary | 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. | Baseline, 4 weeks, 8 weeks, and 12 weeks | |
Secondary | 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 scores mean more intense suicidal ideation. | Baseline, 4 weeks, 8 weeks, and 12 weeks |
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