Pilot Study of Health System/Community Partnership for Enhanced Outreach to Prevent Suicide Attempts
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Enhanced Outreach Intervention (EOI) plus Care as Usual
BehavioralThe 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Enhanced Outreach Intervention plus Care as UsualExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 intervention2
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 interventionSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Samaritans of Boston
Collaborator
Source ClinicalTrials.gov