- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04054947
Suicide Prevention in Rural Veterans During High-risk Care Transition Scenarios
February 21, 2023 updated by: Brian Shiner, White River Junction Veterans Affairs Medical Center
In the United States (U.S.), suicide is a major public health concern.
U.S. Veterans who live in rural areas may be at even higher risk for suicide than their urban counterparts.
Available evidence indicates that suicide risk in rural U.S. Veterans is most concentrated during high-risk care transition scenarios such as discharge from an emergency room.
There is limited knowledge about effective interventions to address suicide risk.
There is a critical need to develop targeted interventions that address suicide risk during high-risk care transition periods.
To be effective, these interventions should address key contributors to suicide risk such as reduced engagement in treatment.
This clinical trial evaluates the effect of a suicide prevention intervention to support treatment engagement during high risk transition periods such as discharge from an emergency room.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
In the United States (U.S.), death by suicide is a notable public health concern and a particular problem in the U.S. Veteran population.
Furthermore, U.S. Veterans who live in rural areas may be at even greater risk for suicide than their urban counterparts.
These risks may be concentrated during times of transition in their treatment such as after emergency room discharge.
Multiple interventions have been developed to target suicide risk during periods of transition but there is limited evidence regarding their efficacy in preventing suicide.
Furthermore, a key contributor to suicide risk may include limited or no engagement in care.
Therefore, developing interventions to support engagement in treatment may be effective ways to help mitigate suicide risk and promote participation in care.
This clinical trial studies an intervention that is designed to help support treatment engagement during periods of high risk in Veterans who live in rural areas.
The trial will recruit Veterans from various treatment settings such as the emergency room, residential drug treatment programs, primary care mental health clinics, and/or inpatient psychiatric units and follow them for a period of six months.
The trial evaluates not only the effect of the intervention on suicidal behavior but also measures of engagement.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vermont
-
White River Junction, Vermont, United States, 05009
- White River Junction VA Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Inpatient psychiatric unit:
- Per the unit psychiatrist, hospitalization was due to concerns about acute risk for self-harm including suicidal ideation, suicide attempt, and/or admitting provider deemed the patient was at imminent risk for self-harm
- Be a Veteran eligible to receive VA services
- Be able to speak English
Inpatient medical-surgical unit:
- Received a mental health consultation during admission on the medical-surgical unit
- Per the consult-liaison psychiatrist, patient was recently (within past three months of hospitalization) or is currently at risk for self-harm including suicidal ideation, suicide attempt, or self-harm
- Be a Veteran eligible to receive VA services; be 18 years or older; be able to speak English
Residential Rehabilitation Center (RRC) program:
- Per the RRC treatment team, patient was recently (within past three months of hospitalization) or is currently at risk for self-harm including suicidal ideation, suicide attempt, or self-harm
- Be a Veteran eligible to receive VA services; be 18 years or older; be able to speak English
Primary Mental Health Clinic (PMHC):
- The patient was recently seen for a new evaluation in the WRJ PMHC clinic or a local integrated care clinic that are part of the White River Junction VA Medical Center Catchment Area (i.e., Burlington, Littleton, Rutland, Bennington, Brattleboro, or Keene) by either the mental health nurse practitioner, the psychologist, the psychiatry resident or a psychiatric attending
- The patient is currently at risk for self-harm including suicidal ideation of any severity, suicide attempt, or self-harm; This could have been identified based on a formal suicide assessment scale such as the Columbia Suicide Severity Rating Scale or by clinician assessment as documented in the intake note
- Be a Veteran eligible to receive VA services; be 18 years or older; be able to speak English
Exclusion Criteria:
- Unable to provide informed consent
- Potentially vulnerable populations including prisoners, institutionalized patients, or involuntarily committed patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
|
|
Experimental: Suicide Prevention Program
|
Structured care management to improve adherence to discharge planning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Beck Scale for Suicidal Ideation (BSS)
Time Frame: Change from Baseline BSS at 1-, 3-, and 6-months
|
The BSSI ranges from 0-38.
While there is no established BSS cutoff score to classify suicide risk, here is evidence that higher scores on the BSS correspond to more severe suicidal ideation and that an improvement of five points or more on the total BSS scores may be clinically relevant.
|
Change from Baseline BSS at 1-, 3-, and 6-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Beck Scale for Hopelessness (BHS)
Time Frame: Change from Baseline BHS at 1-, 3-, and 6-months
|
The BHS ranges from 0-20 with higher scores associated with increased hopelessness.
|
Change from Baseline BHS at 1-, 3-, and 6-months
|
The Partners in Health Scale (PIH)
Time Frame: Change from Baseline PIH at 1-, 3-, and 6-months
|
The PIH is used to measure patient self-management of chronic conditions.
It is a 12-item instrument, each question measured on a Likert scale of 0-8.
Higher scores indicate better self-management.
|
Change from Baseline PIH at 1-, 3-, and 6-months
|
Interpersonal Needs Questionnaire 15 (INQ-15)
Time Frame: Change from Baseline INQ-15 at 1-, 3-, and 6-months
|
The INQ-15 is a 15-item self-report scale that measures thwarted belongingness (9 items) and perceived burdensomeness (6 items).
Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness.
|
Change from Baseline INQ-15 at 1-, 3-, and 6-months
|
Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: Number of events according to the CSSR-S at 1-, 3-, and 6-months
|
The C-SSRS is a valid and reliable scale that includes a seven-item subscale that asks patients to self-report on actual attempts, interrupted attempts, aborted attempts, and preparatory acts or behaviors.
|
Number of events according to the CSSR-S at 1-, 3-, and 6-months
|
Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: Change from Baseline MSPSS at 1-, 3-, and 6-months
|
The MSPSS is a 12-item self-reported scale that is designed to ask about support from several sources including friends, family and significant other.
The scale has been shown to have good internal and test-retest reliability as well as good validity.
|
Change from Baseline MSPSS at 1-, 3-, and 6-months
|
Suicide-Related Coping Scale (SRCS)
Time Frame: Change from Baseline SRCS at 1-, 3-, and 6-months
|
This scale includes 17 questions related to a patient's perception of their ability to cope with suicidal thoughts.
Each item is assessed using a 5-point Likert scale and the measure has been developed based on two studies of suicide prevention strategies conducted within Veteran populations.
The scale includes two subscales including an External Coping subscale and an Internal Coping Subscale.
Both subscales have shown good acceptable internal consistency.
|
Change from Baseline SRCS at 1-, 3-, and 6-months
|
App Engagement Scale (AES)
Time Frame: Change from Baseline AES at 1- and 6-months
|
The AES is adapted from the end-user version of the Mobile Application Rating Scale (uMARS).
The AES has been studied in patients with mental health conditions, has been shown to have good internal reliability, and is strongly related to app engagement.
|
Change from Baseline AES at 1- and 6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Anticipated)
September 30, 2023
Study Completion (Anticipated)
September 30, 2023
Study Registration Dates
First Submitted
August 9, 2019
First Submitted That Met QC Criteria
August 12, 2019
First Posted (Actual)
August 13, 2019
Study Record Updates
Last Update Posted (Actual)
February 24, 2023
Last Update Submitted That Met QC Criteria
February 21, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1439938
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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