Suicidal and Self-injurious BehaviorNCT04054947
Suicide Prevention in Rural Veterans During High-risk Care Transition Scenarios
A study testing Suicide Prevention Program in people with Suicidal and Self-injurious Behavior, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal and Self-injurious Behavior
- What is being tested?
- Suicide Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- Unable to provide informed consent
- Potentially vulnerable populations including prisoners, institutionalized patients, or involuntarily committed patients
Trial locations and contacts
1 site in 1 country.
United States1 site
White River Junction VA Medical Center
White River Junction, Vermont, 05009
About this study
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.
Read the 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.
- Conditions
- Suicidal and Self-injurious Behavior
- Being tested
- Suicide Prevention Program
- Keywords
- Suicidal and Self-injurious Behavior
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suicide Prevention ProgramBehavioural
Structured care management to improve adherence to discharge planning.
| Study group | Role | What they receive |
|---|---|---|
| Suicide Prevention Program | Experimental | Behavioral: Suicide Prevention Program Structured care management to improve adherence to discharge planning. Receives: Behavioral: Suicide Prevention Program |
| Usual Care | No intervention | Standard care that occurs as part of mental health treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Beck Scale for Suicidal Ideation (BSS)
The BSS ranges from 0-38. While there is no established BSS cutoff score to classify suicide risk, there is evidence that higher scores on the BSS correspond to more severe suicidal ideation and that a change of five points or more on the total BSS scores may be clinically relevant. Mean scores at baseline were calculated.
Measured: Change from Baseline BSS at 1-, 3-, and 6-months
Secondary outcomes (8)
The Beck Scale for Hopelessness (BHS)
The BHS ranges from 0-20 with higher scores associated with increased hopelessness.
Measured: Change from Baseline BHS at 1-, 3-, and 6-months
The Partners in Health Scale (PIH) (Self Management)
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. Scores range from 0-72. Higher scores indicate better self-management. Mean scores at baseline were calculated.
Measured: Change from Baseline PIH at 1-, 3-, and 6-months
The Interpersonal Needs Questionnaire-15: Thwarted Belongingness (INQ-15 TB)
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. The score range for the entire scale is 15-105, with the score range for thwarted belongingness being 7-49. Mean scores at baseline were calculated.
Measured: Baseline, 1-month, 3-month, 6-month
Interpersonal Needs Questionnaire 15: Perceived Burdensomeness (INQ-15 PB)
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. The score range for the entire scale is 15-105, with the score range for perceived burdensomeness being 7-49. The perceived burdensomeness Mean scores at baseline were calculated.
Measured: Change from Baseline INQ-15 PB at 1-, 3-, and 6-months
Columbia Suicide Severity Rating Scale (C-SSRS)
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.
Measured: Number of events according to the CSSR-S at 1-, 3-, and 6-months
Multidimensional Scale of Perceived Social Support (MSPSS)
The MSPSS is a 12-item self-reported scale that is designed to ask about support from several sources including friends, family and significant others. The scale has been shown to have good internal and test-retest reliability as well as good validity. The score range is 1-7 with higher values indicating increased perception of social support.
Measured: Change from Baseline MSPSS at 1-, 3-, and 6-months
Suicide-Related Coping Scale (SRCS)
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. The scale includes two subscales including an External Coping subscale and an Internal Coping Subscale. The score range for the entire scale is 0-68 with the External Coping being 0-28 and the Internal Coping being 0-28. Higher scores indicate increased perception of suicide-related coping. Mean scores at baseline were calculated.
Measured: Change from Baseline SRCS at 1-, 3-, and 6-months
App Engagement Scale (AES) - for Mobile Applications
The App Engagement Scale (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. All items are rated on a 5-point scale from "1.Inadequate" to "5.Excellent" with scores ranging from 0 - 40. Higher scores are associated with increased perceived quality of the mobile application.
Measured: Change in AES scores at 1- and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Oct 2019
- Primary completion21 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal and Self-injurious BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- White River Junction Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Brian Shiner, White River Junction Veterans Affairs Medical Center
- Investigators
- Brian R Shiner, MD, MPH, Principal investigator, White River Junction Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054947
- Sponsor's protocol ID
- 1439938
- Status last verified
- Jun 2024
- First submitted
- 9 Aug 2019
- Last updated
- 26 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riblet NB, Kenneally L, Stevens S, Watts BV, Gui J, Forehand J, Cornelius S, Rousseau GS, Schwartz JC, Shiner B. A virtual, pilot randomized trial of a brief intervention to prevent suicide in an integrated healthcare setting. Gen Hosp Psychiatry. 2022 Mar-Apr;75:68-74. doi: 10.1016/j.genhosppsych.2022.02.002. Epub 2022 Feb 18.
PubMed 35202942
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicide Prevention in Rural Veterans During High-risk Care Transition Scenarios
- ClinicalTrials.gov ID
- NCT04054947
- Acronym / sponsor ID
- 1439938
- Conditions
- Suicidal and Self-injurious Behavior
- Keywords
- Suicidal and Self-injurious Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- White River Junction Veterans Affairs Medical CenterUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Posted 26 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suicide Prevention Program | Experimental | Behavioral: Suicide Prevention ProgramBehavioral: Suicide Prevention Program Structured care management to improve adherence to discharge planning. |
| Usual Care | No intervention | –Standard care that occurs as part of mental health treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- 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
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Potentially vulnerable populations including prisoners, institutionalized patients, or involuntarily committed patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suicide Prevention ProgramStructured care management to improve adherence to discharge planning. | Behavioural | Suicide Prevention Program |
Primary outcome
The Beck Scale for Suicidal Ideation (BSS)
Time frame: Change from Baseline BSS at 1-, 3-, and 6-months
The BSS ranges from 0-38. While there is no established BSS cutoff score to classify suicide risk, there is evidence that higher scores on the BSS correspond to more severe suicidal ideation and that a change of five points or more on the total BSS scores may be clinically relevant. Mean scores at baseline were calculated.
8 secondary outcomes
The Beck Scale for Hopelessness (BHS)
Time frame: Change from Baseline BHS at 1-, 3-, and 6-months
The Partners in Health Scale (PIH) (Self Management)
Time frame: Change from Baseline PIH at 1-, 3-, and 6-months
The Interpersonal Needs Questionnaire-15: Thwarted Belongingness (INQ-15 TB)
Time frame: Baseline, 1-month, 3-month, 6-month
Interpersonal Needs Questionnaire 15: Perceived Burdensomeness (INQ-15 PB)
Time frame: Change from Baseline INQ-15 PB 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
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: 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
App Engagement Scale (AES) - for Mobile Applications
Time frame: Change in AES scores at 1- and 6-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35202942Riblet NB, Kenneally L, Stevens S, Watts BV, Gui J, Forehand J, Cornelius S, Rousseau GS, Schwartz JC, Shiner B. A virtual, pilot randomized trial of a brief intervention to prevent suicide in an integrated healthcare setting. Gen Hosp Psychiatry. 2022 Mar-Apr;75:68-74. doi: 10.1016/j.genhosppsych.2022.02.002. Epub 2022 Feb 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian R Shiner, MD, MPH principal investigator
White River Junction Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suicide Prevention Program in people with Suicidal and Self-injurious Behavior, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Beck Scale for Suicidal Ideation (BSS) (time frame: Change from Baseline BSS at 1-, 3-, and 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04054947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.