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Completed

NCT Number: NCT04054947

Suicide Prevention in Rural Veterans During High-risk Care Transition Scenarios

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

White River Junction VA Medical Center

White River Junction, Vermont, 05009, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suicide Prevention Program

Behavioral

Structured care management to improve adherence to discharge planning.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. The Partners in Health Scale (PIH) (Self Management)

    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. Scores range from 0-72. Higher scores indicate better self-management. Mean scores at baseline were calculated.

  3. The Interpersonal Needs Questionnaire-15: Thwarted Belongingness (INQ-15 TB)

    Time frame: Baseline, 1-month, 3-month, 6-month

    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.

  4. Interpersonal Needs Questionnaire 15: Perceived Burdensomeness (INQ-15 PB)

    Time frame: Change from Baseline INQ-15 PB 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. 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.

  5. 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.

  6. 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 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.

  7. 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. 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.

  8. App Engagement Scale (AES) - for Mobile Applications

    Time frame: Change in AES scores at 1- and 6-months

    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.

Sponsors and collaborators

Lead sponsor

White River Junction Veterans Affairs Medical Center

Fed

Collaborators

  • US Department of Veterans Affairs

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 13, 2019
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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