A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL)
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Purpose
The investigators propose to test the efficacy of the Safety Planning for Military (SAFE-MIL) intervention on military patients admitted due to severe suicide ideation and/or a recent suicide attempt hospitalized at the Walter Reed Army Medical Center.
| Condition | Intervention |
|---|---|
|
Suicide Ideation Suicide Attempts |
Behavioral: Safety Planning - Military (SAFE-MIL) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 |
- Suicide Ideation [ Time Frame: discharge, 1 month, and 6 months post-discharge ] [ Designated as safety issue: Yes ]Suicide ideation will be measured using the Columbia Suicide Severity Rating Scale (C-SSRS) and the Scale for Suicide Ideation (SSI). Both measures assess for presence, intensity, frequency, and specificity of suicide related thoughts (ideations).
- Acceptability and Initiation of Mental Health Care and Substance Use Treatment [ Time Frame: discharge, 1 month, and 6-months post-discharge ] [ Designated as safety issue: No ]Acceptability and initiaion of mental health and substance use treatment will be assessed for using the Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPH), the National Health and Nutrition Examination Survey (NHNES), and Barriers to Care Items.
- Suicide-related Coping [ Time Frame: discharge, 1 month, and 6 months post-discharge ] [ Designated as safety issue: Yes ]Coping strategies will be measured using a checklist of tactics and coping strategies used by individuals to cope with suicidal thoughts, feelings, and urges.
| Estimated Enrollment: | 186 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Safety Planning - Military (SAFE-MIL) |
Behavioral: Safety Planning - Military (SAFE-MIL)
The SAFE-MIL condition will consist of three targeted suicide prevention components including: (1)structured risk assessment; (2) strategies to increase coping with suicidal thoughts and urges in order to reduce suicide risk; and (3) problem solving and motivational enhancement to increase acceptability of mental health treatment and maximize likelihood for post-discharge utilization of health services.
Other Name: Safety Planning
|
| No Intervention: E-CARE |
Detailed Description:
Background: Recently, the Army Suicide Event Reporting (ASER) and the Total Army Injury and Health Outcomes Database (TAIHOD) systems have indicated increasing rates of suicide among active Army, Guard, and Reserve units over the last several years. Additionally, research has indicated that veterans are more than twice as likely to kill themselves as compared to the general population. There are limited evidence-based suicide prevention interventions that have been developed for military personnel and veterans who are experiencing suicide ideation or who have made a suicide attempt.
Objectives: To evaluate the efficacy of the safety planning intervention on suicide ideation, suicide-related coping, and attitudes toward help seeking for hospitalized military personnel at high suicide risk.
Methodology: To test the efficacy of the adapted intervention, the investigators will randomize 186 patients to one of two conditions: Safety Planning for Military (SAFE-MIL) or Enhanced Usual Care (E-CARE). The SAFE-MIL condition(intervention) will consist of three targeted suicide prevention components including: a)structured risk assessment; b) strategies to increase coping with suicidal thoughts and urges in order to reduce suicide risk; and c) problem solving and motivational enhancement to increase acceptability of mental health treatment and maximize likelihood for post-discharge utilization of health services. The E-Care will consist of the usual care patients receive at an inpatient facility during their hospitalization in addition to assessment services provided by independent evaluators who work directly with our research team. Primary outcomes include suicide ideation, suicide-related coping, and acceptability and initiation of mental health care and substance use treatment in the 30 days post hospital discharge. Patients in both conditions will be assessed on the dependent measures at the time of hospital admission (i.e., baseline), at the time discharge (Follow-Up Interval 1 [FU-1]), at 1-month (Follow-Up Interval 2 [FU-2]) and at 6-month (Follow-Up Interval 3 [FU-3]).
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient Admitted Due to Recent Suicide Intent and/or Suicide Attempt within past month
- Baseline Assessment Completed within 48 Hours of Hospital Admission
- Age of 18 years or older.
Exclusion Criteria:
- Medical Incapacity to Participate and/or Serious Cognitive Impairment
- Expected Discharge within 72 Hours of Admission
- Expected Deployment within 1-Month
- Inability to read or understand English
- Inability to provide Informed Consent
Contacts and Locations| Contact: Marjan G Holloway, Ph.D. | 301-295-3271 | marjan.holloway@usuhs.edu |
| Contact: Jaime Carreno, Ph.D. | 301-295-1636 | jaime.carreno.ctr@usuhs.edu |
| United States, Maryland | |
| Walter Reed National Military Medical Center | Recruiting |
| Bethesda, Maryland, United States, 20814 | |
| Principal Investigator: Marjan G Holloway, Ph.D. | |
| Uniformed Services University of the Health Sciences | Active, not recruiting |
| Bethesda, Maryland, United States, 20814 | |
| Principal Investigator: | Marjan G Holloway, Ph.D. (Contact) | Uniformed Services University of the Health Sciences |
| Principal Investigator: | Lisa Brenner, Ph.D. | Denver VA |
| Principal Investigator: | Gregory Brown, Ph.D. | University of Pennsylvania |
| Principal Investigator: | Glenn Currier, M.D., MPH | Canandaigua VA; University of Rochester |
| Principal Investigator: | Kerry Knox, Ph.D. | Canandaigua VA; University of Rochester |
| Principal Investigator: | Barbara Stanley, Ph.D. | Columbia University |
More Information
No publications provided
| Responsible Party: | Marjan Holloway, Principal Investigator (Contact PI), Henry M. Jackson Foundation for the Advancement of Military Medicine |
| ClinicalTrials.gov Identifier: | NCT01360736 History of Changes |
| Other Study ID Numbers: | W81XWH-09-2-0129-2 |
| Study First Received: | May 17, 2011 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
|
Suicide Prevention Suicide Attempt Suicide Ideation Randomized Controlled Trial Safety Planning |
Additional relevant MeSH terms:
|
Suicide Suicide, Attempted Self-Injurious Behavior Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013