A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
University of Pennsylvania
University of Rochester
Columbia University
Information provided by (Responsible Party):
Marjan Holloway, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier:
NCT01360736
First received: May 17, 2011
Last updated: March 30, 2015
Last verified: March 2015
  Purpose

The investigators propose to test the efficacy of a brief, readily accessible, and personalized treatment called the Safety Planning for Military (SAFE MIL; Stanley and Brown, 2012).


Condition Intervention
Suicide
Suicide, Attempted
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

Resource links provided by NLM:


Further study details as provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:

Primary Outcome Measures:
  • 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 ]
    Attitudes toward help-seeking [acceptability and initiation of services] will be assessed by the following measures: Attitudes Toward Seeking Professional Psychological Help Scale: modified shortened version (ATSPPH); Cornell Services Index (CSI); Perceived Barriers to Care (PBTC); Brief SAFE MIL Intervention Survey.

  • 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: September 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Safety Planning - Military (SAFE-MIL)
Brief Safety Planning Using Stanley and Brown (2012) Model
Behavioral: Safety Planning - Military (SAFE MIL)
The Safety Planning Intervention (SPI) which is delivered in the SAFE MIL condition aims to help individuals lower their imminent suicide risk by having them collaborate with the study clinician to generate a detailed, hierarchically-arranged action plan for managing suicidal thoughts and urges.
Other Name: Safety Planning
No Intervention: E-CARE
Treatment As Usual and Assessment Services of Study; Control Condition

Detailed Description:

Background: Mental health related hospitalizations and suicide are both significant public health problems within the United States Department of Defense (DoD). 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 for Military (SAFE MIL) 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 the Safety Planning Intervention to help the suicidal individual with a collaboratively generated personal plan to mitigate or prevent a future suicidal crisis. 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 attitudes toward help-seeking [acceptability and initiation of services]. 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360736

Locations
United States, Maryland
Uniformed Services University of the Health Sciences
Bethesda, Maryland, United States, 20814
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
U.S. Army Medical Research and Materiel Command
University of Pennsylvania
University of Rochester
Columbia University
Investigators
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

Publications:
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 Study 2
Study First Received: May 17, 2011
Last Updated: March 30, 2015
Health Authority: United States: Federal Government
United States: Institutional Review Board

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
Behavioral Symptoms
Self-Injurious Behavior

ClinicalTrials.gov processed this record on July 05, 2015