A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL) (SAFEMIL)
|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 ]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.
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
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]).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360736
|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|
|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|