- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01360736
A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL) (SAFEMIL)
A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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]).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Maryland
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Bethesda, Maryland, Forenede Stater, 20814
- Uniformed Services University of the Health Sciences
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Bethesda, Maryland, Forenede Stater, 20814
- Walter Reed National Military Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Safety Planning - Military (SAFE-MIL)
Brief Safety Planning Using Stanley and Brown (2012) Model
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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.
Andre navne:
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Ingen indgriben: E-CARE
Treatment As Usual and Assessment Services of Study; Control Condition
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Suicide Ideation
Tidsramme: discharge, 1 month, and 6 months post-discharge
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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).
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discharge, 1 month, and 6 months post-discharge
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Acceptability and Initiation of Mental Health Care and Substance Use Treatment
Tidsramme: discharge, 1 month, and 6-months post-discharge
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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.
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discharge, 1 month, and 6-months post-discharge
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Suicide-related Coping
Tidsramme: discharge, 1 month, and 6 months post-discharge
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Coping strategies will be measured using a checklist of tactics and coping strategies used by individuals to cope with suicidal thoughts, feelings, and urges.
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discharge, 1 month, and 6 months post-discharge
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marjan G Holloway, Ph.D., Uniformed Services University of the Health Sciences
- Ledende efterforsker: Gregory Brown, Ph.D., University of Pennsylvania
- Ledende efterforsker: Barbara Stanley, Ph.D., Columbia University
- Ledende efterforsker: Lisa Brenner, Ph.D., Denver VA
- Ledende efterforsker: Glenn Currier, M.D., MPH, Canandaigua VA; University of Rochester
- Ledende efterforsker: Kerry Knox, Ph.D., Canandaigua VA; University of Rochester
Publikationer og nyttige links
Generelle publikationer
- Knox KL, Stanley B, Currier GW, Brenner L, Ghahramanlou-Holloway M, Brown G. An emergency department-based brief intervention for veterans at risk for suicide (SAFE VET). Am J Public Health. 2012 Mar;102 Suppl 1(Suppl 1):S33-7. doi: 10.2105/AJPH.2011.300501.
- Ghahramanlou-Holloway M, Brown GK, Currier GW, Brenner L, Knox KL, Grammer G, Carreno-Ponce JT, Stanley B. Safety Planning for Military (SAFE MIL): rationale, design, and safety considerations of a randomized controlled trial to reduce suicide risk among psychiatric inpatients. Contemp Clin Trials. 2014 Sep;39(1):113-23. doi: 10.1016/j.cct.2014.07.003. Epub 2014 Jul 12.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- W81XWH-09-2-0129 Study 2
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Safety Planning - Military (SAFE MIL)
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Ohio State UniversityAktiv, ikke rekrutterendeSelvmordstanker | Selvmord, Forsøg | PtsdForenede Stater
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Aalborg University HospitalAalborg UniversityAfsluttet
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Seattle Children's HospitalNationwide Children's HospitalRekrutteringSelvmordstanker | Selvmordstrussel | Selvmord og selvskade | SelvmordsforsøgForenede Stater
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Johns Hopkins UniversityChildren's Hospital of Philadelphia; Columbia University; Research Foundation... og andre samarbejdspartnereIkke rekrutterer endnuSelvmord, Forsøg | Selvmord | Selvmordstanker | Selvmordsforebyggelse