- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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]).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Maryland
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Bethesda, Maryland, Forente stater, 20814
- Uniformed Services University of the Health Sciences
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Bethesda, Maryland, Forente stater, 20814
- Walter Reed National Military Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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 navn:
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Ingen inngripen: E-CARE
Treatment As Usual and Assessment Services of Study; Control Condition
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Suicide Ideation
Tidsramme: discharge, 1 month, and 6 months post-discharge
|
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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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Marjan G Holloway, Ph.D., Uniformed Services University of the Health Sciences
- Hovedetterforsker: Gregory Brown, Ph.D., University of Pennsylvania
- Hovedetterforsker: Barbara Stanley, Ph.D., Columbia University
- Hovedetterforsker: Lisa Brenner, Ph.D., Denver VA
- Hovedetterforsker: Glenn Currier, M.D., MPH, Canandaigua VA; University of Rochester
- Hovedetterforsker: Kerry Knox, Ph.D., Canandaigua VA; University of Rochester
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- W81XWH-09-2-0129 Study 2
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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