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Improving Care Provided to Patients Treated in a Level 1 Trauma Center Post-suicide Attempt

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ClinicalTrials.gov Identifier: NCT01355848
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
Stephen O'Connor, University of Washington

Brief Summary:
The aim of the study is to refine, elaborate, and pilot a brief intervention for adult patients following a suicide attempt provided during hospitalization in an acute medical setting. 40 participants will be randomized to receive the brief intervention + care as usual or only care as usual. It is hypothesized that the intervention will be acceptable and feasible to both patients and intervention clinicians.

Condition or disease Intervention/treatment Phase
Suicidal Ideas Behavioral: Brief Intervention for Suicidality Phase 1

Detailed Description:
The aim of the study is to refine, elaborate, and pilot a brief intervention for adult patients following a suicide attempt provided during hospitalization in an acute medical setting, and will be addressed with a sample of cases (N = 40) from Harborview. The participants will be randomized into one of two groups: those that receive the intervention and those that do not. All participants will complete a battery of assessments The intervention is based on the theory of teachable moments, wherein timing in proximity to injury and appropriate treatment setting provide a unique opportunity to create patient behavioral change. The brief intervention consists of engaging the patient in conversation regarding suicidal ambivalence (desire to live vs. desire to die), collaborative discovery of primary and secondary drivers of suicidality, and safety planning. A guide to delivering the intervention has been completed and may undergo changes throughout the study. Adherence measures will be developed in order to assess the degree to which the clinician accurately provided the brief intervention without including additional therapeutic elements or leaving out elements required in the intervention guide. Best methods for integrating the brief intervention into services provided on medical and surgical units will be determined, as well.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Care Provided to Patients Treated in a Level 1 Trauma Center Post-suicide Attempt
Study Start Date : May 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Brief Intervention
The brief intervention consists of stepped care protocol, including building rapport, functional analysis of suicidal behavior, and crisis planning
Behavioral: Brief Intervention for Suicidality
Focuses on behavioral elements of care, including building rapport, functional analysis, and crisis planning
No Intervention: care as usual
Patients randomized to the care as usual arm will not receive the brief intervention.



Primary Outcome Measures :
  1. Patient Satisfaction Questionnaire [ Time Frame: (baseline) Assessment taking place immediately after completion of intervention ]
    The Patient Satisfaction Questionnaire will be used to determine the acceptability of the intervention by the patient.


Secondary Outcome Measures :
  1. Scale for Suicide Ideation [ Time Frame: One month follow-up assessment ]
    The Scale for Suicide Ideation will be used to determine the severity of current suicidality in all participants at the one-month follow-up as compared to the baseline assessment.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • at least 15 years of age
  • Inpatient on medical/surgical unit
  • Admitted following a suicide attempt
  • Sufficient English to benefit from psychotherapy in English
  • Consents to be a research participant

Exclusion Criteria:

  • Lack of sufficient English to participate in psychotherapy in English
  • Prisoner/inmate at time of admission
  • Too cognitively impaired, delirious, or psychotic to respond to psychotherapeutic intervention before end of stay on medical/surgical unit. Determination of cognitive impairment, delirium, agitation, and psychosis will be determined through the referral phone call between the PI and the referring care provider, as well as the PI's own clinical assessment of the patient at the outset of the brief intervention.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355848


Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Stephen O'Connor, PhD University of Washington

Responsible Party: Stephen O'Connor, Acting Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01355848     History of Changes
Other Study ID Numbers: 39417-C
T32HS013835_1
First Posted: May 18, 2011    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015

Keywords provided by Stephen O'Connor, University of Washington:
Suicide
Brief Intervention
Youth
Acute Medical Setting
Readiness to Change
Suicidality

Additional relevant MeSH terms:
Suicide
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms