- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01355848
Improving Care Provided to Patients Treated in a Level 1 Trauma Center Post-suicide Attempt
March 6, 2015 updated by: Stephen O'Connor, University of Washington
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Washington
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Seattle, Washington, United States, 98104
- Harborview Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
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Focuses on behavioral elements of care, including building rapport, functional analysis, and crisis planning
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No Intervention: care as usual
Patients randomized to the care as usual arm will not receive the brief intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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(baseline) Assessment taking place immediately after completion of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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One month follow-up assessment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen O'Connor, PhD, University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
May 10, 2011
First Submitted That Met QC Criteria
May 17, 2011
First Posted (Estimate)
May 18, 2011
Study Record Updates
Last Update Posted (Estimate)
March 10, 2015
Last Update Submitted That Met QC Criteria
March 6, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 39417-C
- T32HS013835_1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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