Motivational Interviewing to Prevent Suicide in High Risk Veterans
Primary Purpose
Suicidal Ideation, Treatment Engagement
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MI-SI+TAU
MI-SI-R+TAU
TAU Alone
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation focused on measuring Veterans, Motivational Interviewing, Inpatients, Suicide, Attempted
Eligibility Criteria
Inclusion Criteria:
- Veteran status,
- admitted to psychiatric inpatient unit,
- age 18 and over,
- English speaking,
- able to understand the study and provide informed consent,
- clinically cleared to participate by unit staff,
- receive health care from a VHA facility in upstate New York
- at increased risk for suicide (Scale for Suicidal Ideation [SSI] > 2)
Exclusion Criteria:
- current psychosis,
- current mania,
- dementia,
- prisoner status,
- being inaccessible
- being discharged from the unit less than 48 hours after being identified by study staff
Sites / Locations
- Syracuse VA Medical Center, Syracuse, NY
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
MI-SI+TAU
MI-SI-R+TAU
TAU Alone
Arm Description
Motivational Interviewing to Address Suicidal Ideation
Motivational Interviewing to Address Suicidal Ideation Revised
Treatment as usual
Outcomes
Primary Outcome Measures
Number of Participants With Suicidal Ideation
The number of participants with suicidal ideation and severity of suicidal ideation was measured using the Scale for Suicidal Ideation (SSI) at 1, 3, and 6 months after discharge. Scores range from 0-38, with scores of 1 or greater indicating the presence of suicidal ideation.
Severity of Suicidal Ideation Among Those With It
Severity of suicidal ideation was measured by the Scale for Suicidal Ideation at 1, 3, and 6 months after discharge. Scores range from 0 to 38, with higher scores indicating more severe suicidal ideation.
Secondary Outcome Measures
Number of Participants With Two Outpatient Mental Health or Substance Treatment Sessions
Treatment engagement was measured using the Treatment Services Review-6 (TSR-6) at 1 month after discharge.
Full Information
NCT ID
NCT01544127
First Posted
February 28, 2012
Last Updated
February 23, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01544127
Brief Title
Motivational Interviewing to Prevent Suicide in High Risk Veterans
Official Title
Motivational Interviewing to Prevent Suicide in High Risk Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 30, 2012 (Actual)
Primary Completion Date
December 5, 2017 (Actual)
Study Completion Date
December 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of study is to test the efficacy of an adaptation of Motivational Interviewing to Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically hospitalized Veterans at high risk for suicide.
Detailed Description
Veterans who receive health care from the VA are at elevated risk for suicide, and the number of Veterans at high risk may be growing. Although the months following discharge from psychiatric hospitalization are a period of acute risk for Veterans, there is a dearth of empirically supported treatments tailored to psychiatric inpatients and no studies examining treatments for psychiatrically hospitalized Veterans. This randomized controlled trial will test the efficacy of an adaptation of Motivational Interviewing to Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically hospitalized Veterans at high risk for suicide. Participants will be recruited from the Acute Psychiatric Inpatient Unit at the Syracuse VA Medical Center. To meet high-risk criteria, Veterans must score over two on the Scale for Suicidal Ideation (SSI), which is prospectively predictive of death by suicide. Participants will complete a screening assessment to confirm eligibility and a baseline assessment of risk factors for suicide. They will be randomized to receive Motivational Interviewing to Address Suicidal Ideation (MI-SI) or a revised version (MI-SI-R) plus treatment as usual (TAU), or TAU alone. The MI-SI groups will receive two sessions of MI-SI during hospitalization and one telephone booster session after discharge. Participants in all conditions will be asked to complete telephone follow-up interviews at 1, 3, and 6 months after discharge. Change in the severity of suicidal ideation will be measured using the SSI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Treatment Engagement
Keywords
Veterans, Motivational Interviewing, Inpatients, Suicide, Attempted
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MI-SI+TAU
Arm Type
Experimental
Arm Description
Motivational Interviewing to Address Suicidal Ideation
Arm Title
MI-SI-R+TAU
Arm Type
Experimental
Arm Description
Motivational Interviewing to Address Suicidal Ideation Revised
Arm Title
TAU Alone
Arm Type
Other
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
MI-SI+TAU
Other Intervention Name(s)
Motivational Interviewing to Address Suicidal Ideation
Intervention Description
MI-SI focuses on exploring and resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins)
Intervention Type
Behavioral
Intervention Name(s)
MI-SI-R+TAU
Other Intervention Name(s)
MI-SI Revised
Intervention Description
MI-SI-R focuses on resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins)
Intervention Type
Other
Intervention Name(s)
TAU Alone
Other Intervention Name(s)
Treatment as usual
Intervention Description
Inpatient treatment includes medication management, case management, meals and a bed, milieu therapy consisting of creative and social activities, and a safety plan. Some families of veterans also received education to create a supportive home environment. As part of Veterans Health Administration (VHA) suicide prevention policy, the care of suicidal patients is also overseen by a local Suicide Prevention Coordinator and case managers.
Primary Outcome Measure Information:
Title
Number of Participants With Suicidal Ideation
Description
The number of participants with suicidal ideation and severity of suicidal ideation was measured using the Scale for Suicidal Ideation (SSI) at 1, 3, and 6 months after discharge. Scores range from 0-38, with scores of 1 or greater indicating the presence of suicidal ideation.
Time Frame
6 months
Title
Severity of Suicidal Ideation Among Those With It
Description
Severity of suicidal ideation was measured by the Scale for Suicidal Ideation at 1, 3, and 6 months after discharge. Scores range from 0 to 38, with higher scores indicating more severe suicidal ideation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants With Two Outpatient Mental Health or Substance Treatment Sessions
Description
Treatment engagement was measured using the Treatment Services Review-6 (TSR-6) at 1 month after discharge.
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Number of Participants With a Suicide Attempt
Description
Presence of a suicide attempt was measured with the Columbia Suicide Severity Rating Scale (C-SSRS) at 1, 3, and 6 months after discharge.
Time Frame
1, 3, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Veteran status,
admitted to psychiatric inpatient unit,
age 18 and over,
English speaking,
able to understand the study and provide informed consent,
clinically cleared to participate by unit staff,
receive health care from a VHA facility in upstate New York
at increased risk for suicide (Scale for Suicidal Ideation [SSI] > 2)
Exclusion Criteria:
current psychosis,
current mania,
dementia,
prisoner status,
being inaccessible
being discharged from the unit less than 48 hours after being identified by study staff
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C. Britton, PhD MS
Organizational Affiliation
Syracuse VA Medical Center, Syracuse, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syracuse VA Medical Center, Syracuse, NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31393029
Citation
Britton PC, Conner KR, Chapman BP, Maisto SA. Motivational Interviewing to Address Suicidal Ideation: A Randomized Controlled Trial in Veterans. Suicide Life Threat Behav. 2020 Feb;50(1):233-248. doi: 10.1111/sltb.12581. Epub 2019 Aug 8.
Results Reference
derived
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Motivational Interviewing to Prevent Suicide in High Risk Veterans
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