Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide (MI-SI)
Primary Purpose
Suicide, Attempted, Suicidal Ideation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R)
Enhanced usual care (EUC)
Sponsored by
About this trial
This is an interventional treatment trial for Suicide, Attempted focused on measuring veterans, motivational interviewing
Eligibility Criteria
Inclusion Criteria:
- Veteran status,
- admitted to an inpatient unit, referred by a suicide prevention coordinator, or identified as high-risk via data extraction,
- age 18 and over,
- English speaking and reading, and
- ability to understand the study and provide informed consent,
- high-risk status confirmed by suicide attempt within a month on the Columbia- Suicide Severity Rating Scale or a score > 5 on the Scale for Suicidal Ideation
Exclusion Criteria:
- current psychosis,
- active mania,
- dementia,
- impaired decision making capacity, and
- institutionalization due to hospitalization in a non-VA facility, jail, or prison.
Sites / Locations
- Canandaigua VA Medical Center, Canandaigua, NYRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R)
Enhanced usual care (EUC)
Arm Description
Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) was developed to help Veterans resolve ambivalence about living by increasing the motivation to live, and is delivered in three sessions in person, virtually, or by telephone.
Enhanced usual care (EUC) includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline.
Outcomes
Primary Outcome Measures
Columbia-Suicide Severity Rating Scale
The first primary outcome is the presence (vs. absence) of non-fatal suicide attempts as reported on the Columbia-Suicide Severity Rating Scale.
Beck Scale for Suicidal Ideation
The second primary outcome is suicidal ideation as reported on the Beck Scale for Suicidal Ideation, which has a range from 0-38, with higher scores indicating more severe suicidal ideation.
Secondary Outcome Measures
Full Information
NCT ID
NCT05256940
First Posted
February 16, 2022
Last Updated
December 8, 2022
Sponsor
VA Office of Research and Development
Collaborators
Syracuse VA Medical Center, Portland VA Medical Center, Ralph H. Johnson VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05256940
Brief Title
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
Acronym
MI-SI
Official Title
Motivational Interviewing to Address Suicidal Ideation: A Randomized Controlled Trial With Suicidal Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
June 29, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Syracuse VA Medical Center, Portland VA Medical Center, Ralph H. Johnson VA Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this project is to conduct a randomized control trial with 470 Veterans to examine the impact of a revised version of Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) on risk for suicide attempts and suicidal ideation when compared to high quality usual care.
Detailed Description
Research suggests that treatments to reduce suicidal behavior may need to focus on both the motivation to live and the motivation to die to obtain optimal effects. The PI developed a revised version of Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) to help Veterans resolve ambivalence about living by increasing the motivation to live, that consists of three sessions delivered in-person, virtually, or by telephone. Enhanced usual care (EUC) for high-risk Veterans includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline. In a preliminary randomized controlled trial (RCT) in psychiatrically hospitalized Veterans, MI-SI-R plus EUC was associated with 50% fewer suicide attempts and 41% lower likelihood of suicidal ideation compared to EUC alone. The investigators are proposing an RCT comparing MI-SI-R plus EUC (MI-SI-R+EUC) to EUC alone in a sample of 470 high-risk Veterans with recent suicidal crises from three VHA Medical Centers, with "high-risk" defined as a suicide attempt within a month or suicidal ideation > 5 on the Beck Scale for Suicidal Ideation. Half (n = 235) will be randomized to MI-SI-R+EUC (three sessions in-person, via Video Connect, or telephone) and the remaining participants (n = 235) will receive EUC alone. All participants will be asked to complete telephone follow-up assessments at 1, 3, 6, and 12-months after randomization. This will allow the investigators to determine the efficacy of MI-SI-R+EUC in reducing risk for suicide attempts (Aim 1) and reducing overall suicidal ideation (Aim 2) when compared to EUC alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Suicidal Ideation
Keywords
veterans, motivational interviewing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) was developed to help participants at high-risk for suicide resolve their ambivalence about living by increasing their motivation to live, and is delivered in three sessions in-person, virtually, or by telephone.
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blinded to treatment received by participants.
Allocation
Randomized
Enrollment
470 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R)
Arm Type
Experimental
Arm Description
Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) was developed to help Veterans resolve ambivalence about living by increasing the motivation to live, and is delivered in three sessions in person, virtually, or by telephone.
Arm Title
Enhanced usual care (EUC)
Arm Type
Active Comparator
Arm Description
Enhanced usual care (EUC) includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R)
Intervention Description
Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) was developed to help Veterans resolve ambivalence about living by increasing the motivation to live, that is delivered in three sessions in person, virtually, or by telephone.
Intervention Type
Other
Intervention Name(s)
Enhanced usual care (EUC)
Intervention Description
Enhanced usual care (EUC) includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline.
Primary Outcome Measure Information:
Title
Columbia-Suicide Severity Rating Scale
Description
The first primary outcome is the presence (vs. absence) of non-fatal suicide attempts as reported on the Columbia-Suicide Severity Rating Scale.
Time Frame
12-months
Title
Beck Scale for Suicidal Ideation
Description
The second primary outcome is suicidal ideation as reported on the Beck Scale for Suicidal Ideation, which has a range from 0-38, with higher scores indicating more severe suicidal ideation.
Time Frame
12-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Veteran status,
admitted to an inpatient unit, referred by a suicide prevention coordinator, or identified as high-risk via data extraction,
age 18 and over,
English speaking and reading, and
ability to understand the study and provide informed consent,
high-risk status confirmed by suicide attempt within a month on the Columbia- Suicide Severity Rating Scale or a score > 5 on the Scale for Suicidal Ideation
Exclusion Criteria:
current psychosis,
active mania,
dementia,
impaired decision making capacity, and
institutionalization due to hospitalization in a non-VA facility, jail, or prison.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne Gillespie, MD BS
Phone
(585) 393-7763
Email
Suzanne.Gillespie@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Dorian L Savino, MPA
Phone
(585) 463-2673
Email
dorian.savino@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C. Britton, PhD MS
Organizational Affiliation
Canandaigua VA Medical Center, Canandaigua, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canandaigua VA Medical Center, Canandaigua, NY
City
Canandaigua
State/Province
New York
ZIP/Postal Code
14424
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Gillespie, MD BS
Phone
585-393-7763
Email
Suzanne.Gillespie@va.gov
First Name & Middle Initial & Last Name & Degree
Dorian L Savino, MPA
Phone
(585) 463-2673
Email
dorian.savino@va.gov
First Name & Middle Initial & Last Name & Degree
Peter C. Britton, PhD MS
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Members of the scientific community who would like a copy of limited data sets (i.e., data sets underlying any publication) from this study can request a copy by e-mailing the PI at Peter.Britton@va.gov. They should state their reason for requesting the data, their plans for analyzing the data, and agree not to attempt to re-identify participants. Limited data sets will be encrypted uploaded to a protected share-point; and the password will be sent to the requestor via a separate e-mail.
IPD Sharing Time Frame
Limited data sets will be available per a Data Use Agreement (DUA), which will determine the time frame.
IPD Sharing Access Criteria
Limited data will be provided after requestors sign a Data Use Agreement (DUA).
Learn more about this trial
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
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