Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide (MI-SI)

Motivational Interviewing to Address Suicidal Ideation: A Randomized Controlled Trial With Suicidal Veterans

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.

Study Overview

• Status: Recruiting
• Conditions: Suicidal Ideation; Suicide, Attempted
• Intervention / Treatment: Behavioral: Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R); Other: Enhanced usual care (EUC)

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.

• Study Type: Interventional
• Enrollment (Estimated): 470
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dorian L Savino, MPA; Phone Number: (585) 463-2673; Email: dorian.savino@va.gov
• Study Contact Backup: Name: Richard J Servatius, PhD; Phone Number: (315) 744-3370; Email: Richard.Servatius@va.gov

Study Locations

• United States
  • New York
    • Canandaigua, New York, United States, 14424-1159
      • Recruiting
      • VA Finger Lakes Healthcare System, Canandaigua, NY
      • Contact: Dorian L Savino, MPA; Phone Number: (585) 463-2673; Email: dorian.savino@va.gov
      • Principal Investigator: Peter C. Britton, PhD MS
      • Contact: Richard J Servatius, PhD; Phone Number: 315-744-3370; Email: Richard.Servatius@va.gov
  • Oregon
    • Portland, Oregon, United States, 97207-2964
      • Recruiting
      • VA Portland Health Care System, Portland, OR
      • Contact: David Cohen, MD; Email: david.cohen2@va.gov
      • Contact: Sonemany Salinthone, PhD; Email: Sonemany.Salinthone@va.gov
  • South Carolina
    • Charleston, South Carolina, United States, 29401-5703
      • Recruiting
      • Ralph H. Johnson VA Medical Center, Charleston, SC
      • Contact: Rutha Larue, PhD; Email: Rutha.LaRue@va.gov
      • Contact: Jesus Garcia, MS; Email: jesus.garcia@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R); 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.	Behavioral: Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R); 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.; Other: Enhanced usual care (EUC); Enhanced usual care (EUC) includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline.
Active Comparator: Enhanced usual care (EUC); Enhanced usual care (EUC) includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline.	Other: Enhanced usual care (EUC); Enhanced usual care (EUC) includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12-months
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.	12-month

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Portland VA Medical Center; Syracuse VA Medical Center; Ralph H. Johnson VA Medical Center
• Investigators: Principal Investigator: Peter C. Britton, PhD MS, VA Finger Lakes Healthcare System, Canandaigua, NY

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): June 29, 2027

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: veterans; motivational interviewing
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Suicide, Attempted
• Other Study ID Numbers: MHBC-001-21S; I01CX002359 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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).
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• 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