Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide

Suicidal Ideation Clinical Trial

— MI-SI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05256940
• Other study ID #: MHBC-001-21S
• Secondary ID: I01CX002359
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: June 29, 2027

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: Richard J Servatius, PhD
• Phone: (315) 744-3370
• Email: Richard.Servatius[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: June 29, 2027
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

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.

Locations

Country	Name	City	State
United States	VA Finger Lakes Healthcare System, Canandaigua, NY	Canandaigua	New York
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
VA Office of Research and Development	Portland VA Medical Center, Ralph H. Johnson VA Medical Center, Syracuse VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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