NCT05256940

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Nov 2022Jun 2027

First Submitted

Initial submission to the registry

February 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

November 30, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2027

Expected
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

February 16, 2022

Last Update Submit

April 22, 2026

Conditions

Keywords

veteransmotivational interviewing

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R)

EXPERIMENTAL

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)Other: Enhanced usual care (EUC)

Enhanced usual care (EUC)

ACTIVE COMPARATOR

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)

Interventions

Enhanced usual care (EUC) includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline.

Enhanced usual care (EUC)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.

Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • current psychosis,
  • active mania,
  • dementia,
  • impaired decision making capacity, and
  • institutionalization due to hospitalization in a non-VA facility, jail, or prison.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA Finger Lakes Healthcare System, Canandaigua, NY

Canandaigua, New York, 14424-1159, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location

MeSH Terms

Conditions

Suicide, AttemptedSuicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Peter C. Britton, PhD MS

    VA Finger Lakes Healthcare System, Canandaigua, NY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be blinded to treatment received by participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2022

First Posted

February 25, 2022

Study Start

November 30, 2022

Primary Completion

March 31, 2026

Study Completion (Estimated)

June 29, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
CSR
Time Frame
Limited data sets will be available per a Data Use Agreement (DUA), which will determine the time frame.
Access Criteria
Limited data will be provided after requestors sign a Data Use Agreement (DUA).

Locations