Clinical trial NCT05256940: Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
Official title: Motivational Interviewing to Address Suicidal Ideation: A Randomized Controlled Trial With Suicidal Veterans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide, Attempted
Suicidal Ideation
Keywords: veterans
motivational interviewing
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Syracuse VA Medical Center
name: Portland VA Medical Center
name: Ralph H. Johnson VA Medical Center
First posted: 2022-02-25
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Columbia-Suicide Severity Rating Scale
timeFrame: 12-months
measure: Beck Scale for Suicidal Ideation
timeFrame: 12-month
Secondary outcomes:
Other outcomes:
Locations:
city: Canandaigua
country: United States
facility: VA Finger Lakes Healthcare System, Canandaigua, NY
state: New York
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: VA Finger Lakes Healthcare System, Canandaigua, NY
name: Peter C. Britton, PhD MS
role: PRINCIPAL_INVESTIGATOR
References: