- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01544127
Motivational Interviewing to Prevent Suicide in High Risk Veterans
February 23, 2022 updated by: VA Office of Research and Development
The purpose of study is to test the efficacy of an adaptation of Motivational Interviewing to Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically hospitalized Veterans at high risk for suicide.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Veterans who receive health care from the VA are at elevated risk for suicide, and the number of Veterans at high risk may be growing.
Although the months following discharge from psychiatric hospitalization are a period of acute risk for Veterans, there is a dearth of empirically supported treatments tailored to psychiatric inpatients and no studies examining treatments for psychiatrically hospitalized Veterans.
This randomized controlled trial will test the efficacy of an adaptation of Motivational Interviewing to Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically hospitalized Veterans at high risk for suicide.
Participants will be recruited from the Acute Psychiatric Inpatient Unit at the Syracuse VA Medical Center.
To meet high-risk criteria, Veterans must score over two on the Scale for Suicidal Ideation (SSI), which is prospectively predictive of death by suicide.
Participants will complete a screening assessment to confirm eligibility and a baseline assessment of risk factors for suicide.
They will be randomized to receive Motivational Interviewing to Address Suicidal Ideation (MI-SI) or a revised version (MI-SI-R) plus treatment as usual (TAU), or TAU alone.
The MI-SI groups will receive two sessions of MI-SI during hospitalization and one telephone booster session after discharge.
Participants in all conditions will be asked to complete telephone follow-up interviews at 1, 3, and 6 months after discharge.
Change in the severity of suicidal ideation will be measured using the SSI.
Study Type
Interventional
Enrollment (Actual)
132
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13210
- Syracuse VA Medical Center, Syracuse, NY
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Veteran status,
- admitted to psychiatric inpatient unit,
- age 18 and over,
- English speaking,
- able to understand the study and provide informed consent,
- clinically cleared to participate by unit staff,
- receive health care from a VHA facility in upstate New York
- at increased risk for suicide (Scale for Suicidal Ideation [SSI] > 2)
Exclusion Criteria:
- current psychosis,
- current mania,
- dementia,
- prisoner status,
- being inaccessible
- being discharged from the unit less than 48 hours after being identified by study staff
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MI-SI+TAU
Motivational Interviewing to Address Suicidal Ideation
|
MI-SI focuses on exploring and resolving ambivalence about living.
It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins)
Other Names:
|
|
Experimental: MI-SI-R+TAU
Motivational Interviewing to Address Suicidal Ideation Revised
|
MI-SI-R focuses on resolving ambivalence about living.
It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins)
Other Names:
|
|
Other: TAU Alone
Treatment as usual
|
Inpatient treatment includes medication management, case management, meals and a bed, milieu therapy consisting of creative and social activities, and a safety plan.
Some families of veterans also received education to create a supportive home environment.
As part of Veterans Health Administration (VHA) suicide prevention policy, the care of suicidal patients is also overseen by a local Suicide Prevention Coordinator and case managers.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Suicidal Ideation
Time Frame: 6 months
|
The number of participants with suicidal ideation and severity of suicidal ideation was measured using the Scale for Suicidal Ideation (SSI) at 1, 3, and 6 months after discharge.
Scores range from 0-38, with scores of 1 or greater indicating the presence of suicidal ideation.
|
6 months
|
|
Severity of Suicidal Ideation Among Those With It
Time Frame: 6 months
|
Severity of suicidal ideation was measured by the Scale for Suicidal Ideation at 1, 3, and 6 months after discharge.
Scores range from 0 to 38, with higher scores indicating more severe suicidal ideation.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Two Outpatient Mental Health or Substance Treatment Sessions
Time Frame: 1 month
|
Treatment engagement was measured using the Treatment Services Review-6 (TSR-6) at 1 month after discharge.
|
1 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With a Suicide Attempt
Time Frame: 1, 3, and 6 months
|
Presence of a suicide attempt was measured with the Columbia Suicide Severity Rating Scale (C-SSRS) at 1, 3, and 6 months after discharge.
|
1, 3, and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Peter C. Britton, PhD MS, Syracuse VA Medical Center, Syracuse, NY
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2012
Primary Completion (Actual)
December 5, 2017
Study Completion (Actual)
December 5, 2017
Study Registration Dates
First Submitted
February 28, 2012
First Submitted That Met QC Criteria
March 2, 2012
First Posted (Estimate)
March 5, 2012
Study Record Updates
Last Update Posted (Actual)
February 25, 2022
Last Update Submitted That Met QC Criteria
February 23, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MHBA-20-11S
- IK2CX00064 (Other Grant/Funding Number: Department of Veterans Affairs)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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