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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01544127
Other study ID # MHBA-20-11S
Secondary ID IK2CX00064
Status Completed
Phase N/A
First received
Last updated
Start date July 30, 2012
Est. completion date December 5, 2017

Study information

Verified date February 2022
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date December 5, 2017
Est. primary completion date December 5, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MI-SI+TAU
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)
MI-SI-R+TAU
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:
TAU Alone
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.

Locations

Country Name City State
United States Syracuse VA Medical Center, Syracuse, NY Syracuse New York

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants With a Suicide Attempt 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
Primary Number of Participants With Suicidal Ideation 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
Primary Severity of Suicidal Ideation Among Those With It 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 Number of Participants With Two Outpatient Mental Health or Substance Treatment Sessions Treatment engagement was measured using the Treatment Services Review-6 (TSR-6) at 1 month after discharge. 1 month
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