NCT01544127

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

July 30, 2012

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 11, 2019

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

5.4 years

First QC Date

February 28, 2012

Results QC Date

March 19, 2019

Last Update Submit

February 23, 2022

Conditions

Keywords

VeteransMotivational InterviewingInpatientsSuicide, Attempted

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Number of Participants With Two Outpatient Mental Health or Substance Treatment Sessions

    1 month

Other Outcomes (1)

  • Number of Participants With a Suicide Attempt

    1, 3, and 6 months

Study Arms (3)

MI-SI+TAU

EXPERIMENTAL

Motivational Interviewing to Address Suicidal Ideation

Behavioral: MI-SI+TAU

MI-SI-R+TAU

EXPERIMENTAL

Motivational Interviewing to Address Suicidal Ideation Revised

Behavioral: MI-SI-R+TAU

TAU Alone

OTHER

Treatment as usual

Other: TAU Alone

Interventions

MI-SI+TAUBEHAVIORAL

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)

Also known as: Motivational Interviewing to Address Suicidal Ideation
MI-SI+TAU
MI-SI-R+TAUBEHAVIORAL

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)

Also known as: MI-SI Revised
MI-SI-R+TAU

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.

Also known as: Treatment as usual
TAU Alone

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • current psychosis,
  • current mania,
  • dementia,
  • prisoner status,
  • being inaccessible
  • being discharged from the unit less than 48 hours after being identified by study staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210, United States

Location

Related Publications (1)

  • Britton PC, Conner KR, Chapman BP, Maisto SA. Motivational Interviewing to Address Suicidal Ideation: A Randomized Controlled Trial in Veterans. Suicide Life Threat Behav. 2020 Feb;50(1):233-248. doi: 10.1111/sltb.12581. Epub 2019 Aug 8.

MeSH Terms

Conditions

Suicidal IdeationSuicide, Attempted

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Limitations and Caveats

Due to theoretical and empirically supported changes to motivational interviewing that were published during the trial, we changed the intervention mid-trial leading to small numbers of participants in the experimental conditions.

Results Point of Contact

Title
Dr. Peter Britton
Organization
Canandaigu VA Medical Center

Study Officials

  • Peter C. Britton, PhD MS

    Syracuse VA Medical Center, Syracuse, NY

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 5, 2012

Study Start

July 30, 2012

Primary Completion

December 5, 2017

Study Completion

December 5, 2017

Last Updated

February 25, 2022

Results First Posted

September 11, 2019

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations