NCT02459587

Brief Summary

This study is a randomized controlled trial (n = 301) of a new single-session intervention, called Crisis Line Facilitation (CLF), compared to an enhanced usual care condition on utilization of the Veterans Crisis Line and other mental health services as well as suicide attempt(s). All participants were recruited during an inpatient psychiatric stay for the treatment of a recent suicidal crisis and will be re-assessed at 3-, 6- and 12-months post baseline. If successful, the proposed study will provide key data on the potential efficacy of a brief tool to improve the utilization of an existing resource, the Veterans Crisis Line, to reduce suicidal behaviors in VHA patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
307

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

March 24, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2019

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 22, 2021

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

3.5 years

First QC Date

May 29, 2015

Results QC Date

November 25, 2020

Last Update Submit

July 19, 2023

Conditions

Keywords

Self-Injurious Behaviorsuicide prevention

Outcome Measures

Primary Outcomes (1)

  • Number of Veterans Crisis Line (VCL) Contact Events Per Days at Risk

    The primary data source for information regarding use of the VCL was collected via researcher-administered interview questions during the TimeLine Follow Back assessment. Participants were asked to recall how many times since the last assessment in which they contacted the VCL for any reason. For contacts that occurred, participants were asked to recall the date of these contacts and the type of contact that was made (e.g. phone call, text, or chat).

    1 year

Secondary Outcomes (2)

  • Number of Suicide Behavior Events Per Days at Risk

    1 year

  • Outpatient General Mental Health Clinic Visit

    1 year

Study Arms (2)

Crisis Line Facilitation (CLF)

EXPERIMENTAL

Crisis Line Facilitation

Behavioral: Crisis Line Facilitation (CLF)

Enhanced Usual Care (EUC)

PLACEBO COMPARATOR

Enhanced Usual Care

Behavioral: Enhanced Usual Care (EUC)

Interventions

This single session therapist-delivered intervention addresses Veterans' perceived barriers and facilitators of crisis line use during periods of suicidal crisis. The CLF session culminates with the Veteran calling the Crisis Line with the therapist in the room as a way for the Veteran to practice the logistics of making the call and to have direct experiences that may counter any negative beliefs about Crisis Line use.

Crisis Line Facilitation (CLF)

Those in the EUC condition received the same promotional items and information about the Veterans Crisis Line (VCL) as the CLF condition. Participants were encouraged to seek help via a provider or the VCL if they felt suicidal in the future. Research staff briefly explained key information about the VCL to those in the EUC condition (e.g., the links between the VCL and the VA, the 24/7/365 availability, etc.).

Enhanced Usual Care (EUC)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults age 18 years of age or older receiving care in an inpatient psychiatric unit at either the BC VAMC or AA VAMC;
  • mention of a significant suicidal crisis within the intake note;
  • medically stable and able to provide informed consent; and
  • Mini-Mental State Examination (MMSE) score greater than or equal to 21.
  • no reported use of the Veterans Crisis Line within the past 12-months;
  • report current suicidal ideation (BSS greater than or equals 5 during the week prior to hospitalization) as reported during the screening interview.

You may not qualify if:

  • patients who do not understand English;
  • prisoners;
  • patients deemed unable to provide informed consent as stated above;
  • patients who recently received or are scheduled to receive electroconvulsive therapy (ECT); and
  • profound psychotic symptoms and/or cognitive deficits that would prevent patients from understanding the content of the intervention and/or assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

Battle Creek VA Medical Center, Battle Creek, MI

Battle Creek, Michigan, 49037, United States

Location

MeSH Terms

Conditions

SuicideSuicide, AttemptedSelf-Injurious BehaviorSuicide Prevention

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Mark Ilgen
Organization
Veterans Health Administration

Study Officials

  • Mark A. Ilgen, PhD

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

May 29, 2015

First Posted

June 2, 2015

Study Start

March 24, 2016

Primary Completion

October 7, 2019

Study Completion

December 11, 2019

Last Updated

July 28, 2023

Results First Posted

April 22, 2021

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations