- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02459587
Crisis Line Facilitation (CLF)
July 19, 2023 updated by: VA Office of Research and Development
Facilitating Use of the Veterans Crisis Line in High-Risk Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Veterans Health Administration (VHA) patients are at a significantly elevated risk for fatal and non-fatal suicide attempts and identifying strategies to reduce the risk of suicidal behavior among members of the military and Veterans is a high national priority.
The VHA has invested extensively in suicide prevention and, as part of these efforts; the Veterans Crisis Line was developed as an important resource for Veterans and their families.
Utilization of the Veterans Crisis Line has expanded steadily since it first opened and, currently, it receives over 20,000 calls per month.
Despite high utilization of the Crisis Line, no data are currently available on whether use of the Veterans Crisis Line reduces an individual's likelihood of a suicide attempt or death and it is not feasible to test the efficacy of the Crisis Line in a randomized controlled trial because it is nationally available to all Veterans and their families.
More importantly, the Veterans Crisis Line may not reach those individuals at most acute risk for suicide.
The investigators' study team conducted a small survey of Veterans treated for recent suicidal crisis in a VHA inpatient psychiatric unit and found that less than half had ever utilized the Veterans Crisis Line and less than a third had used it within the past year.
Consequently, the investigators have developed and gathered pilot data on a brief intervention designed to increase utilization of the Veterans Crisis Line among high risk patients, called Crisis Line Facilitation (CLF).
This single-session intervention involves a discussion of the patient's perceived barriers of crisis line use during periods of suicidal crisis.
The CLF session ends with the patient calling the Crisis Line with the therapist in the room as a way for Veterans to practice the logistics of making the call and to have direct experiences that may counter any negative beliefs about Veterans Crisis Line use.
This study recruited 301 participants who were treated for a suicidal crisis in VHA inpatient psychiatric but had not recently used the Veterans Crisis Line.
This study is a randomized controlled trial of the impact of CLF compared to enhanced usual care (EUC) on utilization of the Veterans Crisis Line and other mental health services as well as suicide attempt(s).
All participants will be re-assessed at 3-, 6- and 12-months post baseline.
Analyses will also examine the extent to which post-baseline Crisis Line use mediates the effect of random assignment to CLF on subsequent suicidal behaviors.
Qualitative interviews at the end of the study will help understand barriers and facilitators of future implementation of the CLF intervention.
If successful, the proposed study will provide key data on the potential efficacy of a brief intervention to improve the utilization of an existing resource, the Veterans Crisis Line, to reduce suicidal behaviors in VHA patients.
Developing a brief and effective approach to encourage use of the Crisis Line has the potential to have a significant and substantial impact on suicide rates within the VHA and could be modified and exported to other populations and settings.
Study Type
Interventional
Enrollment (Actual)
307
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
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48105-2303
- VA Ann Arbor Healthcare System, Ann Arbor, MI
-
Battle Creek, Michigan, United States, 49037
- Battle Creek VA Medical Center, Battle Creek, MI
-
-
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
16 years to 97 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Inclusion criteria for screening (Part 1).
- 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.
Additional inclusion criteria for the full randomized study (Part 2):
- 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.
Exclusion Criteria:
Exclusion criteria for screening and full study:
- 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.
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: Crisis Line Facilitation (CLF)
Crisis Line Facilitation
|
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.
|
Placebo Comparator: Enhanced Usual Care (EUC)
Enhanced Usual Care
|
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.).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Veterans Crisis Line (VCL) Contact Events Per Days at Risk
Time Frame: 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Suicide Behavior Events Per Days at Risk
Time Frame: 1 year
|
The primary data source for suicidal behaviors was the TimeLine Follow Back, a semi-structured researcher-administered interview.
Participants were asked to report actual, interrupted, and aborted attempt events that occurred since the last study assessment.
Definitions for these events were derived from the Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Behaviors subsection [also administered during the assessment], and dates for these events were entered into the TimeLine Follow Back.
|
1 year
|
Outpatient General Mental Health Clinic Visit
Time Frame: 1 year
|
The primary data source for general mental health treatment service utilization was a modified version of the Treatment Services Review, an researcher-administered structured interview.
Participants were asked to report whether or not they had been to a mental health clinic for therapy or medications since the last study assessment.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mark A. Ilgen, PhD, VA Ann Arbor Healthcare System, Ann Arbor, MI
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)
March 24, 2016
Primary Completion (Actual)
October 7, 2019
Study Completion (Actual)
December 11, 2019
Study Registration Dates
First Submitted
May 29, 2015
First Submitted That Met QC Criteria
May 29, 2015
First Posted (Estimated)
June 2, 2015
Study Record Updates
Last Update Posted (Actual)
July 28, 2023
Last Update Submitted That Met QC Criteria
July 19, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 14-103
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
product manufactured in and exported from the U.S.
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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