SuicideCLFNCT02459587
Crisis Line Facilitation
A study testing Crisis Line Facilitation (CLF) in people with Suicide and Suicide, Attempted, run by VA Office of Research and Development at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Suicide, Suicide, Attempted, Hospitals, Psychiatric
- What is being tested?
- Crisis Line Facilitation (CLF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 307 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Mar 2016to 11 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
Battle Creek VA Medical Center, Battle Creek, MI
Battle Creek, Michigan, 49037
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide, Suicide, Attempted, Hospitals, Psychiatric
- Being tested
- Crisis Line Facilitation (CLF), Enhanced Usual Care (EUC)
- Keywords
- Self-Injurious Behavior, suicide prevention
- Medical subject headings
- Suicide, Suicide, Attempted, Self-Injurious Behavior, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisis Line Facilitation (CLF)Behavioural
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.
Enhanced Usual Care (EUC)Behavioural
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.).
| Study group | Role | What they receive |
|---|---|---|
| Crisis Line Facilitation (CLF) | Experimental | Crisis Line Facilitation Receives: Behavioral: Crisis Line Facilitation (CLF) |
| Enhanced Usual Care (EUC) | Placebo comparator | Enhanced Usual Care Receives: Behavioral: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (2)
Number of Suicide Behavior Events Per Days at Risk
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.
Measured: 1 year
Outpatient General Mental Health Clinic Visit
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study start24 Mar 2016
- Primary completion7 Oct 2019
- Study completion11 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mark A. Ilgen, PhD, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459587
- Sponsor's protocol ID
- IIR 14-103
- Acronym
- CLF
- Status last verified
- Jul 2023
- First submitted
- 29 May 2015
- Last updated
- 28 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Use of the Veterans Crisis Line in High-Risk Patients
- ClinicalTrials.gov ID
- NCT02459587
- Acronym / sponsor ID
- CLF / IIR 14-103
- Conditions
- Suicide, Suicide, Attempted, Hospitals, Psychiatric
- Keywords
- Self-Injurious Behavior, suicide prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 24 Mar 2016 (actual)
- Primary completion
- 7 Oct 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Posted 22 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crisis Line Facilitation (CLF) | Experimental | Behavioral: Crisis Line Facilitation (CLF)Crisis Line Facilitation |
| Enhanced Usual Care (EUC) | Placebo comparator | Behavioral: Enhanced Usual Care (EUC)Enhanced Usual Care |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crisis Line Facilitation (CLF)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. | Behavioural | Crisis Line Facilitation (CLF) |
| Enhanced Usual Care (EUC)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.). | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
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).
2 secondary outcomes
Number of Suicide Behavior Events Per Days at Risk
Time frame: 1 year
Outpatient General Mental Health Clinic Visit
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A. Ilgen, PhD principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crisis Line Facilitation (CLF) in people with Suicide and Suicide, Attempted, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Veterans Crisis Line (VCL) Contact Events Per Days at Risk (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.