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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crisis Line Facilitation (CLF) | Experimental | Crisis Line Facilitation |
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| Enhanced Usual Care (EUC) | Placebo Comparator | Enhanced Usual Care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crisis Line Facilitation (CLF) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Inclusion criteria for screening (Part 1).
Additional inclusion criteria for the full randomized study (Part 2):
Exclusion Criteria:
Exclusion criteria for screening and full study:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A. Ilgen, PhD | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105-2303 | United States | ||
| Battle Creek VA Medical Center, Battle Creek, MI |
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| ID | Title | Description |
|---|---|---|
| FG000 | Crisis Line Facilitation | Crisis Line Facilitation (CLF) is a single-session intervention which focuses on increasing awareness and motivation to contact the Veterans Crisis Line during a suicidal crisis. |
| FG001 | Enhanced Usual Care | Enhanced Usual Care (EUC) provided educational materials about the Veterans Crisis Line in addition to the standard of care provided on the inpatient hospital unit. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3-Month Follow-up Assessment |
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| 6-month Follow-up Assessment |
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| 12-month Follow-up Assessment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Crisis Line Facilitation | Crisis Line Facilitation (CLF) is a single-session intervention which focuses on increasing awareness and motivation to contact the Veterans Crisis Line during a suicidal crisis. |
| BG001 | Enhanced Usual Care |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Analytical sample consists of participants who completed at least one follow-up. | Posted | Number | VCL Contact Events | 1 year | Person-days | Person-days |
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1 year
Serious adverse events were death and other life-threatening events. Adverse events were suicidal ideation or behaviors, breach of confidentiality, hospitalizations or other interventions resulting from suicidal thoughts, behaviors, or substance use (e.g. overdose, acute intoxication), hospitalizations for medical reasons, accidents or injuries (including non-suicidal self-injury), and discomfort associated with answering difficult questions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Crisis Line Facilitation | Crisis Line Facilitation (CLF) is a single-session intervention which focuses on increasing awareness and motivation to contact the Veterans Crisis Line during a suicidal crisis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death by heart attack | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric Hospitalization: Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Ilgen | Veterans Health Administration | 7349366266 | mark.ilgen@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Ann Arbor | Jul 29, 2019 | Nov 24, 2020 | Prot_SAP_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Battle Creek | Jul 29, 2019 | Nov 24, 2020 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Main Study Consent | Jun 9, 2016 | Nov 24, 2020 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Qualitative Interview Consents | Feb 14, 2019 | Nov 24, 2020 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D013406 | Suicide, Attempted |
| D016728 | Self-Injurious Behavior |
| D000092864 | Suicide Prevention |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Enhanced Usual Care (EUC) | Behavioral | 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.). |
|
| 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. | 1 year |
| Battle Creek |
| Michigan |
| 49037 |
| United States |
| Lost to Follow-up |
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| Researcher withdrew |
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| NOT COMPLETED |
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| NOT COMPLETED |
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Enhanced Usual Care (EUC) provided educational materials about the Veterans Crisis Line in addition to the standard of care provided on the inpatient hospital unit.
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Columbia Suicide Severity Scale (C-SSRS): Most severe suicidal ideation, Lifetime | Count of Participants | Participants |
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| Columbia Suicide Severity Scale (C-SSRS): Lifetime Suicide Attempts | Count of Participants | Participants |
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| Utilization of the Veterans Crisis Line, Lifetime | For participants who endorsed contacting the VCL in their lifetime, these contacts were not within the previous 12 months. | Count of Participants | Participants |
|
| OG001 | Enhanced Usual Care | Enhanced Usual Care (EUC) provided educational materials about the Veterans Crisis Line in addition to the standard of care provided on the inpatient hospital unit. |
|
|
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| Secondary | 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. | Analytical sample consists of participants who completed at least one follow-up. | Posted | Number | Suicide Behavior Events | 1 year | Person-days | Person-days |
|
|
|
|
| Secondary | 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. | Analytical sample consists of participants who completed at least one follow-up. | Posted | Mean | Standard Deviation | Mean number of visits | 1 year |
|
|
|
|
| 4 |
| 157 |
| 4 |
| 157 |
| 91 |
| 157 |
| EG001 | Enhanced Usual Care | Enhanced Usual Care (EUC) provided educational materials about the Veterans Crisis Line in addition to the standard of care provided on the inpatient hospital unit. | 3 | 150 | 7 | 150 | 97 | 150 |
| Death by suicide | Psychiatric disorders | Non-systematic Assessment |
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| Death by overdose | Psychiatric disorders | Non-systematic Assessment |
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| Hospitalization | Psychiatric disorders | Non-systematic Assessment | Participant inpatient hospitalization for to a suicide or substance related reason immediately following a study interaction |
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| Medical Hospitalization | Surgical and medical procedures | Non-systematic Assessment | Includes hospitalizations for medical related events only (e.g. surgery, accidents, injuries, illnesses) |
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| Residential Treatment | Psychiatric disorders | Non-systematic Assessment | Treatment for psychiatric or substance use disorders |
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| Suicide Attempt | Psychiatric disorders | Non-systematic Assessment |
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| Psychiatric Hospitalization: Acute Substance Use | Psychiatric disorders | Non-systematic Assessment | Includes hospitalizations for detoxification, intoxication, overdose, or increased substance use. |
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| Psychiatric Hospitalization: General | Psychiatric disorders | Non-systematic Assessment | Includes hospitalizations for general mental health reasons, excluding suicidal ideation or substance use |
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