Trial Outcomes & Findings for Crisis Line Facilitation (NCT NCT02459587)
NCT ID: NCT02459587
Last Updated: 2023-07-28
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
307 participants
Primary outcome timeframe
1 year
Results posted on
2023-07-28
Participant Flow
Participant milestones
| Measure |
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.
|
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-Month Follow-up Assessment
STARTED
|
157
|
150
|
|
3-Month Follow-up Assessment
COMPLETED
|
125
|
119
|
|
3-Month Follow-up Assessment
NOT COMPLETED
|
32
|
31
|
|
6-month Follow-up Assessment
STARTED
|
152
|
141
|
|
6-month Follow-up Assessment
COMPLETED
|
128
|
116
|
|
6-month Follow-up Assessment
NOT COMPLETED
|
24
|
25
|
|
12-month Follow-up Assessment
STARTED
|
149
|
138
|
|
12-month Follow-up Assessment
COMPLETED
|
127
|
111
|
|
12-month Follow-up Assessment
NOT COMPLETED
|
22
|
27
|
Reasons for withdrawal
| Measure |
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.
|
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-Month Follow-up Assessment
Death
|
0
|
2
|
|
3-Month Follow-up Assessment
Withdrawal by Subject
|
3
|
3
|
|
3-Month Follow-up Assessment
Lost to Follow-up
|
27
|
22
|
|
3-Month Follow-up Assessment
Researcher withdrew
|
2
|
4
|
|
6-month Follow-up Assessment
Death
|
2
|
1
|
|
6-month Follow-up Assessment
Withdrawal by Subject
|
1
|
2
|
|
6-month Follow-up Assessment
Lost to Follow-up
|
21
|
22
|
|
12-month Follow-up Assessment
Death
|
2
|
0
|
|
12-month Follow-up Assessment
Withdrawal by Subject
|
2
|
4
|
|
12-month Follow-up Assessment
Lost to Follow-up
|
18
|
22
|
|
12-month Follow-up Assessment
Researcher withdrew
|
0
|
1
|
Baseline Characteristics
Crisis Line Facilitation
Baseline characteristics by cohort
| Measure |
Crisis Line Facilitation
n=157 Participants
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.
|
Enhanced Usual Care
n=150 Participants
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.
|
Total
n=307 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
46.8 Years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
47.0 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
112 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
157 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
307 Participants
n=5 Participants
|
|
Columbia Suicide Severity Scale (C-SSRS): Most severe suicidal ideation, Lifetime
No suicidal ideation
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Columbia Suicide Severity Scale (C-SSRS): Most severe suicidal ideation, Lifetime
Wish to be dead / Non-Specific Active Suicidal Thoughts
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Columbia Suicide Severity Scale (C-SSRS): Most severe suicidal ideation, Lifetime
Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Columbia Suicide Severity Scale (C-SSRS): Most severe suicidal ideation, Lifetime
Active Suicidal Ideation with Some Intent to Act, without Specific Plan
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Columbia Suicide Severity Scale (C-SSRS): Most severe suicidal ideation, Lifetime
Active Suicidal Ideation with Specific Plan and Intent
|
92 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Columbia Suicide Severity Scale (C-SSRS): Lifetime Suicide Attempts
No attempts
|
46 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Columbia Suicide Severity Scale (C-SSRS): Lifetime Suicide Attempts
One attempt
|
31 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Columbia Suicide Severity Scale (C-SSRS): Lifetime Suicide Attempts
2 or more attempts
|
80 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Utilization of the Veterans Crisis Line, Lifetime
Never contacted VCL
|
104 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Utilization of the Veterans Crisis Line, Lifetime
Contacted VCL once
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Utilization of the Veterans Crisis Line, Lifetime
Contacted VCL 2 or more times
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Analytical sample consists of participants who completed at least one follow-up.
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).
Outcome measures
| Measure |
Crisis Line Facilitation
n=50488 Person-days
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
|
Enhanced Usual Care
n=44194 Person-days
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.
|
|---|---|---|
|
Number of Veterans Crisis Line (VCL) Contact Events Per Days at Risk
|
48 VCL Contact Events
|
35 VCL Contact Events
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Analytical sample consists of participants who completed at least one follow-up.
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.
Outcome measures
| Measure |
Crisis Line Facilitation
n=50485 Person-days
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
|
Enhanced Usual Care
n=44192 Person-days
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.
|
|---|---|---|
|
Number of Suicide Behavior Events Per Days at Risk
|
67 Suicide Behavior Events
|
116 Suicide Behavior Events
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Analytical sample consists of participants who completed at least one follow-up.
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.
Outcome measures
| Measure |
Crisis Line Facilitation
n=141 Participants
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
|
Enhanced Usual Care
n=131 Participants
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.
|
|---|---|---|
|
Outpatient General Mental Health Clinic Visit
|
24.5 Mean number of visits
Standard Deviation 25.2
|
21.2 Mean number of visits
Standard Deviation 20.7
|
Adverse Events
Crisis Line Facilitation
Serious events: 4 serious events
Other events: 91 other events
Deaths: 4 deaths
Enhanced Usual Care
Serious events: 7 serious events
Other events: 97 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Crisis Line Facilitation
n=157 participants at risk
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.
|
Enhanced Usual Care
n=150 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Death by heart attack
|
0.00%
0/157 • 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.
|
0.67%
1/150 • Number of events 1 • 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.
|
|
Psychiatric disorders
Death by suicide
|
1.3%
2/157 • Number of events 2 • 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.
|
1.3%
2/150 • Number of events 2 • 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.
|
|
Psychiatric disorders
Death by overdose
|
1.3%
2/157 • Number of events 2 • 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.
|
0.00%
0/150 • 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.
|
|
Psychiatric disorders
Hospitalization
|
0.00%
0/157 • 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.
|
2.7%
4/150 • Number of events 4 • 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.
|
Other adverse events
| Measure |
Crisis Line Facilitation
n=157 participants at risk
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.
|
Enhanced Usual Care
n=150 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Psychiatric Hospitalization: Suicidal Ideation
|
27.1%
42/155 • Number of events 74 • 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.
|
26.7%
40/150 • Number of events 74 • 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.
|
|
Surgical and medical procedures
Medical Hospitalization
|
5.1%
8/157 • Number of events 11 • 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.
|
12.0%
18/150 • Number of events 23 • 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.
|
|
Psychiatric disorders
Residential Treatment
|
28.0%
44/157 • Number of events 53 • 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.
|
22.0%
33/150 • Number of events 38 • 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.
|
|
Psychiatric disorders
Suicide Attempt
|
12.1%
19/157 • Number of events 36 • 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.
|
13.3%
20/150 • Number of events 26 • 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.
|
|
Psychiatric disorders
Psychiatric Hospitalization: Acute Substance Use
|
5.7%
9/157 • Number of events 10 • 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.
|
4.0%
6/150 • Number of events 9 • 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.
|
|
Psychiatric disorders
Psychiatric Hospitalization: General
|
3.8%
6/157 • Number of events 8 • 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.
|
8.0%
12/150 • Number of events 15 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place