Suicidal Ideation, Treatment Engagement
Conditions
Keywords
Veterans, Motivational Interviewing, Inpatients, Suicide, Attempted
Brief summary
The purpose of study is to test the efficacy of an adaptation of Motivational Interviewing to Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically hospitalized Veterans at high risk for suicide.
Detailed description
Veterans who receive health care from the VA are at elevated risk for suicide, and the number of Veterans at high risk may be growing. Although the months following discharge from psychiatric hospitalization are a period of acute risk for Veterans, there is a dearth of empirically supported treatments tailored to psychiatric inpatients and no studies examining treatments for psychiatrically hospitalized Veterans. This randomized controlled trial will test the efficacy of an adaptation of Motivational Interviewing to Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically hospitalized Veterans at high risk for suicide. Participants will be recruited from the Acute Psychiatric Inpatient Unit at the Syracuse VA Medical Center. To meet high-risk criteria, Veterans must score over two on the Scale for Suicidal Ideation (SSI), which is prospectively predictive of death by suicide. Participants will complete a screening assessment to confirm eligibility and a baseline assessment of risk factors for suicide. They will be randomized to receive Motivational Interviewing to Address Suicidal Ideation (MI-SI) or a revised version (MI-SI-R) plus treatment as usual (TAU), or TAU alone. The MI-SI groups will receive two sessions of MI-SI during hospitalization and one telephone booster session after discharge. Participants in all conditions will be asked to complete telephone follow-up interviews at 1, 3, and 6 months after discharge. Change in the severity of suicidal ideation will be measured using the SSI.
Interventions
BEHAVIORALMI-SI+TAU
MI-SI focuses on exploring and resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins)
BEHAVIORALMI-SI-R+TAU
MI-SI-R focuses on resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins)
OTHERTAU Alone
Inpatient treatment includes medication management, case management, meals and a bed, milieu therapy consisting of creative and social activities, and a safety plan. Some families of veterans also received education to create a supportive home environment. As part of Veterans Health Administration (VHA) suicide prevention policy, the care of suicidal patients is also overseen by a local Suicide Prevention Coordinator and case managers.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veteran status, * admitted to psychiatric inpatient unit, * age 18 and over, * English speaking, * able to understand the study and provide informed consent, * clinically cleared to participate by unit staff, * receive health care from a VHA facility in upstate New York * at increased risk for suicide (Scale for Suicidal Ideation \[SSI\] \> 2)
Exclusion criteria
* current psychosis, * current mania, * dementia, * prisoner status, * being inaccessible * being discharged from the unit less than 48 hours after being identified by study staff
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Suicidal Ideation | 6 months | The number of participants with suicidal ideation and severity of suicidal ideation was measured using the Scale for Suicidal Ideation (SSI) at 1, 3, and 6 months after discharge. Scores range from 0-38, with scores of 1 or greater indicating the presence of suicidal ideation. |
| Severity of Suicidal Ideation Among Those With It | 6 months | Severity of suicidal ideation was measured by the Scale for Suicidal Ideation at 1, 3, and 6 months after discharge. Scores range from 0 to 38, with higher scores indicating more severe suicidal ideation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Two Outpatient Mental Health or Substance Treatment Sessions | 1 month | Treatment engagement was measured using the Treatment Services Review-6 (TSR-6) at 1 month after discharge. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Suicide Attempt | 1, 3, and 6 months | Presence of a suicide attempt was measured with the Columbia Suicide Severity Rating Scale (C-SSRS) at 1, 3, and 6 months after discharge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MI-SI+TAU Motivational Interviewing to Address Suicidal Ideation (MI-SI)
MI-SI focuses on exploring and resolving ambivalence about living. It consist of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up session (30-50 mins) | 33 |
| MI-SI-R+TAU Motivational Interviewing to Address Suicidal Ideation Revised (MI-SI-R)
MI-SI-R focuses on resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins) | 33 |
| Treatment as Usual (TAU) Treatment as Usual (TAU)
TAU consisted of standard inpatient treatment that includes medication management, case management, meals and a bed, and milieu therapy consisting of creative and social activities. Some families of veterans also received education to create a supportive home environment. Suicidal patients also completed a safety plan prior to discharge, and their care was overseen by a local Suicide Prevention Coordinator and case managers. | 66 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Became Psychotic | 1 | 0 | 0 |
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Discharged out of catchment area | 1 | 1 | 1 |
| Overall Study | Jail or Prison | 1 | 1 | 2 |
| Overall Study | Lost to Follow-up | 4 | 2 | 9 |
| Overall Study | Researcher withdrew | 1 | 0 | 0 |
| Overall Study | Went active duty | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 1 |
Baseline characteristics
| Characteristic | Total | MI-SI+TAU | MI-SI-R+TAU | Treatment as Usual (TAU) |
|---|---|---|---|---|
| Addiction Severity Index (ASI) (past 28 days) Any Mental Health Inpatient Days | 1.97 days STANDARD_DEVIATION 5.87 | 0.27 days STANDARD_DEVIATION 1.15 | 2.82 days STANDARD_DEVIATION 7.38 | 2.39 days STANDARD_DEVIATION 6.32 |
| Addiction Severity Index (ASI) (past 28 days) Any Mental Health Outpatient Days | 2.82 days STANDARD_DEVIATION 4.43 | 2.58 days STANDARD_DEVIATION 4.47 | 2.83 days STANDARD_DEVIATION 4.43 | 3.58 days STANDARD_DEVIATION 5.5 |
| Addiction Severity Index (ASI) (past 28 days) Medical Medication | 14.77 days STANDARD_DEVIATION 13.35 | 16.15 days STANDARD_DEVIATION 12.96 | 14.00 days STANDARD_DEVIATION 14 | 14.45 days STANDARD_DEVIATION 13.36 |
| Addiction Severity Index (ASI) (past 28 days) Psychiatric Medication | 16.98 days STANDARD_DEVIATION 12.76 | 14.82 days STANDARD_DEVIATION 12.87 | 18.70 days STANDARD_DEVIATION 12.61 | 17.20 days STANDARD_DEVIATION 12.82 |
| Addiction Severity Index (ASI) (past 28 days) Substance Abuse Medication | 1.54 days STANDARD_DEVIATION 5.89 | 1.85 days STANDARD_DEVIATION 6.09 | 0.03 days STANDARD_DEVIATION 0.17 | 2.14 days STANDARD_DEVIATION 7.08 |
| Age, Continuous | 45.64 years STANDARD_DEVIATION 12.61 | 46.61 years STANDARD_DEVIATION 12.69 | 43.91 years STANDARD_DEVIATION 12.44 | 46.03 years STANDARD_DEVIATION 12.77 |
| Alcohol Use Disorders Identification Test (AUDIT) | 12.80 units on a scale STANDARD_DEVIATION 11.81 | 14.54 units on a scale STANDARD_DEVIATION 11.5 | 9.67 units on a scale STANDARD_DEVIATION 10.19 | 14.48 units on a scale STANDARD_DEVIATION 12.53 |
| Beck Anxiety Inventory (BAI) | 26.91 units on a scale STANDARD_DEVIATION 11.08 | 26.09 units on a scale STANDARD_DEVIATION 10.72 | 27.21 units on a scale STANDARD_DEVIATION 12.72 | 28.24 units on a scale STANDARD_DEVIATION 10.2 |
| Columbia- Suicide Severity Rating Scale (C-SSRS): Suicide Attempt Last Month | 30 Participants | 6 Participants | 7 Participants | 17 Participants |
| C-SSRS: Lifetime Suicide Attempts | 1.80 events STANDARD_DEVIATION 2.57 | 2.85 events STANDARD_DEVIATION 3.44 | 1.84 events STANDARD_DEVIATION 2.81 | 1.24 events STANDARD_DEVIATION 1.66 |
| Deployed to Combat Zone | 62 Participants | 15 Participants | 17 Participants | 30 Participants |
| Drug Abuse Screening Test (DAST) | 2.86 units on a scale STANDARD_DEVIATION 3.21 | 2.58 units on a scale STANDARD_DEVIATION 2.9 | 2.85 units on a scale STANDARD_DEVIATION 3.38 | 3.02 units on a scale STANDARD_DEVIATION 3.31 |
| Employment Disabled/Retired | 70 Participants | 18 Participants | 21 Participants | 31 Participants |
| Employment Other | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Employment Part/Fulltime/Self-Employed | 24 Participants | 4 Participants | 6 Participants | 14 Participants |
| Employment Student/Homemaker | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Employment Unemployed | 35 Participants | 11 Participants | 6 Participants | 18 Participants |
| Era Desert Storm/Shield (1990-2001) | 10 Participants | 2 Participants | 3 Participants | 5 Participants |
| Era Multiple Eras | 40 Participants | 9 Participants | 10 Participants | 21 Participants |
| Era Post 9/11 (2001-Present) | 37 Participants | 7 Participants | 13 Participants | 17 Participants |
| Era Post-Korea Peace (1955-1964) | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Era Post-Vietnam Peace (1975-1990) | 31 Participants | 9 Participants | 6 Participants | 16 Participants |
| Era Vietnam War (1964-1975) | 12 Participants | 6 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 129 Participants | 32 Participants | 33 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Divorced/Separated | 57 Participants | 9 Participants | 15 Participants | 33 Participants |
| Marital Status Married | 44 Participants | 13 Participants | 9 Participants | 22 Participants |
| Marital Status Never Married | 25 Participants | 8 Participants | 7 Participants | 10 Participants |
| Marital Status Widowed | 6 Participants | 3 Participants | 2 Participants | 1 Participants |
| Ohio State University Traumatic Brain Injury Identification Method (TBI-ID): Loss of Consciousness #Times | 1.58 events STANDARD_DEVIATION 1.98 | 2.03 events STANDARD_DEVIATION 2.23 | 1.91 events STANDARD_DEVIATION 2.11 | 1.18 events STANDARD_DEVIATION 1.71 |
| Ohio State University Traumatic Brain Injury Identification Method (TBI-ID): Loss of Consciousness # Times >= 30 mins | 0.24 events STANDARD_DEVIATION 0.5 | 0.42 events STANDARD_DEVIATION 0.66 | 0.21 events STANDARD_DEVIATION 0.42 | 0.17 events STANDARD_DEVIATION 0.41 |
| Patient Health Questionnaire (PHQ-9): Depression | 18.13 units on a scale STANDARD_DEVIATION 4.88 | 18.54 units on a scale STANDARD_DEVIATION 4.29 | 18.12 units on a scale STANDARD_DEVIATION 4.74 | 17.92 units on a scale STANDARD_DEVIATION 5.28 |
| Posttraumatic Stress Disorder (PTSD) Checklist Civilian Version (PCL-C) | 58.08 units on a scale STANDARD_DEVIATION 12.64 | 60.12 units on a scale STANDARD_DEVIATION 11.07 | 58.39 units on a scale STANDARD_DEVIATION 12.73 | 56.89 units on a scale STANDARD_DEVIATION 13.35 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 5 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 0 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 102 Participants | 25 Participants | 25 Participants | 52 Participants |
| Scale for Suicidal Ideation (SSI) Current (week before hospitalization) | 21.11 units on a scale STANDARD_DEVIATION 24.85 | 23.27 units on a scale STANDARD_DEVIATION 8.33 | 20.06 units on a scale STANDARD_DEVIATION 7.73 | 20.54 units on a scale STANDARD_DEVIATION 8.64 |
| Scale for Suicidal Ideation (SSI) Worst Point | 24.85 units on a scale STANDARD_DEVIATION 8.92 | 26.75 units on a scale STANDARD_DEVIATION 8.5 | 25.76 units on a scale STANDARD_DEVIATION 8.81 | 23.45 units on a scale STANDARD_DEVIATION 9.07 |
| Sex: Female, Male Female | 14 Participants | 3 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 118 Participants | 30 Participants | 30 Participants | 58 Participants |
| TBI-ID: Loss of Consciousness Before 15 Years of Age | 35 Participants | 11 Participants | 12 Participants | 12 Participants |
| TBI-ID: Worst TBI | 2.64 units on a scale STANDARD_DEVIATION 1.15 | 3.00 units on a scale STANDARD_DEVIATION 1.06 | 2.70 units on a scale STANDARD_DEVIATION 1.1 | 2.44 units on a scale STANDARD_DEVIATION 1.18 |
| Years of Service | 6.55 years STANDARD_DEVIATION 6.4 | 6.21 years STANDARD_DEVIATION 7.05 | 5.82 years STANDARD_DEVIATION 4.82 | 7.09 years STANDARD_DEVIATION 6.78 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 33 | 0 / 33 | 0 / 66 |
| other Total, other adverse events | 10 / 33 | 10 / 33 | 21 / 66 |
| serious Total, serious adverse events | 7 / 33 | 3 / 33 | 12 / 66 |
Outcome results
Primary
Number of Participants With Suicidal Ideation
The number of participants with suicidal ideation and severity of suicidal ideation was measured using the Scale for Suicidal Ideation (SSI) at 1, 3, and 6 months after discharge. Scores range from 0-38, with scores of 1 or greater indicating the presence of suicidal ideation.
Time frame: 6 months
Population: Analytical sample consists of participants who completed at least one follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MI-SI+TAU | Number of Participants With Suicidal Ideation | 1 Month | 16 Participants |
| MI-SI+TAU | Number of Participants With Suicidal Ideation | 3 Months | 17 Participants |
| MI-SI+TAU | Number of Participants With Suicidal Ideation | 6 Months | 13 Participants |
| MI-SI-R+TAU | Number of Participants With Suicidal Ideation | 6 Months | 18 Participants |
| MI-SI-R+TAU | Number of Participants With Suicidal Ideation | 3 Months | 16 Participants |
| MI-SI-R+TAU | Number of Participants With Suicidal Ideation | 1 Month | 19 Participants |
| TAU Alone | Number of Participants With Suicidal Ideation | 6 Months | 40 Participants |
| TAU Alone | Number of Participants With Suicidal Ideation | 3 Months | 42 Participants |
| TAU Alone | Number of Participants With Suicidal Ideation | 1 Month | 38 Participants |
Comparison: MI-SI + TAU and MI-SI-R + TAU vs. TAU Alone~A hurdle model was used to examine the effect of the experimental interventions on the presence of suicidal ideation and the severity of suicidal ideation among those with it. These analyses examined the presence of suicidal ideation in the combined MI-SI + TAU and MI-SI-R + TAU treatment group.p-value: 0.05495% CI: [0.31, 1.12]Zero-Inflated Poisson
Comparison: MI-SI+TAU vs. TAU Alonep-value: 0.1295% CI: [0.26, 1.4]Zero-Inflated Poisson
Comparison: MI-SI-R + TAU vs. TAU Alonep-value: 0.0895% CI: [0.28, 1.24]Zero-Inflated Poisson
Primary
Severity of Suicidal Ideation Among Those With It
Severity of suicidal ideation was measured by the Scale for Suicidal Ideation at 1, 3, and 6 months after discharge. Scores range from 0 to 38, with higher scores indicating more severe suicidal ideation.
Time frame: 6 months
Population: Analyses were limited to the participants who reported suicidal ideation over follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MI-SI+TAU | Severity of Suicidal Ideation Among Those With It | 3 months | 8.88 score on a scale | Standard Deviation 9.05 |
| MI-SI+TAU | Severity of Suicidal Ideation Among Those With It | 1 month | 16.94 score on a scale | Standard Deviation 9.05 |
| MI-SI+TAU | Severity of Suicidal Ideation Among Those With It | 6 months | 18.15 score on a scale | Standard Deviation 10.52 |
| MI-SI-R+TAU | Severity of Suicidal Ideation Among Those With It | 3 months | 15.25 score on a scale | Standard Deviation 9.39 |
| MI-SI-R+TAU | Severity of Suicidal Ideation Among Those With It | 1 month | 14.26 score on a scale | Standard Deviation 9.7 |
| MI-SI-R+TAU | Severity of Suicidal Ideation Among Those With It | 6 months | 16.89 score on a scale | Standard Deviation 9.18 |
| TAU Alone | Severity of Suicidal Ideation Among Those With It | 1 month | 14.21 score on a scale | Standard Deviation 9.62 |
| TAU Alone | Severity of Suicidal Ideation Among Those With It | 6 months | 15.45 score on a scale | Standard Deviation 10.06 |
| TAU Alone | Severity of Suicidal Ideation Among Those With It | 3 months | 12.74 score on a scale | Standard Deviation 8.57 |
Comparison: MI-SI + TAU vs. MI-SI-R + TAU vs. TAU Alone~A hurdle model was used to examine the effect of the experimental interventions on the presence/absence of suicidal ideation and the severity of suicidal ideation among those with it. These analyses examined the severity of suicidal ideation among participants with suicidal ideation in the combined MI-SI + TAU and MI-SI-R + TAU treatment group.p-value: 0.3Zero-Inflated Poisson
Comparison: MI-SI vs. TAU Alonep-value: 0.23Zero-Inflated Poisson
Comparison: MI-SI-R vs. TAU Alonep-value: 0.46Zero-Inflated Poisson
Secondary
Number of Participants With Two Outpatient Mental Health or Substance Treatment Sessions
Treatment engagement was measured using the Treatment Services Review-6 (TSR-6) at 1 month after discharge.
Time frame: 1 month
Population: Analyses were limited to participants who were immediately discharged to outpatient treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MI-SI+TAU | Number of Participants With Two Outpatient Mental Health or Substance Treatment Sessions | 16 Participants |
| MI-SI-R+TAU | Number of Participants With Two Outpatient Mental Health or Substance Treatment Sessions | 17 Participants |
| TAU Alone | Number of Participants With Two Outpatient Mental Health or Substance Treatment Sessions | 31 Participants |
Comparison: MI-SI + TAU vs. TAU Alonep-value: 0.960.95% CI: [0.3, 3.54]Regression, Logistic
Comparison: MI-SI-R + TAU vs. TAU Alonep-value: 0.595% CI: [0.23, 2.06]Regression, Logistic
Other Pre-specified
Number of Participants With a Suicide Attempt
Presence of a suicide attempt was measured with the Columbia Suicide Severity Rating Scale (C-SSRS) at 1, 3, and 6 months after discharge.
Time frame: 1, 3, and 6 months
Population: All participants were entered into analyses and censored at suicide attempt or the last follow-up assessment. Follow-up assessments were completed by 122 participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MI-SI+TAU | Number of Participants With a Suicide Attempt | 3 Months | 2 Participants |
| MI-SI+TAU | Number of Participants With a Suicide Attempt | 1 Month | 2 Participants |
| MI-SI+TAU | Number of Participants With a Suicide Attempt | 6 Months | 2 Participants |
| MI-SI-R+TAU | Number of Participants With a Suicide Attempt | 3 Months | 1 Participants |
| MI-SI-R+TAU | Number of Participants With a Suicide Attempt | 1 Month | 1 Participants |
| MI-SI-R+TAU | Number of Participants With a Suicide Attempt | 6 Months | 0 Participants |
| TAU Alone | Number of Participants With a Suicide Attempt | 1 Month | 5 Participants |
| TAU Alone | Number of Participants With a Suicide Attempt | 6 Months | 2 Participants |
| TAU Alone | Number of Participants With a Suicide Attempt | 3 Months | 1 Participants |
Comparison: MI-SI + TAU vs. TAU Alonep-value: 0.3195% CI: [0.59, 4.88]Log Rank
Comparison: MI-SI-R vs. TAU Alonep-value: 0.2495% CI: [0.1, 2.31]Log Rank
Comparison: MI-SI-R + TAU vs. MI-SI + TAU~Because the impact of MI-SI + TAU and MI-SI-R + TAU were in different directions when compared to TAU Alone, they were compared. For this analysis, the null hypothesis was that the revisions did not change the impact of MI-SI + TAU.p-value: 0.195% CI: [0.06, 1.43]Log Rank