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| ID | Type | Description | Link |
|---|---|---|---|
| IK2CX00064 | Other Grant/Funding Number | Department of Veterans Affairs |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MI-SI+TAU | Experimental | Motivational Interviewing to Address Suicidal Ideation |
|
| MI-SI-R+TAU | Experimental | Motivational Interviewing to Address Suicidal Ideation Revised |
|
| TAU Alone | Other | Treatment as usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MI-SI+TAU | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1, 3, and 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter C. Britton, PhD MS | Syracuse VA Medical Center, Syracuse, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syracuse VA Medical Center, Syracuse, NY | Syracuse | New York | 13210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31393029 | Derived | Britton PC, Conner KR, Chapman BP, Maisto SA. Motivational Interviewing to Address Suicidal Ideation: A Randomized Controlled Trial in Veterans. Suicide Life Threat Behav. 2020 Feb;50(1):233-248. doi: 10.1111/sltb.12581. Epub 2019 Aug 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MI-SI | Motivational interviewing to address suicidal ideation (MI-SI) is an adaptation of motivational interviewing that is focused on exploring and resolving ambivalence about living. |
| FG001 | MI-SI-R | Motivational interviewing to address suicidal ideation revised (MI-SI-R) is an adaptation of motivational interviewing that is focused on resolving ambivalence about living. |
| FG002 | VA TAU | Treatment as usual is standard treatment received during acute psychiatric hospitalization in a Department of Veterans Affairs (VA) medical center and after discharge. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | MI-SI-R+TAU |
| Units | Counts |
|---|---|
| Participants |
|
| 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 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. | Analytical sample consists of participants who completed at least one follow-up. | Posted | Count of Participants | Participants | 6 months |
|
6 months
For this study, serious adverse events were death and other life-threatening events including suicide attempts and accidental overdose. Adverse events were suicidal ideation or psychiatric symptoms that led to an Emergency Department visit and/or hospitalization.
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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 | MI-SI+TAU | Motivational Interviewing to Address Suicidal Ideation MI-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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide Attempt | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment | that led to Emergency Department visit and/or hospitalization. |
Due to theoretical and empirically supported changes to motivational interviewing that were published during the trial, we changed the intervention mid-trial leading to small numbers of participants in the experimental conditions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Britton | Canandaigu VA Medical Center | 585-393-7926 | peter.britton@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 | Jun 2, 2016 | Mar 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| D013406 | Suicide, Attempted |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| MI-SI-R+TAU | Behavioral | 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) |
|
|
| TAU Alone | Other | 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. |
|
|
| Discharged out of catchment area |
|
| Death |
|
| Jail or Prison |
|
| Became Psychotic |
|
| Researcher withdrew |
|
| Went active duty |
|
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) |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Years of Service | Mean | Standard Deviation | years |
|
| Era | Count of Participants | Participants |
|
| Deployed to Combat Zone | Count of Participants | Participants |
|
| Scale for Suicidal Ideation (SSI) | Scores range from 0 to 38, with higher scores indicating more severe suicidal ideation. | Mean | Standard Deviation | units on a scale |
|
| Columbia- Suicide Severity Rating Scale (C-SSRS): Suicide Attempt Last Month | Count of Participants | Participants |
|
| C-SSRS: Lifetime Suicide Attempts | Mean | Standard Deviation | events |
|
| Ohio State University Traumatic Brain Injury Identification Method (TBI-ID): Loss of Consciousness | Mean | Standard Deviation | events |
|
| TBI-ID: Loss of Consciousness Before 15 Years of Age | Count of Participants | Participants |
|
| TBI-ID: Worst TBI | Scores range from 1 to 5, with higher scores indicating more severe TBI. | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire (PHQ-9): Depression | Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| Posttraumatic Stress Disorder (PTSD) Checklist Civilian Version (PCL-C) | Scores range from 17 to 85, with higher scores indicating more severe PTSD symptoms. | Mean | Standard Deviation | units on a scale |
|
| Beck Anxiety Inventory (BAI) | Scores range from 0 to 63, with higher score indicating more severe anxiety symptoms. | Mean | Standard Deviation | units on a scale |
|
| Alcohol Use Disorders Identification Test (AUDIT) | Scores range from 0 to 40, with higher scores indicating hazardous alcohol use. | Mean | Standard Deviation | units on a scale |
|
| Drug Abuse Screening Test (DAST) | Scores range from 0 to 10, with higher score indicating more hazardous non-alcohol drug use. | Mean | Standard Deviation | units on a scale |
|
| Addiction Severity Index (ASI) (past 28 days) | Mean | Standard Deviation | days |
|
| MI-SI-R+TAU |
Motivational Interviewing to Address Suicidal Ideation Revised MI-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) |
| OG002 | TAU Alone | Treatment as usual TAU: 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. |
|
|
|
| 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. | Analyses were limited to the participants who reported suicidal ideation over follow-up. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 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. | Analyses were limited to participants who were immediately discharged to outpatient treatment. | Posted | Count of Participants | Participants | 1 month |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 1, 3, and 6 months |
|
|
|
|
| 1 |
| 33 |
| 7 |
| 33 |
| 10 |
| 33 |
| EG001 | MI-SI-R+TAU | Motivational Interviewing to Address Suicidal Ideation Revised MI-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) | 0 | 33 | 3 | 33 | 10 | 33 |
| EG002 | TAU Alone | Treatment as usual TAU: 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 VHA suicide prevention policy, the care of suicidal patients is also overseen by a local Suicide Prevention Coordinator and case managers. | 0 | 66 | 12 | 66 | 21 | 66 |
| Accidental Overdose | Psychiatric disorders | Non-systematic Assessment |
|
| Death | Cardiac disorders | Non-systematic Assessment |
|
|
| Psychiatric Symptoms | Psychiatric disorders | Non-systematic Assessment | that led to Emergency Department visit and/or hospitalization |
|
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| 3 months |
|
|
| 6 months |
|
|
| Superiority |
| MI-SI vs. TAU Alone | Zero-Inflated Poisson | A robust standard error clustered on participants was used. | 0.23 | A priori, analyses were proposed to be one-sided, with p set at 0.05. | Beta | 0.09 | Standard Error of the Mean | 0.12 | 2-Sided | Superiority |
| MI-SI-R vs. TAU Alone | Zero-Inflated Poisson | A robust standard error clustered on participants was used. | 0.46 | A priori, analyses were proposed to be one-sided, with p set at 0.05. | Beta | 0.01 | Standard Error of the Mean | 0.13 | 2-Sided | Superiority |
MI-SI-R + TAU vs. TAU Alone
| Regression, Logistic |
| 0.50 |
A priori, p was set at 0.01 for multiple comparisons. |
| Odds Ratio (OR) |
| 0.68 |
| Standard Error of the Mean |
| 0.38 |
| 2-Sided |
| 95 |
| 0.23 |
| 2.06 |
| Superiority |
| 3 Months |
|
|
| 6 Months |
|
|
MI-SI-R vs. TAU Alone
| Log Rank |
| 0.24 |
A priori, p was set at 0.01 for multiple comparisons. |
| Cox Proportional Hazard |
| 0.49 |
| Standard Error of the Mean |
| 0.39 |
| 2-Sided |
| 95 |
| 0.10 |
| 2.31 |
| Superiority |
| 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. | Log Rank | 0.10 | A priori, p was set at 0.01 for multiple comparisons. | Cox Proportional Hazard | 0.29 | Standard Error of the Mean | 0.23 | 2-Sided | 95 | 0.06 | 1.43 | Superiority |