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| Name | Class |
|---|---|
| Columbia University | OTHER |
| Rutgers, The State University of New Jersey | OTHER |
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The purpose of this study is to test a psychotherapeutic intervention that integrates cognitive therapy and mindfulness meditation techniques to prevent suicide in military Veterans.
Every month the VA becomes aware of approximately 1,100 Veterans in VA care who attempt suicide. While the VA has implemented a comprehensive, multifaceted suicide prevention approach, it has yet to implement nationally any evidence-based psychotherapies targeting suicide, a gap due largely to the dearth of evidence-based therapies for suicide. Primary aims of this proposal are to conduct a randomized controlled trial testing an adaptation of a cognitive-behavioral intervention, Mindfulness-Based Cognitive Therapy (MBCT), for Veterans on the VA's High Risk for Suicide List. The investigators' adapted version of MBCT for suicide (MBCT-S) integrates mindfulness meditation techniques with the VA Safety Plan to enhance patients' awareness of suicide triggers and appropriate coping strategies. This study has the potential to increase the range of cost effective treatment alternatives for the large number of suicidal Veterans for whom evidence-based therapies are severely limited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Cognitive Therapy + Treatment As Usual | Active Comparator | Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. |
|
| Treatment As Usual | Other | VA standard care for suicide prevention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Cognitive Therapy for Suicide | Behavioral | Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. |
| Measure | Description | Time Frame |
|---|---|---|
| Suicide Event | The investigators define "event" broadly as a range of suicidal behaviors defined according to the VA's Self-Directed Violence Classification System (SDVCS). Based on the SDVCS, an event may include self-directed violence, with or without injury, in which evidence of suicidal intent is clear or undetermined; or suicidal preparatory behaviors. The study definition of a suicide event also includes suicidal ideation resulting in the need for emergency care or psychiatric hospitalization. | 12-months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Suicide Attempt | Defined as deliberate self-directed violence with injury or potential for injury and with explicit/implicit suicidal intent | 12 months post-baseline |
| Suicidal Ideation | clinician-administered Scale for Suicide Ideation (SSI), 0-38, higher score = higher suicidal ideation. |
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Inclusion Criteria:
The following criteria were formulated to recruit a sample at high risk for suicide behavior.
The subject has experienced a suicidal event during the past 30 days. A suicidal event involves
AND
The subject is on or will be placed on the VA High Risk for Suicide List
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro Interian, PhD | Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ | East Orange | New Jersey | 07018 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40134457 | Derived | Interian A, Miller R, Dave C, Latorre M, St Hill L, King A, Boschulte DR, Kline A, Siegel D, Sedita MM, Chesin MS. Examining the Occurrence and Clinical Impact of Difficult Experiences that Emerge during a Mindfulness-Based Intervention among Individuals at High-Risk of Suicide. Mindfulness (N Y). 2024 Jun 18;15:1701-1712. | |
| 34464524 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness-Based Cognitive Therapy + Treatment As Usual | Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. Mindfulness-Based Cognitive Therapy for Suicide: Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. |
| FG001 | Treatment As Usual | VA standard care for suicide prevention Treatment as usual: VA standard care for suicide prevention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness-Based Cognitive Therapy + Treatment As Usual | Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. Mindfulness-Based Cognitive Therapy for Suicide: Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. |
| 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 | Suicide Event | The investigators define "event" broadly as a range of suicidal behaviors defined according to the VA's Self-Directed Violence Classification System (SDVCS). Based on the SDVCS, an event may include self-directed violence, with or without injury, in which evidence of suicidal intent is clear or undetermined; or suicidal preparatory behaviors. The study definition of a suicide event also includes suicidal ideation resulting in the need for emergency care or psychiatric hospitalization. | Total number of suicidal events within the 12-month observation period by study condition. | Posted | Number | count of events | 12-months post-baseline |
|
12-month study participation period
all serious adverse events were reported to IRB and reviewed by a DSMB
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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 | Mindfulness-Based Cognitive Therapy + Treatment As Usual | Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. Mindfulness-Based Cognitive Therapy for Suicide: Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychatric Adverse Events | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric other (not including serious) | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alejandro Interian, PHD | VA New Jersey Healthcare System | 908-647-0180 | 4617 | alejandro.interian@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 | May 14, 2013 | Apr 7, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D000092864 | Suicide Prevention |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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|
| Treatment as usual | Behavioral | VA standard care for suicide prevention |
|
| Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline |
| Hopelessness | Hopelessness will be measured using the Beck Hopelessness Scale, score range 0-20, with higher scores indicating more hopelessness. | Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline |
| Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ |
| Lyons |
| New Jersey |
| 07939 |
| United States |
| Interian A, Chesin MS, Stanley B, Latorre M, St Hill LM, Miller RB, King AR, Boschulte DR, Rodriguez KM, Kline A. Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans: A Randomized Clinical Trial. J Clin Psychiatry. 2021 Aug 31;82(5):20m13791. doi: 10.4088/JCP.20m13791. |
| BG001 | Treatment As Usual | VA standard care for suicide prevention Treatment as usual: VA standard care for suicide prevention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Suicide Attempt History | Count of Participants | Participants |
|
| OG001 | Treatment As Usual | VA standard care for suicide prevention Treatment as usual: VA standard care for suicide prevention |
|
|
|
| Secondary | Suicide Attempt | Defined as deliberate self-directed violence with injury or potential for injury and with explicit/implicit suicidal intent | count of suicide attempts over 12-month period by study condition | Posted | Number | count of suicide attempts | 12 months post-baseline |
|
|
|
|
| Secondary | Suicidal Ideation | clinician-administered Scale for Suicide Ideation (SSI), 0-38, higher score = higher suicidal ideation. | Linear mixed models, examining change from baseline over 12 months (5 assessments total), with effect of interest being time*cond interaction. | Posted | Mean | Standard Error | score on a scale | Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline |
|
|
|
|
| Secondary | Hopelessness | Hopelessness will be measured using the Beck Hopelessness Scale, score range 0-20, with higher scores indicating more hopelessness. | Posted | Mean | Standard Error | score on a scale | Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline |
|
|
|
|
| 3 |
| 66 |
| 31 |
| 66 |
| 4 |
| 66 |
| EG001 | Treatment As Usual | VA standard care for suicide prevention Treatment as usual: VA standard care for suicide prevention | 1 | 69 | 40 | 69 | 4 | 69 |
| Medical SAE | Cardiac disorders | Non-systematic Assessment | **no adverse events were determined by IRB to be related to the research procedures or intervention |
|
| Medical SAE | Endocrine disorders | Non-systematic Assessment | **no adverse events were determined by IRB to be related to the research procedures or intervention |
|
| Medical SAE | Gastrointestinal disorders | Non-systematic Assessment | **no adverse events were determined by IRB to be related to the research procedures or intervention |
|
| Medical SAE | General disorders | Non-systematic Assessment | **no adverse events were determined by IRB to be related to the research procedures or intervention |
|
| Medical SAE | Infections and infestations | Non-systematic Assessment | **no adverse events were determined by IRB to be related to the research procedures or intervention |
|
| Medical SAE | Injury, poisoning and procedural complications | Non-systematic Assessment | **no adverse events were determined by IRB to be related to the research procedures or intervention |
|
| Medical SAE | Nervous system disorders | Non-systematic Assessment | **no adverse events were determined by IRB to be related to the research procedures or intervention |
|
| Medical SAE | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | **no adverse events were determined by IRB to be related to the research procedures or intervention |
|
| Medical SAE | Surgical and medical procedures | Non-systematic Assessment | **no adverse events were determined by IRB to be related to the research procedures or intervention |
|
| Medical SAE | Vascular disorders | Non-systematic Assessment | **no adverse events were determined by IRB to be related to the research procedures or intervention |
|
| SAE Other | Social circumstances | Non-systematic Assessment | **no adverse events were determined by IRB to be related to the research** |
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| D004191 |
| Behavioral Disciplines and Activities |
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| Time 4 |
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| Time 5 |
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| Time 3 |
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| Time 4 |
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