Suicide
Conditions
Keywords
suicide prevention, mindfulness-based cognitive therapy, mindfulness meditation, Veterans, safety planning
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMindfulness-Based Cognitive Therapy for Suicide
Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.
BEHAVIORALTreatment as usual
VA standard care for suicide prevention
Sponsors
Columbia University
Rutgers, The State University of New Jersey
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
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 * 1\) psychiatric hospitalization due to suicidal risk, * 2\) psychiatric hospitalization if subject was already on the High Risk for Suicide List, * 3\) suicidal ideation with suicidal intent, * 4\) suicidal preparatory behaviors, or * 5\) actual, interrupted, or aborted suicide attempt. AND * The subject is on or will be placed on the VA High Risk for Suicide List * OR The subject had an actual, interrupted, or aborted attempt in the last year * OR In the study clinician's opinion (i.e., Masters or Doctoral level study personnel with formal mental health training) in consultation with the PI, the suicidal event is significant enough to warrant treatment to reduce suicidal risk.
Exclusion criteria
* cognitive deficits that decrease the likelihood of benefit from MBCT-S * severe symptoms of hallucinations or delusions * disorganized or disruptive behaviors * medically unstable * current mindfulness-based psychotherapy or receipt of 2 or more sessions of a mindfulness-based psychotherapy in the last 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suicide Event | 12-months post-baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Suicide Attempt | 12 months post-baseline | Defined as deliberate self-directed violence with injury or potential for injury and with explicit/implicit suicidal intent |
| Suicidal Ideation | Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline | clinician-administered Scale for Suicide Ideation (SSI), 0-38, higher score = higher suicidal ideation. |
| Hopelessness | Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline | Hopelessness will be measured using the Beck Hopelessness Scale, score range 0-20, with higher scores indicating more hopelessness. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 66 |
| Treatment As Usual VA standard care for suicide prevention
Treatment as usual: VA standard care for suicide prevention | 69 |
| Total | 135 |
Baseline characteristics
| Characteristic | Mindfulness-Based Cognitive Therapy + Treatment As Usual | Treatment As Usual | Total |
|---|---|---|---|
| Age, Continuous | 47.54 years STANDARD_DEVIATION 13.2 | 45.97 years STANDARD_DEVIATION 14.3 | 46.96 years STANDARD_DEVIATION 11.9 |
| Race/Ethnicity, Customized RACE/ETHNICITY Asian, American Indian, or other | 7 Participants | 2 Participants | 9 Participants |
| Race/Ethnicity, Customized RACE/ETHNICITY Black | 15 Participants | 21 Participants | 36 Participants |
| Race/Ethnicity, Customized RACE/ETHNICITY Latino | 14 Participants | 15 Participants | 29 Participants |
| Race/Ethnicity, Customized RACE/ETHNICITY White | 30 Participants | 31 Participants | 61 Participants |
| Region of Enrollment United States | 66 Participants | 69 Participants | 135 Participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Male | 59 Participants | 60 Participants | 119 Participants |
| Suicide Attempt History multiple | 36 Participants | 40 Participants | 76 Participants |
| Suicide Attempt History none | 9 Participants | 12 Participants | 21 Participants |
| Suicide Attempt History one | 21 Participants | 17 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 66 | 1 / 69 |
| other Total, other adverse events | 4 / 66 | 4 / 69 |
| serious Total, serious adverse events | 31 / 66 | 40 / 69 |
Outcome results
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.
Time frame: 12-months post-baseline
Population: Total number of suicidal events within the 12-month observation period by study condition.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mindfulness-Based Cognitive Therapy + Treatment As Usual | Suicide Event | 44 count of events |
| Treatment As Usual | Suicide Event | 92 count of events |
p-value: 0.01595% CI: [0.29, 0.87]negative binomial regression
Secondary
Hopelessness
Hopelessness will be measured using the Beck Hopelessness Scale, score range 0-20, with higher scores indicating more hopelessness.
Time frame: Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-Based Cognitive Therapy + Treatment As Usual | Hopelessness | Time 2 | 8.4 score on a scale | Standard Error 0.9 |
| Mindfulness-Based Cognitive Therapy + Treatment As Usual | Hopelessness | Time 4 | 8.0 score on a scale | Standard Error 0.9 |
| Mindfulness-Based Cognitive Therapy + Treatment As Usual | Hopelessness | Time 3 | 7.4 score on a scale | Standard Error 0.9 |
| Mindfulness-Based Cognitive Therapy + Treatment As Usual | Hopelessness | Time 5 | 8.7 score on a scale | Standard Error 1 |
| Mindfulness-Based Cognitive Therapy + Treatment As Usual | Hopelessness | Time 1 | 13.4 score on a scale | Standard Error 0.7 |
| Treatment As Usual | Hopelessness | Time 5 | 8.6 score on a scale | Standard Error 0.9 |
| Treatment As Usual | Hopelessness | Time 1 | 11.8 score on a scale | Standard Error 0.7 |
| Treatment As Usual | Hopelessness | Time 2 | 8.1 score on a scale | Standard Error 0.8 |
| Treatment As Usual | Hopelessness | Time 3 | 8.3 score on a scale | Standard Error 0.9 |
| Treatment As Usual | Hopelessness | Time 4 | 7.7 score on a scale | Standard Error 0.9 |
p-value: 0.23Regression, Linear
Secondary
Suicidal Ideation
clinician-administered Scale for Suicide Ideation (SSI), 0-38, higher score = higher suicidal ideation.
Time frame: Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline
Population: Linear mixed models, examining change from baseline over 12 months (5 assessments total), with effect of interest being time\*cond interaction.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-Based Cognitive Therapy + Treatment As Usual | Suicidal Ideation | Time 2 | 5.8 score on a scale | Standard Error 1.2 |
| Mindfulness-Based Cognitive Therapy + Treatment As Usual | Suicidal Ideation | Time 4 | 6.1 score on a scale | Standard Error 1.1 |
| Mindfulness-Based Cognitive Therapy + Treatment As Usual | Suicidal Ideation | Time 1 | 12.4 score on a scale | Standard Error 1.2 |
| Mindfulness-Based Cognitive Therapy + Treatment As Usual | Suicidal Ideation | Time 5 | 3.8 score on a scale | Standard Error 0.9 |
| Mindfulness-Based Cognitive Therapy + Treatment As Usual | Suicidal Ideation | Time 3 | 4.8 score on a scale | Standard Error 1.1 |
| Treatment As Usual | Suicidal Ideation | Time 5 | 2.3 score on a scale | Standard Error 0.8 |
| Treatment As Usual | Suicidal Ideation | Time 1 | 11.2 score on a scale | Standard Error 1.2 |
| Treatment As Usual | Suicidal Ideation | Time 2 | 6.1 score on a scale | Standard Error 1.2 |
| Treatment As Usual | Suicidal Ideation | Time 3 | 4.7 score on a scale | Standard Error 1 |
| Treatment As Usual | Suicidal Ideation | Time 4 | 3.3 score on a scale | Standard Error 1 |
p-value: 0.34Regression, Linear
Secondary
Suicide Attempt
Defined as deliberate self-directed violence with injury or potential for injury and with explicit/implicit suicidal intent
Time frame: 12 months post-baseline
Population: count of suicide attempts over 12-month period by study condition
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mindfulness-Based Cognitive Therapy + Treatment As Usual | Suicide Attempt | 11 count of suicide attempts |
| Treatment As Usual | Suicide Attempt | 27 count of suicide attempts |
p-value: 0.0195% CI: [0.22, 0.82]negative binomial regression