Suicide
Conditions
Brief summary
For suicidal individuals, minimizing future risk and fostering recovery are critical public health concerns, especially among Veterans, as very few effective interventions exist. This proposal tests a novel group psychotherapy treatment that combines emotion regulation skill based, and psychoeducational approaches, with suicide safety planning development and implementation. Project Life Force (PLF), a novel suicide safety planning group intervention has been designed to fill this critical gap and provide a mechanism to develop and enhance suicide safety planning over time. PLF, a 12-session, group psychotherapy intervention, combines Dialectical Behavioral Therapy (DBT) skill based and psychoeducational approaches, to enhance suicide safety planning development and implementation. Veterans revise their plans over several weeks while learning distress tolerance, emotion regulation, and friendship building/interpersonal skills to incorporate into their safety plans and also receive lessons on gun safety and minimizing access to lethal means. Sessions are augmented with 1) training in the use of a suicide safety planning mobile App to promote accessibility and maximize implementation, and 2) didactic information to bolster recovery, including fostering improved connection with the treatment team, and Veteran's family.
Detailed description
Despite the enrichment of VA suicide prevention services and implementation of the national suicide hotline, Veteran suicide completions have risen to 22 per day and suicide attempts numbered over 15,000 in 2012. These data underscore the urgency of developing additional interventions targeting suicidal Veterans. The construction of a Suicide Safety Plan (SSP); a best practice, is mandated throughout the VA system, and a vital component of the VA's coordinated effort at suicide prevention and recovery. The investigators' pilot data on patterns of SSP use in suicidal Veterans over a 30 day time frame demonstrates that only 65% of Veterans used their safety plans, coping strategies listed on the plan were often mismatched or inadequate to the individual's needs, and limited access to the SSP during times of stress negatively impacted its utility. To the investigators' knowledge, there are currently no recommended guidelines or mechanisms for refinement of the SSP in adult populations beyond its initial development. Project Life Force (PLF), a novel suicide safety planning group intervention has been designed to fill this critical gap and provide a mechanism to develop and enhance suicide safety planning over time. PLF, a 12-session, group psychotherapy intervention, combines Dialectical Behavioral Therapy (DBT) skill based and psychoeducational approaches, to enhance suicide safety planning development and implementation. Veterans revise their plans over several weeks while learning distress tolerance, emotion regulation, and friendship building/interpersonal skills to incorporate into their safety plans and also receive lessons on gun safety and minimizing access to lethal means. Sessions are augmented with 1) training in the use of a suicide safety planning mobile App to promote accessibility and maximize implementation, and 2) didactic information to bolster recovery, including fostering improved connection with the treatment team, and Veteran's family. Importantly, the group format mitigates loneliness and fosters increased belongingness, both key risk factors for suicide. Additionally, PLF's weekly format facilitates VA-mandated monitoring for any Veteran placed on the suicide high risk list. Data from this project will test the intervention's feasibility, acceptability and preliminary efficacy and provide pilot data for a larger randomized clinical trial. The project is comprised of two phases. In Phase 1, the investigators will finalize the PLF intervention and accompanying manual and handouts. In Phase 2, the investigators will conduct an open label trial of PLF in 50 suicidal Veterans to evaluate the feasibility and acceptability of the intervention. The investigators will also test whether PLF affects outcomes of suicide ideation, depression, hopelessness, and outpatient compliance by examining clinically meaningful differences in these measures before and after PLF.
Interventions
BEHAVIORALProject Life Force Group Treatment
PLF, a 12-session, group psychotherapy intervention, combines Dialectical Behavioral Therapy (DBT) skill based and psychoeducational approaches, to enhance suicide safety planning development and implementation. Veterans revise their plans over several weeks while learning distress tolerance, emotion regulation, and friendship building/interpersonal skills to incorporate into their safety plans and also receive lessons on gun safety and minimizing access to lethal means. Sessions are augmented with 1) training in the use of a suicide safety planning mobile App to promote accessibility and maximize implementation, and 2) didactic information to bolster recovery, including fostering improved connection with the treatment team, and Veteran's family. Importantly, the group format mitigates loneliness and fosters increased belongingness, both key risk factors for suicide.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Veterans \> 18 * Able to give consent * Recent Completion of a VA suicide safety plan
Exclusion criteria
* IQ\<80 * Does not speak English * Inability to tolerate group therapy format * There is no exclusion based on medical or psychiatric treatment status. * There are no special restrictions with regard to gender, ethnic status or race
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Scale for Suicide Ideation (BSS) | Baseline, 3 Month, 6 Month | Beck Scale for Suicide Ideation is designed to assess severity of suicidal attitudes and plans for suicide. BSS is a 21 item self-report, rated on a scale of 0-2, with a total score range of 0-38 with higher score indicating higher ideation. |
| Columbia Suicide Rating Scale (C-SSRS) | Baseline, 3 Month, 6 Month | The Columbia Suicide Rating Scale (C-SSRS) will be used to count prospective or treatment emergent suicidal behaviors. The C-SSRS has been used in many treatment trials, and to measure treatment emergent suicidal events during pharmacotherapy. C-SSRS contains a subscale on suicidal ideation which is scored from 1-5; higher numbers indicate increased suicidal thinking. The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt according to the C-SSRS. |
| Beck Depression Inventory-II | Baseline, 3 Month, 6 Month | Depression will be measured with the Beck Depression Inventory-II. This scale consisting of 21 items and scored based on a Likert scale, has high internal consistency (Cronbach coefficient = .92). Each question has a set of at least four possible answer choices, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is used to quantify the participant's degree of depression from 0 = no depression to 63 = maximally severe depression. |
| Beck Hopelessness Scale | Baseline, 3 Month, 6 Month | Hopelessness is assessed with the Beck Hopelessness Scale, a 20-item self-report measure with true-false items that assess hopelessness and the extent of positive and negative beliefs about the future. Summed scores range from 0 to 20. Scores provide a measure of the severity of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe. Adequate reliability and concurrent validity data exist for this measure, which has been shown to be predictive of eventual suicide in psychiatric inpatients. |
Countries
United States
Participant flow
Recruitment details
During the life of the project, 45 subjects signed consent. Of those that consented 37 completed baseline assessments.
Participants by arm
| Arm | Count |
|---|---|
| Project Life Force Group Treatment A manualized, weekly 90-minute group treatment lasting 3 months coinciding with the time frame for enhanced monitoring of Veterans identified as high-risk. This is an open-label pilot study. All participants received the intervention. | 37 |
| Total | 37 |
Baseline characteristics
| Characteristic | Project Life Force Group Treatment |
|---|---|
| Age, Categorical Age <=18 years | 0 Participants |
| Age, Categorical Age >=65 years | 2 Participants |
| Age, Categorical Age Between 18 and 65 years | 35 Participants |
| Age, Continuous | 46.43 years STANDARD_DEVIATION 11.83 |
| Ethnicity (NIH/OMB) Ethnicity Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Ethnicity Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Ethnicity Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Race American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Race Asian | 1 Participants |
| Race (NIH/OMB) Race Black or African American | 14 Participants |
| Race (NIH/OMB) Race More than one race | 1 Participants |
| Race (NIH/OMB) Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Race Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) Race White | 12 Participants |
| Region of Enrollment United States | 37 Participants |
| Sex: Female, Male Sex Female | 8 Participants |
| Sex: Female, Male Sex Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 37 |
| other Total, other adverse events | 8 / 37 |
| serious Total, serious adverse events | 10 / 37 |
Outcome results
Primary
Beck Depression Inventory-II
Depression will be measured with the Beck Depression Inventory-II. This scale consisting of 21 items and scored based on a Likert scale, has high internal consistency (Cronbach coefficient = .92). Each question has a set of at least four possible answer choices, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is used to quantify the participant's degree of depression from 0 = no depression to 63 = maximally severe depression.
Time frame: Baseline, 3 Month, 6 Month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Project Life Force Group Treatment | Beck Depression Inventory-II | Baseline | 33.51 score on a scale | Standard Deviation 10.64 |
| Project Life Force Group Treatment | Beck Depression Inventory-II | 3 Month | 23 score on a scale | Standard Deviation 13.16 |
| Project Life Force Group Treatment | Beck Depression Inventory-II | 6 Month | 18.13 score on a scale | Standard Deviation 14.59 |
Primary
Beck Hopelessness Scale
Hopelessness is assessed with the Beck Hopelessness Scale, a 20-item self-report measure with true-false items that assess hopelessness and the extent of positive and negative beliefs about the future. Summed scores range from 0 to 20. Scores provide a measure of the severity of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe. Adequate reliability and concurrent validity data exist for this measure, which has been shown to be predictive of eventual suicide in psychiatric inpatients.
Time frame: Baseline, 3 Month, 6 Month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Project Life Force Group Treatment | Beck Hopelessness Scale | Baseline | 11.69 score on a scale | Standard Deviation 5.83 |
| Project Life Force Group Treatment | Beck Hopelessness Scale | 3 Month | 9.52 score on a scale | Standard Deviation 5.26 |
| Project Life Force Group Treatment | Beck Hopelessness Scale | 6 Month | 7.25 score on a scale | Standard Deviation 7.07 |
Primary
Beck Scale for Suicide Ideation (BSS)
Beck Scale for Suicide Ideation is designed to assess severity of suicidal attitudes and plans for suicide. BSS is a 21 item self-report, rated on a scale of 0-2, with a total score range of 0-38 with higher score indicating higher ideation.
Time frame: Baseline, 3 Month, 6 Month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Project Life Force Group Treatment | Beck Scale for Suicide Ideation (BSS) | Baseline | 17.68 score on a scale | Standard Deviation 9.2 |
| Project Life Force Group Treatment | Beck Scale for Suicide Ideation (BSS) | 3 Month | 11.6 score on a scale | Standard Deviation 11.04 |
| Project Life Force Group Treatment | Beck Scale for Suicide Ideation (BSS) | 6 Month | 10.71 score on a scale | Standard Deviation 11.01 |
Primary
Columbia Suicide Rating Scale (C-SSRS)
The Columbia Suicide Rating Scale (C-SSRS) will be used to count prospective or treatment emergent suicidal behaviors. The C-SSRS has been used in many treatment trials, and to measure treatment emergent suicidal events during pharmacotherapy. C-SSRS contains a subscale on suicidal ideation which is scored from 1-5; higher numbers indicate increased suicidal thinking. The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt according to the C-SSRS.
Time frame: Baseline, 3 Month, 6 Month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Project Life Force Group Treatment | Columbia Suicide Rating Scale (C-SSRS) | Baseline | 3.93 score on a scale | Standard Deviation 1.16 |
| Project Life Force Group Treatment | Columbia Suicide Rating Scale (C-SSRS) | 3 Month | 2.25 score on a scale | Standard Deviation 1.25 |
| Project Life Force Group Treatment | Columbia Suicide Rating Scale (C-SSRS) | 6 Month | 2.13 score on a scale | Standard Deviation 1.25 |