Trial Outcomes & Findings for Suicide Safety Planning Group Treatment: "Project Life Force" (NCT NCT02525575)

Last Updated: 2019-10-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

Baseline, 3 Month, 6 Month

Results posted on

2019-10-25

Participant Flow

During the life of the project, 45 subjects signed consent. Of those that consented 37 completed baseline assessments.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	37
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Suicide Safety Planning Group Treatment: "Project Life Force"

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Project Life Force Group Treatment n=37 Participants 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.
Age, Categorical Age · <=18 years	0 Participants n=5 Participants
Age, Categorical Age · Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical Age · >=65 years	2 Participants n=5 Participants
Age, Continuous	46.43 years STANDARD_DEVIATION 11.83 • n=5 Participants
Sex: Female, Male Sex · Female	8 Participants n=5 Participants
Sex: Female, Male Sex · Male	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Ethnicity · Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Ethnicity · Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Ethnicity · Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) Race · American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Race · Asian	1 Participants n=5 Participants
Race (NIH/OMB) Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Race · Black or African American	14 Participants n=5 Participants
Race (NIH/OMB) Race · White	12 Participants n=5 Participants
Race (NIH/OMB) Race · More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Race · Unknown or Not Reported	9 Participants n=5 Participants
Region of Enrollment United States	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 Month, 6 Month

Outcome measures

Outcome measures
Measure	Project Life Force Group Treatment n=37 Participants A novel, 10-session intervention to enhance currently mandated VA suicide safety planning in a group setting to support its implementation. PLF is a manualized, weekly 90-minute group treatment lasting 10 weeks coinciding with the time frame for enhanced monitoring of Veterans identified as "high-risk". Six of the PLF sessions correspond to a step of the safety plan and teach skills to maximize the use of that particular step of the plan. The use of emotion regulation skills in PLF differs from other DBT interventions in that it focuses primarily on emotion regulation, distraction and developing social support in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on physical health management, education pertaining to suicide risk, promoting positive emotion and suicide prevention mobile apps. PLF patients also receive usual care.
Beck Scale for Suicide Ideation (BSS) 3 Month	11.6 score on a scale Standard Deviation 11.04
Beck Scale for Suicide Ideation (BSS) 6 Month	10.71 score on a scale Standard Deviation 11.01
Beck Scale for Suicide Ideation (BSS) Baseline	17.68 score on a scale Standard Deviation 9.20

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Project Life Force Group Treatment n=37 Participants A novel, 10-session intervention to enhance currently mandated VA suicide safety planning in a group setting to support its implementation. PLF is a manualized, weekly 90-minute group treatment lasting 10 weeks coinciding with the time frame for enhanced monitoring of Veterans identified as "high-risk". Six of the PLF sessions correspond to a step of the safety plan and teach skills to maximize the use of that particular step of the plan. The use of emotion regulation skills in PLF differs from other DBT interventions in that it focuses primarily on emotion regulation, distraction and developing social support in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on physical health management, education pertaining to suicide risk, promoting positive emotion and suicide prevention mobile apps. PLF patients also receive usual care.
Columbia Suicide Rating Scale (C-SSRS) Baseline	3.93 score on a scale Standard Deviation 1.16
Columbia Suicide Rating Scale (C-SSRS) 3 Month	2.25 score on a scale Standard Deviation 1.25
Columbia Suicide Rating Scale (C-SSRS) 6 Month	2.13 score on a scale Standard Deviation 1.25

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Project Life Force Group Treatment n=37 Participants A novel, 10-session intervention to enhance currently mandated VA suicide safety planning in a group setting to support its implementation. PLF is a manualized, weekly 90-minute group treatment lasting 10 weeks coinciding with the time frame for enhanced monitoring of Veterans identified as "high-risk". Six of the PLF sessions correspond to a step of the safety plan and teach skills to maximize the use of that particular step of the plan. The use of emotion regulation skills in PLF differs from other DBT interventions in that it focuses primarily on emotion regulation, distraction and developing social support in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on physical health management, education pertaining to suicide risk, promoting positive emotion and suicide prevention mobile apps. PLF patients also receive usual care.
Beck Depression Inventory-II Baseline	33.51 score on a scale Standard Deviation 10.64
Beck Depression Inventory-II 3 Month	23 score on a scale Standard Deviation 13.16
Beck Depression Inventory-II 6 Month	18.13 score on a scale Standard Deviation 14.59

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Project Life Force Group Treatment n=37 Participants A novel, 10-session intervention to enhance currently mandated VA suicide safety planning in a group setting to support its implementation. PLF is a manualized, weekly 90-minute group treatment lasting 10 weeks coinciding with the time frame for enhanced monitoring of Veterans identified as "high-risk". Six of the PLF sessions correspond to a step of the safety plan and teach skills to maximize the use of that particular step of the plan. The use of emotion regulation skills in PLF differs from other DBT interventions in that it focuses primarily on emotion regulation, distraction and developing social support in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on physical health management, education pertaining to suicide risk, promoting positive emotion and suicide prevention mobile apps. PLF patients also receive usual care.
Beck Hopelessness Scale 6 Month	7.25 score on a scale Standard Deviation 7.07
Beck Hopelessness Scale Baseline	11.69 score on a scale Standard Deviation 5.83
Beck Hopelessness Scale 3 Month	9.52 score on a scale Standard Deviation 5.26

Adverse Events

Project Life Force Group Treatment

Serious events: 10 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Project Life Force Group Treatment n=37 participants at risk A novel, 10-session intervention to enhance currently mandated VA suicide safety planning in a group setting to support its implementation. PLF is a manualized, weekly 90-minute group treatment lasting 10 weeks coinciding with the time frame for enhanced monitoring of Veterans identified as "high-risk". Six of the PLF sessions correspond to a step of the safety plan and teach skills to maximize the use of that particular step of the plan. The use of emotion regulation skills in PLF differs from other DBT interventions in that it focuses primarily on emotion regulation, distraction and developing social support in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on physical health management, education pertaining to suicide risk, promoting positive emotion and suicide prevention mobile apps. PLF patients also receive usual care.
Psychiatric disorders Possible Related Adverse Events	27.0% 10/37 • Number of events 10 • 29 months

Other adverse events

Other adverse events
Measure	Project Life Force Group Treatment n=37 participants at risk A novel, 10-session intervention to enhance currently mandated VA suicide safety planning in a group setting to support its implementation. PLF is a manualized, weekly 90-minute group treatment lasting 10 weeks coinciding with the time frame for enhanced monitoring of Veterans identified as "high-risk". Six of the PLF sessions correspond to a step of the safety plan and teach skills to maximize the use of that particular step of the plan. The use of emotion regulation skills in PLF differs from other DBT interventions in that it focuses primarily on emotion regulation, distraction and developing social support in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on physical health management, education pertaining to suicide risk, promoting positive emotion and suicide prevention mobile apps. PLF patients also receive usual care.
Surgical and medical procedures Non-Serious Adverse Events	21.6% 8/37 • Number of events 8 • 29 months

Additional Information

Marianne Goodman, MD

Department of Veteran Affairs

Phone: 718-584-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place