Ignite Creation Date:
2024-05-06 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03653637
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2018-08-29
Brief Title:
Group Project Life Force vs Individual Suicide Safety Planning RCT
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Group Project Life Force vs Individual Suicide Safety Planning RCT
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLF
Brief Summary:
The management of suicide risk is a pressing national public health issue especially among Veterans This grant consists of two arms the novel treatment and treatment-as-usual Project Life Force PLF a novel suicide safety planning group intervention has been developed to provide a mechanism to develop and enhance the Suicide Safety Plan SSP over time PLF a 10-session group intervention combines cognitive behavior therapy CBTdialectical behavior therapy DBT skill based and psychoeducational approaches to maximize suicide safety planning development and implementation Veterans revise their plans over several weeks while learning coping emotion regulation and interpersonal skills to incorporate into their safety plans
Detailed Description:
Worldwide someone dies by suicide every 40 seconds In the United States Veterans exhibit significantly higher suicide risk when compared to the general United States population One in five suicide deaths is a Veteran and in spite of enhanced suicide prevention services in the Veterans Administration VA twenty Veterans commit suicide daily These very concerning numbers demonstrate an urgent need to develop additional empirically validated interventions for suicidal Veterans
One component of the VAs coordinated effort to treat high-risk suicidal Veterans and diminish suicide risk is through the construction of a Suicide Safety Plan Considered a best practice the SSP instructs one to recognize personal warning signs of suicide use internal coping strategies engage social contacts that can offer support and serve as distraction from suicidal thoughts contact family members or friends who may help resolve a crisis provide contact information for VA professionals to help and specify steps for how to make the immediate environment safer The patient takes the SSP home for his or her use during or at the onset of a suicidal crisis Safety planning is based on the idea that suicide risk fluctuates over time and aims to prevent suicidal crises from escalating and stop individuals from acting on their suicidal thoughts and urges Research suggests creation of the SSP is effective one study found that Veterans who present to an emergency room show decreased suicide behavior after creating a SSP
This study aims to fill this treatment gap by examining a novel intervention integrating skills training with safety planning for high risk suicidal Veterans Project Life Force PLF The PLF intervention augments the SSP with skills training and psychoeducation to maximize use and effectiveness of the plan in a group setting This interventions skill instruction is delivered in a group format Research suggests groups mitigate loneliness and increase a sense of belonging which is in line with the extensive literature supporting the interpersonal psychological theory ie that those who die by suicide have a low sense of belonging More recently reports on the relation of military unit cohesion and suicide risk suggests that increasing unit cohesion may have a protective effect Overall PLF aims to enhance suicide coping skills safety planning and connection to others
The main objective of this RCT is to examine if Veterans who are at high risk for suicide will benefit from the novel group intervention PLF compared to Veterans who receive TAUThe specific aims and hypotheses of PLF are
Aim 1 To conduct a multi-site randomized clinical trial RCT of a group safety planning intervention PLF versus individual safety planning in 265 suicidal Veterans PLF will be compared with the comparison condition- individual safety planning the current standard of care designated as TAU
Exploratory Aim 2 To test whether increased suicide coping and improved belongingness partially mediates treatment response in PLFTAU
Exploratory Aim 3 To test whether group cohesion partially mediates treatment response in PLF
Exploratory Aim 4 To test whether the change in Safety Plan Quality post intervention - baseline is greater PLFTAU as well as whether the change in safety plan quality partially mediates treatment response in the follow up period
Hypothesis A1 Compared to TAU Veterans who participate in PLF will demonstrate a decrease in suicidal behavior
Hypothesis A2 Compared to TAU Veterans who participate in PLF will show a decrease in depression and hopelessness
Hypothesis A3 Compared to TAU Veterans who participate in PLF will have increased compliance and attitudes towards mental health treatment
One component of the VAs coordinated effort to treat high-risk suicidal Veterans and diminish suicide risk is through the construction of a Suicide Safety Plan Considered a best practice the SSP instructs one to recognize personal warning signs of suicide use internal coping strategies engage social contacts that can offer support and serve as distraction from suicidal thoughts contact family members or friends who may help resolve a crisis provide contact information for VA professionals to help and specify steps for how to make the immediate environment safer The patient takes the SSP home for his or her use during or at the onset of a suicidal crisis Safety planning is based on the idea that suicide risk fluctuates over time and aims to prevent suicidal crises from escalating and stop individuals from acting on their suicidal thoughts and urges Research suggests creation of the SSP is effective one study found that Veterans who present to an emergency room show decreased suicide behavior after creating a SSP
This study aims to fill this treatment gap by examining a novel intervention integrating skills training with safety planning for high risk suicidal Veterans Project Life Force PLF The PLF intervention augments the SSP with skills training and psychoeducation to maximize use and effectiveness of the plan in a group setting This interventions skill instruction is delivered in a group format Research suggests groups mitigate loneliness and increase a sense of belonging which is in line with the extensive literature supporting the interpersonal psychological theory ie that those who die by suicide have a low sense of belonging More recently reports on the relation of military unit cohesion and suicide risk suggests that increasing unit cohesion may have a protective effect Overall PLF aims to enhance suicide coping skills safety planning and connection to others
The main objective of this RCT is to examine if Veterans who are at high risk for suicide will benefit from the novel group intervention PLF compared to Veterans who receive TAUThe specific aims and hypotheses of PLF are
Aim 1 To conduct a multi-site randomized clinical trial RCT of a group safety planning intervention PLF versus individual safety planning in 265 suicidal Veterans PLF will be compared with the comparison condition- individual safety planning the current standard of care designated as TAU
Exploratory Aim 2 To test whether increased suicide coping and improved belongingness partially mediates treatment response in PLFTAU
Exploratory Aim 3 To test whether group cohesion partially mediates treatment response in PLF
Exploratory Aim 4 To test whether the change in Safety Plan Quality post intervention - baseline is greater PLFTAU as well as whether the change in safety plan quality partially mediates treatment response in the follow up period
Hypothesis A1 Compared to TAU Veterans who participate in PLF will demonstrate a decrease in suicidal behavior
Hypothesis A2 Compared to TAU Veterans who participate in PLF will show a decrease in depression and hopelessness
Hypothesis A3 Compared to TAU Veterans who participate in PLF will have increased compliance and attitudes towards mental health treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1I01CX001705-01A1 | NIH | None | httpsreporternihgovquickSearch1I01CX001705-01A1 |