Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230887
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-30
First Post:
2024-01-19
Brief Title:
Implementation of Innovative Treatment for Moral Injury Syndrome A Hybrid Type 2 Study
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Implementation of Innovative Treatment for Moral Injury Syndrome A Hybrid Type 2 Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
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:
None
Brief Summary:
Moral Injury Syndrome MIS affects up to 35-60 of Veterans managing combat-related PTSD it results from experiences that challenge deeply held values or spiritual beliefs Symptoms of MIS may include hopelessness helplessness loss of spiritual beliefs difficulty with forgiveness loss of meaning or purpose reduced trust in self or others or intractable guilt shame or anger
Veterans managing MIS have difficulty responding to mental health treatment and are at increased risk for suicide ideation or attempts To date evidence-based interventions for MIS are not widely available in VA This study will implement an evidence-based intervention for MIS in four VA facilities collect data on the effectiveness of the intervention and develop an implementation toolkit This data will inform national dissemination in collaboration with the Office of Mental Health and Suicide Prevention and the National Chaplain Service
Veterans managing MIS have difficulty responding to mental health treatment and are at increased risk for suicide ideation or attempts To date evidence-based interventions for MIS are not widely available in VA This study will implement an evidence-based intervention for MIS in four VA facilities collect data on the effectiveness of the intervention and develop an implementation toolkit This data will inform national dissemination in collaboration with the Office of Mental Health and Suicide Prevention and the National Chaplain Service
Detailed Description:
Background Moral injury syndrome MIS consists of the psychological and behavioral sequelae of experiences that challenge moral spiritual or values related beliefs Symptoms of MIS may include hopelessness helplessness loss of previously held spiritual beliefs struggle with a Higher Power difficulty with forgiveness lack of meaning or purpose reduced trust in self or others or intractable guilt shame or anger Individuals managing MIS are up to twice as likely as their peers to consider and attempt suicide and derive less benefit from psychotherapy There are few evidence-based interventions for moral injury one such intervention is a manualized group intervention called Building Spiritual Strength BSS In previous randomized controlled trials BSS has been shown to reduce both symptoms of PTSD and spiritual distress
This clinical trial will be one of the first to measure symptoms of MIS as a primary outcome Hypotheses are
1 Compared to Present Centered Group Therapy PCGT BSS will significantly decrease symptoms of MIS
2 Compared to PCGT BSS will significantly decrease symptoms of PTSD depression and suicidal ideation
Significance To date there are not standard procedures for assessing and treating MIS so it is likely that untreated MIS is contributing to poor outcomes including suicides Developing an implementation toolkit so that BSS is widely available in VA facilities could reduce the impact of MIS on Veterans mental health
Innovation and Impact To date there have not been funded implementation studies on treatments for MIS in Veterans and very few VA facilities provide evidence-based care for MIS This study can clear the way to make evidence-based care for MIS more accessible in the VA system
Specific Aims
1 Conduct a mixed methods pre-implementation evaluation to identify barriers and facilitators for BSS implementation at each site and to develop local implementation strategies Specific implementation variables assessed based on the Proctor and EBQI models include acceptability appropriateness and feasibility Specific variables to be assessed will include a acceptability of BSS to stakeholders b available implementation resources and c organizational openness to adding a new EBP
2 Conduct a randomized controlled trial comparing BSS to Present Centered Group Therapy PCGT for Veterans who score above cutoff on the Moral Injury Outcomes Scale Effectiveness and functional outcomes will be informed by the psychospiritual developmental model of MIS
3 Conduct a mixed methods post-implementation evaluation to compare outcomes across chaplaincy managed vs mental health managed BSS programs Proctor model outcomes will include adoption fidelity penetration and sustainability Specific outcomes related to this framework include a successful BSS implementation b fidelity in implementation of BSS c percentage of eligible referred Veterans who access BSS services and d qualitative reports of intent to maintain the BSS program when the study is complete
Methodology This will be a type 2 hybrid study combining pre- and post-implementation evaluations with a randomized clinical trial at 4 culturally diverse VA sites
Next Steps and Implementation Data on barriers and facilitators will be used to develop a toolkit and collaborate with study partners at the Office of Mental Health and Suicide Prevention and the National Chaplain Service to develop a national dissemination plan for BSS The investigators will work with existing clinical staffing at the study sites so that those sites can continue to provide BSS services after the study Furthermore after completing this study BSS leaders will be qualified to train BSS leaders at other sites creating resources for training and national dissemination
This clinical trial will be one of the first to measure symptoms of MIS as a primary outcome Hypotheses are
1 Compared to Present Centered Group Therapy PCGT BSS will significantly decrease symptoms of MIS
2 Compared to PCGT BSS will significantly decrease symptoms of PTSD depression and suicidal ideation
Significance To date there are not standard procedures for assessing and treating MIS so it is likely that untreated MIS is contributing to poor outcomes including suicides Developing an implementation toolkit so that BSS is widely available in VA facilities could reduce the impact of MIS on Veterans mental health
Innovation and Impact To date there have not been funded implementation studies on treatments for MIS in Veterans and very few VA facilities provide evidence-based care for MIS This study can clear the way to make evidence-based care for MIS more accessible in the VA system
Specific Aims
1 Conduct a mixed methods pre-implementation evaluation to identify barriers and facilitators for BSS implementation at each site and to develop local implementation strategies Specific implementation variables assessed based on the Proctor and EBQI models include acceptability appropriateness and feasibility Specific variables to be assessed will include a acceptability of BSS to stakeholders b available implementation resources and c organizational openness to adding a new EBP
2 Conduct a randomized controlled trial comparing BSS to Present Centered Group Therapy PCGT for Veterans who score above cutoff on the Moral Injury Outcomes Scale Effectiveness and functional outcomes will be informed by the psychospiritual developmental model of MIS
3 Conduct a mixed methods post-implementation evaluation to compare outcomes across chaplaincy managed vs mental health managed BSS programs Proctor model outcomes will include adoption fidelity penetration and sustainability Specific outcomes related to this framework include a successful BSS implementation b fidelity in implementation of BSS c percentage of eligible referred Veterans who access BSS services and d qualitative reports of intent to maintain the BSS program when the study is complete
Methodology This will be a type 2 hybrid study combining pre- and post-implementation evaluations with a randomized clinical trial at 4 culturally diverse VA sites
Next Steps and Implementation Data on barriers and facilitators will be used to develop a toolkit and collaborate with study partners at the Office of Mental Health and Suicide Prevention and the National Chaplain Service to develop a national dissemination plan for BSS The investigators will work with existing clinical staffing at the study sites so that those sites can continue to provide BSS services after the study Furthermore after completing this study BSS leaders will be qualified to train BSS leaders at other sites creating resources for training and national dissemination
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