Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03429166
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2018-02-05
Brief Title:
Connecting Women to Care Home-based Psychotherapy for Women With MST Living in Rural Areas
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Connecting Women to Care Home-based Psychotherapy for Women With MST Living in Rural Areas
Status:
COMPLETED
Status Verified Date:
2023-03
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:
CWC
Brief Summary:
Military sexual trauma MST is a common duty-related stressor which occurs among one in four female Veterans and is associated with substantial concerns about social isolation and high rates of PTSD Women with MST also experience numerous person-level barriers to care including the desire to avoid male-dominated VA clinics transportation difficulties and childcare responsibilities Treatment programs that address the social and mental health needs of this population and acknowledge barriers to care that disproportionately affect women are lacking The proposed study will use a hybrid effectiveness-implementation design to evaluate the in-home delivery of a gender-sensitive evidence-based coping skills program to improve social and role functioning as well as reduce PTSD and will prioritize enrolling rural women in a representative manner If the program is found to be successful at improving social functioning and PTSD and in reducing barriers to care it will provide a tremendous benefit to women Veterans with MST particularly those in rural areas
Detailed Description:
Background - Military Sexual Trauma MST among women Veterans is a problem of epidemic proportion associated with significant mental health and functional impairment and substantial access to care barriers Surveillance data indicate that one in four women Veterans reports MST when screened Compared to women Veterans with other service-related stressors those experiencing MST have greater mental health problems are more likely to report difficulty in functioning in social family and intimate relationships and are more likely to be unemployed and to report difficulties in finding a job Nevertheless women with MST engage less frequently in VA health care than other women Veterans Barriers to care include distance from specialty services financial difficulties childcare and family responsibilities and gender-related discomfort in male-dominated VA facilities Research over the past decade has identified the problems and concerns of women Veterans with MST but programs addressing their mental health needs and responsive to identified barriers are lacking The proposed study addresses this gap by evaluating a gender-sensitive evidence-based skills training program delivered via home-based video technology
Specific Aims - The study will conduct a Hybrid Type 1 effectiveness-implementation study to accomplish two aims The first is to determine the effectiveness of the HBVT-delivered Skills Training in Affective Regulation STAIR relative to a HBVT-delivered nonspecific active comparator Present Centered Therapy PCT among women Veterans with MST It is hypothesized that STAIR will be superior to PCT in regards to improvement in CAPS PTSD symptoms primary outcome as well as in perceived social support and social engagement secondary outcomes The second aim is to conduct a multi-stakeholder mixed method evaluation to inform future potential implementation plans by identify barriers and facilitators of implementing STAIR via HBVT and to contextualize and interpret the quantitative data on treatment processes and clinical effectiveness
Methodology - This is a four-year two-site Hybrid Type 1 effectiveness-implementation study design A total of 200 women Veterans with MST and PTSD symptoms with DSM-5 PTSD Screen cut-off 3 will be enrolled into the study Participants will be stratified by rurality status in a proportion representative of the national population 34 rural vs 66 nonrural Stratification will ensure that resources are dedicated to recruit the identified number of rural women Within each level of stratification participants will be randomized into one of two treatments conditions STAIR or PCT each of which is comprised of 10 weekly sessions Assessments will be conducted at five time-points baseline week 0 midtreatment week 5 immediately posttreatment week 10 2-month follow-up week 18 and 4-month follow-up week 26 Rurality will be included as a covariate and assessed for variations in aspects such as retention and outcome which will help inform future implementation plans Multi-stakeholder mixed-method process evaluation concerning STAIR and the use of in-home delivery of services will include administrator clinician and patient stakeholders
Expected Results and Anticipated Impacts on Veterans Healthcare - It is expected that the proposed study has the potential to improve the quality of VA healthcare by establishing the effectiveness of a social skills intervention Skills Training in Affective and Interpersonal Regulation STAIR delivered via home-based video technology HBVT to women Veterans with MST particularly those living in rural areas The treatment simultaneously addresses social concerns and PTSD symptoms both of which are identified needs of women Veterans who have experienced MST STAIR has been demonstrated as efficacious in community populations and pilot data with women Veterans with MST indicate similar outcomes regarding improvements in perceived social support social engagement and PTSD symptoms The use of HBVT has the potential of increasing access to care to this geographically dispersed and underserved population
Specific Aims - The study will conduct a Hybrid Type 1 effectiveness-implementation study to accomplish two aims The first is to determine the effectiveness of the HBVT-delivered Skills Training in Affective Regulation STAIR relative to a HBVT-delivered nonspecific active comparator Present Centered Therapy PCT among women Veterans with MST It is hypothesized that STAIR will be superior to PCT in regards to improvement in CAPS PTSD symptoms primary outcome as well as in perceived social support and social engagement secondary outcomes The second aim is to conduct a multi-stakeholder mixed method evaluation to inform future potential implementation plans by identify barriers and facilitators of implementing STAIR via HBVT and to contextualize and interpret the quantitative data on treatment processes and clinical effectiveness
Methodology - This is a four-year two-site Hybrid Type 1 effectiveness-implementation study design A total of 200 women Veterans with MST and PTSD symptoms with DSM-5 PTSD Screen cut-off 3 will be enrolled into the study Participants will be stratified by rurality status in a proportion representative of the national population 34 rural vs 66 nonrural Stratification will ensure that resources are dedicated to recruit the identified number of rural women Within each level of stratification participants will be randomized into one of two treatments conditions STAIR or PCT each of which is comprised of 10 weekly sessions Assessments will be conducted at five time-points baseline week 0 midtreatment week 5 immediately posttreatment week 10 2-month follow-up week 18 and 4-month follow-up week 26 Rurality will be included as a covariate and assessed for variations in aspects such as retention and outcome which will help inform future implementation plans Multi-stakeholder mixed-method process evaluation concerning STAIR and the use of in-home delivery of services will include administrator clinician and patient stakeholders
Expected Results and Anticipated Impacts on Veterans Healthcare - It is expected that the proposed study has the potential to improve the quality of VA healthcare by establishing the effectiveness of a social skills intervention Skills Training in Affective and Interpersonal Regulation STAIR delivered via home-based video technology HBVT to women Veterans with MST particularly those living in rural areas The treatment simultaneously addresses social concerns and PTSD symptoms both of which are identified needs of women Veterans who have experienced MST STAIR has been demonstrated as efficacious in community populations and pilot data with women Veterans with MST indicate similar outcomes regarding improvements in perceived social support social engagement and PTSD symptoms The use of HBVT has the potential of increasing access to care to this geographically dispersed and underserved population
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