Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/9/2019 |
| Start Date: | September 3, 2018 |
| End Date: | February 28, 2022 |
| Contact: | Marylene Cloitre, PhD |
| Email: | marylene.cloitre@va.gov |
| Phone: | (650) 493-5000 |
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.
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.
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.
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.
Inclusion Criteria:
- Veteran
- A positive screen for MST
- A positive PTSD screen defined as PC-PTSD cut-off of > 3
Exclusion Criteria:
- Substance abuse not in remission for at least 3 months
- Current psychotic symptoms
- unmedicated mania or bipolar disorder
- prominent current suicidal or homicidal ideation
- Cognitive impairment indicated by chart diagnoses or observable cognitive difficulties
- Current involvement in a violent relationship defined as more than casual contact
- e.g., dating or living with an abusive partner
We found this trial at
2
sites
Palo Alto, California 94304
Principal Investigator: Marylene Cloitre, PhD
Phone: 650-493-5000
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