Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas

Study Overview
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Brief Summary
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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
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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.

Official Title
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Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Skills Training in Affective and Interpersonal Regulation
* Behavioral: Present Centered Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The current study proposes a blending of design components of clinical effectiveness and implementation research for the purposes increasing translational gains and providing useful information to inform future implementation that would otherwise not be available or take much longer to obtain. This Hybrid Type 1 design combines a randomized clinical effectiveness trial with a mixed-method, multi-stakeholder process evaluation of the delivery of the intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STAIR stands for Skills Training in Affective and Interpersonal Regulation<br>STAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment | Behavioral: Skills Training in Affective and Interpersonal Regulation<br>* A non-trauma-focused treatment<br>* Other names: STAIR;|
| Active Comparator: Present Centered Therapy<br>PCT , a non-trauma-focused treatment | Behavioral: Present Centered Therapy<br>* A non-trauma-focused treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | Clinician Administered measure of PTSD Diagnosis. 20 item queries that allow diagnosis of PTSD in DSM-5 | Change from Baseline clinician assessed PTSD symptoms at 16 week,change hrough 16 week FU | 
| PTSD Checklist for DSM-5 (PCL-5) | Self-reported PTSD symptoms 20 item measure, higher scores indicate more severe symptoms. | Change from Baseline self-report PTSD symptoms at 16 weeks, no change through 16 week FU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interpersonal Support Evaluation List -12 (ISEL-12) | Measure of social support 12 item measure, higher scores indicate greater social support. | Change from Baseline social support at 16 weeks, no change though 16 week FU | 
| Difficulties in Emotion Regulation Scale-16 (DERS-16) | Measure of interpersonal problems 16 item measure, higher scores indicate greater problems | Change from Baseline emotion regulation problems at 16 weeks, no change through 16 week FU | 
| Beck Depression Inventory-11 (BDI-11) | 11 items, higher scores indicate worse depression | Change from Baseline depression at 16 weeks, no change through 16 week follow up | 
| Personal Maladaptive Belief Scale | Measure of negative cognitions, 15 items higher scores indicate higher maladaptive cognitions | Change from Baseline depression at 16 weeks, no change through 16 week follow up | 
| WHODAS 2.0 Life Activities Subscale | Measure of psychosocial functioning, 8 items where higher scores indicate greater difficulty | Change from Baseline anxiety at 16 weeks, no change through 16 week follow up |