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

NCT ID: NCT03429166

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-03
• Study Completion Date: 2022-12-30

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 (HBVT).

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 PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS) (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 cut-off of 3 or more from the Diagnostic Statistical Manual 5 (DSM-5) PTSD Screen 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), mid-treatment (week 8), immediately posttreatment (week 16), 2-month follow-up (week 24) and 4-month follow-up (week 32). 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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

STAIR stands for Skills Training in Affective and Interpersonal Regulation

STAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment

Group Type: EXPERIMENTAL

Skills Training in Affective and Interpersonal Regulation

Intervention Type: BEHAVIORAL

A non-trauma-focused treatment

Present Centered Therapy

PCT , a non-trauma-focused treatment

Group Type: ACTIVE_COMPARATOR

Present Centered Therapy

Intervention Type: BEHAVIORAL

A non-trauma-focused treatment

Interventions

Skills Training in Affective and Interpersonal Regulation

A non-trauma-focused treatment

Intervention Type: BEHAVIORAL

Present Centered Therapy

A non-trauma-focused treatment

Intervention Type: BEHAVIORAL

Other Intervention Names

STAIR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

San Diego Veterans Healthcare System

FED

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marylene Cloitre, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Countries

United States

References

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Reference Type: DERIVED

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IIR 16-070

Identifier Type: -

Identifier Source: org_study_id