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

March 28, 2023 updated by: VA Office of Research and Development
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304-1290
        • VA Palo Alto Health Care System, Palo Alto, CA
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System, San Diego, CA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: Skills Training in Affective and Interpersonal Regulation
A non-trauma-focused treatment
Other Names:
  • STAIR
Active Comparator: Present Centered Therapy
PCT , a non-trauma-focused treatment
Behavioral: Present Centered Therapy
A non-trauma-focused treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: Change from Baseline clinician assessed PTSD symptoms at 16 week,change hrough 16 week FU
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)
Time Frame: Change from Baseline self-report PTSD symptoms at 16 weeks, no change through 16 week FU
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)
Time Frame: Change from Baseline social support at 16 weeks, no change though 16 week FU
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)
Time Frame: Change from Baseline emotion regulation problems at 16 weeks, no change through 16 week FU
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)
Time Frame: Change from Baseline depression at 16 weeks, no change through 16 week follow up
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
Time Frame: Change from Baseline depression at 16 weeks, no change through 16 week follow up
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
Time Frame: Change from Baseline anxiety at 16 weeks, no change through 16 week follow up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

San Diego Veterans Healthcare System

Investigators

  • Principal Investigator: Marylene Cloitre, PhD, VA Palo Alto Health Care System, Palo Alto, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2018

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IIR 16-070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Sharing Time Frame

Protocol will be shared 1 year from study launch.

IPD Sharing Access Criteria

Data will become available after papers reporting results of study hypotheses have been published. Duration of availability of data contingent on resources to maintain the database.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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