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

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ClinicalTrials.gov Identifier: NCT03429166
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : February 7, 2019
Sponsor:
Collaborator:
San Diego Veterans Healthcare System
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
PTSD Behavioral: STAIR Behavioral: PCT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : February 28, 2022

Arm Intervention/treatment
Experimental: STAIR
STAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment
Behavioral: STAIR
A non-trauma-focused treatment
Other Name: Skills Training in Affective and Interpersonal Regulation

Active Comparator: PCT
PCT stands for Present Centered Therapy, a non-trauma-focused treatment
Behavioral: PCT
A non-trauma-focused treatment
Other Name: Present Centered Therapy




Primary Outcome Measures :
  1. Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Change from Baseline clinician assessed PTSD symptoms at 26 weeks ]
    Clinician Administered measure of PTSD Diagnosis. 20 item queries that allow diagnosis of PTSD in DSM-5

  2. PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Change from Baseline self-report PTSD symptoms at 26 weeks ]
    Self-reported PTSD symptoms 20 item measure, higher scores indicate more severe symptoms.


Secondary Outcome Measures :
  1. Interpersonal Support Evaluation List -12(ISEL-12) [ Time Frame: Change from Baseline social support at 26 weeks ]
    Measure of social support 12 item measure, higher scores indicate greater social support.

  2. Inventory of Interpersonal Problems-32 (IIP-32) [ Time Frame: Change from Baseline interpersonal problems at 26 weeks ]
    Measure of interpersonal problems 32 item measure, higher scores indicate greater problems.

  3. Difficulties in Emotion Regulation Scale-16 (DERS-16) [ Time Frame: Change from Baseline emotion regulation problems at 26 weeks ]
    Difficulties in emotion regulation 16 item measure, higher scores indicate greater problems

  4. Beck Depression Inventory-11 (BDI-11) [ Time Frame: Change from Baseline depression at 26 weeks ]
    measure of depression 11 items, higher scores indicate worse depression

  5. General Anxiety Disorder Scale 7 (GAD-7) [ Time Frame: Change from Baseline anxiety at 26 weeks ]
    Measure of anxiety 7 items, higher scores indicate worse anxiety



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429166


Contacts
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Contact: Marylene Cloitre, PhD (650) 493-5000 ext 28353 marylene.cloitre@va.gov
Contact: Ashley S Bauer (650) 493-5000 ext 26072 Ashley.Bauer@va.gov

Locations
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United States, California
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Marylene Cloitre, PhD    650-493-5000 ext 28353    marylene.cloitre@va.gov   
Contact: Ashley S Bauer    (650) 493-5000 ext 26072    Ashley.Bauer@va.gov   
Principal Investigator: Marylene Cloitre, PhD         
VA San Diego Healthcare System, San Diego, CA Recruiting
San Diego, California, United States, 92161
Contact: Leslie A Morland, PsyD    619-497-8406    Leslie.Morland@va.gov   
Contact: Benjamin M Rooney, BA    (858) 552-8585 ext 4325    benjamin.rooney@va.gov   
Sub-Investigator: Leslie A. Morland, PsyD         
Sponsors and Collaborators
VA Office of Research and Development
San Diego Veterans Healthcare System
Investigators
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Principal Investigator: Marylene Cloitre, PhD VA Palo Alto Health Care System, Palo Alto, CA

Publications of Results:
Kazlauskas E, Gegieckaite G, Hyland P, Zelviene P, Cloitre M. The structure of ICD-11 PTSD and complex PTSD in Lithuanian mental health services. European journal of psychotraumatology. 2018 Jan 11; 9(1):https://doi.org/10.1080/20008198.2017.1414559.

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03429166     History of Changes
Other Study ID Numbers: IIR 16-070
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Protocol will be shared 1 year from study launch.
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.

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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