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 : June 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Behavioral: STAIR Behavioral: PCT||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|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|
STAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment
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
A non-trauma-focused treatment
Other Name: Present Centered Therapy
- 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
- 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.
- 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.
- 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.
- 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
- 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
- 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
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
|Contact: Marylene Cloitre, PhD||(650) 493-5000 ext email@example.com|
|Contact: Ashley S Bauer||(650) 493-5000 ext 26072||Ashley.Bauer@va.gov|
|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 firstname.lastname@example.org|
|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: Madeline R Armstrong, BS (858) 552-8585 ext 4325 Madeline.Armstrong@va.gov|
|Sub-Investigator: Leslie A. Morland, PsyD|
|Principal Investigator:||Marylene Cloitre, PhD||VA Palo Alto Health Care System, Palo Alto, CA|