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

PTSD Clinical Trial

— CWC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429166
• Other study ID #: IIR 16-070
• Status: Completed
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: December 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Skills Training in Affective and Interpersonal Regulation
A non-trauma-focused treatment
• Present Centered Therapy
A non-trauma-focused treatment

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	San Diego Veterans Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (13)

Ben-Ezra M, Karatzias T, Hyland P, Brewin CR, Cloitre M, Bisson JI, Roberts NP, Lueger-Schuster B, Shevlin M. Posttraumatic stress disorder (PTSD) and complex PTSD (CPTSD) as per ICD-11 proposals: A population study in Israel. Depress Anxiety. 2018 Mar;35 — View Citation

Cloitre M, Garvert DW, Weiss BJ. Depression as a moderator of STAIR Narrative Therapy for women with post-traumatic stress disorder related to childhood abuse. Eur J Psychotraumatol. 2017 Oct 10;8(1):1377028. doi: 10.1080/20008198.2017.1377028. eCollectio — View Citation

Cloitre M, Khan C, Mackintosh MA, Garvert DW, Henn-Haase CM, Falvey EC, Saito J. Emotion regulation mediates the relationship between ACES and physical and mental health. Psychol Trauma. 2019 Jan;11(1):82-89. doi: 10.1037/tra0000374. Epub 2018 May 10. — View Citation

Coventry PA, Meader N, Melton H, Temple M, Dale H, Wright K, Cloitre M, Karatzias T, Bisson J, Roberts NP, Brown JVE, Barbui C, Churchill R, Lovell K, McMillan D, Gilbody S. Psychological and pharmacological interventions for posttraumatic stress disorder — View Citation

Ho GWK, Karatzias T, Vallieres F, Bondjers K, Shevlin M, Cloitre M, Ben-Ezra M, Bisson JI, Roberts NP, Astill Wright L, Hyland P. Complex PTSD symptoms mediate the association between childhood trauma and physical health problems. J Psychosom Res. 2021 Ma — View Citation

Hyland P, Shevlin M, Cloitre M, Karatzias T, Vallieres F, McGinty G, Fox R, Power JM. Quality not quantity: loneliness subtypes, psychological trauma, and mental health in the US adult population. Soc Psychiatry Psychiatr Epidemiol. 2019 Sep;54(9):1089-10 — View Citation

Jackson C, Weiss BJ, Cloitre M. STAIR Group Treatment for Veterans with PTSD: Efficacy and Impact of Gender on Outcome. Mil Med. 2019 Jan 1;184(1-2):e143-e147. doi: 10.1093/milmed/usy164. — View Citation

Karatzias T, Hyland P, Bradley A, Fyvie C, Logan K, Easton P, Thomas J, Philips S, Bisson JI, Roberts NP, Cloitre M, Shevlin M. Is Self-Compassion a Worthwhile Therapeutic Target for ICD-11 Complex PTSD (CPTSD)? Behav Cogn Psychother. 2019 May;47(3):257-2 — View Citation

Kazlauskas E, Gegieckaite G, Hyland P, Zelviene P, Cloitre M. The structure of ICD-11 PTSD and complex PTSD in Lithuanian mental health services. Eur J Psychotraumatol. 2018 Jan 11;9(1):1414559. doi: 10.1080/20008198.2017.1414559. — View Citation

McGinty G, Fox R, Ben-Ezra M, Cloitre M, Karatzias T, Shevlin M, Hyland P. Sex and age differences in ICD-11 PTSD and complex PTSD: An analysis of four general population samples. Eur Psychiatry. 2021 Oct 4;64(1):e66. doi: 10.1192/j.eurpsy.2021.2239. — View Citation

Olff M, Amstadter A, Armour C, Birkeland MS, Bui E, Cloitre M, Ehlers A, Ford JD, Greene T, Hansen M, Lanius R, Roberts N, Rosner R, Thoresen S. A decennial review of psychotraumatology: what did we learn and where are we going? Eur J Psychotraumatol. 201 — View Citation

Schnyder U, Schafer I, Aakvaag HF, Ajdukovic D, Bakker A, Bisson JI, Brewer D, Cloitre M, Dyb GA, Frewen P, Lanza J, Le Brocque R, Lueger-Schuster B, Mwiti GK, Oe M, Rosner R, Schellong J, Shigemura J, Wu K, Olff M. The global collaboration on traumatic s — View Citation

Weiss BJ, Azevedo K, Webb K, Gimeno J, Cloitre M. Telemental Health Delivery of Skills Training in Affective and Interpersonal Regulation (STAIR) for Rural Women Veterans Who Have Experienced Military Sexual Trauma. J Trauma Stress. 2018 Aug;31(4):620-625 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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