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IIR 16-070 – HSR Study

IIR 16-070
Connecting Women to Care: Home-based Psychotherapy for Women with MST Living in Rural Areas
Marylene Cloitre, PhD
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, CA
Funding Period: April 2018 - December 2022
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 clearly 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 current application addresses this gap.

The objectives of the current proposal are:

1. To evaluate the effectiveness of a skills training treatment, Skills Training in Affective and Interpersonal Regulation (STAIR) compared to an active nonspecific treatment, Present Centered Therapy (PCT), both delivered via home-based video. It is hypothesized that STAIR will be superior to PCT in reducing PTSD and related symptoms and in improving perceived social support, community engagement and social functioning. Assessments will occur five times: baseline (week 0), mid-treatment (week 5), post-treatment (week 10), 2 month follow-up (week 18) and 4 month follow-up (week 26).

2. To elucidate facilitators and barriers of implementing STAIR via home- based video treatment (HBVT) and (b) contextualize the quantitative findings of the clinical trial to enhance our understanding of both treatment processes and effectiveness.

The current study proposes to conduct a Hybrid Type 1 effectiveness-implementation design to assess the effectiveness of STAIR relative to a nonspecific active comparator, Present Centered Therapy (PCT) among women Veterans with MST, with dedicated resources to ensure engagement of those living in rural areas. We will also evaluate remote delivery of the treatment to the home rather than a VA clinic.

1. A randomized controlled trial will be conducted to assess the relative effectiveness of STAIR vs. PCT.

2. Qualitative assessment will be conducted via a multi-stakeholder mixed-methods evaluation of the delivery of STAIR via HBVT, based on two integrated frameworks: the Consolidated Framework for Implementation Research (CFIR) and the Replicating Effective Programs (REP).

PTSD symptoms declined in both conditions by posttreatment but significantly more in STAIR (d = 1.13 [0.87, 1.37]) than PCT (d = 0.71 [0.54, 1.02]). STAIR was also superior in improving social support, emotion regulation, depression and negative cognitions. Improvement in psychosocial functioning was moderate (d = 0.44, 0.40, respectively) and did not differ between conditions. All changes were maintained through follow-up. Dropout rates were low and equivalent (17.4%, 12.5%, respectively). Both interventions provided significant reduction in suicidal ideation, however, STAIR provided these benefits 6 weeks into treatment and maintained them through 4-month follow-up while PCT benefits were observed at 2-month follow-up and maintained them to 4-month follow-up. Participants in PCT engaged in significantly more additional treatment interventions during the study but this did not influence outcomes.

STAIR provided superior outcomes to PCT across several outcomes. These results could have a major impact on the treatment of women veterans with MST where interventions addressing social support and multiple types of mental health problems are needed. The substantial effect sizes in PTSD symptoms in both treatments suggest the viability of treatments that do not focus on trauma as an alternative intervention among individuals who do not wish to engage in trauma-focused CBT. Availability of these types of treatment may increase engagement in mental health services.

External Links for this Project

NIH Reporter

Grant Number: I01HX002211-01A2

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Journal Articles

  1. 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? European journal of psychotraumatology. 2019 Nov 20; 10(1):1672948. [view]
  2. Ho GWK, Karatzias T, Vallières 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. Journal of psychosomatic research. 2021 Mar 1; 142:110358. [view]
  3. 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. European journal of psychotraumatology. 2017 Oct 10; 8(1):1377028. [view]
  4. 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. Psychological trauma : theory, research, practice and policy. 2019 Jan 1; 11(1):82-89. [view]
  5. 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)?. Behavioural and cognitive psychotherapy. 2019 May 1; 47(3):257-269. [view]
  6. 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. Depression and anxiety. 2018 Mar 1; 35(3):264-274. [view]
  7. 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 and comorbid mental health problems following complex traumatic events: Systematic review and component network meta-analysis. PLoS Medicine. 2020 Aug 1; 17(8):e1003262. [view]
  8. Hyland P, Shevlin M, Cloitre M, Karatzias T, Vallières F, McGinty G, Fox R, Power JM. Quality not quantity: loneliness subtypes, psychological trauma, and mental health in the US adult population. Social psychiatry and psychiatric epidemiology. 2019 Sep 1; 54(9):1089-1099. [view]
  9. 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. European psychiatry : the journal of the Association of European Psychiatrists. 2021 Oct 4; 64(1):e66. [view]
  10. Jackson C, Weiss BJ, Cloitre M. STAIR Group Treatment for Veterans with PTSD: Efficacy and Impact of Gender on Outcome. Military medicine. 2019 Jan 1; 184(1-2):e143-e147. [view]
  11. 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. Journal of traumatic stress. 2018 Aug 2; 31(4):620-625. [view]
  12. Schnyder U, Schäfer 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 stress. European journal of psychotraumatology. 2017 Nov 30; 8(sup7):1403257. [view]
  13. 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): [view]

DRA: Mental, Cognitive and Behavioral Disorders, Health Systems
DRE: Treatment - Comparative Effectiveness, TRL - Applied/Translational
Keywords: Outcomes - Patient, PTSD, Rural, Sexual Trauma/Assault
MeSH Terms: none

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