Cognitive Processing Intervention for Trauma, HIV/STI Risks, and Substance Use Among Native Women

Nearly one of three American Indian (AI) women can expect to be raped in their lifetime
putting them at great risk for revictimization and human immunodeficiency virus (HIV). The
high prevalence of sexual and physical assault in Indian country has led Amnesty
International to declare a state of emergency for AI women in the United States. This
application is part of a community led effort by the Yakama Nation to turn this tide in
their tribal community.

Situated in the plateau region of Eastern Washington, the Yakama Nation is the largest tribe
in Washington State (comprising over 10,000 members.) Since 2008, Investigators at the
University of Washington have been collaborating with the Yakama Reservation Wellness
Coalition who has mobilized activists and researchers through a community-based
participatory research (CBPR) process to address the trauma and associated mental health
concerns disproportionately affecting community women. This application, in response to "R34
PA-09-146: Pilot and Feasibility Studies in Preparation for Drug Abuse Prevention Trials"
proposes a 3-year project to culturally adapt and pilot an empirically supported
trauma-focused treatment, Cognitive Processing Therapy (CPT) for post-traumatic stress
disorder (PTSD), substance use and HIV/STI sexual risk behavior among 56 AI women in a
resource-limited rural area.

Additionally, the investigators will assess the feasibility, acceptability and treatment
fidelity of delivering this CPT via AI community health workers. Based on the investigators
promising preliminary work, their multidisciplinary collaboration includes experienced AI
and non-AI HIV, trauma, health service, and mental health academic researchers and an
8-member community research team of Yakama Nation tribal leaders, potential consumers, and
health care providers with strong community connections.

High rates of comorbidity between substance and alcohol use disorders (SAUD) and PTSD have
been well established especially for women. Moreover, 25-40% of those seeking treatment for
substance use meet criteria for PTSD. Additionally, PTSD is associated with increased
HIV-risk sexual behavior (HRSB) in women. Prevailing theory suggests that alcohol and other
drugs may be used to self-medicate or mitigate PTSD symptoms, which then reinforces more
substance use leading to substance abuse-related consequences and problems, particularly
HIV/STI exposure. Avoidance of trauma-related cues and affect including avoidance through
substance use is thought to maintain PTSD and enhance risky sexual behavior. Therefore,
treatment of PTSD should decrease substance use and risky sexual behavior.

Many AI women never receive services for serious mental health problems resulting from
traumatic events, violence exposure and maltreatment. AI women suffer higher lifetime rates
of PTSD (20-23%), and are 2-3 times more likely than the general U.S. population to engage
in excessive drinking which often co-occurs with risky sexual behaviors. These factors
magnify risk for HIV and sexually transmitted infections (HIV/STI).

This project is innovative in both its focus and its methods. It brings a culturally
responsive intervention to an understudied and highly vulnerable population. It will
culturally adapt and modify an evidence-based community health worker delivered intervention
to address health risk behaviors (SAUD and HRSB). Its significance lies in its potential to
advance science in the area of PTSD and SAUD treatment and HIV/STI prevention among AI
women. Study data would be a significant contribution to tribal and rural communities and
the mental health field. Finally, it is geared toward developing the research infrastructure
and mental health treatment capacity serving AI women living in rural settings, a group at
risk for an expanding AIDS and STI epidemic. If successful, findings from this study will
inform a larger efficacy trial.

AIM I. Adapt the evidence-based CPT intervention in full collaboration with tribal partners.
This will be done in accordance with the CDC's Map of Adaptation Process and involved
formative research with tribal leaders, potential consumers, providers, and health care
administrators using qualitative methodology.

AIM 2. Assess this intervention delivered by Native American community health workers for
feasibility and acceptability in a resource-limited rural reservation setting.

AIM 2. Conduct a two-group, single-site waitlist randomized controlled pilot trial of a
12-session, 6-week CPT intervention among 56 (6 pilot) sexually active and substance using
AI women with PTSD or sub-threshold PTSD. Determine preliminary efficacy and estimate an
effect size in terms of three primary outcomes: (a) PTSD symptomatology; (b) substance use;
(c) high risk sexual behavior.

Inclusion Criteria:

- Current Substance Use At least 2 days of heavy drinking in the past 30 day period (4
or more drinks over the course of 2 hours) OR Recent substance consumption (other
than opioids) in the last 3 months

- Desire to abstain from substances

- Current Diagnostic and Statistical Manual -IV diagnosis of Post-traumatic stress
disorder symptoms [score 30 or hire on the PTSD Checklist (PCL]

- Sexually active (past 12 months)

- Age ≥ 18 years

- Capacity to provide informed consent

Exclusion Criteria:

- Unstable psychiatric medication regimen (i.e., medication changes or dose changes in
the past 2 months)

- Recent use of opioids (past 3 months)

- Current trauma-focused mental health treatment (MH) in the past 30 days

- Suicide attempt or suicidal ideation with intent or plan, or self-harm in the past
month

- Presence of a psychotic disorder or uncontrolled Bipolar Disorder