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Cognitive Processing Intervention for Trauma, HIV/STI Risks, and Substance Use Among Native Women
Not Recruiting
Trial ID: NCT01849029
Purpose
Many American Indian (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 Post-traumatic Stress Disorder (PTSD) (20-23%), that often co-occur with
excessive drinking and risky sexual behaviors. These factors magnify risk for human
immunodeficiency virus and sexually transmitted disease (HIV/STI). In full development with
tribal partners, this application, proposes a 3-year project to culturally adapt and pilot an
empirically supported trauma-focused treatment, Cognitive Processing Therapy (CPT) for PTSD,
substance use and HIV/STI sexual risk behavior among 50 AI women. Additionally, the
investigators will assess the feasibility, acceptability and treatment fidelity of delivering
CPT via AI community health workers in a resource-limited tribal reservation. This project
brings a culturally responsive intervention to an understudied and highly vulnerable
population. Its significance lies in its potential to advance science in the area of PTSD,
substance use treatment and HIV/STI prevention among AI women. Study data would benefit
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 HIV/AIDS epidemic. If successful,
findings from this pilot will provide evidence for a larger effectiveness trial.
The AIMS are 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
involves 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 3. 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.
Official Title
Cognitive Processing Intervention for HIV/STI and Substance Use Among Native Women
Stanford Investigator(s)
Debra Lee Kaysen
Professor of Psychiatry and Behavioral Sciences (Public Mental Health & Population Sciences)
Eligibility
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
Intervention(s):
behavioral: Cognitive Processing Therapy-Cognitive
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305