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

Completed · Not applicable

Conditions studied: Post Traumatic Stress Disorders, Unsafe Sex, Substance Use Disorders

In brief

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.

Key facts

Study ID: NCT01849029
Run by: University of Washington
People needed: 60
Starts: 2013-10-15
Expected to finish: 2017-07-30
Last updated by the study team: 2017-08-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Yakama Nation Behavioral Health and Comprehensive Community Alcoholism Program and Youth Treatment Program — Toppenish, Washington, United States

Full record on ClinicalTrials.gov

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