Clinical trial NCT01849029: Cognitive Processing Intervention for Trauma, HIV/STI Risks, and Substance Use Among Native Women
Official title: Cognitive Processing Intervention for HIV/STI and Substance Use Among Native Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorders
Unsafe Sex
Substance Use Disorders
Keywords: Post traumatic Stress Disorders
PTSD
HIV risk
sexual risk
substance use
alcohol misuse
Substance Abuse
Substance Addiction
Substance Dependence
Substance Use Disorders
Alcohol-Related Disorders
Binge Drinking
Sexual Partners
Sexual Behavior
Unsafe Sex
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-05-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: PTSD Symptom Scale interview (PSS-I)
timeFrame: Change from baseline (week 0) to Post intervention (week 6-8 weeks)
measure: PTSD Symptom Scale interview (PSS-I)
timeFrame: Change from baseline (week 0) to follow-up (week 12-14)
Secondary outcomes:
measure: Drug use Frequency (DUF)
timeFrame: Change from baseline (week 0) to Post intervention (week 6-8 weeks)
measure: Drug use Frequency (DUF)
timeFrame: Change from baseline (week 0) to follow-up (week 12-14)
measure: Short Inventory of Problems - Alcohol and Drugs, (SIP-AD)
timeFrame: Change from baseline (week 0) to Post intervention (week 6-8 weeks)
measure: Short Inventory of Problems - Alcohol and Drugs, (SIP-AD)
timeFrame: Change from baseline (week 0) to follow-up (week 12-14)
measure: Condom-protected sex
timeFrame: Change from baseline (week 0) to Post intervention (week 6-8 weeks)
measure: Condom-protected sex
timeFrame: Change from baseline (week 0) to follow-up (week 12-14)
Other outcomes:
measure: Penn Alcohol Craving Scale (PACS)
timeFrame: Change from baseline (week 0) to Post intervention (week 6-8 weeks)
measure: Penn Alcohol Craving Scale (PACS)
timeFrame: Change from baseline (week 0) to follow-up (week 12-14)
measure: number of sex partners
timeFrame: Change from baseline (week 0) to Post intervention (week 6-8 weeks)
measure: number of sex partners
timeFrame: Change from baseline (week 0) to follow-up (week 12-14)
measure: sex under the influence of substances
timeFrame: Change from baseline (week 0) to Post intervention (week 6-8 weeks)
measure: sex under the influence of substances
timeFrame: Change from baseline (week 0) to follow-up (week 12-14)
measure: concurrent sexual partners
timeFrame: Change from baseline (week 0) to Post intervention (week 6-8 weeks)
measure: concurrent sexual partners
timeFrame: Change from baseline (week 0) to follow-up (week 12-14)
Locations:
city: Toppenish
country: United States
facility: Yakama Nation Behavioral Health and Comprehensive Community Alcoholism Program and Youth Treatment Program
state: Washington
Study officials:
affiliation: Indigenous Wellness Research Institute, University of Washington
name: Cynthia R Pearson, PhD
role: PRINCIPAL_INVESTIGATOR
References: