Cognitive Processing Intervention for Trauma, HIV/STI Risks, and Substance Use Among Native Women
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2013
CompletedFirst Posted
Study publicly available on registry
May 8, 2013
CompletedStudy Start
First participant enrolled
October 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2017
CompletedAugust 22, 2017
August 1, 2017
3.5 years
May 4, 2013
August 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PTSD Symptom Scale interview (PSS-I)
Post-traumatic stress disorder symptom severity scale range from 0 (no PTSD symptoms) to 51 (high PSTD symptoms); units on a scale
Change from baseline (week 0) to Post intervention (week 6-8 weeks)
PTSD Symptom Scale interview (PSS-I)
Post-traumatic stress disorder symptom severity scale range from 0 (no PTSD symptoms) to 51 (high PSTD symptoms); continuous, units on a scale
Change from baseline (week 0) to follow-up (week 12-14)
Secondary Outcomes (6)
Drug use Frequency (DUF)
Change from baseline (week 0) to Post intervention (week 6-8 weeks)
Drug use Frequency (DUF)
Change from baseline (week 0) to follow-up (week 12-14)
Short Inventory of Problems - Alcohol and Drugs, (SIP-AD)
Change from baseline (week 0) to Post intervention (week 6-8 weeks)
Short Inventory of Problems - Alcohol and Drugs, (SIP-AD)
Change from baseline (week 0) to follow-up (week 12-14)
Condom-protected sex
Change from baseline (week 0) to Post intervention (week 6-8 weeks)
- +1 more secondary outcomes
Other Outcomes (8)
Penn Alcohol Craving Scale (PACS)
Change from baseline (week 0) to Post intervention (week 6-8 weeks)
Penn Alcohol Craving Scale (PACS)
Change from baseline (week 0) to follow-up (week 12-14)
number of sex partners
Change from baseline (week 0) to Post intervention (week 6-8 weeks)
- +5 more other outcomes
Study Arms (2)
Cognitive Processing Theapy-Cognitive
EXPERIMENTALImmediate group receives Cognitive Processing Therapy-Cognitive CPT-C intervention within one week of being consented into the study
Cognitive Processing Threapy-Cognitive
OTHERWait list group: waits 6 weeks before receiving the Cognitive Processing Therapy-Cognitive (CPT-C) intervention. During this period no intervention is received
Interventions
Cognitive Processing Therapy-Cognitive (CPT-C) uses education about trauma reactions, emotional processing, and cognitive strategies to reduce trauma-related cognitive distortions. CPT is a manualised 12 session cognitive behavioral treatment for PTSD which offers an alternative to purely exposure based interventions. CPT has a smaller exposure component than imaginal exposure therapy and is therefore potentially more acceptable to clients or practitioners seeking alternatives to purely exposure focused treatments. CPT-C omits the written trauma account, and includes more practice of cognitive techniques during the sessions. The treatment was developed for twice weekly sessions over 6 weeks. It also directly targets associated problems such as depression, guilt and anger.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Yakama Nation Behavioral Health and Comprehensive Community Alcoholism Program and Youth Treatment Program
Toppenish, Washington, 98948, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia R Pearson, PhD
Indigenous Wellness Research Institute, University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor
Study Record Dates
First Submitted
May 4, 2013
First Posted
May 8, 2013
Study Start
October 15, 2013
Primary Completion
March 30, 2017
Study Completion
July 30, 2017
Last Updated
August 22, 2017
Record last verified: 2017-08