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NCT01849029 · ClinicalTrials.gov registry record · NA
Cognitive Processing Intervention for Trauma, HIV/STI Risks, and Substance Use Among Native Women
A NA study, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT01849029: Completed NA study, sponsored by University of Washington.
NCT01849029 is a NA study that has completed, run by University of Washington. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01849029, a NA study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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 r
Primary Outcome
Post-traumatic stress disorder symptom severity scale range from 0 (no PTSD symptoms) to 51 (high PSTD symptoms); units on a scale
Interventions
- BEHAVIORAL Cognitive Processing Therapy-Cognitive
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-10-15 |
| Est. Completion | 2017-07-30 |
| Phase | NA |
What the finished NCT01849029 record still lists
NCT01849029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Cognitive Processing Therapy-Cognitive is the first listed.
NCT01849029 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01849029 about?
NCT01849029 is a clinical study titled "Cognitive Processing Intervention for Trauma, HIV/STI Risks, and Substance Use Among Native Women". 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 risk...
What is the current status of trial NCT01849029?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2013-10-15. Estimated completion is 2017-07-30.
What interventions are being tested in trial NCT01849029?
The interventions under investigation include: Cognitive Processing Therapy-Cognitive (BEHAVIORAL).
Who is sponsoring clinical trial NCT01849029?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01849029's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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