Trauma Informed Treatment Algorithms for Novel Outcomes — TITAN  

Post-Traumatic Stress Disorder Clinical Trial

Official title: Enhancing Capacity for Mental Health Research and Care in Cambodia: Trauma Informed Treatment Algorithms for Novel Outcomes

Status Recruiting

Clinical Trial Summary

This randomized controlled trial (RCT) will examine the feasibility, acceptability, and preliminary efficacy of a beginning treatment for Post-Traumatic Stress Disorder (PTSD) with Behavioral Activation (BA). Cambodian men and women who screen positive for PTSD will be randomized to receive six individually delivered sessions of either: 1) Stabilization Techniques alone (ST); or 2) ST+BA. After two months, all participants who continue to report clinically meaningful elevations in PTSD will receive Eye Movement Desensitization Reprocessing (EMDR). All participants will complete a follow-up assessment at four months post-randomization.

Clinical Trial Description

Nearly half of the Cambodian population reports elevated levels of psychological distress and PTSD. The high levels of psychological distress are linked directly to the report of remote and more recent trauma exposures, the most notable of which is the agrarian political regime of the Khmer Rouge during the 1970s, which occurred in the aftermath of the Vietnam War. During this period, approximately 1.5 million Cambodian residents died of starvation and sickness, 500,000 individuals were executed, and another two million were displaced over the course of several years. Political stability took shape in the early 1990s after the enactment of the United Nations Transitional Authority in Cambodia. However, the prior violence undermined an already fragile healthcare system, including mental health institutions and physicians providing direct patient care.

The combination of high trauma exposure, sustained conflict, and limited psychiatric capacity has created heightened vulnerability for Cambodians, and the need to assist those struggling with PTSD. There is a pressing need to reverse this trajectory using novel approaches to address mental health needs that are effective and scalable, providing a strong basis to conduct the proposed work in Cambodia. In partnership with the Cambodian Department of Mental Health and Substance Abuse, Ministry of Health, this NIH-sponsored study will examine the feasibility, acceptability, and preliminary efficacy integrating BA into trauma treatment that is being delivered by the Mekong Project in Cambodia. ;

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT04304378
• Study type: Interventional
• Source: University of Missouri, St. Louis
• Contact: Robert Paul, Ph.D.
• Phone: (314) 516-8403
• Email: paulro@umsl.edu
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2020
• Completion date: July 2023